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Coronary Artery Disease: HELP
Articles by Stefan K. James
Based on 46 articles published since 2010
(Why 46 articles?)
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Between 2010 and 2020, S. James wrote the following 46 articles about Coronary Artery Disease.
 
+ Citations + Abstracts
Pages: 1 · 2
1 Guideline Report of an ESC-EAPCI Task Force on the evaluation and use of bioresorbable scaffolds for percutaneous coronary intervention: executive summary. 2018

Byrne, Robert A / Stefanini, Giulio G / Capodanno, Davide / Onuma, Yoshinobu / Baumbach, Andreas / Escaned, Javier / Haude, Michael / James, Stefan / Joner, Michael / Jüni, Peter / Kastrati, Adnan / Oktay, Semih / Wijns, William / Serruys, Patrick W / Windecker, Stephan. ·Deutsches Herzzentrum München, Technische Universität München, Germany. ·EuroIntervention · Pubmed #28948934.

ABSTRACT: A previous Task Force of the European Society of Cardiology (ESC) and European Association of Percutaneous Cardiovascular Interventions (EAPCI) provided a report on recommendations for the non-clinical and clinical evaluation of coronary stents. Following dialogue with the European Commission, the Task Force was asked to prepare an additional report on the class of devices known as bioresorbable scaffolds (BRS). Five BRS have CE-mark approval for use in Europe. Only one device -the Absorb bioresorbable vascular scaffold- has published randomized clinical trial data and this data show inferior outcomes to conventional drug-eluting stents (DES) at 2-3 years. For this reason, at present BRS should not be preferred to conventional DES in clinical practice. The Task Force recommends that new BRS devices should undergo systematic non-clinical testing according to standardized criteria prior to evaluation in clinical studies. A clinical evaluation plan should include data from a medium sized, randomized trial against DES powered for a surrogate end point of clinical efficacy. Manufacturers of successful devices receive CE- mark approval for use and must have an approved plan for a large-scale randomized clinical trial with planned long-term follow-up.

2 Guideline 2013 ESC guidelines on the management of stable coronary artery disease: the Task Force on the management of stable coronary artery disease of the European Society of Cardiology. 2013

Anonymous21063 / Montalescot, Gilles / Sechtem, Udo / Achenbach, Stephan / Andreotti, Felicita / Arden, Chris / Budaj, Andrzej / Bugiardini, Raffaele / Crea, Filippo / Cuisset, Thomas / Di Mario, Carlo / Ferreira, J Rafael / Gersh, Bernard J / Gitt, Anselm K / Hulot, Jean-Sebastien / Marx, Nikolaus / Opie, Lionel H / Pfisterer, Matthias / Prescott, Eva / Ruschitzka, Frank / Sabaté, Manel / Senior, Roxy / Taggart, David Paul / van der Wall, Ernst E / Vrints, Christiaan J M / Anonymous31063 / Zamorano, Jose Luis / Achenbach, Stephan / Baumgartner, Helmut / Bax, Jeroen J / Bueno, Héctor / Dean, Veronica / Deaton, Christi / Erol, Cetin / Fagard, Robert / Ferrari, Roberto / Hasdai, David / Hoes, Arno W / Kirchhof, Paulus / Knuuti, Juhani / Kolh, Philippe / Lancellotti, Patrizio / Linhart, Ales / Nihoyannopoulos, Petros / Piepoli, Massimo F / Ponikowski, Piotr / Sirnes, Per Anton / Tamargo, Juan Luis / Tendera, Michal / Torbicki, Adam / Wijns, William / Windecker, Stephan / Anonymous41063 / Knuuti, Juhani / Valgimigli, Marco / Bueno, Héctor / Claeys, Marc J / Donner-Banzhoff, Norbert / Erol, Cetin / Frank, Herbert / Funck-Brentano, Christian / Gaemperli, Oliver / Gonzalez-Juanatey, José R / Hamilos, Michalis / Hasdai, David / Husted, Steen / James, Stefan K / Kervinen, Kari / Kolh, Philippe / Kristensen, Steen Dalby / Lancellotti, Patrizio / Maggioni, Aldo Pietro / Piepoli, Massimo F / Pries, Axel R / Romeo, Francesco / Rydén, Lars / Simoons, Maarten L / Sirnes, Per Anton / Steg, Ph Gabriel / Timmis, Adam / Wijns, William / Windecker, Stephan / Yildirir, Aylin / Zamorano, Jose Luis. ·The disclosure forms of the authors and reviewers are available on the ESC website www.escardio.org/guidelines. ·Eur Heart J · Pubmed #23996286.

ABSTRACT: -- No abstract --

3 Editorial Non-Vitamin K Antagonist Preferred in Patients With Nonvalvular Atrial Fibrillation and Indication for Aspirin Therapy. 2018

James, Stefan. ·Department of Medical Sciences and Uppsala Clinical Research Center, Uppsala University, Sweden. Stefan.james@ucr.uu.se. ·Circulation · Pubmed #29530891.

ABSTRACT: -- No abstract --

4 Review Culprit Vessel-Only Versus Multivessel Percutaneous Coronary Intervention in Patients With Cardiogenic Shock Complicating ST-Segment-Elevation Myocardial Infarction: A Collaborative Meta-Analysis. 2017

Kolte, Dhaval / Sardar, Partha / Khera, Sahil / Zeymer, Uwe / Thiele, Holger / Hochadel, Matthias / Radovanovic, Dragana / Erne, Paul / Hambraeus, Kristina / James, Stefan / Claessen, Bimmer E / Henriques, Jose P S / Mylotte, Darren / Garot, Philippe / Aronow, Wilbert S / Owan, Theophilus / Jain, Diwakar / Panza, Julio A / Frishman, William H / Fonarow, Gregg C / Bhatt, Deepak L / Aronow, Herbert D / Abbott, J Dawn. ·From the Department of Medicine, Division of Cardiology, Brown University, Providence, RI (D.K., H.D.A., J.D.A.) · Department of Medicine, Division of Cardiology, University of Utah, Salt Lake City (P.S., T.O.) · Department of Medicine, Division of Cardiology, New York Medical College at Westchester Medical Center, Valhalla (S.K., W.S.A., D.J., J.A.P., W.H.F.) · Department of Cardiology, Institut für Herzinfarktforschung Ludwigshafen, Germany (U.Z., M.H.) · Department of Cardiology, University Heart Center Lübeck, Medical Clinic II, University Hospital Schleswig-Holstein, Germany (H.T.) · German Cardiovascular Research Center (DZHK), Partner Site Hamburg/Kiel/Lübeck, Germany (H.T.) · AMIS Plus Data Center, University of Zurich, Switzerland (D.R., P.E.) · Department of Cardiology, Falun Hospital, Sweden (K.H.) · Department of Medical Sciences, Uppsala University, Sweden (K.H., S.J.) · Department of Cardiology, Academic Medical Center, University of Amsterdam, the Netherlands (B.E.C., J.P.S.H.) · Department of Cardiology, Galway University Hospital, SAOLTA Healthcare Group, National University of Ireland (D.M.) · Department of Cardiology, Ramsay Générale de Santé, Institut Cardiovasculaire Paris Sud, Hopital Privé Jacques Cartier, Massy, France (P.G.) · Department of Medicine, Division of Cardiology, David-Geffen School of Medicine, University of California at Los Angeles (G.C.F.) · and Department of Medicine, Division of Cardiology, Brigham and Women's Hospital Heart and Vascular Center, Harvard Medical School, Boston, MA (D.L.B.). ·Circ Cardiovasc Interv · Pubmed #29146672.

ABSTRACT: BACKGROUND: The optimal revascularization strategy in patients with multivessel disease presenting with cardiogenic shock complicating ST-segment-elevation myocardial infarction remains unknown. METHODS AND RESULTS: Databases were searched from 1999 to October 2016. Studies comparing immediate/single-stage multivessel percutaneous coronary intervention (MV-PCI) versus culprit vessel-only PCI (CO-PCI) in patients with multivessel disease, ST-segment-elevation myocardial infarction, and cardiogenic shock were included. Primary end point was short-term (in-hospital or 30 days) mortality. Secondary end points included long-term mortality, cardiovascular death, reinfarction, and repeat revascularization. Safety end points were in-hospital stroke, renal failure, and major bleeding. The meta-analysis included 11 nonrandomized studies and 5850 patients (1157 MV-PCI and 4693 CO-PCI). There was no significant difference in short-term mortality with MV-PCI versus CO-PCI (odds ratio [OR], 1.08; 95% confidence interval [CI], 0.81-1.43; CONCLUSIONS: This meta-analysis of nonrandomized studies suggests that in patients with cardiogenic shock complicating ST-segment-elevation myocardial infarction, there may be no significant benefit with single-stage MV-PCI compared with CO-PCI. Given the limitations of observational data, randomized trials are needed to determine the role of MV-PCI in this setting.

5 Review Derivation and validation of the predicting bleeding complications in patients undergoing stent implantation and subsequent dual antiplatelet therapy (PRECISE-DAPT) score: a pooled analysis of individual-patient datasets from clinical trials. 2017

Costa, Francesco / van Klaveren, David / James, Stefan / Heg, Dik / Räber, Lorenz / Feres, Fausto / Pilgrim, Thomas / Hong, Myeong-Ki / Kim, Hyo-Soo / Colombo, Antonio / Steg, Philippe Gabriel / Zanchin, Thomas / Palmerini, Tullio / Wallentin, Lars / Bhatt, Deepak L / Stone, Gregg W / Windecker, Stephan / Steyerberg, Ewout W / Valgimigli, Marco / Anonymous3640899. ·Swiss Cardiovascular Center Bern, Bern University Hospital, Bern, Switzerland; Erasmus University Medical Center, Rotterdam, Netherlands; Department of Clinical and Experimental Medicine, Policlinic "G Martino", University of Messina, Messina, Italy. · Erasmus University Medical Center, Rotterdam, Netherlands; Institute for Clinical Research and Health Policy Studies, Tufts Medical Center, Boston, MA, USA. · Department of Medical Sciences and Uppsala Clinical Research Center, Uppsala University, Uppsala, Sweden. · Institute of Social and Preventive Medicine, University of Bern, Bern, Switzerland. · Swiss Cardiovascular Center Bern, Bern University Hospital, Bern, Switzerland. · Istituto Dante Pazzanese de Cardiologia, Sao Paulo, Brazil. · Severance Cardiovascular Hospital, Yonsei University College of Medicine and Severance Biomedical Science Institute, Yonsei University College of Medicine, Seoul, South Korea. · Department of Internal Medicine, Seoul National University Hospital, Seoul, South Korea. · EMO-GVM Centro Cuore Columbus, Milan, Italy; Interventional Cardiology Department, San Raffaele Scientific Institute, Milan, Italy. · Department of Cardiology, Assistance Publique-Hôpitaux de Paris (AP-HP), Bichat Hospital, Paris, France. · Dipartimento Cardio-Toraco-Vascolare, University of Bologna, Bologna, Italy. · Brigham and Women's Hospital Heart & Vascular Center and Harvard Medical School, Boston, MA, USA. · Columbia University Medical Center/New York-Presbyterian Hospital and the Cardiovascular Research Foundation, New York, NY, USA. · Erasmus University Medical Center, Rotterdam, Netherlands. · Swiss Cardiovascular Center Bern, Bern University Hospital, Bern, Switzerland; Erasmus University Medical Center, Rotterdam, Netherlands. Electronic address: marco.valgimigli@insel.ch. ·Lancet · Pubmed #28290994.

ABSTRACT: BACKGROUND: Dual antiplatelet therapy (DAPT) with aspirin plus a P2Y METHODS: A total of 14 963 patients treated with DAPT after coronary stenting-largely consisting of aspirin and clopidogrel and without indication to oral anticoagulation-were pooled at a single-patient level from eight multicentre randomised clinical trials with independent adjudication of events. Using Cox proportional hazards regression, we identified predictors of out-of-hospital Thrombosis in Myocardial Infarction (TIMI) major or minor bleeding stratified by trial, and developed a numerical bleeding risk score. The predictive performance of the novel score was assessed in the derivation cohort and validated in patients treated with percutaneous coronary intervention from the PLATelet inhibition and patient Outcomes (PLATO) trial (n=8595) and BernPCI registry (n=6172). The novel score was assessed within patients randomised to different DAPT durations (n=10 081) to identify the effect on bleeding and ischaemia of a long (12-24 months) or short (3-6 months) treatment in relation to baseline bleeding risk. FINDINGS: The PRECISE-DAPT score (age, creatinine clearance, haemoglobin, white-blood-cell count, and previous spontaneous bleeding) showed a c-index for out-of-hospital TIMI major or minor bleeding of 0·73 (95% CI 0·61-0·85) in the derivation cohort, and 0·70 (0·65-0·74) in the PLATO trial validation cohort and 0·66 (0·61-0·71) in the BernPCI registry validation cohort. A longer DAPT duration significantly increased bleeding in patients at high risk (score ≥25), but not in those with lower risk profiles (p INTERPRETATION: The PRECISE-DAPT score is a simple five-item risk score, which provides a standardised tool for the prediction of out-of-hospital bleeding during DAPT. In the context of a comprehensive clinical evaluation process, this tool can support clinical decision making for treatment duration. FUNDING: None.

6 Review Bioresorbable Stents in PCI. 2016

Lindholm, Daniel / James, Stefan. ·Department of Medical Sciences, Cardiology, Uppsala University, Uppsala, Sweden. daniel.lindholm@ucr.uu.se. · Uppsala Clinical Research Center, Dag Hammarskjölds väg 14B, SE-752 37, Uppsala, Sweden. daniel.lindholm@ucr.uu.se. · Department of Medical Sciences, Cardiology, Uppsala University, Uppsala, Sweden. · Uppsala Clinical Research Center, Dag Hammarskjölds väg 14B, SE-752 37, Uppsala, Sweden. ·Curr Cardiol Rep · Pubmed #27312934.

ABSTRACT: The evolution of percutaneous coronary intervention has been considerable. Coronary stents were introduced to avoid vessel recoil and reduce acute and late vessel complications. Later, drug-eluting stents were developed to decrease the neointimal hyperplasia associated with bare metal stents in order to reduce restenosis. However, very late stent thrombosis remains problematic, and the permanent presence of a metal stent could be associated with local inflammation and impaired vascular physiology. Thus, bioresorbable stents have been developed, to prevent recoil initially when this risk is the highest, with subsequent degradation over time, to avoid long-term complications of the presence of stents in the coronary vasculature. Here, we review the current status of bioresorbable stents in percutaneous coronary intervention (PCI), with focus on the platforms that have been studied the most: ABSORB, DESolve, and DREAMS. In terms of clinical outcomes, bioresorbable stents have not yet shown superiority compared with current generation drug-eluting stents, but rather a signal of increased stent thrombosis. Further development and longer-term studies are needed before the routine implementation of bioresorbable stents in clinical practice.

7 Review Report of a European Society of Cardiology-European Association of Percutaneous Cardiovascular Interventions task force on the evaluation of coronary stents in Europe: executive summary. 2015

Byrne, Robert A / Serruys, Patrick W / Baumbach, Andreas / Escaned, Javier / Fajadet, Jean / James, Stefan / Joner, Michael / Oktay, Semih / Jüni, Peter / Kastrati, Adnan / Sianos, George / Stefanini, Giulio G / Wijns, William / Windecker, Stephan. ·Deutsches Herzzentrum München, Technische Universität München, Munich, Germany. · Erasmus Medical Center Rotterdam, Rotterdam, The Netherlands. · Bristol Heart Institute, Bristol, UK. · Interventional Cardiology, Hospital San Carlos, Madrid, Spain. · Interventional Cardiology, Clinique Pasteur, Toulouse, France. · Clinical Research Center, Uppsala University, Uppsala, Sweden. · CVPath Institute, Inc., Gaithersburg, USA. · Cardio Med Device Consultants, Baltimore, USA. · Institute of Primary Health Care (BIHAM), University of Bern, Bern, Switzerland. · AHEPA University Hospital, Thessaloniki, Greece. · Swiss Cardiovascular Center Bern, Bern University Hospital, Bern, Switzerland. · Cardiovascular Center O.L.V.Z., Aalst, Belgium. · Swiss Cardiovascular Center Bern, Bern University Hospital, Bern, Switzerland stephan.windecker@insel.ch. ·Eur Heart J · Pubmed #26071600.

ABSTRACT: The evaluation for European Union market approval of coronary stents falls under the Medical Device Directive that was adopted in 1993. Specific requirements for the assessment of coronary stents are laid out in supplementary advisory documents. In response to a call by the European Commission to make recommendations for a revision of the advisory document on the evaluation of coronary stents (Appendix 1 of MEDDEV 2.7.1), the European Society of Cardiology (ESC) and the European Association of Percutaneous Cardiovascular Interventions (EAPCI) established a Task Force to develop an expert advisory report. As basis for its report, the ESC-EAPCI Task Force reviewed existing processes, established a comprehensive list of all coronary drug-eluting stents that have received a CE mark to date, and undertook a systematic review of the literature of all published randomized clinical trials evaluating clinical and angiographic outcomes of coronary artery stents between 2002 and 2013. Based on these data, the TF provided recommendations to inform a new regulatory process for coronary stents. The main recommendations of the task force include implementation of a standardized non-clinical assessment of stents and a novel clinical evaluation pathway for market approval. The two-stage clinical evaluation plan includes recommendation for an initial pre-market trial with objective performance criteria (OPC) benchmarking using invasive imaging follow-up leading to conditional CE-mark approval and a subsequent mandatory, large-scale randomized trial with clinical endpoint evaluation leading to unconditional CE-mark. The data analysis from the systematic review of the Task Force may provide a basis for determination of OPC for use in future studies. This paper represents an executive summary of the Task Force's report.

8 Review STEMI guidelines: from formulation to implementation. 2012

Di Mario, Carlo / Syrseloudis, Dimitrios / James, Stefan / Viceconte, Nicola / Wijns, William. ·Cardiovascular Biomedical Research Unit, Royal Brompton & Harefield NHS Foundation Trust, London, United Kingdom. ·EuroIntervention · Pubmed #22917781.

ABSTRACT: -- No abstract --

9 Clinical Trial Ticagrelor in patients with diabetes and stable coronary artery disease with a history of previous percutaneous coronary intervention (THEMIS-PCI): a phase 3, placebo-controlled, randomised trial. 2019

Bhatt, Deepak L / Steg, Philippe Gabriel / Mehta, Shamir R / Leiter, Lawrence A / Simon, Tabassome / Fox, Kim / Held, Claes / Andersson, Marielle / Himmelmann, Anders / Ridderstråle, Wilhelm / Chen, Jersey / Song, Yang / Diaz, Rafael / Goto, Shinya / James, Stefan K / Ray, Kausik K / Parkhomenko, Alexander N / Kosiborod, Mikhail N / McGuire, Darren K / Harrington, Robert A / Anonymous3221003. ·Brigham and Women's Hospital Heart and Vascular Center and Harvard Medical School Boston, MA, USA. Electronic address: dlbhattmd@post.harvard.edu. · French Alliance for Cardiovascular Trials, Département Hospitalo-Universitaire FIRE, AP-HP, Hôpital Bichat, Université de Paris, Institut National de la Santé et de la Recherche Médicale U-1148, Paris, France; National Heart and Lung Institute, Royal Brompton Hospital, Imperial College London, London, UK. · Population Health Research Institute, Hamilton Health Sciences, Hamilton, ON, Canada; McMaster University, Hamilton, ON, Canada. · Li Ka Shing Knowledge Institute, St Michael's Hospital, University of Toronto, Toronto, ON, Canada. · Department of Clinical Pharmacology-Clinical Research Platform (URCEST-CRB-CRCEST), AP-HP, Hôpital Saint Antoine, Sorbonne-Université, Paris, France. · National Heart and Lung Institute, Royal Brompton Hospital, Imperial College London, London, UK. · Department of Medical Sciences, Cardiology, Uppsala Clinical Research Center, Uppsala University, Uppsala, Sweden. · AstraZeneca BioPharmaceuticals Research & Development, Late-stage Development, Cardiovascular, Renal and Metabolic, Mölndal, Sweden. · AstraZeneca BioPharmaceuticals Research & Development, Late-stage Development, Cardiovascular, Renal and Metabolic, Gaithersburg, MD, USA. · Baim Institute for Clinical Research, Boston, MA, USA. · Department of Medicine, Estudios Clínicos Latino América, Rosario, Argentina. · Department of Medicine (Cardiology), Tokai University School of Medicine, Isehara, Japan. · Department of Medical Sciences, Cardiology and Uppsala Clinical Research Center, Uppsala University, Uppsala, Sweden. · Department of Primary Care and Public Health, Imperial Centre for Cardiovascular Disease Prevention, Imperial College London, London, UK. · Institute of Cardiology, Emergency Cardiology Department, Kiev, Ukraine. · Saint Luke's Mid-America Heart Institute, University of Missouri-Kansas City, Kansas City, MO, USA; The George Institute for Global Health, University of New South Wales, Sydney, NSW, Australia. · University of Texas Southwestern Medical Center, Dallas, TX, USA. · Department of Medicine, Stanford University, Stanford, CA, USA. ·Lancet · Pubmed #31484629.

ABSTRACT: BACKGROUND: Patients with stable coronary artery disease and diabetes with previous percutaneous coronary intervention (PCI), particularly those with previous stenting, are at high risk of ischaemic events. These patients are generally treated with aspirin. In this trial, we aimed to investigate if these patients would benefit from treatment with aspirin plus ticagrelor. METHODS: The Effect of Ticagrelor on Health Outcomes in diabEtes Mellitus patients Intervention Study (THEMIS) was a phase 3 randomised, double-blinded, placebo-controlled trial, done in 1315 sites in 42 countries. Patients were eligible if 50 years or older, with type 2 diabetes, receiving anti-hyperglycaemic drugs for at least 6 months, with stable coronary artery disease, and one of three other mutually non-exclusive criteria: a history of previous PCI or of coronary artery bypass grafting, or documentation of angiographic stenosis of 50% or more in at least one coronary artery. Eligible patients were randomly assigned (1:1) to either ticagrelor or placebo, by use of an interactive voice-response or web-response system. The THEMIS-PCI trial comprised a prespecified subgroup of patients with previous PCI. The primary efficacy outcome was a composite of cardiovascular death, myocardial infarction, or stroke (measured in the intention-to-treat population). FINDINGS: Between Feb 17, 2014, and May 24, 2016, 11 154 patients (58% of the overall THEMIS trial) with a history of previous PCI were enrolled in the THEMIS-PCI trial. Median follow-up was 3·3 years (IQR 2·8-3·8). In the previous PCI group, fewer patients receiving ticagrelor had a primary efficacy outcome event than in the placebo group (404 [7·3%] of 5558 vs 480 [8·6%] of 5596; HR 0·85 [95% CI 0·74-0·97], p=0·013). The same effect was not observed in patients without PCI (p=0·76, p INTERPRETATION: In patients with diabetes, stable coronary artery disease, and previous PCI, ticagrelor added to aspirin reduced cardiovascular death, myocardial infarction, and stroke, although with increased major bleeding. In that large, easily identified population, ticagrelor provided a favourable net clinical benefit (more than in patients without history of PCI). This effect shows that long-term therapy with ticagrelor in addition to aspirin should be considered in patients with diabetes and a history of PCI who have tolerated antiplatelet therapy, have high ischaemic risk, and low bleeding risk. FUNDING: AstraZeneca.

10 Clinical Trial The effect of CYP2C19 gene polymorphisms on the pharmacokinetics and pharmacodynamics of prasugrel 5-mg, prasugrel 10-mg and clopidogrel 75-mg in patients with coronary artery disease. 2014

Gurbel, P A / Bergmeijer, T O / Tantry, U S / ten Berg, J M / Angiolillo, D J / James, S / Lindahl, T L / Svensson, P / Jakubowski, J A / Brown, P B / Duvvuru, S / Sundseth, S / Walker, J R / Small, D / Moser, B A / Winters, K J / Erlinge, D. ·Paul A. Gurbel, MD, Sinai Center for Thrombosis Research, Cardiac Catheterization Laboratory, 2401 W. Belvedere Ave, Baltimore, MD 21215, USA, Tel.: +1 410 601 9600, Fax: +1 410 601 9601, E-mail: PGURBEL@LIFEBRIDGEHEALTH.ORG. ·Thromb Haemost · Pubmed #25008027.

ABSTRACT: CYP2C19 genotype has been shown to impact response to clopidogrel 75-mg but not prasugrel 10-mg. Here, we assessed effects of CYP2C19 metaboliser status on pharmacokinetics (PK) and pharmacodynamic (PD) responses to prasugrel 5-mg and 10-mg and clopidogrel 75-mg using data from two PK/PD studies in stable coronary artery disease (CAD) patients (GENERATIONS and FEATHER). Active metabolite concentrations (area under the curve, AUC[0-tlast]), maximum platelet aggregation (MPA) measured by light transmission aggregometry, vasodilator-stimulated phosphoprotein platelet reactivity index, and VerifyNow P2Y12-platelet reaction units (VN-PRU) were analysed by CYP2C19-predicted phenotype (extensive metaboliser [EM; N=154], *2-*8 non-carriers, vs reduced metaboliser [RM; N=41],*2-*8 carriers/*17 non-carriers). AUC(0-tlast) was unaffected by metaboliser status for prasugrel 5-mg and 10-mg (geometric mean EM/RM ratios 1.00, 95% confidence interval [CI]: 0.86,1.17, p>0.99; and 0.97, 95% CI:0.85,1.12, p=0.71, respectively), but was lower among RMs receiving clopidogrel 75-mg (1.37, 95% CI:1.14,1.65, p<0.001). Platelet reactivity was not significantly affected by CYP2C19 metaboliser status for prasugrel 5-mg, or for prasugrel 10-mg by MPA and VN-PRU, but for clopidogrel 75-mg was significantly higher in reduced metabolisers (all measures p<0.01). Prasugrel 10-mg showed greater antiplatelet effects vs clopidogrel 75-mg (all comparisons p<0.001). Prasugrel 5-mg showed greater antiplatelet effects vs clopidogrel 75-mg in RMs (all p<0.001), and comparable effects in EMs (all p≥0.37). In contrast to clopidogrel, prasugrel active metabolite PK was not influenced by CYP2C19 genotype. Antiplatelet effect for prasugrel 10-mg was greater irrespective of metaboliser status and for prasugrel 5-mg was greater for RMs and comparable for EMs as compared to clopidogrel 75-mg.

11 Clinical Trial Prasugrel 5 mg in the very elderly attenuates platelet inhibition but maintains noninferiority to prasugrel 10 mg in nonelderly patients: the GENERATIONS trial, a pharmacodynamic and pharmacokinetic study in stable coronary artery disease patients. 2013

Erlinge, David / Gurbel, Paul A / James, Stefan / Lindahl, Tomas L / Svensson, Peter / Ten Berg, Jurrien M / Foley, David P / Wagner, Henrik / Brown, Patricia B / Luo, Junxiang / Zhou, Chunmei / Moser, Brian A / Jakubowski, Joseph A / Small, David S / Winters, Kenneth J / Angiolillo, Dominick J. ·Department of Cardiology, Lund University, Lund, Sweden. david.erlinge@med.lu.se ·J Am Coll Cardiol · Pubmed #23747759.

ABSTRACT: OBJECTIVES: This study assessed pharmacodynamic (PD) response to the reduced prasugrel maintenance dose of 5 mg in very elderly (VE) patients (≥75 years of age). BACKGROUND: In the TRITON-TIMI 38 (TRial to Assess Improvement in Therapeutic Outcomes by Optimizing Platelet InhibitioN with Prasugrel-Thrombolysis In Myocardial Infarction 38) study prasugrel 10 mg reduced ischemic events versus clopidogrel 75 mg, but increased bleeding in VE patients. METHODS: We examined PD and active metabolite pharmacokinetics (PKs) with prasugrel 5 and 10 mg and clopidogrel 75 mg in a 3-period (12 days each) blinded, crossover study in VE (n = 73; mean: 79 ± 3 years of age) or (n = 82) nonelderly (NE) (≥45 to <65 years of age; mean: 56 ± 5 years of age) stable coronary artery disease (CAD) patients receiving background aspirin. Assays included light transmission aggregometry (LTA), VerifyNow P2Y12 (VN-P2Y12), and vasodilator-associated stimulated phosphoprotein (VASP). The primary comparison was noninferiority of maximum platelet aggregation (MPA) comparing the median for prasugrel 5 mg in VE versus the 75th percentile for prasugrel 10 mg in NE, using a pre-specified 1-sided 97.5% confidence interval for the difference <15%. RESULTS: Prasugrel 5 mg in VE met the primary PD noninferiority criterion versus prasugrel 10 mg in NE. For prasugrel 5 mg, MPA was significantly lower (57 ± 14%) than clopidogrel (63 ± 14%; p < 0.001) in VE but higher than prasugrel 10 mg in NE (46 ± 12%; p < 0.001). PD response by LTA, VN-P2Y12, and VASP during all treatments appeared similar between age cohorts. Prasugrel 5 mg resulted in fewer VE poor responders than clopidogrel. Rates of mild bleeding were higher with prasugrel 10 mg but similar for prasugrel 5 mg versus clopidogrel 75 mg. CONCLUSIONS: In aspirin-treated stable CAD patients, prasugrel 5 mg in VE attenuated platelet inhibition while meeting pre-specified noninferiority criterion versus prasugrel 10 mg in NE, with significantly better PD response and fewer poor responders compared to clopidogrel 75 mg in VE. (Comparison of Prasugrel and Clopidogrel in Very Elderly and Non-Elderly Patients With Stable Coronary Artery Disease [GENERATIONS]; NCT01107912).

12 Clinical Trial Randomized comparison of final kissing balloon dilatation versus no final kissing balloon dilatation in patients with coronary bifurcation lesions treated with main vessel stenting: the Nordic-Baltic Bifurcation Study III. 2011

Niemelä, Matti / Kervinen, Kari / Erglis, Andrejs / Holm, Niels R / Maeng, Michael / Christiansen, Evald H / Kumsars, Indulis / Jegere, Sanda / Dombrovskis, Andis / Gunnes, Pål / Stavnes, Sindre / Steigen, Terje K / Trovik, Thor / Eskola, Markku / Vikman, Saila / Romppanen, Hannu / Mäkikallio, Timo / Hansen, Knud N / Thayssen, Per / Aberge, Lars / Jensen, Lisette O / Hervold, Anders / Airaksinen, Juhani / Pietilä, Mikko / Frobert, Ole / Kellerth, Thomas / Ravkilde, Jan / Aarøe, Jens / Jensen, Jan S / Helqvist, Steffen / Sjögren, Iwar / James, Stefan / Miettinen, Heikki / Lassen, Jens F / Thuesen, Leif / Anonymous1020682. ·Division of Cardiology, Department of Internal Medicine, University of Oulu, Finland. matti.niemela@ppshp.fi ·Circulation · Pubmed #21173348.

ABSTRACT: BACKGROUND: It is unknown whether the preferred 1-stent bifurcation stenting approach with stenting of the main vessel (MV) and optional side branch stenting using drug-eluting stents should be finalized by a kissing balloon dilatation (FKBD). Therefore, we compared strategies of MV stenting with and without FKBD. METHODS AND RESULTS: We randomized 477 patients with a bifurcation lesion to FKBD (n=238) or no FKBD (n=239) after MV stenting. The primary end point was major adverse cardiac events: cardiac death, non-procedure-related index lesion myocardial infarction, target lesion revascularization, or stent thrombosis within 6 months. The 6-month major adverse cardiac event rates were 2.1% and 2.5% (P=1.00) in the FKBD and no-FKBD groups, respectively. Procedure and fluoroscopy times were longer and more contrast media was needed in the FKBD group than in the no-FKBD group. Three hundred twenty-six patients had a quantitative coronary assessment. At 8 months, the rate of binary (re)stenosis in the entire bifurcation lesion (MV and side branch) was 11.0% versus 17.3% (P=0.11), in the MV was 3.1% versus 2.5% (P=0.68), and in the side branch was 7.9% versus 15.4% (P=0.039) in the FKBD versus no-FKBD groups, respectively. In patients with true bifurcation lesions, the side branch restenosis rate was 7.6% versus 20.0% (P=0.024) in the FKBD and no-FKBD groups, respectively. CONCLUSIONS: MV stenting strategies with and without FKBD were associated with similar clinical outcomes. FKBD reduced angiographic side branch (re)stenosis, especially in patients with true bifurcation lesions. The simple no-FKBD procedures resulted in reduced use of contrast media and shorter procedure and fluoroscopy times. Long-term data on stent thrombosis are needed. Clinical Trial Registration- URL: http://clinicaltrials.gov. Unique identifier: NCT00914199.

13 Article Pharmacodynamics, pharmacokinetics, and safety of single-dose subcutaneous administration of selatogrel, a novel P2Y12 receptor antagonist, in patients with chronic coronary syndromes. 2019

Storey, Robert F / Gurbel, Paul A / Ten Berg, Jurrien / Bernaud, Corine / Dangas, George D / Frenoux, Jean-Marie / Gorog, Diana A / Hmissi, Abdel / Kunadian, Vijay / James, Stefan K / Tanguay, Jean-Francois / Tran, Henry / Trenk, Dietmar / Ufer, Mike / Van der Harst, Pim / Van't Hof, Arnoud W J / Angiolillo, Dominick J. ·Department of Infection, Immunity and Cardiovascular Disease, University of Sheffield, Sheffield, UK. · Inova Heart and Vascular Institute, Falls Church, VA, USA. · Department of Cardiologie, St Antonius Hospital, Nieuwegein, Netherlands. · Idorsia Pharmaceuticals Ltd, Allschwil, Switzerland. · Division of Cardiology, Mount Sinai Hospital, New York, NY, USA. · University of Hertfordshire, Hertfordshire, UK. · National Heart & Lung Institute, Imperial College, London, UK. · Faculty of Medical Sciences, Newcastle University, Newcastle, UK. · Cardiothoracic Centre, Freeman Hospital, Newcastle upon Tyne Hospitals NHS Foundations Trust, Newcastle Upon Tyne, UK. · Department of Medical Sciences, Uppsala Clinical Research Center, Uppsala University, Uppsala, Sweden. · Department of Medicine, Institut de Cardiologie de Montréal, Université de Montréal, Montreal, Canada. · Department of Cardiology and Angiology II, University Heart Center Freiburg-Bad Krozingen, Bad Krozingen, Germany. · Department of Cardiology, University of Groningen, University Medical Center Groningen, Groningen, The Netherlands. · Department of Cardiology, Maastricht University Medical Centre (MUMC), Maastricht, Netherlands. · Department of Cardiology, Zuyderland Medical Centre (ZMC), Heerlen, Netherlands. · Department of Cardiology, Isala Hospital, Zwolle, Netherlands; and. · Division of Cardiology, University of Florida College of Medicine, Jacksonville, FL, USA. ·Eur Heart J · Pubmed #31994703.

ABSTRACT: AIMS : To study the pharmacodynamics and pharmacokinetics of selatogrel, a novel P2Y12 receptor antagonist for subcutaneous administration, in patients with chronic coronary syndromes (CCS). METHODS AND RESULTS : In this double-blind, randomized study of 345 patients with CCS on background oral antiplatelet therapy, subcutaneous selatogrel (8 mg, n = 114; or 16 mg, n = 115) was compared with placebo (n = 116) (ClinicalTrials.gov: NCT03384966). Platelet aggregation was assessed over 24 h (VerifyNow assay) and 8 h (light transmittance aggregometry; LTA). Pharmacodynamic responders were defined as patients having P2Y12 reaction units (PRU) <100 at 30 min post-dose and lasting ≥3 h. At 30 min post-dose, 89% of patients were responders to selatogrel 8 mg, 90% to selatogrel 16 mg, and 16% to placebo (P < 0.0001). PRU values (mean ± standard deviation) were 10 ± 25 (8 mg), 4 ± 10 (16 mg), and 163 ± 73 (placebo) at 15 min and remained <100 up to 8 h for both doses, returning to pre-dose or near pre-dose levels by 24 h post-dose. LTA data showed similarly rapid and potent inhibition of platelet aggregation. Selatogrel plasma concentrations peaked ∼30 min post-dose. Selatogrel was safe and well-tolerated with transient dyspnoea occurring overall in 7% (16/229) of patients (95% confidence interval: 4-11%). CONCLUSIONS : Selatogrel was rapidly absorbed following subcutaneous administration in CCS patients, providing prompt, potent, and consistent platelet P2Y12 inhibition sustained for ≥8 h and reversible within 24 h. Further studies of subcutaneous selatogrel are warranted in clinical scenarios where rapid platelet inhibition is desirable.

14 Article Subsequent Event Risk in Individuals With Established Coronary Heart Disease. 2019

Patel, Riyaz S / Tragante, Vinicius / Schmidt, Amand F / McCubrey, Raymond O / Holmes, Michael V / Howe, Laurence J / Direk, Kenan / Åkerblom, Axel / Leander, Karin / Virani, Salim S / Kaminski, Karol A / Muehlschlegel, Jochen D / Allayee, Hooman / Almgren, Peter / Alver, Maris / Baranova, Ekaterina V / Behloui, Hassan / Boeckx, Bram / Braund, Peter S / Breitling, Lutz P / Delgado, Graciela / Duarte, Nubia E / Dubé, Marie-Pierre / Dufresne, Line / Eriksson, Niclas / Foco, Luisa / Scholz, Markus / Gijsberts, Crystel M / Glinge, Charlotte / Gong, Yan / Hartiala, Jaana / Heydarpour, Mahyar / Hubacek, Jaroslav A / Kleber, Marcus / Kofink, Daniel / Kotti, Salma / Kuukasjärvi, Pekka / Lee, Vei-Vei / Leiherer, Andreas / Lenzini, Petra A / Levin, Daniel / Lyytikäinen, Leo-Pekka / Martinelli, Nicola / Mons, Ute / Nelson, Christopher P / Nikus, Kjell / Pilbrow, Anna P / Ploski, Rafal / Sun, Yan V / Tanck, Michael W T / Tang, W H Wilson / Trompet, Stella / van der Laan, Sander W / Van Setten, Jessica / Vilmundarson, Ragnar O / Viviani Anselmi, Chiara / Vlachopoulou, Efthymia / Al Ali, Lawien / Boerwinkle, Eric / Briguori, Carlo / Carlquist, John F / Carruthers, Kathryn F / Casu, Gavino / Deanfield, John / Deloukas, Panos / Dudbridge, Frank / Engstrøm, Thomas / Fitzpatrick, Natalie / Fox, Kim / Gigante, Bruna / James, Stefan / Lokki, Marja-Liisa / Lotufo, Paulo A / Marziliano, Nicola / Mordi, Ify R / Muhlestein, Joseph B / Newton-Cheh, Christopher / Pitha, Jan / Saely, Christoph H / Samman-Tahhan, Ayman / Sandesara, Pratik B / Teren, Andrej / Timmis, Adam / Van de Werf, Frans / Wauters, Els / Wilde, Arthur A M / Ford, Ian / Stott, David J / Algra, Ale / Andreassi, Maria G / Ardissino, Diego / Arsenault, Benoit J / Ballantyne, Christie M / Bergmeijer, Thomas O / Bezzina, Connie R / Body, Simon C / Boersma, Eric H / Bogaty, Peter / Bots, Michiel L / Brenner, Hermann / Brugts, Jasper J / Burkhardt, Ralph / Carpeggiani, Clara / Condorelli, Gianluigi / Cooper-DeHoff, Rhonda M / Cresci, Sharon / Danchin, Nicolas / de Faire, Ulf / Doughty, Robert N / Drexel, Heinz / Engert, James C / Fox, Keith A A / Girelli, Domenico / Grobbee, Diederick E / Hagström, Emil / Hazen, Stanley L / Held, Claes / Hemingway, Harry / Hoefer, Imo E / Hovingh, G Kees / Jabbari, Reza / Johnson, Julie A / Jukema, J Wouter / Kaczor, Marcin P / Kähönen, Mika / Kettner, Jiri / Kiliszek, Marek / Klungel, Olaf H / Lagerqvist, Bo / Lambrechts, Diether / Laurikka, Jari O / Lehtimäki, Terho / Lindholm, Daniel / Mahmoodi, B K / Maitland-van der Zee, Anke H / McPherson, Ruth / Melander, Olle / Metspalu, Andres / Niemcunowicz-Janica, Anna / Olivieri, Oliviero / Opolski, Grzegorz / Palmer, Colin N / Pasterkamp, Gerard / Pepine, Carl J / Pereira, Alexandre C / Pilote, Louise / Quyyumi, Arshed A / Richards, A Mark / Sanak, Marek / Siegbahn, Agneta / Simon, Tabassome / Sinisalo, Juha / Smith, J Gustav / Spertus, John A / Stender, Steen / Stewart, Alexandre F R / Szczeklik, Wojciech / Szpakowicz, Anna / Tardif, Jean-Claude / Ten Berg, Jurriën M / Tfelt-Hansen, Jacob / Thanassoulis, George / Thiery, Joachim / Torp-Pedersen, Christian / van der Graaf, Yolanda / Visseren, Frank L J / Waltenberger, Johannes / Weeke, Peter E / Van der Harst, Pim / Lang, Chim C / Sattar, Naveed / Cameron, Vicky A / Anderson, Jeffrey L / Brophy, James M / Pare, Guillaume / Horne, Benjamin D / März, Winfried / Wallentin, Lars / Samani, Nilesh J / Hingorani, Aroon D / Asselbergs, Folkert W. ·Institute of Cardiovascular Science (R.S.P., A.F.S., L.J.H., K.D., J.D., A.D.H., F.W.A), Faculty of Population Health Science, University College London, United Kingdom. · Bart's Heart Centre, St Bartholomew's Hospital, London (R.S.P., J.D., A. Timmis). · Division of Heart and Lungs, Department of Cardiology (V.T., A.F.S.,D.K.,F.W.A.), UMC Utrecht, the Netherlands. · Intermountain Heart Institute, Intermountain Medical Center, Salt Lake City, UT (R.O.M., J.F.C., J.B.M., J.L.A., B.D.H). · Clinical Trial Service Unit and Epidemiological Studies Unit, Nuffield Department of Population Health, Medical Research Council Population Health Research Unit, University of Oxford, United Kingdom (M.V.H). · National Institute for Health Research Oxford Biomedical Research Centre, Oxford University Hospital, United Kingdom (M.V.H.). · Uppsala Clinical Research Center, Sweden (A. Åkerblom, N.E., S.J., C.H., B.L., D. Lindholm, A. Siegbahn, L.W.). · Division of Cardiology, Department of Medical Sciences (A. Åkerblom, C.H., D. Lindholm, S.J., B.L., L.W.), Uppsala University, Sweden. · Institute of Environmental Medicine, Karolinska Institute, Stockholm, Sweden (K.L., B.G., U.d.F.). · Section of Cardiology, Michael E. DeBakey Veterans Affairs Medical Center, Houston, TX (S.S.V.). · Section of Cardiovascular Research, Department of Medicine, Baylor College of Medicine, Houston, TX (S.S.V., C.M.B.). · Department of Population Medicine and Civilization Disease Prevention (K.A.K.), Medical University of Bialystok, Poland. · Department of Cardiology (K.A.K., A. Szpakowicz), Medical University of Bialystok, Poland. · Department of Anesthesiology, Perioperative and Pain Medicine, Brigham and Women's Hospital, Boston, MA (J.D.M., M.H.). · Harvard Medical School, Boston, MA (J.D.M., M.H., S.C.B). · Departments of Preventive Medicine and Biochemistry and Molecular Medicine (H.A., J.H.), Keck School of Medicine of USC, Los Angeles, CA. · Department of Clinical Sciences, Lund University, Malmö, Sweden (P.A., O.M.). · Estonian Genome Centre, Department of Biotechnology, Institute of Genomics, Institute of Molecular and Cell Biology, University of Tartu, Estonia (M.A., A.M.). · Division of Pharmacoepidemiology and Clinical Pharmacology, Utrecht University, the Netherlands (E.V.B., O.H.K., A.H.M.-v.d.Z.). · Centre for Outcomes Research and Evaluation, Research Institute of the McGill University Health Centre, Montreal, QC, Canada (H.B., L.D., L.P., G.T., J.M.B.). · Laboratory for Translational Genetics, Department of Human Genetics (B.B., D. Lambrechts), Katholieke Universiteit Leuven, Belgium. · Laboratory for Translational Genetics, VIB Center for Cancer Biology, Belgium (B.B., D. Lambrechts). · Department of Cardiovascular Sciences, BHF Cardiovascular Research Centre, University of Leicester, United Kingdom (P.S.B., C.P.N., N.J.S.). · NIHR Leicester Biomedical Research Centre, Glenfield Hospital, United Kingdom (P.S.B., C.P.N., N.J.S.). · Division of Clinical Epidemiology and Aging Research, German Cancer Research Center (DKFZ), Heidelberg (L.P.B., U.M.). · Fifth Department of Medicine, Medical Faculty Mannheim, Heidelberg University, Germany (G.D., M. Kleber, W.M.). · Heart Institute, University of Sao Paulo, Brazil (N.E.D., A.C.P.). · Montreal Heart Institute, OC, Canada (M.-P.D., J.-C.T.). · Faculty of Medicine, Université de Montréal, QC, Canada (M.-P.D., J.-C.T.). · Preventive and Genomic Cardiology, McGill University Health Centre, Montreal, QC, Canada (L.D., J.C.E., G.T.). · Institute for Biomedicine, Eurac Research, Affiliated Institute of the University of Lübeck, Bolzano, Italy (L.F.). · Institute for Medical Informatics, Statistics, and Epidemiology (M.S.), University of Leipzig, Germany. · LIFE Research Centre for Civilization Diseases (M.S., A. Teren, R.B., J.T.), University of Leipzig, Germany. · Laboratory of Experimental Cardiology (C.M.G.), UMC Utrecht, the Netherlands. · Department of Cardiology, The Heart Centre, Copenhagen University Hospital, Rigshospitalet (C.G., T.E., R.J.). · Amsterdam UMC, University of Amsterdam, Clinical and Experimental Cardiology, Amsterdam Cardiovascular Sciences, AMC Heart Center, the Netherlands (C.G., A.A.M.W., C.R.B.). · Department of Pharmacotherapy and Translational Research, Centre for Pharmacogenomics (Y.G., R.M.C.-D., J.A.J.), University of Florida, Gainesville. · Institute for Genetic Medicine (J.H.), Keck School of Medicine of USC, Los Angeles, CA. · Centre for Experimental Medicine, Institute for Clinical and Experimental Medicine, Prague, Czech Republic (J.A.H., J.P.). · Assistance Publique-Hôpitaux de Paris (AP-HP), Department of Clinical Pharmacology, Platform of Clinical Research of East Paris (URCEST-CRCEST-CRB HUEP-UPMC), France (S.K.). · Department of Cardio-Thoracic Surgery (P.K.), University of Tampere, Finland. · Department of Biostatistics and Epidemiology, Texas Heart Institute, Houston (V.-V.L.). · Vorarlberg Institute for Vascular Investigation and Treatment (VIVIT), Feldkirch, Austria (A. Leiherer, C.H.S., H.D.). · Private University of the Principality of Liechtenstein, Triesen (A. Leiherer, C.H.S., H.D.). · Medical Central Laboratories, Feldkirch, Austria (A. Leiherer). · Statistical Genomics Division, Department of Genetics (P.A. Lenzini, S.C.), Washington University School of Medicine, Saint Louis, MO. · Division of Molecular and Clinical Medicine, School of Medicine, University of Dundee, Scotland, United Kingdom (D. Levin, I.R.M., C.C.L.). · Department of Clinical Chemistry (L.-P.L., T.L.), University of Tampere, Finland. · Department of Clinical Chemistry, Fimlab Laboratories, Tampere, Finland (L.-P.L., T.L.). · Department of Medicine, University of Verona, Italy (N.M., D.G., O.O.). · Department of Cardiology (K.N.), University of Tampere, Finland. · Department of Cardiology, Heart Center (K.N.), Tampere University Hospital, Finland. · The Christchurch Heart Institute, University of Otago Christchurch, New Zealand (A.P.P., A.M.R., V.A.C.). · Department of Medical Genetics (R. Ploski), Medical University of Warsaw, Poland. · Department of Epidemiology, Emory University Rollins School of Public Health, Atlanta, GA (Y.V.S.). · Department of Biomedical Informatics (Y.V.S.), Emory Clinical Cardiovascular Research Institute, Emory University School of Medicine, Atlanta, GA. · Amsterdam UMC, University of Amsterdam, Clinical Epidemiology and Biostatistics, The Netherlands (M.W.T.T.). · Department of Cellular and Molecular Medicine, Lerner Research Institute, Cleveland Clinic, OH (W.H.W.T., S.L.H.). · Department of Cardiovascular Medicine, Heart and Vascular Institute, and Centre for Clinical Genomics, Cleveland Clinic, OH (W.H.W.T.). · Section of Gerontology and Geriatrics, Department of Internal Medicine (S.T.), Leiden University Medical Centre, the Netherlands. · Department of Cardiology (S.T., J.W.J.), Leiden University Medical Centre, the Netherlands. · Division Laboratories, Pharmacy, and Biomedical Genetics, Laboratory of Clinical Chemistry and Hematology (S.W.v.d.L.), UMC Utrecht, Utrecht University, the Netherlands. · Division Heart and Lungs, Department of Cardiology, UMC Utrecht, University of Utrecht, the Netherlands (J.V.S.). · Ruddy Canadian Cardiovascular Genetics Centre, University of Ottawa Heart Institute, ON, Canada (R.O.V., R.M., A.F.R.S.). · Department of Biochemistry, Microbiology and Immunology (R.O.V., A.F.R.S.), University of Ottawa, ON, Canada. · Department of Cardiovascular Medicine, Humanitas Clinical and Research Centre, Milan, Italy (C.V.A., G.C.). · Transplantation Laboratory (E.V., M.-L.L.), Helsinki University Hospital and University of Helsinki, Finland. · University Medical Centre, University of Groningen, the Netherlands (L.A.A., P.V.d.H.). · University of Texas School of Public Health, Houston(E.B.). · Clinica Mediterranea, Naples, Italy (C.B.). · Cardiology Division, Department of Internal Medicine (J.F.C., J.B.M., J.L.A.), University of Utah, Salt Lake City. · QMRI, Cardiovascular Sciences, University of Edinburgh, United Kingdom (K.F.C.). · ATS Sardegna, ASSL Nuoro-Ospedale San Francesco, Nuoro, Italy (G.C.). · Department of Biomedical Sciences, Humanitas University, Milan, Italy (G.C.). · William Harvey Research Institute, Barts and the London Medical School (P.D), Queen Mary University of London, United Kingdom. · Centre for Genomic Health (P.D.), Queen Mary University of London, United Kingdom. · Department of Health Sciences, University of Leicester, United Kingdom (F.D.). · Department of Cardiology, University of Lund, Sweden (T.E.). · Institute of Health Informatics (N.F., A. Timmis, H.H., F.W.A.), Faculty of Population Health Science, University College London, United Kingdom. · National Heart and Lung Institute, Imperial College and Institute of Cardiovascular Medicine and Science, Royal Brompton Hospital, London, United Kingdom (K.F.). · Centro de Pesquisa Clinica, Hospital Universitario, Universidade de Sao Paulo, São Paulo, Brazil (P.A. Lotufo, ). · ATS Sardegna, ASL 3 Nuoro, Nuoro, Italy (N. Marziliano). · Cardiovascular Research Center, Center for Human Genetic Research, Massachusetts General Hospital, Boston (C.N.-C.). · Program in Medical and Population Genetics, Broad Institute, Cambridge, MA (C.N.-C.). · Department of Medicine and Cardiology, Academic Teaching Hospital Feldkirch, Austria (C.H.S.). · Division of Cardiology, Department of Medicine (A.S.-T., P.B.S., A.A.Q.), Emory Clinical Cardiovascular Research Institute, Emory University School of Medicine, Atlanta, GA. · Heart Centre Leipzig, Germany (A. Teren). · Department of Cardiovascular Sciences (F.V.d.W.), Katholieke Universiteit Leuven, Belgium. · Respiratory Oncology Unit, Department of Respiratory Medicine, University Hospitals KU Leuven, Belgium (E.W.). · Princess Al-Jawhara Al-Brahim Centre of Excellence in Research of Hereditary Disorders, Jeddah, Saudi Arabia (A.A.M.W.). · Robertson Centre for Biostatistics, University of Glasgow, United Kingdom (I.F.). · Institute of Cardiovascular and Medical Sciences, University of Glasgow, United Kingdom (D.J.S., N.S.). · Department of Neurology and Neurosurgery, Brain Centre Rudolf Magnus and Julius Centre for Health Sciences and Primary Care (A. Algra), UMC Utrecht, Utrecht University, the Netherlands. · CNR Institute of Clinical Physiology, Pisa (M.G.A, C.C). · Cardiology Department, Parma University Hospital, Italy (D.A.). · Centre de recherche de l'Institut Universitaire de cardiologie et de pneumologie de Québec, Canada (B.J.A.). · Department of Medicine, Faculty of Medicine, Université Laval, QC, Canada (B.J.A.). · St Antonius Hospital, Department Cardiology, Nieuwegein, the Netherlands (T.O.B., B.K.M., J.M.t.B.). · Department of Anesthesia, Critical Care & Pain Medicine, Beth Israel Deaconess Medical Center, Boston, MA (S.B.). · Department of Cardiology, Erasmus MC, Thoraxcenter (E.H.B., J.J.B.). · Cardiovascular Research School, Erasmus Medical Center (COEUR), Rotterdam, the Netherlands(E.H.B.). · Laval University, Institute universitaire de cardiologie et de pneumologie de Québec, Canada (P.B.). · Julius Center for Health Sciences and Primary Care (M.B., D.E.G., Y.v.d.G.), UMC Utrecht, Utrecht University, the Netherlands. · Network Aging Research (NAR), University of Heidelberg (H.B.). · Institute of Clinical Chemistry and Laboratory Medicine, University Hospital Regensburg, Germany (R.B.). · Division of Cardiovascular Medicine, College of Medicine (R.M.C.-D., J.A.J., C.J.P.), University of Florida, Gainesville. · Cardiovascular Division, Department of Medicine (S.C.), Washington University School of Medicine, Saint Louis, MO. · Assistance Publique-Hôpitaux de Paris (AP-HP), Department of Cardiology, Hôpital Européen Georges Pompidou & FACT (French Alliance For Cardiovascular Trials), Université Paris Descartes, France (N.D.). · Université Paris-Descartes, France (N.D.). · Heart Health Research Group, University of Auckland, New Zealand (R.N.D.). · Drexel University College of Medicine, Philadelphia PA (H.D.). · Research Institute of the McGill University Health Centre, Montreal, QC, Canada (J.C.E.). · Division of Cardiology, Department of Medicine, Royal Victoria Hospital, McGill Univ Health Centre, Montreal, QC, Canada (J.C.E., G.T.). · The University of Edinburgh, United Kingdom (K.A.A.F). · Department of Cardiology, Uppsala Clinical Research Centre, Uppsala University, Sweden (E.H.). · Department of Cardiovascular Medicine, Centre for Microbiome and Human Health, Heart and Vascular Institute, Cleveland Clinic, OH (S.L.H.). · Department of Clinical Chemistry and Hematology (I.E.H.), UMC Utrecht, the Netherlands. · Department of Vascular Medicine, Academic Medical Centre, Amsterdam (G.K.H.). · Einthoven Laboratory for Experimental Vascular Medicine, LUMC, Leiden (J.W.J.). · Interuniversity Cardiology Institute of the Netherlands, Utrecht (J.W.J.). · Department of Internal Medicine, Jagiellonian University Medical College, Kraków, Poland (M.P.K., M.S., W.S). · Department of Clinical Physiology (M. Kähönen), University of Tampere, Finland. · Department of Clinical Physiology (M. Kähönen), Tampere University Hospital, Finland. · Cardiology Centre, Institute for Clinical and Experimental Medicine, Prague, Czech Republic (J.K.). · Department of Cardiology and Internal Diseases, Military Institute of Medicine, Warsaw, Poland (M. Kiliszek). · Department of Cardio-Thoracic Surgery, Finnish Cardiovascular Research Center, Faculty of Medicine & Life Sciences (J.O.L.), University of Tampere, Finland. · Department of Cardio-Thoracic Surgery, Heart Centre (J.O.L.), Tampere University Hospital, Finland. · Department of Respiratory Medicine, Academic Medical Centre, University of Amsterdam (A.H.M.-v.d.Z.). · Departments of Medicine and Biochemistry, Microbiology and Immunology(R.M.), University of Ottawa, ON, Canada. · Department of Internal Medicine, Skåne University Hospital, Malmö, Sweden (O.M.). · Department of Forensic Medicine; Medical University of Bialystok (A.N.-J.). · first Chair and Department of Cardiology (G.O.), Medical University of Warsaw, Poland. · Pat Macpherson Centre for Pharmacogenetics and Pharmacogenomics, Division of Molecular and Clinical Medicine, Ninewells Hospital and Medical School, Dundee (C.N.P.). · Department of Clinical Chemistry (G.P.), UMC Utrecht, the Netherlands. · Department of Medicine, McGill University Health Centre, Montreal, QC, Canada (L.P., J.M.B.). · Cardiovascular Research Institute, National University of Singapore (A.M.R.). · Division of Clinical Chemistry, Department of Medical Sciences (A. Siegbahn), Uppsala University, Sweden. · Assistance Publique-Hôpitaux de Paris (AP-HP), Department of Clinical Pharmacology, Platform of Clinical Research of East Paris (URCEST-CRCEST-CRB HUEP-UPMC), FACT (French Alliance for Cardiovascular Trials), Sorbonne Université (T.S.). · Paris-Sorbonne University, UPMC-Site St Antoine, France (T.S.). · Heart and Lung Centre (J.S.), Helsinki University Hospital and University of Helsinki, Finland. · Department of Cardiology, Clinical Sciences, Lund University, Skåne University Hospital (J.G.S.). · Wallenberg Centre for Molecular Medicine, Lund University Diabetes Centre, Lund University, Sweden (J.G.S.). · Program in Medical and Population Genetics, Broad Institute, Cambridge, MA (J.G.S.). · Saint Luke's Mid America Heart Institute, University of Missouri-Kansas City (J.A.S.). · Saint Luke's Mid America Heart Insti Kansas City, MO (J.A.S.). · Department of Clinical Biochemistry, Copenhagen University Hospital, Gentofte (S.S.). · Department of Cardiology, The Heart Centre, Copenhagen University Hospital, Rigshospitalet (J.T.-H.). · Department of Forensic Medicine, Faculty of Medical Sciences, University of Copenhagen, Denmark (J.T.-Hansen). · Institute of Laboratory Medicine, Clinical Chemistry and Molecular Diagnostics, University Hospital, Leipzig, Germany (J.T.). · Unit of Epidemiology and Biostatistics, Department of Health Science and Technology, Aalborg University Hospital, Denmark (C.T.-Pedersen). · Department of Vascular Medicine (F.L.J.V), UMC Utrecht, Utrecht University, the Netherlands. · Department of Cardiovascular Medicine, University of Münster, Germany (J.W.). · Department of Cardiology, Herlev and Gentofte Hospital, Hellerup, Denmark (P.E.W.). · Department of Pathology and Molecular Medicine, McMaster University (G.P.). · Population Health Research Institute, Hamilton, ON, Canada (G.P.). · Department of Biomedical Informatics (B.D.H.), University of Utah, Salt Lake City. · Synlab Academy, Synlab Holding Deutschland GmbH, Mannheim, Germany (W.M.). · Clinical Institute of Medical and Chemical Laboratory Diagnostics, Medical University of Graz, Austria (W.M.). · Durrer Centre of Cardiogenetic Research, ICIN-Netherlands Heart Institute, Utrecht (F.W.A.). ·Circ Genom Precis Med · Pubmed #30896328.

ABSTRACT: BACKGROUND: The Genetics of Subsequent Coronary Heart Disease (GENIUS-CHD) consortium was established to facilitate discovery and validation of genetic variants and biomarkers for risk of subsequent CHD events, in individuals with established CHD. METHODS: The consortium currently includes 57 studies from 18 countries, recruiting 185 614 participants with either acute coronary syndrome, stable CHD, or a mixture of both at baseline. All studies collected biological samples and followed-up study participants prospectively for subsequent events. RESULTS: Enrollment into the individual studies took place between 1985 to present day with a duration of follow-up ranging from 9 months to 15 years. Within each study, participants with CHD are predominantly of self-reported European descent (38%-100%), mostly male (44%-91%) with mean ages at recruitment ranging from 40 to 75 years. Initial feasibility analyses, using a federated analysis approach, yielded expected associations between age (hazard ratio, 1.15; 95% CI, 1.14-1.16) per 5-year increase, male sex (hazard ratio, 1.17; 95% CI, 1.13-1.21) and smoking (hazard ratio, 1.43; 95% CI, 1.35-1.51) with risk of subsequent CHD death or myocardial infarction and differing associations with other individual and composite cardiovascular endpoints. CONCLUSIONS: GENIUS-CHD is a global collaboration seeking to elucidate genetic and nongenetic determinants of subsequent event risk in individuals with established CHD, to improve residual risk prediction and identify novel drug targets for secondary prevention. Initial analyses demonstrate the feasibility and reliability of a federated analysis approach. The consortium now plans to initiate and test novel hypotheses as well as supporting replication and validation analyses for other investigators.

15 Article Design and rationale of the Management of High Bleeding Risk Patients Post Bioresorbable Polymer Coated Stent Implantation With an Abbreviated Versus Standard DAPT Regimen (MASTER DAPT) Study. 2019

Frigoli, Enrico / Smits, Pieter / Vranckx, Pascal / Ozaki, Yokio / Tijssen, Jan / Jüni, Peter / Morice, Marie-Claude / Onuma, Yoshinobu / Windecker, Stephan / Frenk, Andrè / Spaulding, Christian / Chevalier, Bernard / Barbato, Emanuele / Tonino, Pim / Hildick-Smith, David / Roffi, Marco / Kornowski, Ran / Schultz, Carl / Lesiak, Maciej / Iñiguez, Andrés / Colombo, Antonio / Alasnag, Mirvat / Mullasari, Ajit / James, Stefan / Stankovic, Goran / Ong, Paul J L / Rodriguez, Alfredo E / Mahfoud, Felix / Bartunek, Jozef / Moschovitis, Aris / Laanmets, Peep / Leonardi, Sergio / Heg, Dik / Sunnåker, Mikael / Valgimigli, Marco. ·Clinical Trials Unit, University of Bern, Bern, Switzerland. · Department of Cardiology, Maasstad Hospital, Rotterdam, the Netherlands. · Department of Cardiology and Critical Care Medicine, Hartcentrum Hasselt, Jessa Ziekenhuis, Hasselt, Belgium; Faculty of Medicine and Life Sciences, Hasselt University, Hasselt, Belgium. · Department of Cardiology, School of Medicine, Fujita Health University, Toyoake, Aichi, Japan. · AMC Heartcenter, Academic Medical Center, University of Amsterdam, Amsterdam, the Netherlands. · University of Toronto, Applied Health Research Centre, Li Ka Shing Knowledge Institute, St Michael's Hospital, Toronto, Ontario, Canada. · Cardiovascular European Research Center (CERC), Massy, France. · Thorax Center, Erasmus Medical Center, Rotterdam, the Netherlands. · Department of Cardiology, Bern University Hospital, Bern, Switzerland. · Cardiology department, Hôpital Européen Georges Pompidou, Assistance Publique Hôpitaux de Paris, Sudden Death Expert Center, INSERM U 970, Paris Descartes Université, Paris, France. · Ramsay Générale de Santé, Interventional Cardiology Department, Institut Cardiovasculaire Paris Sud, Massy, France. · Cardiovascular Research Center Aalst, Aalst, Belgium; Division of Cardiology, Department of Advanced Biomedical Sciences, University Federico II of Naples, Italy. · Department of Cardiology, Catharina Hospital, Eindhoven, the Netherlands. · Brighton and Sussex University Hospitals NHS Trust, Brighton, United Kingdom. · Division of Cardiology, Geneva University Hospitals, Geneva, Switzerland. · Rabin Medical Center, Sackler School of Medicine, Tel Aviv University, Tel Aviv, Israel. · Department of Cardiology, Royal Perth Hospital Campus, University of Western Australia, Perth, Australia. · 1st Department of Cardiology, University of Medical Sciences, Poznan, Poland. · Hospital Alvaro Cunqueiro, Vigo, Spain. · Unit of Cardiovascular Interventions, IRCCS San Raffaele Scientific Institute, Milan, Italy. · Department of Cardiology, King Fahad Armed Forces Hospital, Jeddah, Saudi Arabia. · Madras Medical Mission, Chennai, India. · Department of Medical Sciences, Cardiology, Uppsala University, Uppsala, Sweden. · Department of Cardiology, Clinical Center of Serbia, and Faculty of medicine, University of Belgrade, Belgrade, Serbia. · Tan Tock Seng Hospital, Singapore, Singapore. · Cardiac Unit Otamendi Hospital, Buenos Aires School of Medicine Cardiovascular Research Center (CECI), Buenos Aires, Argentina. · Saarland University Hospital, Homburg, Germany. · Cardiovascular Research Center Aalst, Aalst, Belgium. · North-Estonia Medical Centre Foundation, Tallinn, Estonia. · Fondazione IRCCS Policlinico San Matteo, Pavia, Italy. · Department of Cardiology, Bern University Hospital, Bern, Switzerland. Electronic address: marco.valgimigli@insel.ch. ·Am Heart J · Pubmed #30703644.

ABSTRACT: BACKGROUND: The optimal duration of antiplatelet therapy in high-bleeding risk (HBR) patients with coronary artery disease treated with newer-generation drug-eluting bioresorbable polymer-coated stents remains unclear. DESIGN: MASTER DAPT (clinicaltrial.govNCT03023020) is an investigator-initiated, open-label, multicenter, randomized controlled trial comparing an abbreviated versus a standard duration of antiplatelet therapy after bioresorbable polymer-coated Ultimaster (TANSEI) sirolimus-eluting stent implantation in approximately 4,300 HBR patients recruited from ≥100 interventional cardiology centers globally. After a mandatory 30-day dual-antiplatelet therapy (DAPT) run-in phase, patients are randomized to (a) a single antiplatelet regimen until study completion or up to 5 months in patients with clinically indicated oral anticoagulation (experimental 1-month DAPT group) or (b) continue DAPT for at least 5 months in patients without or 2 in patients with concomitant indication to oral anticoagulation, followed by a single antiplatelet regimen (standard antiplatelet regimen). With a final sample size of 4,300 patients, this study is powered to assess the noninferiority of the abbreviated antiplatelet regimen with respect to the net adverse clinical and major adverse cardiac and cerebral events composite end points and if satisfied for the superiority of abbreviated as compared to standard antiplatelet therapy duration in terms of major or clinically relevant nonmajor bleeding. Study end points will be adjudicated by a blinded Clinical Events Committee. CONCLUSIONS: The MASTER DAPT study is the first randomized controlled trial aiming at ascertaining the optimal duration of antiplatelet therapy in HBR patients treated with sirolimus-eluting bioresorbable polymer-coated stent implantation.

16 Article Stent thrombosis rates the first year and beyond with new- and old-generation drug-eluting stents compared to bare metal stents. 2018

Varenhorst, Christoph / Lindholm, Martin / Sarno, Giovanna / Olivecrona, Göran / Jensen, Ulf / Nilsson, Johan / Carlsson, Jörg / James, Stefan / Lagerqvist, Bo. ·Uppsala Clinical Research Center, Uppsala University, Uppsala, Sweden. christoph.varenhorst@medsci.uu.se. · Department of Medical Sciences, Cardiology, Uppsala University, Dag Hammarsköldsväg 14B, 75337, Uppsala, Sweden. christoph.varenhorst@medsci.uu.se. · Department of Internal Medicine, Cardiology, Västerås County Hospital, Västerås, Sweden. · Uppsala Clinical Research Center, Uppsala University, Uppsala, Sweden. · Department of Medical Sciences, Cardiology, Uppsala University, Dag Hammarsköldsväg 14B, 75337, Uppsala, Sweden. · Department of Cardiology, Lund University, Lund, Sweden. · Department of Clinical Science and Education, Södersjukhuset, Karolinska Institutet, Stockholm, Sweden. · Department of Cardiology, Heart Centre, Umeå University, Umeå, Sweden. · Faculty of Health and Life Sciences, Linnaeus University, Kalmar, Sweden. ·Clin Res Cardiol · Pubmed #29667015.

ABSTRACT: OBJECTIVES: Old-generation drug-eluting coronary stents (o-DES) have despite being safe and effective been associated with an increased propensity of late stent thrombosis (ST). We evaluated ST rates in o-DES, new-generation DES (n-DES) and bare metal stents (BMS) the first year (< 1 year) and beyond 1 year (> 1 year). METHODS: We evaluated all implantations with BMS, o-DES (Cordis Cypher, Boston Scientific Taxus Liberté and Medtronic Endeavor) and n-DES in the Swedish coronary angiography and angioplasty registry (SCAAR) between 1 January 2007 and 8 January 2014 (n = 207 291). All cases of ST (n = 2 268) until 31 December 2014 were analyzed. RESULTS: The overall risk of ST was lower in both n-DES and o-DES compared with BMS up to 1 year (n-DES versus BMS: adjusted risk ratio (RR) 0.48 (0.41-0.58) and o-DES versus BMS: 0.56 (0.46-0.67), both p < 0.001). From 1 year after stent implantation and onward, the risk for ST was higher in o-DES compared with BMS [adjusted RR, 1.82 (1.47-2.25], p < 0.001). N-DES were associated with similar low ST rates as BMS from 1 year and onward [adjusted RR 1.21 (0.94-1.56), p = 0.135]. CONCLUSION: New-generation DES were associated with lower ST rates in comparison to BMS during the first-year post-stenting. After 1 year, n-DES and BMS were associated with similar ST rates. TRIAL REGISTRATION: This study was a retrospective observational study and as such did not require clinical trial database registration.

17 Article Outcomes in patients treated with ticagrelor versus clopidogrel after acute myocardial infarction stratified by renal function. 2018

Edfors, Robert / Sahlén, Anders / Szummer, Karolina / Renlund, Henrik / Evans, Marie / Carrero, Juan-Jesus / Spaak, Jonas / James, Stefan K / Lagerqvist, Bo / Varenhorst, Christoph / Jernberg, Tomas. ·Department of Medicine, Huddinge, Karolinska Institute, Stockholm, Sweden. · Department of Cardiology, Karolinska University Hospital, Stockholm, Sweden. · National Heart Centre, Singapore, Singapore. · Department of Medical Sciences, Uppsala Clinical Research Center, Uppsala University, Uppsala, Sweden. · Center for Molecular Medicine, Karolinska Institutet, Stockholm, Sweden. · Division of Renal Medicine, Karolinska Institutet, Stockholm, Sweden. · Department of Medical Epidemiology and Biostatistics, Karolinska Institutet, Stockholm, Sweden. · Department of Clinical Sciences, Danderyd University Hospital, Karolinska Institutet, Stockholm, Sweden. ·Heart · Pubmed #29574413.

ABSTRACT: OBJECTIVES: We aimed to analyse outcomes of ticagrelor and clopidogrel stratified by estimated glomerular filtration rate (eGFR) in a large unselected cohort of patients with acute myocardial infarction (MI). METHODS: We used follow-up data in MI survivors discharged on ticagrelor or clopidogrel enrolled in the Swedish Web-System for Enhancement and Development of Evidence-Based Care in Heart Disease Evaluated According to Recommended Therapies registry. The association between ticagrelor versus clopidogrel and the primary composite outcome of death, MI or stroke and the secondary outcome rehospitalisation with bleeding diagnosis at 1 year, was studied using adjusted Cox proportional hazards models, stratifying after eGFR levels. RESULTS: In total, 45 206 patients with MI discharged on clopidogrel (n=33 472) or ticagrelor (n=11 734) were included. The unadjusted 1-year event rate for the composite endpoint of death, MI or stroke was 7.0%, 18.0% and 48.0% for ticagrelor treatment and 11.0%, 33.0% and 64.0% for clopidogrel treatment in patients with eGFR CONCLUSIONS: Treatment with ticagrelor as compared with clopidogrel in patients with MI was associated with lower risk for the composite of death, MI or stroke and a higher bleeding risk across all strata of eGFR. Of caution, bleeding events were more abundant in patients with eGFR

18 Article Treatment Trends, Effectiveness, and Safety of Statins on Lipid Goal Attainment in Chinese Percutaneous Coronary Intervention Patients: a Multicenter, Retrospective Cohort Study. 2017

Chen, Yundai / Li, Dandan / Jing, Jing / Yan, Hongbing / Liu, Jinghua / Shen, Zhujun / James, Stefan / Varenhorst, Christoph. ·Department of Cardiology, The Chinese PLA General Hospital (301 Hospital), Beijing, People's Republic of China. Electronic address: cyundai@vip.163.com. · Department of Cardiology, The Chinese PLA General Hospital (301 Hospital), Beijing, People's Republic of China. · National Center for Cardiovascular Diseases, Cardiovascular Institute and FuWai Hospital, Beijing, People's Republic of China. · Department of Cardiology, Beijing Anzhen Hospital, Capital Medical University, Beijing, People's Republic of China. · Department of Cardiology, Peking Union Medical College Hospital, Beijing, People's Republic of China. · Department of Medical Sciences, Cardiology and Uppsala Clinical Research Center, Uppsala University, Uppsala, Sweden. ·Clin Ther · Pubmed #28807393.

ABSTRACT: PURPOSE: Limited data exist on the use of statins in Chinese patients with coronary artery disease (CAD) treated with percutaneous coronary intervention (PCI). We therefore conducted this study to observe the usage trend and the effectiveness of statins on LDL-C goal attainment and other lipid parameters among PCI-treated patients. METHODS: This multicenter, retrospective, observational, longitudinal cohort study was conducted in PCI-treated patients with CAD between July 1, 2011, and February 28, 2015. Primary study outcomes included statin treatment pattern after PCI and proportion of patients achieving target (LDL-C) levels 1 month after PCI and initiating statin therapy. FINDINGS: Data were analyzed for 2708 patients (mean age, 59 [10] years; median body mass index, 25.6 [4.0] kg/m IMPLICATIONS: In real-world, PCI-treated Chinese patients, atorvastatin and rosuvastatin were the most prescribed statins. Compared with atorvastatin 20 mg, rosuvastatin 10 mg was associated with greater LDL-C reductions and achievement of LDL-C targets in a higher percentage of patients. This analysis of real-world data shows that both rosuvastatin and atorvastatin were well tolerated and seemed to be suitable drugs for controlling lipid levels and preventing CVD risk in post-PCI Chinese patients with CAD.

19 Article Real-life clinical outcomes with everolimus eluting platinum chromium stent with an abluminal biodegradable polymer in patients from the Swedish Coronary Angiography and Angioplasty Registry (SCAAR). 2017

Sarno, Giovanna / Lagerqvist, Bo / Olivecrona, Göran / Varenhorst, Christoph / Danielewicz, Mikael / Hambraeus, Kristina / Lindholm, Daniel / Råmunddal, Truls / Witt, Nils / James, Stefan. ·Department of Medical Sciences, Cardiology and Uppsala Clinical Research Center, Uppsala University, Uppsala, Sweden. · UCR, Uppsala Clinical Research Center, Uppsala, Sweden. · Department of Cardiology, Lund University Hospital, Lund, Sweden. · Department of Cardiology, Karlstad Hospital, Karlstad, Sweden. · Department of Cardiology, Falun Lasarett, Falun, Sweden. · Department of Cardiology, Sahlgrenska University Hospital, Göteborg, Sweden. · Department of Cardiology, Södersjukhuset University Hospital, Stockholm, Sweden. ·Catheter Cardiovasc Interv · Pubmed #28544146.

ABSTRACT: BACKGROUND: No previous studies have evaluated the performance of the Synergy stent in a large real-life population. OBJECTIVES: To describe the initial real-life experience with a novel everolimus eluting platinum chromium stent with abluminal biodegradable polymer (SYNERGY) in unselected patients from a nationwide registry. METHODS: All implanted Synergy stents were compared with other new generation drug eluting stents (n-DES) with >1,000 implantations in Sweden between March 2013 and October 2015. Restenosis, definite stent thrombosis (ST), myocardial infarction (MI) and death rates were assessed using propensity score and Cox regression analyses. RESULTS: A total of 7,886 of Synergy stents and 64,429 other n-DES (BioMatrix, N = 1,953; Orsiro, N = 4,946; Promus Element Plus, N= 2,543; Promus Premier, N= 20,414; Xience Xpedition, N= 7,971, Resolute/Resolute Integrity, N = 19,021; Ultimaster, N = 1,156; Resolute Onyx, N = 6,425) were implanted in 42,357 procedures. Restenosis and stent thrombosis occurred in 642 and 314 cases, respectively, in the overall population at 1 year. The cumulative rate of restenosis (1.1% vs. 1.0%, adjusted HR: 1.24 95% CI: 0.88-1.75; P = 0.21) and ST (0.4% vs. 0.5%, adjusted HR: 0.97; 95% CI: 0.63-1.50; P = 0.17) up to 1 year was low in both the Synergy group and the other n-DES group. Death occurred in 5.2% versus 4.5% (adjusted HR: 1.14; 95% CI: 0.96-1.36; P = 0.11) and MI in 3.2% versus 3.5%, (adjusted HR: 1.11; 95% CI: 0.93-1.33; P = 0.24) up to 1 year. CONCLUSIONS: In a large real-life population the Synergy stent appears to be safe and effective with a low rate of restenosis and ST comparable with other n-DES. © 2017 Wiley Periodicals, Inc.

20 Article Intravascular Ultrasound Guidance Is Associated With Better Outcome in Patients Undergoing Unprotected Left Main Coronary Artery Stenting Compared With Angiography Guidance Alone. 2017

Andell, Pontus / Karlsson, Sofia / Mohammad, Moman A / Götberg, Matthias / James, Stefan / Jensen, Jens / Fröbert, Ole / Angerås, Oskar / Nilsson, Johan / Omerovic, Elmir / Lagerqvist, Bo / Persson, Jonas / Koul, Sasha / Erlinge, David. ·From the Department of Cardiology, Clinical Sciences, Lund University, Skane University Hospital, Sweden (P.A., S.K., M.A.M., M.G., S.K., D.E.) · Department of Medical Sciences, Uppsala University, Sweden (S.J., B.L.) · Department of Clinical Science and Education, Södersjukhuset, Karolinska Institutet, and Unit of Medicine, Capio St Görans Sjukhus, Stockholm, Sweden (J.J.) · Department of Cardiology, Faculty of Health, Örebro University, Sweden (O.F.) · Department of Molecular and Clinical Medicine, Institute of Medicine, Sahlgrenska Academy, Gothenburg, Sweden (O.A., E.O.) · University and Department of Cardiology, Sahlgrenska University Hospital, Gothenburg, Sweden (O.A., E.O.) · Department of Cardiology, Umeå University Hospital, Heart Centre, Sweden (J.N.) · and Division of Cardiovascular Medicine, Department of Clinical Sciences, Karolinska Institutet, Danderyd Hospital, Stockholm, Sweden (J.P.). ·Circ Cardiovasc Interv · Pubmed #28487356.

ABSTRACT: BACKGROUND: Small observational studies have indicated better outcome with intravascular ultrasound (IVUS) guidance when performing unprotected left main coronary artery (LMCA) percutaneous coronary intervention (PCI), but the overall picture remains inconclusive and warrants further investigation. We studied the impact of IVUS guidance on outcome in patients undergoing unprotected LMCA PCI in a Swedish nationwide observational study. METHODS AND RESULTS: Patients who underwent unprotected LMCA PCI between 2005 and 2014 because of stable coronary artery disease or acute coronary syndrome were included from the nationwide SCAAR (Swedish Coronary Angiography and Angioplasty Registry). Of 2468 patients, IVUS guidance was used in 621 (25.2%). The IVUS group was younger (median age, 70 versus 75 years) and had fewer comorbidities but more complex lesions. IVUS was associated with larger stent diameters (median, 4 mm versus 3.5 mm). After adjusting for potential confounders, IVUS was associated with significantly lower occurrence of the primary composite end point of all-cause mortality, restenosis, or definite stent thrombosis (hazard ratio, 0.65; 95% confidence interval, 0.50-0.84) and all-cause mortality alone (hazard ratio, 0.62; 95% confidence interval, 0.47-0.82). In 340 propensity score-matched pairs, IVUS was also associated with significantly lower occurrence of the primary end point (hazard ratio, 0.54; 95% confidence interval, 0.37-0.80). CONCLUSIONS: IVUS was associated with an independent and significant outcome benefit when performing unprotected LMCA PCI. Potential mediators of this benefit include larger and more appropriately sized stents, perhaps translating into lower risk of subsequent stent thrombosis. Although residual confounding cannot be ruled out, our findings indicate a possible hazard when performing unprotected LMCA PCI without IVUS guidance.

21 Article Ranolazine After Incomplete Percutaneous Coronary Revascularization in Patients With Versus Without Diabetes Mellitus: RIVER-PCI Trial. 2017

Fanaroff, Alexander C / James, Stefan K / Weisz, Giora / Prather, Kristi / Anstrom, Kevin J / Mark, Daniel B / Ben-Yehuda, Ori / Alexander, Karen P / Stone, Gregg W / Ohman, E Magnus. ·Department of Medicine, Division of Cardiology, Duke University Medical Center, Durham, North Carolina; Duke Clinical Research Institute, Duke University Medical Center, Durham, North Carolina. · Department of Medical Sciences and Uppsala Clinical Research Center, Uppsala University, Uppsala, Sweden. · Division of Cardiology, Columbia University, New York, New York; Cardiovascular Research Foundation, New York, New York; Department of Cardiology, Shaare Zedek Medical Center, Jerusalem, Israel. · Duke Clinical Research Institute, Duke University Medical Center, Durham, North Carolina. · Cardiovascular Research Foundation, New York, New York. · Department of Medicine, Division of Cardiology, Duke University Medical Center, Durham, North Carolina; Duke Clinical Research Institute, Duke University Medical Center, Durham, North Carolina. Electronic address: karen.alexander@duke.edu. · Division of Cardiology, Columbia University, New York, New York; Cardiovascular Research Foundation, New York, New York. ·J Am Coll Cardiol · Pubmed #28473136.

ABSTRACT: BACKGROUND: Chronic angina is more common in patients with diabetes mellitus (DM) with poor glucose control. Ranolazine both treats chronic angina and improves glucose control. OBJECTIVES: This study sought to examine ranolazine's antianginal effect in relation to glucose control. METHODS: The authors performed a secondary analysis of the RIVER-PCI (Ranolazine in Patients with Incomplete Revascularization after Percutaneous Coronary Intervention) trial, a clinical trial in which 2,604 patients with chronic angina and incomplete revascularization following percutaneous coronary intervention were randomized to ranolazine versus placebo. Mixed-effects models were used to compare the effects of ranolazine versus placebo on glycosylated hemoglobin (HbA RESULTS: Overall, 961 patients (36.9%) had DM at baseline. Compared with placebo, ranolazine significantly decreased HbA CONCLUSIONS: In patients with DM and chronic angina with incomplete revascularization after percutaneous coronary intervention, ranolazine's effect on glucose control and angina at 6 months was proportionate to baseline HbA

22 Article Potent P2Y 2017

Lau, Emily S / Braunwald, Eugene / Murphy, Sabina A / Wiviott, Stephen D / Bonaca, Marc P / Husted, Steen / James, Stefan K / Wallentin, Lars / Clemmensen, Peter / Roe, Matthew T / Ohman, E Magnus / Harrington, Robert A / Mega, Jessica L / Bhatt, Deepak L / Sabatine, Marc S / O'Donoghue, Michelle L. ·Department of Medicine, Brigham and Women's Hospital, Boston, Massachusetts. · TIMI Study Group, Cardiovascular Division, Brigham and Women's Hospital, Boston, Massachusetts. · Department of Cardiology, Århus University Hospital, Århus, Denmark. · Department of Medical Sciences and Uppsala Clinical Research Center, Uppsala University, Uppsala, Sweden. · Department of General and Interventional Cardiology, University Heart Center Hamburg-Eppendorf, Hamburg, Germany; Department of Medicine, Nykoebing F Hospital, University of Southern Denmark, Odense, Denmark. · Division of Cardiology, Duke Clinical Research Institute, Durham, North Carolina. · Department of Medicine, Stanford University, Stanford, California. · Verily Life Sciences, Mountain View, California. · TIMI Study Group, Cardiovascular Division, Brigham and Women's Hospital, Boston, Massachusetts. Electronic address: modonoghue@partners.org. ·J Am Coll Cardiol · Pubmed #28335837.

ABSTRACT: BACKGROUND: Sex-specific differences in response to antiplatelet therapies have been described. Whether women and men derive comparable benefit from intensification of antiplatelet therapy remains uncertain. OBJECTIVES: The study investigated the efficacy and safety of the potent P2Y METHODS: A collaborative sex-specific meta-analysis was conducted of phase III or IV randomized trials of potent P2Y RESULTS: Potent P2Y CONCLUSIONS: In randomized trials, the efficacy and safety of the potent P2Y

23 Article Long-Term Outcome of Incomplete Revascularization After Percutaneous Coronary Intervention in SCAAR (Swedish Coronary Angiography and Angioplasty Registry). 2016

Hambraeus, Kristina / Jensevik, Karin / Lagerqvist, Bo / Lindahl, Bertil / Carlsson, Roland / Farzaneh-Far, Ramin / Kellerth, Thomas / Omerovic, Elmir / Stone, Gregg / Varenhorst, Christoph / James, Stefan. ·Department of Cardiology, Falun Hospital, Falun, Sweden; Department of Medical Sciences, Cardiology, Uppsala University, Uppsala, Sweden. Electronic address: Kristina.hambraeus@ltdalarna.se. · Uppsala Clinical Research Center, Uppsala University, Uppsala, Sweden. · Department of Medical Sciences, Cardiology, Uppsala University, Uppsala, Sweden; Uppsala Clinical Research Center, Uppsala University, Uppsala, Sweden. · PCI Unit, Department of Cardiology, Central Hospital, Karlstad, Sweden. · Gilead Sciences, Inc., Foster City, California. · Department of Cardiology, University Hospital, Örebro, Sweden. · Department of Cardiology, Sahlgrenska University Hospital, Gothenburg, Sweden. · New York Presbyterian Hospital, Columbia University Medical Center, and the Cardiovascular Research Foundation, New York, New York. ·JACC Cardiovasc Interv · Pubmed #26847112.

ABSTRACT: OBJECTIVES: The aim of this study was to describe current practice regarding completeness of revascularization in patients with multivessel disease undergoing percutaneous coronary intervention (PCI) and to investigate the association of incomplete revascularization (IR) with death, repeat revascularization, and myocardial infarction (MI) in a large nationwide registry. BACKGROUND: The benefits of multivessel PCI are controversial. METHODS: Between 2006 and 2010 we identified 23,342 patients with multivessel disease in the SCAAR (Swedish Coronary Angiography and Angioplasty Registry) and merged data with official Swedish health data registries. IR was defined as any nontreated significant (60%) stenosis in a coronary artery supplying >10% of the myocardium. RESULTS: Patients with IR (n = 15,165) were older, had more extensive coronary disease, and more often had ST-segment elevation MI at presentation than those with complete revascularization (CR) (n = 8,177). All-cause 1-year mortality, MI, and repeat revascularization were higher in IR than CR: 7.1% versus 3.8%, 10.4% versus 6.0%, and 20.5% versus 8.5%, respectively. Propensity score methodology was used in the adjusted analyses. Adjusted hazard ratio (HR) for the composite of death, MI, or repeat revascularization at 1 year was higher in IR than CR: 2.12 (95% confidence interval [CI]: 1.98 to 2.28; p < 0.0001). Adjusted HR for death and the combination of death/MI were 1.29 (95% CI: 1.12 to 1.49; p = 0.0005) and 1.42 (95% CI: 1.30 to 1.56; p < 0.0001), respectively. CONCLUSIONS: Incomplete revascularization at the time of hospital discharge in patients with multivessel disease undergoing PCI is associated with a high risk of recurrent 1-year adverse cardiac events.

24 Article Ranolazine in patients with incomplete revascularisation after percutaneous coronary intervention (RIVER-PCI): a multicentre, randomised, double-blind, placebo-controlled trial. 2016

Weisz, Giora / Généreux, Philippe / Iñiguez, Andres / Zurakowski, Aleksander / Shechter, Michael / Alexander, Karen P / Dressler, Ovidiu / Osmukhina, Anna / James, Stefan / Ohman, E Magnus / Ben-Yehuda, Ori / Farzaneh-Far, Ramin / Stone, Gregg W / Anonymous7500845. ·Shaare Zedek Medical Center, Jerusalem, Israel; New York Presbyterian Hospital, Columbia University Medical Center, New York, NY, USA; Cardiovascular Research Foundation, New York, NY, USA. Electronic address: weiszg@szmc.org.il. · Cardiovascular Research Foundation, New York, NY, USA; Hôpital du Sacré-Coeur de Montreal, Université de Montreal, Montreal, QC, Canada. · Hospital de Meixoeiro, Vigo, Spain. · American Heart of Poland SA, Katowice, Poland. · Chaim Sheba Medical Center, Tel Hashomer, Israel. · Duke Clinical Research Institute and Duke University, Durham, NC, USA. · Cardiovascular Research Foundation, New York, NY, USA. · Gilead Sciences, Foster City, CA, USA. · Department of Medical Sciences, Cardiology, Uppsala University, Uppsala, Sweden. · New York Presbyterian Hospital, Columbia University Medical Center, New York, NY, USA; Cardiovascular Research Foundation, New York, NY, USA. ·Lancet · Pubmed #26474810.

ABSTRACT: BACKGROUND: Incomplete revascularisation is common after percutaneous coronary intervention and is associated with increased mortality and adverse cardiovascular events. We aimed to assess whether adjunctive anti-ischaemic pharmacotherapy with ranolazine would improve the prognosis of patients with incomplete revascularisation after percutaneous coronary intervention. METHODS: We performed this multicentre, randomised, parallel-group, double-blind, placebo-controlled, event-driven trial at 245 centres in 15 countries in Europe, Israel, Russia, and the USA. Patients (aged ≥18 years) with a history of chronic angina with incomplete revascularisation after percutaneous coronary intervention (defined as one or more lesions with ≥50% diameter stenosis in a coronary artery ≥2 mm diameter) were randomly assigned (1:1), via an interactive web-based block randomisation system (block sizes of ten), to receive either twice-daily oral ranolazine 1000 mg or matching placebo. Randomisation was stratified by diabetes history (presence vs absence) and acute coronary syndrome presentation (acute coronary syndrome vs non-acute coronary syndrome). Study investigators, including all research teams, and patients were masked to treatment allocation. The primary endpoint was time to first occurrence of ischaemia-driven revascularisation or ischaemia-driven hospitalisation without revascularisation. Analysis was by intention to treat. This study is registered at ClinicalTrials.gov, number NCT01442038. FINDINGS: Between Nov 3, 2011, and May 27, 2013, we randomly assigned 2651 patients to receive ranolazine (n=1332) or placebo (n=1319); 2604 (98%) patients comprised the full analysis set. After a median follow-up of 643 days (IQR 575-758), the composite primary endpoint occurred in 345 (26%) patients assigned to ranolazine and 364 (28%) patients assigned to placebo (hazard ratio 0·95, 95% CI 0·82-1·10; p=0·48). Incidence of ischaemia-driven revascularisation and ischaemia-driven hospitalisation did not differ significantly between groups. 189 (14%) patients in the ranolazine group and 137 (11%) patients in the placebo group discontinued study drug because of an adverse event (p=0·04). INTERPRETATION: Ranolazine did not reduce the composite rate of ischaemia-driven revascularisation or hospitalisation without revascularisation in patients with a history of chronic angina who had incomplete revascularisation after percutaneous coronary intervention. Further studies are warranted to establish whether other treatment could be effective in improving the prognosis of high-risk patients in this population. FUNDING: Gilead Sciences, Menarini.

25 Article Relationship Between Cancer and Cardiovascular Outcomes Following Percutaneous Coronary Intervention. 2015

Hess, Connie N / Roe, Matthew T / Clare, Robert M / Chiswell, Karen / Kelly, Joseph / Tcheng, James E / Hagstrom, Emil / James, Stefan K / Khouri, Michel G / Hirsch, Bradford R / Kong, David F / Abernethy, Amy P / Krucoff, Mitchell W. ·Division of Cardiology, Department of Medicine, Duke University Medical Center, Durham, NC (C.N.H., M.T.R., J.E.T., M.G.K., D.F.K., M.W.K.) Duke Clinical Research Institute, Durham, NC (C.N.H., M.T.R., R.M.C., K.C., J.E.T., B.R.H., D.F.K., M.W.K.). · Duke Clinical Research Institute, Durham, NC (C.N.H., M.T.R., R.M.C., K.C., J.E.T., B.R.H., D.F.K., M.W.K.). · Center for Learning Healthcare, Duke Clinical Research Institute, Durham, NC (J.K., A.P.A.). · Department of Medical Sciences, Cardiology, and Uppsala Clinical Research Center, Uppsala University, Sweden (E.H., S.K.J.). · Division of Cardiology, Department of Medicine, Duke University Medical Center, Durham, NC (C.N.H., M.T.R., J.E.T., M.G.K., D.F.K., M.W.K.). · Duke Clinical Research Institute, Durham, NC (C.N.H., M.T.R., R.M.C., K.C., J.E.T., B.R.H., D.F.K., M.W.K.) Duke Cancer Institute, Durham, NC (B.R.H., A.P.A.). · Division of Medical Oncology, Department of Medicine, Duke University Medical Center, Durham, NC (A.P.A.) Center for Learning Healthcare, Duke Clinical Research Institute, Durham, NC (J.K., A.P.A.) Duke Cancer Institute, Durham, NC (B.R.H., A.P.A.). ·J Am Heart Assoc · Pubmed #26150477.

ABSTRACT: BACKGROUND: Cardiovascular disease and cancer increasingly coexist, yet relationships between cancer and long-term cardiovascular outcomes post-percutaneous coronary intervention (PCI) are not well studied. METHODS AND RESULTS: We examined stented PCI patients at Duke (1996-2010) using linked data from the Duke Information Systems for Cardiovascular Care and the Duke Tumor Registry (a cancer treatment registry). Our primary outcome was cardiovascular mortality. Secondary outcomes included composite cardiovascular mortality, myocardial infarction, or repeat revascularization and all-cause mortality. We used adjusted cause-specific hazard models to examine outcomes among cancer patients (cancer treatment pre-PCI) versus controls (no cancer treatment pre-PCI). Cardiovascular mortality was explored in a cancer subgroup with recent (within 1 year pre-PCI) cancer and in post-PCI cancer patients using post-PCI cancer as a time-dependent variable. Among 15 008 patients, 3.3% (n=496) were cancer patients. Observed rates of 14-year cardiovascular mortality (31.4% versus 27.7%, P=0.31) and composite cardiovascular death, myocardial infarction, or revascularization (51.1% versus 55.8%, P=0.37) were similar for cancer versus control groups; all-cause mortality rates were higher (79.7% versus 49.3%, P<0.01). Adjusted risk of cardiovascular mortality was similar for cancer patients versus controls (hazard ratio 0.95; 95% CI 0.76 to 1.20) and for patients with versus without recent cancer (hazard ratio 1.46; 95% CI 0.92 to 2.33). Post-PCI cancer, present in 4.3% (n=647) of patients, was associated with cardiovascular mortality (adjusted hazard ratio 1.51; 95% CI 1.11 to 2.03). CONCLUSIONS: Cancer history was present in a minority of PCI patients but was not associated with worse long-term cardiovascular outcomes. Further investigation into PCI outcomes in this population is warranted.

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