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Coronary Artery Disease: HELP
Articles by Christian W. Hamm
Based on 63 articles published since 2008
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Between 2008 and 2019, C. Hamm wrote the following 63 articles about Coronary Artery Disease.
 
+ Citations + Abstracts
Pages: 1 · 2 · 3
1 Guideline [ESC/EACTS guidelines on myocardial revascularization : Amendments 2014]. 2014

Nef, H / Renker, M / Hamm, C W / Anonymous820812 / Anonymous830812. ·Medizinische Klinik I, Kardiologie und Angiologie, Universitätsklinikum Gießen, Klinikstr. 33, 35392, Gießen, Deutschland, holger.nef@me.com. ·Herz · Pubmed #25406330.

ABSTRACT: One of the most important treatment principles in interventional cardiology relies on myocardial revascularization by percutaneous coronary intervention (PCI) or surgical placement of coronary artery bypass grafts (CABG). However, in order to apply these principles effectively, it is important to identify patients who require revascularization. Consequently, the appropriate method has to be selected to effectively restore blood flow. Patients will only benefit from the interventional or surgical procedures when those revascularization measures that can cause more harm than good are avoided. In the new European Society of Cardiology and European Association for Cardio-Thoracic Surgery (ESC/EACTS) guidelines on myocardial revascularization some new aspects will be addressed.

2 Editorial Calcium and C-reactive protein hot enough to predict the future? 2011

Hamm, Christian W / Nef, Holger M / Rolf, Andreas / Möllmann, Helge. · ·J Am Coll Cardiol · Pubmed #21435515.

ABSTRACT: -- No abstract --

3 Review Bioresorbable scaffolds in daily clinical routine: a practical review of all-comers results. 2015

Wiebe, Jens / Hamm, Christian W / Nef, Holger M. ·aUniversity of Giessen, Medizinische Klinik I, Department of Cardiology, Giessen bDeutsches Herzzentrum München, Munich cKerckhoff Heart and Thorax Center, Department of Cardiology, Bad Nauheim, Germany. ·Curr Opin Cardiol · Pubmed #26447503.

ABSTRACT: PURPOSE OF REVIEW: Bioresorbable scaffolds (BRS) are a major advancement in interventional cardiology, but experience with BRS use in daily routine is currently limited. Here, we review technical features of commercially available BRS and place them in context with current clinical scientific evidence. RECENT FINDINGS: Everolimus and novolimus-eluting poly-L-lactic acid (PLLA)-based BRS are commercially available in Europe. The everolimus-eluting BRS is the most widely investigated BRS and several all-comers investigations with this device are ongoing. Of the patients in these studies, 37-100% underwent catheterization due to acute coronary syndrome and up to 25% were diabetic. Up to 64.7% of all lesions treated were considered to be complex. Follow-up varied between 30 days and 1 year. The target lesion revascularization rate was up to 10% and scaffold thrombosis was 0-3%. SUMMARY: Accumulating data on BRS application are now available. Several studies have demonstrated that BRS implantation is technically feasible in a variety of different patient subsets and clinical presentations, and follow-up results support BRS use. Patients with acute coronary syndrome represent the most investigated subpopulation, and results suggest that BRS use for this indication is reasonable.

4 Review Current status of bioresorbable scaffolds in the treatment of coronary artery disease. 2014

Wiebe, Jens / Nef, Holger M / Hamm, Christian W. ·Department of Cardiology, Kerckhoff Heart Center, University of Giessen, Giessen, Germany. · Department of Cardiology, Kerckhoff Heart Center, University of Giessen, Giessen, Germany. Electronic address: christian.hamm@innere.med.uni-giessen.de. ·J Am Coll Cardiol · Pubmed #25500240.

ABSTRACT: State-of-the-art drug-eluting metal stents are the gold standard for interventional treatment of coronary artery disease. Although they overcome some disadvantages and limitations of plain balloon angioplasty and bare-metal stents, some limitations apply, most notably a chronic local inflammatory reaction due to permanent implantation of a foreign body, restriction of vascular vasomotion due to a metal cage, and the risk of late and very late stent thrombosis. The development of biodegradable scaffolds is a new approach that attempts to circumvent these drawbacks. These devices provide short-term scaffolding of the vessel and then dissolve, which should theoretically circumvent the side effects of metal drug-eluting stents. Various types of these bioresorbable scaffolds are currently under clinical evaluation. This review discusses different concepts of bioresorbable scaffolds with respect to material, design, and drug elution and presents the most recent evidence.

5 Review Open issues in transcatheter aortic valve implantation. Part 1: patient selection and treatment strategy for transcatheter aortic valve implantation. 2014

Bax, Jeroen J / Delgado, Victoria / Bapat, Vinayak / Baumgartner, Helmut / Collet, Jean P / Erbel, Raimund / Hamm, Christian / Kappetein, Arie P / Leipsic, Jonathon / Leon, Martin B / MacCarthy, Philip / Piazza, Nicolo / Pibarot, Philippe / Roberts, William C / Rodés-Cabau, Josep / Serruys, Patrick W / Thomas, Martyn / Vahanian, Alec / Webb, John / Zamorano, Jose Luis / Windecker, Stephan. ·Department of Cardiology, Leiden University Medical Center, Albinusdreef 2 2300 RC, Leiden, The Netherlands j.j.bax@lumc.nl. · Department of Cardiology, Leiden University Medical Center, Albinusdreef 2 2300 RC, Leiden, The Netherlands. · Department of Cardiology and Cardiothoracic Surgery, St Thomas' Hospital, London, UK. · Division of Adult Congenital and Valvular Heart Disease, Department of Cardiovascular Medicine, University Hospital Muenster, Muenster, Germany. · Institut de Cardiologie, Groupe Hospitalier Pitié-Salpêtrière, Paris, France. · Department of Cardiology, West-German Heart Center Essen, University Duisburg Essen, Essen, Germany. · Department of Cardiology, Kerckhoff-Klinik, Bad Nauheim, Germany. · Erasmus Medical Center, Rotterdam, The Netherlands. · St Paul's Hospital, University of British Columbia, Vancouver, British Columbia, Canada. · Columbia University Medical Center, Center for Interventional Vascular Therapy, New York Presbyterian Hospital, New York, USA. · Cardiovascular Department, King's College Hospital, London, UK. · Interventional Cardiology, McGill University Health Center, Montreal, Canada Cardiovascular Surgery, German Heart Center Munich, Bavaria, Germany. · Quebec Heart and Lung Institute, Québec, Canada. · Baylor Heart and Vascular Institute and the Departments of Internal Medicine (Division of Cardiology) and Pathology, Baylor University Medical Center, Dallas, TX, USA. · Department of Cardiology, Laval University, Quebec, Canada. · Bichat Hospital, University Paris VII, Paris, France. · Cardiac Imaging Department, University Hospital Ramon y Cajal, Madrid, Spain. · Department of Cardiology, Bern University Hospital, Bern, Switzerland. ·Eur Heart J · Pubmed #25062952.

ABSTRACT: An exponential increase in the use of transcatheter aortic valve implantation (TAVI) in patients with severe aortic stenosis has been witnessed over the recent years. The current article reviews different areas of uncertainty related to patient selection. The use and limitations of risk scores are addressed, followed by an extensive discussion on the value of three-dimensional imaging for prosthesis sizing and the assessment of complex valve anatomy such as degenerated bicuspid valves. The uncertainty about valvular stenosis severity in patients with a mismatch between the transvalvular gradient and the aortic valve area, and how integrated use of echocardiography and computed tomographic imaging may help, is also addressed. Finally, patients referred for TAVI may have concomitant mitral regurgitation and/or coronary artery disease and the management of these patients is discussed.

6 Clinical Trial A randomized, parallel group, double-blind study of ticagrelor compared with aspirin for prevention of vascular events in patients undergoing coronary artery bypass graft operation: Rationale and design of the Ticagrelor in CABG (TiCAB) trial: An Investigator-Initiated trial. 2016

de Waha, Antoinette / Sandner, Sigrid / von Scheidt, Moritz / Boening, Andreas / Koch-Buettner, Katharina / Hammel, Dieter / Hambrecht, Rainer / Danner, Bernhard C / Schöndube, Friedrich A / Goerlach, Gerold / Fischlein, Theodor / Schmoeckel, Michael / Oberhoffer, Martin / Schulz, Rainer / Walther, Thomas / Ziegelhöffer, Tibor / Knosalla, Christoph / Schönrath, Felix / Beyersdorf, Friedhelm / Siepe, Matthias / Attmann, Tim / Misfeld, Martin / Mohr, Friedrich-Wilhelm / Sievers, Hans-Hinrich / Joost, Alexander / Putman, Leon M / Laufer, Günther / Hamm, Christian / Zeymer, Uwe / Kastrati, Adnan / Radke, Peter W / Lange, Rüdiger / Cremer, Jochen / Schunkert, Heribert. ·German Heart Center Munich, Technische Universität München, Munich, Germany; DZHK (German Center for Cardiovascular Research), and partner site Munich Heart Alliance, Munich, Germany. Electronic address: dewaha@dhm.mhn.de. · Department of Cardiac Surgery, Vienna General Hospital, Medical University of Vienna, Vienna, Austria. · German Heart Center Munich, Technische Universität München, Munich, Germany; DZHK (German Center for Cardiovascular Research), and partner site Munich Heart Alliance, Munich, Germany. · Department of Cardiovascular Surgery, Justus-Liebig University Gießen, Germany. · Department of Cardiac Surgery, Klinikum Links der Weser, Bremen, Germany. · Department of Cardiology and Angiology, Klinikum Links der Weser, Bremen, Germany. · Department of Thoracic and Cardiovascular Surgery, Georg-August-University Goettingen, Goettingen, Germany. · Department of Cardiac Surgery, Paracelsus Medical University, Klinikum Nürnberg, Germany. · Department of Cardiac Surgery, Asklepios Klinik St. Georg/Cardioclinic Harburg, Hamburg, Germany. · Institute of Physiology, Justus-Liebig University, Giessen, Germany. · Department of Cardiac Surgery, Kerckhoff Heart and Thorax Center, Bad Nauheim, Germany. · Department of Cardiothoracic and Vascular Surgery, German Heart Institute Berlin, Germany. · Department of Cardiothoracic and Vascular Surgery, German Heart Institute Berlin, Germany; DZHK (German Center for Cardiovascular research)-partner side Berlin. · Department of Cardiovascular Surgery, Heart Center Freiburg University, Freiburg, Germany. · Department of Cardiovascular Surgery, University Hospital Schleswig-Holstein, Kiel, Germany. · Department of Cardiac Surgery, Heart Center Leipzig, University of Leipzig, Leipzig, Germany. · Department of Cardiac and Thoracic Vascular Surgery, University of Lübeck, Lübeck, Germany. · Medical Clinic II, Cardiology, Angiology and Intensive Care Medicine, University Hospital Schleswig-Holstein, Campus Lübeck, Lübeck, Germany. · Department of Cardiology, Kerckhoff Heart and Thorax Center, Germany Justus Liebig University of Giessen, Department of Internal Medicine I, Gießen, Germany. · Department of Cardiology, Heart Center Ludwigshafen, Ludwigshafen am Rhein, Germany. · Klinik für Innere Medizin, Schön Klinik Neustadt, Neustadt i.H., Germany. · Department of Cardiovascular Surgery, German Heart Center Munich, Germany. ·Am Heart J · Pubmed #27595681.

ABSTRACT: BACKGROUND: For patients with coronary artery disease undergoing coronary bypass surgery, acetylsalicylic acid (ASA) currently represents the gold standard of antiplatelet treatment. However, adverse cardiovascular event rates in the first year after coronary artery bypass grafting (CABG) still exceed 10%. Graft failure, which is predominantly mediated by platelet aggregation, has been identified as a major contributing factor in this context. Therefore, intensified platelet inhibition is likely to be beneficial. Ticagrelor, an oral, reversibly binding and direct-acting P2Y12 receptor antagonist, provides a rapid, competent, and consistent platelet inhibition and has shown beneficial results compared with clopidogrel in the subset of patients undergoing bypass surgery in a large previous trial. HYPOTHESIS: Ticagrelor is superior to ASA for the prevention of major cardiovascular events within 1 year after CABG. STUDY DESIGN: The TiCAB trial (NCT01755520) is a multicenter, phase III, double-blind, double-dummy, randomized trial comparing ticagrelor with ASA for the prevention of major cardiovascular events within 12 months after CABG. Patients undergoing CABG will be randomized in a 1:1 fashion to either ticagrelor 90 mg twice daily or ASA 100 mg once daily. The study medication will be started within 24 hours after surgery and maintained for 12 months. The primary end point is the composite of cardiovascular death, myocardial infarction, stroke, and repeat revascularization at 12 months after CABG. The sample size is based on an expected event rate of 13% of the primary end point within the first 12 months after randomization in the control group, a 2-sided α level of .0492 (to preserve the overall significance level of .05 after planned interim analysis), a power of 0.80%, 2-sided testing, and an expected relative risk of 0.775 in the active group compared with the control group and a dropout rate of 2%. According to power calculations based on a superiority design for ticagrelor, it is estimated that 3,850 patients should be enrolled. SUMMARY: There is clinical equipoise on the issue of optimal platelet inhibition after CABG. The TiCAB trial will provide a pivotal comparison of the efficacy and safety of ticagrelor compared with ASA after CABG.

7 Clinical Trial β-Blockers and ivabradine differentially affect cardiopulmonary function and left ventricular filling index. 2016

Fischer-Rasokat, Ulrich / Honold, Jörg / Lochmann, Denise / Wolter, Sebastian / Liebetrau, Christoph / Fichtlscherer, Stephan / Möllmann, Helge / Spyridopoulos, Ioakim / Hamm, Christian W. ·Department of Cardiology, Kerckhoff Heart Center, Benekestr. 2-8, 61231, Bad Nauheim, Germany. fischer-rasokat@gmx.de. · Department of Cardiology, University Hospital of the Goethe University, Theodor-Stern-Kai 7, 60596, Frankfurt/Main, Germany. · Department of Cardiology, Kerckhoff Heart Center, Benekestr. 2-8, 61231, Bad Nauheim, Germany. ·Clin Res Cardiol · Pubmed #26687495.

ABSTRACT: OBJECTIVE: Patients with left ventricular (LV) diastolic dysfunction are characterized by exertional dyspnoea. Heart rate (HR) reduction by β-blockers can improve exercise tolerance by prolonging LV filling, but their negative inotropic and lusitropic properties can be detrimental in this disease. We tested the effects of administering ivabradine, a HR-lowering drug without impact on cardiac kinetics that may favorably affect diastolic function. METHODS: Twenty-four patients with coronary artery disease (CAD) and normal LV ejection fraction on chronic β-blocker therapy were included. NT-proBNP serum levels were determined prior to and after cardiopulmonary exercise. β-Blockers were then replaced by ivabradine and patients were re-tested after 6 weeks. Patients were initially classified as having a low (E/e' ≤ 8; n = 11) or high (E/e' > 8; n = 13) LV filling index. RESULTS: E/e' significantly decreased during ivabradine therapy in patients with high E/e' (10.7 ± 2.9 vs. 8.9 ± 1.7; p < 0.01), whereas no difference occurred in patients with low E/e' (6.4 ± 0.7 vs. 6.5 ± 1.1; p = ns). With ivabradine, patients with high E/e' had an increased oxygen uptake at the anaerobic threshold (from 10.8 ± 1.4 to 11.8 ± 1.9 ml/min/kg; p < 0.05) and a steeper slope of the initial oxygen pulse curve (from 293 ± 109 to 359 ± 117 µl/beat/kg/W; p < 0.05). Moreover, patients with high E/e' had lower NT-proBNP serum levels at rest (169 ± 207 vs. 126 ± 146 pg/ml; p < 0.05) and after exercise (190 ± 256 vs. 136 ± 162 pg/ml; p < 0.05) during ivabradine therapy. CONCLUSIONS: In patients with CAD and elevated E/e', switching therapy from β-blockers to ivabradine may cause a reduction in LV filling pressures and an improved stroke volume response to exercise.

8 Clinical Trial Short- and long-term health related quality-of-life and anginal status of the Arterial Revascularisation Therapies Study part II, ARTS-II; sirolimus-eluting stents for the treatment of patients with multivessel coronary artery disease. 2010

van Domburg, Ron T / Daemen, Joost / Morice, Marie-Claude / de Bruyne, Bernard / Colombo, Antonio / Macaya, Carlos / Richardt, Gert / Fajadet, Jean / Hamm, Christian / van Es, Gerrit-Anne / Wittebols, Kristel / Macours, Nathalie / Stoll, Hans Peter / Serruys, Patrick W. ·Erasmus Medical Center, Rotterdam, The Netherlands. r.vandomburg@erasmusmc.nl ·EuroIntervention · Pubmed #20542782.

ABSTRACT: AIMS: Assessment of health related quality-of-life (HRQL) has become increasingly important as not only the clinician's view of the technical success, but also the patient's perception is being measured. We evaluated the HRQL following sirolimus-eluting coronary stent (SES) (CYPHER(R); Cordis, Johnson & Johnson, Warren, NJ, USA) implantation in patients with multivessel disease, comparing the outcomes with the historical surgical and bare metal stent (BMS) arms of the ARTS-I study. METHODS AND RESULTS: The HRQL outcomes were compared to the outcome of the historical cohorts of the randomised ARTS-I trial using the same inclusion and exclusion criteria. HRQL was evaluated at baseline, at one month and at 6, 12 and 36 months after revascularisation using the SF-36 in patients treated with SES (n=585), BMS (n=483) or coronary artery bypass graft (CABG) (n=492). The HRQL compliance rates varied from 100% at baseline to 92% at 36 months. Both stenting and CABG resulted in significant improvement of HRQL and anginal status. There was a trend towards better HRQL after CABG than BMS beyond six months. Already from the first month up to three years, SES patients had, on average, 10% significantly better HRQL than BMS patients on the HRQL subscales physical functioning, role physical functioning, role emotional functioning and mental health (p<0.01) and a trend towards better HRQL in the other subscales. Up to 12 months, the HRQL was better after SES than CABG and was identical thereafter. At all time points, angina was more prevalent in the BMS group than in both the SES and CABG groups, in which the incidence of angina was similar. At three years, 10% of the SES patients suffered from angina, 13% of the CABG patients and 20% of the BMS patients. CONCLUSIONS: Both stenting and CABG resulted in a significant improvement in HRQL and angina. Along with a substantial reduction of restenosis, HRQL after SES was significantly improved as compared with BMS, and was similar to CABG.

9 Clinical Trial 5-year clinical outcomes of the ARTS II (Arterial Revascularization Therapies Study II) of the sirolimus-eluting stent in the treatment of patients with multivessel de novo coronary artery lesions. 2010

Serruys, Patrick W / Onuma, Yoshinobu / Garg, Scot / Vranckx, Pascal / De Bruyne, Bernard / Morice, Marie-Claude / Colombo, Antonio / Macaya, Carlos / Richardt, Gert / Fajadet, Jean / Hamm, Christian / Schuijer, Monique / Rademaker, Tessa / Wittebols, Kristel / Stoll, Hans Peter / Anonymous2230651. ·Thoraxcenter, Erasmus Medical Center, Rotterdam, the Netherlands. p.w.j.c.serruys@erasmusmc.nl ·J Am Coll Cardiol · Pubmed #20171036.

ABSTRACT: OBJECTIVES: The purpose of this study is to compare the 5-year clinical outcomes, safety, and efficacy of sirolimus-eluting stents (SES) in the ARTS II (Arterial Revascularization Therapies Study II) with the outcomes of coronary artery bypass graft (CABG) and bare-metal stenting (BMS) from the ARTS I. BACKGROUND: The long-term outcomes after SES implantation in patients with multivessel disease remains to be established. METHODS: The ARTS I was a randomized trial of 1,205 patients with multivessel disease comparing CABG and BMS. The ARTS II study was a nonrandomized trial with the Cypher sirolimus-eluting stent (Cordis, a Johnson & Johnson Company, Warren, New Jersey), applying the same inclusion and exclusion criteria, end points, and protocol definitions. The ARTS II trial enrolled 607 patients, with an attempt to enroll at least one-third of patients with 3-vessel disease. RESULTS: At 5-year, the death/stroke/myocardial infarction event-free survival rate was 87.1% in ARTS II SES, versus 86.0% (p = 0.1) and 81.9% (p = 0.007) in ARTS I CABG and BMS cohorts, respectively. The 5-year major adverse cardiac and cerebrovascular event (MACCE) rate in ARTS II (27.5%) was significantly higher than ARTS I CABG (21.1%, p = 0.02), and lower than in ARTS I BMS (41.5%, p < 0.001). The cumulative incidence of definite stent thrombosis was 3.8%. Thirty-two percent (56 of 176) of major adverse cardiac events (MACE) at 5 years were related to possible, probable, or definite stent thrombosis. CONCLUSIONS: At 5 years, SES had a safety record comparable to CABG and superior to BMS, and a MACCE rate that was higher than in patients treated with CABG, and lower than in those treated with BMS. Approximately one-third of the events seen with SES could be prevented through the elimination of early, late, and very late stent thrombosis.

10 Article Ticagrelor plus aspirin for 1 month, followed by ticagrelor monotherapy for 23 months vs aspirin plus clopidogrel or ticagrelor for 12 months, followed by aspirin monotherapy for 12 months after implantation of a drug-eluting stent: a multicentre, open-label, randomised superiority trial. 2018

Vranckx, Pascal / Valgimigli, Marco / Jüni, Peter / Hamm, Christian / Steg, Philippe Gabriel / Heg, Dik / van Es, Gerrit Anne / McFadden, Eugene P / Onuma, Yoshinobu / van Meijeren, Cokky / Chichareon, Ply / Benit, Edouard / Möllmann, Helge / Janssens, Luc / Ferrario, Maurizio / Moschovitis, Aris / Zurakowski, Aleksander / Dominici, Marcello / Van Geuns, Robert Jan / Huber, Kurt / Slagboom, Ton / Serruys, Patrick W / Windecker, Stephan / Anonymous2921283. ·Jessa Ziekenhuis, Faculty of Medicine and Life Sciences at the Hasselt University, Hasselt, Belgium. · Department of Cardiology, Inselspital, Bern University Hospital, University of Bern, Bern, Switzerland. · Applied Health Research Centre, Li Ka Shing Knowledge Institute of St Michael's Hospital, Department of Medicine and Institute of Health Policy, Management and Evaluation, University of Toronto, Toronto, ON, Canada. · Kerckhoff Heart and Thorax Center, Bad Nauheim, Germany. · Université Paris-Diderot, Hôpital Bichat, Assistance Publique-Hôpitaux de Paris, INSERM U-1148, French Alliance for Cardiovascular Trials, Paris, France; National Heart and Lung Institute, Royal Brompton Hospital, Imperial College London, London, UK. · Institute of Social and Preventive Medicine, University of Bern, Bern, Switzerland. · European Cardiovascular Research Institute, Rotterdam, Netherlands. · Cork University Hospital, Cork, Ireland. · Erasmus Medical Center, Rotterdam, Netherlands; Cardialysis, Rotterdam, Netherlands. · Cardialysis, Rotterdam, Netherlands. · Academic Medical Center of Amsterdam, Amsterdam, Netherlands. · Imeldaziekenhuis, Bonheiden, Belgium. · UOC Cardiologia, Fondazione IRCCS Policlinico San Matteo, Pavia, Italy. · American Heart of Poland, Center for Cardiovascular Research and Development, Katowice, Poland. · Azienda Ospedaliera S Maria, Terni, Italy. · Erasmus Medical Center, Rotterdam, Netherlands. · 3rd Department of Medicine, Cardiology and Intensive Care Medicine, Wilhelminenhospital and Sigmund Freud University, Medical Faculty, Vienna, Austria. · Onze Lieve vrouwe Gasthuis, Amsterdam, Netherlands. · Erasmus Medical Center, Rotterdam, Netherlands; Academic Medical Center of Amsterdam, Amsterdam, Netherlands. Electronic address: patrick.w.j.c.serruys@gmail.com. · Department of Cardiology, Inselspital, Bern University Hospital, University of Bern, Bern, Switzerland. Electronic address: stephan.windecker@insel.ch. ·Lancet · Pubmed #30166073.

ABSTRACT: BACKGROUND: We hypothesised that ticagrelor, in combination with aspirin for 1 month, followed by ticagrelor alone, improves outcomes after percutaneous coronary intervention compared with standard antiplatelet regimens. METHODS: GLOBAL LEADERS was a randomised, open-label superiority trial at 130 sites in 18 countries. Patients undergoing percutaneous coronary intervention with a biolimus A9-eluting stent for stable coronary artery disease or acute coronary syndromes were randomly assigned (1:1) to 75-100 mg aspirin daily plus 90 mg ticagrelor twice daily for 1 month, followed by 23 months of ticagrelor monotherapy, or standard dual antiplatelet therapy with 75-100 mg aspirin daily plus either 75 mg clopidogrel daily (for patients with stable coronary artery disease) or 90 mg ticagrelor twice daily (for patients with acute coronary syndromes) for 12 months, followed by aspirin monotherapy for 12 months. Randomisation was concealed, stratified by centre and clinical presentation (stable coronary artery disease vs acute coronary syndrome), and blocked, with randomly varied block sizes of two and four. The primary endpoint at 2 years was a composite of all-cause mortality or non-fatal centrally adjudicated new Q-wave myocardial infarction as assessed by a core lab in a blinded manner. The key secondary safety endpoint was site-reported bleeding assessed according to the Bleeding Academic Research Consortium criteria (grade 3 or 5). Analysis was by intention to treat. This trial is registered with ClinicalTrials.gov, number NCT01813435, and is closed to new participants, with follow-up completed. FINDINGS: Between July 1, 2013, and Nov 9, 2015, 15 968 participants were randomly assigned, 7980 to the experimental group and 7988 to the control group. At 2 years, 304 (3·81%) participants in the experimental group had died or had a non-fatal centrally adjudicated new Q-wave myocardial infarction, compared with 349 (4·37%) participants in the control group (rate ratio 0·87 [95% CI 0·75-1·01]; p=0·073]). There was no evidence for a difference in treatment effects for the primary endpoint across prespecified subgroups of acute coronary syndromes and stable coronary artery disease (p=0·93). Grade 3 or 5 bleeding occurred in 163 participants in the experimental group and 169 in the control group (2·04% vs 2·12%; rate ratio 0·97 [95% CI 0·78-1·20]; p=0·77). INTERPRETATION: Ticagrelor in combination with aspirin for 1 month followed by ticagrelor alone for 23 months was not superior to 12 months of standard dual antiplatelet therapy followed by 12 months of aspirin alone in the prevention of all-cause mortality or new Q-wave myocardial infarction 2 years after percutaneous coronary intervention. FUNDING: AstraZeneca, Biosensors, and The Medicines Company.

11 Article Short- and long-term mortality following bleeding events in patients undergoing percutaneous coronary intervention: insights from four validated bleeding scales in the CHAMPION trials. 2018

Vaduganathan, Muthiah / Harrington, Robert A / Stone, Gregg W / Steg, Gabriel / Gibson, C Michael / Hamm, Christian W / Price, Matthew J / Lopes, Renato D / Leonardi, Sergio / Deliargyris, Efthymios N / Prats, Jayne / Mahaffey, Kenneth W / White, Harvey D / Bhatt, Deepak L. ·Brigham and Women's Hospital Heart & Vascular Center and Harvard Medical School, Boston, MA, USA. ·EuroIntervention · Pubmed #28988157.

ABSTRACT: AIMS: The aim of this study was to determine the prognostic significance of periprocedural bleeding based on various definitions on 30-day and one-year all-cause mortality in patients undergoing routine or urgent percutaneous coronary intervention (PCI). METHODS AND RESULTS: In this exploratory analysis of 25,107 patients enrolled in the three phase-3 CHAMPION trials, we assessed the prognostic impact of four bleeding scales (GUSTO, TIMI, ACUITY, and BARC) at 48 hrs. Follow-up all-cause mortality data were available at 30 days in all three trials, and at one year in CHAMPION PCI and CHAMPION PLATFORM. Bleeding rates within 48 hrs of PCI were variably identified by each clinical definition (range: <0.5% to >3.5%). Severe/major bleeding, measured by all bleeding scales, and blood transfusion requirement were independently associated with increased mortality at 30 days and one year after PCI (p<0.001 for all associations). Mild/minor bleeding was not independently predictive of one-year mortality (p>0.07 for all associations). Each bleeding definition demonstrated only modest ability to discriminate 30-day and one-year mortality (adjusted C-statistics range: 0.49 to 0.67). CONCLUSIONS: Commonly employed clinical definitions variably identify rates of bleeding after PCI. Severe or major, but not mild or minor, bleeding is independently associated with increased 30-day and one-year mortality. These data may aid in selection of appropriate bleeding metrics in future clinical trials.

12 Article Cysteine-rich angiogenic inducer 61 (Cyr61): a novel soluble biomarker of acute myocardial injury improves risk stratification after acute coronary syndromes. 2017

Klingenberg, Roland / Aghlmandi, Soheila / Liebetrau, Christoph / Räber, Lorenz / Gencer, Baris / Nanchen, David / Carballo, David / Akhmedov, Alexander / Montecucco, Fabrizio / Zoller, Stefan / Brokopp, Chad / Heg, Dik / Jüni, Peter / Marti Soler, Helena / Marques-Vidal, Pedro-Manuel / Vollenweider, Peter / Dörr, Oliver / Rodondi, Nicolas / Mach, François / Windecker, Stephan / Landmesser, Ulf / von Eckardstein, Arnold / Hamm, Christian W / Matter, Christian M / Lüscher, Thomas F. ·Department of Cardiology, University Heart Center, University Hospital of Zurich and Center for Molecular Cardiology, University of Zurich, Rämistr. 100, CH-8091 Zurich, Switzerland and Wagistr. 12, CH-8952 Schlieren, Switzerland. · Department of Cardiology, Kerckhoff Heart and Thorax Center, Kerckhoff-Klinik, Benekestr. 2-8, D-61231 Bad Nauheim, Germany. · DZHK (German Center for Cardiovascular Research), Partner Site Rhine-Main, Benekestr. 2-8, D-61231 Bad Nauheim, Germany. · Institute of Social and Preventive Medicine (ISPM), University of Bern, Finkenhubelweg 11, CH-3012 Bern, Switzerland. · CTU Bern, University of Bern, Finkenhubelweg 11, CH-3012 Bern, Switzerland. · Institute for Clinical Epidemiology and Biostatistics, University Hospital of Basel, Spitalstr. 12, CH-4056 Basel, Switzerland. · Department of Cardiology, Cardiovascular Center, University Hospital of Bern, Freiburgstr. 18, CH-3010 Bern, Switzerland. · Department of Cardiology, Cardiovascular Center, University Hospital of Geneva, Rue Gabrielle-Perret-Gentil 4, CH-1211 Geneva 14, Switzerland. · Department of Ambulatory Care and Community Medicine, University of Lausanne, Rue du Bugnon 44, CH-1011 Lausanne, Switzerland. · First Clinic of Internal Medicine, Department of Internal Medicine, University of Genoa, 6, Viale Benedetto XV, IT-16132 Genoa, Italy. · Bioinformatics, Genetic Diversity Center, Federal Institute of Technology (ETH), Universitätsstr. 16, CH-8092 Zurich, Switzerland. · Department of Cardiothoracic Surgery, Regenerative Medicine Center, Department of Cardiothoracic Surgery, University Hospital of Zurich, Wagistr. 12, CH-8952 Schlieren, Switzerland. · Applied Health Research Centre (AHRC), Li Ka Shing Knowledge Institute of St. Michael's Hospital, University of Toronto, 209 Victoria St, Toronto, ON M5B 1T8, Canada. · Department of General Internal Medicine, University Hospital of Lausanne, Rue du Bugnon 46, CH-1011 Lausanne, Switzerland. · Department of Cardiology, University Hospital of Giessen, Klinikstr. 33; D-35392 Giessen, Germany. · Institute of Primary Health Care (BIHAM), University of Bern, Gesellschaftsstr. 49, CH-3012 Bern, Switzerland. · Department of General Internal Medicine, University Hospital of Bern, Freiburgstr. 18, CH-3010 Bern, Switzerland. · Department of Cardiology, Charité Campus Benjamin-Franklin, Hindenburgdamm 30, D-12200 Berlin, Germany. · Institute of Clinical Chemistry, University Hospital of Zurich, Rämistr. 100, CH-8091 Zurich, Switzerland. ·Eur Heart J · Pubmed #29155984.

ABSTRACT: Aims: We aimed to identify a novel biomarker involved in the early events leading to an acute coronary syndrome (ACS) and evaluate its role in diagnosis and risk stratification. Methods and results: Biomarker identification was based on gene expression profiling. In coronary thrombi of ACS patients, cysteine-rich angiogenic inducer 61 (Cyr61, CCN1) gene transcripts were highly up-regulated compared with peripheral mononuclear cells. In a murine ischaemia-reperfusion model (I/R), myocardial Cyr61 expression was markedly increased compared with the controls. Cyr61 levels were determined in human serum using an enzyme-linked immunosorbent assay. Cohorts of ACS (n = 2168) referred for coronary angiography, stable coronary artery disease (CAD) (n = 53), and hypertrophic obstructive cardiomyopathy (HOCM) patients (n = 15) served to identify and evaluate the diagnostic and prognostic performance of the biomarker. Cyr61 was markedly elevated in ST-elevation myocardial infarction patients compared with non-ST-elevation myocardial infarction/unstable angina or stable CAD patients, irrespective of whether coronary thrombi were present. Cyr61 was rapidly released after occlusion of a septal branch in HOCM patients undergoing transcoronary ablation of septal hypertrophy. Cyr61 improved risk stratification for all-cause mortality when added to the reference GRACE risk score at 30 days (C-statistic 0.88 to 0.89, P = 0.001) and 1 year (C-statistic 0.77 to 0.80, P < 0.001) comparable to high-sensitivity troponin T (30 days: 0.88 to 0.89, P < 0.001; 1 year: 0.77 to 0.79, P < 0.001). Similar results were obtained for the composite endpoint of all-cause mortality or myocardial infarction. Conversely, in a population-based case-control cohort (n = 362), Cyr61 was not associated with adverse outcome. Conclusion: Cyr61 is a novel early biomarker reflecting myocardial injury that improves risk stratification in ACS patients.

13 Article Everolimus-eluting bioresorbable scaffolds in patients with coronary artery disease: results from the German-Austrian ABSORB RegIstRy (GABI-R). 2017

Nef, Holger M / Wiebe, Jens / Kastner, Johannes / Mehilli, Julinda / Muenzel, Thomas / Naber, Christoph / Neumann, Till / Richardt, Gert / Schmermund, Axel / Woehrle, Jochen / Zahn, Ralf / Riemer, Thomas / Achenbach, Stephan / Hamm, Christian W. ·Medizinische Klinik I, Department of Cardiology, University of Giessen, Giessen, Germany. ·EuroIntervention · Pubmed #28829745.

ABSTRACT: AIMS: The aim of this study was to analyse the procedural results and midterm safety of everolimus-eluting bioresorbable vascular scaffolds (BVS) used for percutaneous coronary intervention in a large all-comers cohort from the German-Austrian ABSORB RegIstRy (GABI-R). METHODS AND RESULTS: A total of 3,231 patients were included in this prospective, observational, multicentre study (ClinicalTrials.gov NCT02066623) of consecutive patients undergoing BVS implantation between November 2013 and January 2016. Endpoints were major adverse cardiac events (MACE; a composite endpoint of death, target vessel revascularisation, and myocardial infarction), and target lesion failure (TLF; a composite endpoint of cardiac death, target vessel myocardial infarction, and target lesion revascularisation). Scaffold thrombosis was a further endpoint. Of all patients, 51.5% presented with acute coronary syndrome. Predilatation and post-dilatation were performed in 91.5% and 71.9% of patients, respectively. Procedural success was 98.9%. After six months, the incidence of MACE was 4.1% and of TLF 2.4%. The rate of target vessel MI was 1.5%, and target lesion revascularisation was performed in 1.8%. Definite/ probable scaffold thrombosis was documented in 1.4% of patients. CONCLUSIONS: GABI-R, the largest registry to provide data regarding safety after BVS implantation in a real-world setting, reveals high procedural success and low six-month event rates.

14 Article Long-term clinical outcome after implantation of the self-expandable STENTYS stent in a large, multicenter cohort. 2017

Gaede, Luise / Liebetrau, Christoph / Dörr, Oliver / Blumenstein, Johannes / Elsässer, Albrecht / Hamm, Christian W / Möllmann, Helge / Schlundt, Christian / Nef, Holger M / Achenbach, Stephan. ·aDepartment of Cardiology and Angiology, Friedrich Alexander University Erlangen-Nürnberg, Nürnberg bDepartment of Internal Medicine, St.-Johannes-Hospital, Dortmund cDepartment of Cardiology, Kerckhoff Heart and Thorax Center, Bad Nauheim dDepartment of Cardiology and Angiology, Medical Clinic I, Justus Liebig University of Giessen, Giessen eDepartment of Cardiology, Klinikum Oldenburg, University of Oldenburg, Oldenburg, Germany. ·Coron Artery Dis · Pubmed #28704242.

ABSTRACT: OBJECTIVE: The objective of the study was to retrospectively evaluate the long-term clinical outcome after implantation of the self-expandable (SE) STENTYS stent in a large multicenter cohort. BACKGROUND: Incomplete stent apposition is known to cause higher rates of myocardial infarction (MI) and stent thrombosis. Because of its self-expanding features, the SE STENTYS stent adapts to the vessel wall and is therefore expected to minimize malapposition and therefore the rates of MI and stent thrombosis. PATIENTS AND METHODS: Treatment with a total of 351 SE coronary stents was attempted in 314 patients of a cohort from three German institutions between 2011 and 2015. Technical success was achieved with 331/351 (94%) stents. Patients treated successfully with SE stents (n=298) were followed up using the primary outcome measure of target lesion failure (TLF), a combined endpoint of cardiac mortality, recurrent target vessel MI, acute stent thrombosis, and clinically driven target lesion revascularization. Follow-up was complete in 268/298 (90%) patients with a median follow-up period of 2.5 (interquartile range: 1.4-3.3) years. RESULTS: TLF occurred in 54/298 (18%) patients. Event rates were 7.5% for cardiac mortality, 11.6% for target vessel MI, and 5.2% for clinically driven target lesion revascularization. Acute stent thrombosis occurred in 2/298 (0.7%). Overall, stent thrombosis had an incidence of 2.6% within the follow-up period. ST-elevation MI at baseline (P=0.02) and a dual antiplatelet therapy with clopidogrel for only 6 months (P=0.04) were the only clinical factors linked to the absence of TLF. CONCLUSION: Technical success of SE coronary stent implantation in an all-comer cohort of patients was high, although the rate of TLF and stent thrombosis during long-term follow-up was also relatively high.

15 Article Clinical restenosis and its predictors after implantation of everolimus-eluting bioresorbable vascular scaffolds: results from GABI-R. 2017

Mehilli, Julinda / Achenbach, Stephan / Woehrle, Jochen / Baquet, Moritz / Riemer, Thomas / Muenzel, Thomas / Nef, Holger / Naber, Christoph / Richardt, Gert / Zahn, Ralf / Gori, Tommaso / Neumann, Till / Kastner, Johannes / Schmermund, Axel / Hamm, Christian. ·Department of Cardiology, Munich University Clinic, LMU, Munich, Germany. ·EuroIntervention · Pubmed #28649953.

ABSTRACT: AIMS: The aim of this study was to assess clinical restenosis and its predictors after implantation of bioresorbable vascular scaffolds (BVS) in everyday practice in the large-scale German-Austrian ABSORB Registry (GABI-R). METHODS AND RESULTS: Between November 2013 and January 2016, 3,264 patients underwent BVS implantation in the 93 centres of GABI-R. At six-month follow-up, 24 patients experienced clinically indicated target lesion revascularisation (cTLR) unrelated to BVS thrombosis (cumulative incidence 0.76%; angiographically, 58.3% of in-BVS restenosis of focal pattern). Compared to patients without cTLR, patients with cTLR had more lesions per patient (1.83±1.0 vs. 1.36±0.7), complex (52.3% vs. 36.2%) and mild-to-moderately calcified lesions (65.9% vs. 60.5%) treated, and more frequently had overlapping BVS (22.2% vs. 10.8%), all p<0.05. Implanted BVS length was 40.0 mm (28.0, 46.9) vs. 23.0 mm (18.0, 30.0), p<0.001, remaining in the multivariable analysis the only independent predictor of cTLR (hazard ratio 1.02, 95% CI: 1.01-1.04, p<0.001). The myocardial infarction rate was also significantly higher among patients with cTLR, 29.2% vs. 1.7%, p<0.0001. CONCLUSIONS: cTLR related to BVS restenosis at six months after BVS implantation is a rare event depending on implanted BVS length. Whether cTLR increases the myocardial infarction risk needs to be evaluated at longer-term follow-up and within the setting of adequately powered randomised trials.

16 Article Impact of strut thickness on acute mechanical performance: A comparison study using optical coherence tomography between DESolve 150 and DESolve 100. 2017

Boeder, Niklas F / Dörr, Oliver / Bauer, Timm / Mattesini, Alessio / Elsässer, Albrecht / Liebetrau, Christoph / Achenbach, Stephan / Hamm, Christian W / Nef, Holger M. ·University of Giessen, Department of Cardiology, Germany. · Interventional Cardiology Unit, Heart and Vessels Department, Careggi Hospital, Florence, Italy. · Klinikum Oldenburg, Department of Cardiology, Germany. · Kerckhoff Klinik Bad Nauheim, Department of Cardiology, Germany. · University of Erlangen, Department of Cardiology, Germany. · University of Giessen, Department of Cardiology, Germany. Electronic address: holger.nef@innere.med.uni-giessen.de. ·Int J Cardiol · Pubmed #28579164.

ABSTRACT: OBJECTIVE: To evaluate the acute performance of a novolimus-eluting bioresorbable scaffold (BRS) with different strut thickness (DESolve system 150 and 100) using optical coherence tomography (OCT) in terms of appropriate scaffold deployment. BACKGROUND: Outcome after BRS implantation seen in registries and meta-analyses continue to show a higher rate of scaffold thrombosis than those reported with DES. Thus, second scaffold generations with lower strut thickness might have potential advantages in terms of flow disturbance. However, whether mechanical properties are comparable has to be evaluated. METHODS AND RESULTS: Fifty-seven patients undergoing OCT-guided scaffold implantation were enrolled consecutively in this retrospective study. The final pullback after DESolve 150 (n=42) and DESolve 100 (n=15) were compared. The following indices were calculated: mean and minimum area, residual area stenosis, incomplete strut apposition, tissue prolapse, eccentricity and symmetry indexes, strut fracture, and edge dissection. Most patients suffered a multi vessel disease. Maximum pre-dilatation balloon inflation pressure was 13.5±3.2 vs 14.5±2.5atm. OCT analysis showed a minimal lumen area of 6.1±1.9 vs 5.2±1.6mm CONCLUSION: OCT showed similar post-procedural scaffold geometry and outcome indicating that both BRS may be implanted with good acute performance. However, the trend towards a smaller MLA and a higher percentage of RAS suggest a decreased radial strength for the 100μm BRS. The attempt to reduce strut thickness should not result in loss of radial strength. CONDENSED ABSTRACT: Rates of scaffold thrombosis after bioresorbable scaffold (BRS) implantation are reported to be higher than after metallic stent (DES) implantation. Thus, second scaffold generations with lower strut thickness might have potential advantages in terms of flow disturbance. We aimed to evaluate the acute performance of a novolimus-eluting BRS with different strut thickness (DESolve system 150 and 100) using optical coherence tomography (OCT) in terms of appropriate scaffold deployment. OCT showed similar post-procedural scaffold geometry and outcome indicating that both BRS may be implanted with good acute performance. However, the data suggest a decreased radial strength for the 100μm BRS.

17 Article Cangrelor reduces the risk of ischemic complications in patients with single-vessel and multi-vessel disease undergoing percutaneous coronary intervention: Insights from the CHAMPION PHOENIX trial. 2017

Abnousi, Freddy / Sundaram, Vandana / Yong, Celina M / Prats, Jayne / Deliargyris, Efthymios N / Stone, Gregg W / Hamm, Christian W / Steg, Philippe Gabriel / Gibson, Charles Michael / White, Harvey D / Price, Matthew J / Généreux, Philippe / Desai, Manisha / Yang, Lingyao / Ding, Victoria Y / Harrington, Robert A / Bhatt, Deepak L / Mahaffey, Kenneth W. ·Stanford Center for Clinical Research, Department of Medicine, Stanford University School of Medicine, Stanford, CA. · Quantitative Sciences Unit, Department of Medicine, Stanford University School of Medicine, Stanford, CA. · The Medicines Company, Parsippany, NJ. · Columbia University Medical Center and the Cardiovascular Research Foundation, NY, New York. · Kerckhoff Heart and Thorax Center, Bad Nauheim, Germany. · DHU (Département Hospitalo-Universitaire)-FIRE (Fibrosis, Inflammation, REmodelling), Hôpital Bichat, AP-HPb (Assistance Publique-Hôpitaux de Paris), Université Paris-Diderot, Sorbonne-Paris Cité, and FACT (French Alliance for Cardiovascular clinical Trials), an F-CRIN network, INSERM U-1148, Paris, France; NLHI, ICMS, Royal Brompton Hospital, Imperial College, London, United Kingdom. · Beth Israel Deaconess Medical Center, Division of Cardiology, Harvard Medical School Boston, Boston, MA. · University of Auckland, Auckland City Hospital, Auckland, New Zealand. · Scripps Clinic and Scripps Translational Science Institute, La Jolla, CA. · Brigham and Women's Hospital Heart & Vascular Center and Harvard Medical School, Boston, MA. · Stanford Center for Clinical Research, Department of Medicine, Stanford University School of Medicine, Stanford, CA. Electronic address: Kenneth.Mahaffey@stanford.edu. ·Am Heart J · Pubmed #28577670.

ABSTRACT: OBJECTIVE: To examine the safety and efficacy of cangrelor in patients with single-vessel disease (SVD) and multi-vessel disease (MVD). BACKGROUND: Cangrelor, an intravenous, rapidly acting P2Y METHODS: We studied a modified intention to treat population of patients with SVD and MVD from the CHAMPION PHOENIX trial. The primary efficacy outcome was the composite of death, myocardial infarction (MI), ischemia-driven revascularization (IDR), and stent thrombosis (ST) at 48hours. The key safety outcome was non-coronary artery bypass grafting GUSTO severe bleeding at 48hours. RESULTS: Among 10,921 patients, 5,220 (48%) had SVD and 5,701 (52%) had MVD. MVD patients were older and more often had diabetes, hyperlipidemia, hypertension, prior stroke, and prior MI. After adjustment, MVD patients had similar rates of 48-hour death/MI/IDR/ST (6.3% vs 4.2%, adjusted odds ratio [OR] 1.6 [95% CI 0.42-6.06]) and GUSTO severe bleeding (0.1% vs 0.2%, P=.67) compared with SVD patients. Consistent with overall trial findings, cangrelor use reduced ischemic complications in patients with both SVD (3.9% vs 4.5%; OR 0.86, 95% CI 0.65-1.12) and MVD (5.5% vs 7.2%; OR 0.74, 95% CI 0.6-0.92, P-interaction=.43). GUSTO severe bleeding outcomes were not significantly increased with cangrelor or clopidogrel in either SVD or MVD patients. CONCLUSION: In the CHAMPION PHOENIX trial, MVD and SVD patients had similar ischemic outcomes at 48hours and 30days. Cangrelor consistently reduced ischemic complications in both SVD and MVD patients without a significant increase in GUSTO severe bleeding. CLINICAL PERSPECTIVES.

18 Article Sex Differences in Percutaneous Coronary Intervention-Insights From the Coronary Angiography and PCI Registry of the German Society of Cardiology. 2017

Heer, Tobias / Hochadel, Matthias / Schmidt, Karin / Mehilli, Julinda / Zahn, Ralf / Kuck, Karl-Heinz / Hamm, Christian / Böhm, Michael / Ertl, Georg / Hoffmeister, Hans Martin / Sack, Stefan / Senges, Jochen / Massberg, Steffen / Gitt, Anselm K / Zeymer, Uwe. ·Klinikum München Schwabing, Academic Teaching Hospital, University of Munich, Germany tobias.heer@klinikum-muenchen.de. · Stiftung Institut für Herzinfarktforschung Ludwigshafen, Ludwigshafen, Germany. · Medizinische Klinik B, Klinikum der Stadt Ludwigshafen, Ludwigshafen, Germany. · Medizinische Klinik I, Klinikum der Ludwig-Maximilians-Universität München, Munich, Germany. · Asklepios Klinik St. Georg Hamburg, Hamburg, Germany. · Kerckhoff Klinik Bad Nauheim, Bad Nauheim, Germany. · Universitätsklinikum des Saarlandes, Homburg/Saar, Germany. · Medizinische Klinik und Poliklinik I/Comprehensive Heart Failure Center, Universitätsklinikum Würzburg, Würzburg, Germany. · Städtisches Klinikum Solingen, Solingen, Germany. · Klinikum München Schwabing, Academic Teaching Hospital, University of Munich, Germany. ·J Am Heart Assoc · Pubmed #28320749.

ABSTRACT: BACKGROUND: Several studies have suggested sex-related differences in diagnostic and invasive therapeutic coronary procedures. METHODS AND RESULTS: Data from consecutive patients who were enrolled in the Coronary Angiography and PCI Registry of the German Society of Cardiology were analyzed. We aimed to compare sex-related differences in in-hospital outcomes of patients undergoing percutaneous coronary intervention (PCI) for stable coronary artery disease, non-ST elevation acute coronary syndromes, ST elevation myocardial infarction, and cardiogenic shock. From 2007 until the end of 2009 data from 185 312 PCIs were prospectively registered: 27.9% of the PCIs were performed in women. Primary PCI success rate was identical between the sexes (94%). There were no sex-related differences in hospital mortality among patients undergoing PCI for stable coronary artery disease, non-ST elevation acute coronary syndromes, or cardiogenic shock except among ST elevation myocardial infarction patients. Compared to men, women undergoing primary PCI for ST elevation myocardial infarction have a higher risk of in-hospital death, age-adjusted odds ratio (1.19, 95% CI 1.06-1.33), and risk of ischemic cardiac and cerebrovascular events (death, myocardial infarction, transient ischemic attack/stroke), (age-adjusted odds ratio 1.19, 95% CI 1.16-1.29). Furthermore, access-related complications were twice as high in women, irrespective of the indication. CONCLUSIONS: Despite identical technical success rates of PCI between the 2 sexes, women with PCI for ST elevation myocardial infarction have a 20% higher age-adjusted risk of death and of ischemic cardiac and cerebrovascular events. Further research is needed to determine the reasons for these differences.

19 Article Everolimus- Versus Novolimus-Eluting Bioresorbable Scaffolds for the Treatment of Coronary Artery Disease: A Matched Comparison. 2017

Wiebe, Jens / Dörr, Oliver / Ilstad, Hanna / Husser, Oliver / Liebetrau, Christoph / Boeder, Niklas / Bauer, Timm / Möllmann, Helge / Kastrati, Adnan / Hamm, Christian W / Nef, Holger M. ·University of Giessen, Medizinische Klinik I, Department of Cardiology, Giessen, Germany; Deutsches Herzzentrum München, Munich, Germany. · University of Giessen, Medizinische Klinik I, Department of Cardiology, Giessen, Germany. · Deutsches Herzzentrum München, Munich, Germany. · Kerckhoff Heart and Thorax Center, Department of Cardiology, Bad Nauheim, Germany. · University of Giessen, Medizinische Klinik I, Department of Cardiology, Giessen, Germany; Kerckhoff Heart and Thorax Center, Department of Cardiology, Bad Nauheim, Germany. · University of Giessen, Medizinische Klinik I, Department of Cardiology, Giessen, Germany. Electronic address: holger.nef@innere.med.uni-giessen.de. ·JACC Cardiovasc Interv · Pubmed #28216214.

ABSTRACT: OBJECTIVES: The purpose of this study was to compare the 1-year outcome of everolimus-eluting bioresorbable scaffolds (eBRS) and Novolimus-eluting bioresorbable scaffolds (nBRS) in patients undergoing percutaneous coronary intervention in a real-life clinical practice scenario. BACKGROUND: eBRS and nBRS are available and have been proved safe for coronary artery stenting in well-selected patients. METHODS: Consecutive patients who underwent bioresorbable scaffold implantation were evaluated retrospectively via 2:1 propensity matching. Target lesion failure comprising cardiac death, target vessel myocardial infarction, and target lesion revascularization was examined after 12 months, along with its individual components as well as scaffold thrombosis. RESULTS: A total 506 patients were available for matching. Of these, 212 eBRS patients (mean age = 62.9 years) and 106 nBRS patients (mean age = 63.1 years) were analyzed after matching. Baseline characteristics and clinical presentation were comparable in both groups. Acute coronary syndromes were present in 53.3% of the eBRS group and in 48.1% of the nBRS group (p = 0.383). Lesion characteristics were also similar. Pre-dilation (99.5% vs. 98.1%; p = 0.218) and post-dilation (84.4% vs. 86.8%; p = 0.576) were performed in the same proportion of matched eBRS and nBRS patients, respectively. The 1-year rates of target lesion failure (4.7% vs. 4.5%; p = 0.851), target lesion revascularization (2.6% vs. 3.5%; p = 0.768), cardiac death (1.5% vs. 2.0%; p = 0.752), and definite scaffold thrombosis (2.0% vs. 1.0%; p = 0.529) did not differ significantly between the eBRS and nBRS groups. CONCLUSIONS: The present study reveals comparable clinical results for the 2 types of bioresorbable scaffolds when used during routine practice, but further evidence from randomized controlled trials is needed.

20 Article Impact of Cerebrovascular Events Older Than One Year on Ischemic and Bleeding Outcomes With Cangrelor in Percutaneous Coronary Intervention. 2017

Sawlani, Neal N / Harrington, Robert A / Stone, Gregg W / Steg, Ph Gabriel / Gibson, C Michael / Hamm, Christian W / Price, Matthew J / Prats, Jayne / Deliargyris, Efthymios N / Mahaffey, Kenneth W / White, Harvey D / Bhatt, Deepak L. ·From the Brigham and Women's Hospital Heart & Vascular Center and Harvard Medical School, Boston, MA (N.N.S., D.L.B.) · Stanford University Medical School, CA (R.A.H., K.W.M.) · Columbia University Medical Center and the Cardiovascular Research Foundation, New York, NY (G.W.S.) · FACT (French Alliance for Cardiovascular clinical Trials), DHU FIRE, INSERM Unité 1148, Université Paris-Diderot, and Hôpital Bichat, Assistance-Publique-Hôpitaux de Paris, Paris, France and NHLI, Imperial College, Royal Brompton Hospital, London, United Kingdom (P.G.S.) · Beth Israel Deaconess Medical Center, Division of Cardiology, Boston, MA (C.M.G.) · Kerckhoff Heart and Thorax Center, Bad Nauheim, Germany (C.W.H.) · Scripps Clinic and Scripps Translational Science Institute, La Jolla, CA (M.J.P.) · The Medicines Company, Parsippany, NJ (J.P., E.N.D.) · and Green Lane Cardiovascular Service, Auckland City Hospital, New Zealand (H.D.W.). ·Circ Cardiovasc Interv · Pubmed #28039321.

ABSTRACT: BACKGROUND: Cangrelor is a potent intravenous adenosine diphosphate-receptor antagonist that in the CHAMPION trials reduced the 48-hour and 30-day rates of ischemic events during percutaneous coronary intervention without an increase in severe bleeding. METHODS AND RESULTS: CHAMPION PCI (A Clinical Trial to Demonstrate the Efficacy of Cangrelor), CHAMPION PLATFORM (Cangrelor Versus Standard Therapy to Achieve Optimal Management of Platelet Inhibition), and CHAMPION PHOENIX (A Clinical Trial Comparing Cangrelor to Clopidogrel Standard Therapy in Subjects Who Require Percutaneous Coronary Intervention) were 3 randomized, double-blind, double-dummy trials in which cangrelor was compared with clopidogrel during percutaneous coronary intervention. The effect of cangrelor on ischemic events and bleeding was analyzed in the subgroup of patients with a history of cerebrovascular events at least 1 year prior to randomization; the Breslow-Day test was used to test for interaction of treatment effect in subgroups with and without such a history. The primary efficacy end point was a composite of death, myocardial infarction, ischemia-driven revascularization, or stent thrombosis at 48 hours. Among 24 910 randomized patients, 1270 patients (5.1%) had a cerebrovascular event >1 year old, including 650 assigned to cangrelor and 620 assigned to clopidogrel. Consistent with the overall trial results, the rate of the primary efficacy end point was 4.3% in the cangrelor group versus 5.3% in the clopidogrel group (odds ratio 0.80; 95% confidence interval 0.48-1.34; P=0.40; P for interaction =0.97), and the rate of GUSTO (Global Use of Strategies to Open Occluded Coronary Arteries) severe bleeding was 0.3% in both groups (P=0.97; P for interaction =0.81). CONCLUSIONS: Among patients in the CHAMPION trials with a prior cerebrovascular event at least 1 year before the percutaneous coronary intervention, the efficacy and bleeding profile of cangrelor compared with clopidogrel was similar to that in the overall trial.

21 Article Bioresorbable scaffold implantation in patients with indication for oral anticoagulation: A propensity matched analysis. 2017

Boeder, Niklas F / Johnson, Victoria / Dörr, Oliver / Wiebe, Jens / Elsässer, Albrecht / Möllmann, Helge / Hamm, Christian W / Nef, Holger M / Bauer, Timm. ·University of Giessen, Department of Cardiology, Giessen, Germany. · Deutsches Herzzentrum München, Munich, Germany. · Klinikum Oldenburg, Department of Cardiology, Oldenburg, Germany. · St. Johannes-Hospital, Department of Internal Medicine, Dortmund, Germany. · University of Giessen, Department of Cardiology, Giessen, Germany. Electronic address: bauer-timm@gmx.de. ·Int J Cardiol · Pubmed #27899203.

ABSTRACT: OBJECTIVES: To examine ischemic and bleeding outcomes in patients on triple antithrombotic therapy (TAT) compared with dual antiplatelet therapy (DAPT) after the implantation of bioresorbable scaffolds (BRS). BACKGROUND: The optimal antithrombotic regimen in patients undergoing percutaneous coronary intervention that have an indication for oral anticoagulation is unclear, in particular among those undergoing BRS implantation. METHODS: Consecutive patients of a single-center, all-comers BRS registry were included. Patients were followed up after 30days, 6 and 12months, and thereafter yearly. Outcome parameters were target vessel failure (TVF), major adverse cardiac events (MACE) including target lesion revascularization (TLR), scaffold thrombosis (ST), death, myocardial infarction, and any bleeding as defined by BARC. Patients on TAT were matched to patients on DAPT. RESULTS: A total of 607 patients were included. Fifty-five patients receiving TAT were matched with 165 patients treated with DAPT. Acute coronary syndrome was an indication for coronary angiography in 50.9% vs 50.4% groups (p=0.97). Major adverse cardiac events occurred in 16.4% of TAT patients vs. 8.9% DAPT patients (p=0.12), TLR in 5.5% vs. 1.9% (p=0.17), ST in 3.6% vs. 1.9% (p=0.46), and TVF in 3.6 vs. 1.9% (p=0.46). Patients died in 7.3% in the TAT group vs. 5.1% in the DAPT group (p=0.26). No severe bleeding was recorded in either of the groups. CONCLUSION: There was no difference in bleeding or ischemic events between the patients on TAT and those on DAPT after BRS implantation. The high rate of scaffold thrombosis in all of these patients, however, is not negligible.

22 Article Optical coherence tomography: influence of contrast concentration on image quality and diagnostic confidence. 2017

Blachutzik, Florian / Achenbach, Stephan / Nef, Holger / Hamm, Christian / Dörr, Oliver / Boeder, Niklas / Marwan, Mohamed / Tröbs, Monique / Schneider, Reinhard / Röther, Jens / Schlundt, Christian. ·Department of Cardiology, Friedrich-Alexander-Universität Erlangen-Nürnberg (FAU), University Hospital Erlangen, Ulmenweg 18, 91054, Erlangen, Germany. florian.blachutzik@uk-erlangen.de. · Department of Cardiology, Friedrich-Alexander-Universität Erlangen-Nürnberg (FAU), University Hospital Erlangen, Ulmenweg 18, 91054, Erlangen, Germany. · Department of Cardiology, University Hospital Giessen, Giessen, Germany. ·Heart Vessels · Pubmed #27830336.

ABSTRACT: OCT requires intracoronary injection of contrast agent to remove blood from the coronary lumen during data acquisition, which is a possible limitation of this method. Aim of this study was to analyze the influence of iodine concentration on image quality and diagnostic certainty of optical coherence tomography (OCT). OCT sequences acquired using contrast agent with a reduced concentration of 150 mg iodine/ml and a standard concentration of 350 mg iodine/ml were analyzed. Cross-sectional images with a spacing of 10 mm were evaluated regarding image quality and diagnostic confidence. A total of 67 OCT sequences acquired in 24 patients were analyzed. 31 sequences were acquired using contrast agent with a concentration of 150 mg iodine/ml and 36 sequences with a concentration of 350 mg iodine/ml. The percentage of remaining blood streaks in the cross sections was significantly lower for 350 mg iodine/ml compared to 150 mg iodine/ml (19 ± 21 vs. 34 ± 26%, p = 0.013). Contrast with 350 mg iodine/ml showed a significantly higher percentage of completely flushed pullback length as compared to 150 mg iodine/ml (78 ± 24 vs. 58 ± 27%, p = 0.004). Diagnostic certainty was significantly higher for 350 mg iodine/ml than for 150 mg iodine/ml (Likert scale average 1.4 ± 0.7 vs. 2.1 ± 1.2, p < 0.001; Likert scale: 1 = absolutely confident, 2 = confident with slight doubts, 3 = doubtful/not confident, 4 = non-diagnostic). Regarding image quality and diagnostic certainty, contrast agent with a concentration of 350 mg iodine/ml is superior to 150 mg iodine/ml.

23 Article Outcome After Long-segment Stenting With Everolimus-eluting Bioresorbable Scaffolds Focusing on the Concept of Overlapping Implantation. 2016

Wiebe, Jens / Dörr, Oliver / Liebetrau, Christoph / Bauer, Timm / Wilkens, Eva / Ilstad, Hanna / Boeder, Niklas / Elsässer, Albrecht / Möllmann, Helge / Hamm, Christian W / Nef, Holger M. ·Department of Cardiology, University of Giessen, Medizinische Klinik I, Giessen, Germany; Deutsches Herzzentrum München, Munich, Germany. Electronic address: jens.wiebe@googlemail.com. · Department of Cardiology, University of Giessen, Medizinische Klinik I, Giessen, Germany. · Department of Cardiology, Kerckhoff Heart and Thorax Center, Bad Nauheim, Germany. · Department of Cardiology, Heart Center Oldenburg, Oldenburg, Germany. · Department of Cardiology, University of Giessen, Medizinische Klinik I, Giessen, Germany; Department of Cardiology, Kerckhoff Heart and Thorax Center, Bad Nauheim, Germany. ·Rev Esp Cardiol (Engl Ed) · Pubmed #28134094.

ABSTRACT: INTRODUCTION AND OBJECTIVES: The implantation of bioresorbable scaffolds (BRS) is an emerging technique used in percutaneous coronary interventions. Their application has been extended to more complex lesions, although evidence is only available for simple lesions. The present study evaluated scaffold implantation in long lesions, focusing on overlapping scaffolds. METHODS: We retrospectively analyzed all consecutive patients eligible for stenting with everolimus-eluting poly-L-lactic acid-based BRS with a minimum total scaffold length of 28mm, irrespective of the number of BRS used. The main target parameters were major adverse cardiac events, comprising cardiac death, any myocardial infarction, and target lesion revascularization, and target lesion failure, including cardiac death, target vessel myocardial infarction, and target lesion revascularization. A subgroup analysis included patients with overlapping BRS. RESULTS: A total of 250 patients were included. The reason for angiography was stable coronary artery disease in 36.4% (91 of 250), an acute coronary syndrome in 61.6% (154 of 250), and other reasons in 2.0% (5 of 250). Procedural success was achieved in 97.8% (267 of 273) of the lesions. During follow-up, the 12-month rates of major adverse cardiac event, target lesion failure, and scaffold thrombosis were 8.5%, 6.6%, and 2.3%, respectively. Subgroup analysis of 239 patients showed that there were no statistically relevant differences between patients with and without overlapping scaffolds after a 12-month follow-up. CONCLUSIONS: Long-segment stenting with a single scaffold or with multiple overlapping scaffolds is technically feasible with adequate mid-term outcomes. However, large-scale randomized studies are needed to provide further proof of concept.

24 Article A new novolimus-eluting bioresorbable scaffold for large coronary arteries: an OCT study of acute mechanical performance. 2016

Boeder, Niklas F / Koepp, Tim / Dörr, Oliver / Bauer, Timm / Mattesini, Alessio / Elsässer, Albrecht / Möllmann, Helge / Blachutzik, Florian / Achenbach, Stephan / Ghanem, Alexander / Hamm, Christian W / Nef, Holger M. ·University of Giessen, Department of Cardiology, Germany. · Interventional Cardiology Unit, Heart and Vessels department, Careggi Hospital, Florence, Italy. · Klinikum Oldenburg, Department of Cardiology, Germany. · Kerckhoff Klinik Bad Nauheim, Department of Cardiology, Germany. · University of Erlangen, Department of Cardiology, Germany. · Asklepios Klinik St. Georg, Department of Cardiology, Germany. · University of Giessen, Department of Cardiology, Germany. Electronic address: holger.nef@me.com. ·Int J Cardiol · Pubmed #27393853.

ABSTRACT: AIMS: To evaluate the acute performance of a novolimus-eluting bioresorbable scaffold (BRS) with a nominal diameter of 4.0mm (DESolve® XL) using optical coherence tomography (OCT) in terms of appropriate scaffold deployment. METHODS AND RESULTS: Ten patients (55.6% male, mean age 60.0 y) undergoing OCT-guided scaffold implantation were enrolled consecutively in this retrospective study. Using data from the final pullback, the following indexes were calculated: mean and minimum area, residual area stenosis, incomplete strut apposition, tissue prolapse, eccentricity and symmetry indexes, strut fracture, and edge dissection. The clinical indication for the procedure was acute coronary syndrome in roughly half (55.5%) of the cases. All three main vessels were affected equally. The maximum post-dilatation balloon inflation pressure was 14.7±4.2atm. OCT analysis showed a lumen area of 11.4±1.9mm(2) and a scaffold area of 11.5±2.1mm(2). Mean residual area stenosis was 28.6%. No strut fractures or edge dissections were apparent. The mean eccentricity index was 0.65±0.16 and the mean symmetry index 0.39±0.25. CONCLUSION: The size of large vessels does not adversely influence acute mechanical performance as assessed by the eccentricity and symmetry indexes. No adverse cardiac event occurred during the hospital stay or the 30-day follow-up. It is feasible to treat large vessels with the DESolve® XL BRS.

25 Article Everolimus-eluting bioresorbable scaffold implantation for the treatment of bifurcation lesions - Implications from early clinical experience during daily practice. 2016

Wiebe, Jens / Dörr, Oliver / Bauer, Timm / Liebetrau, Christoph / Boeder, Niklas / Möllmann, Helge / Hamm, Christian W / Nef, Holger M. ·University of Giessen, Medizinische Klinik I, Department of Cardiology, Klinikstrasse 33, 35392 Giessen, Germany; Deutsches Herzzentrum München, Lazarettstr. 36, 80636 Munich, Germany. Electronic address: jens.wiebe@googlemail.com. · University of Giessen, Medizinische Klinik I, Department of Cardiology, Klinikstrasse 33, 35392 Giessen, Germany. · Kerckhoff Heart and Thorax Center, Department of Cardiology, Benekestrasse 2-8, 61231 Bad Nauheim, Germany. · University of Giessen, Medizinische Klinik I, Department of Cardiology, Klinikstrasse 33, 35392 Giessen, Germany; Kerckhoff Heart and Thorax Center, Department of Cardiology, Benekestrasse 2-8, 61231 Bad Nauheim, Germany. ·Cardiovasc Revasc Med · Pubmed #27085220.

ABSTRACT: BACKGROUND/PURPOSE: The clinical performance of bioresrobable scaffolds (BRSs) in bifurcation lesion is not well investigated so far and information can currently mostly be gleaned from the results of bench testing. The present analysis evaluates the technical feasibility of BRS use in this type of lesion and its mid-term clinical outcome. METHODS/MATERIALS: Consecutive patients with bifurcation lesions treated with at least one everolimus-eluting BRS were enrolled. Procedural success was defined as successful delivery and deployment of at least one BRS and a residual diameter stenosis ≤30%. The primary endpoint (major adverse cardiac events, MACE) included death due to cardiac cause, clinically driven percutaneous or surgical target lesion revascularization (TLR), and any myocardial infarction at the 12-month follow-up. RESULTS: A total of 28 patients were eligible for this evaluation. Median age was 67 (52-73) years and in 46.4% (13/28) an acute coronary syndrome was present. The procedural success rate was 97.1% (33/34). The 1-year Kaplan Meier event rates for MACE, target lesion revascularization, and scaffold thrombosis were 16.1%, 12.1%, and 8.1%, respectively. Half of these patients discontinued the antiplatelet therapy prematurely. CONCLUSIONS: The results for BRS use in bifurcation lesions are not in line with previous studies investigating primarily simple lesions. The impaired outcomes are most likely related to the early stage of BRS use and an exacerbated risk of scaffold thrombosis due to premature discontinuation of the antiplatelet therapy. Hypothesis generated from this investigation has to be proven in further studies. SUMMARY: Technical feasibility of everolimus-eluting bioresorbable scaffold implantation in bifurcation lesion and the clinical mid-term outcomes were evaluated in a real world scenario. Technical success rate was high; however the clinical results were not in line with previous studies investigating primarily simple lesions. The impaired outcomes were mostly driven by an exacerbated risk of scaffold thrombosis due to premature discontinuation of the antiplatelet therapy.

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