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Coronary Artery Disease: HELP
Articles by Laura Mauri
Based on 68 articles published since 2010
(Why 68 articles?)
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Between 2010 and 2020, Laura Mauri wrote the following 68 articles about Coronary Artery Disease.
 
+ Citations + Abstracts
Pages: 1 · 2 · 3
26 Article The OPTIMIZE randomized trial to assess safety and efficacy of the Svelte IDS and RX Sirolimus-eluting coronary stent Systems for the Treatment of atherosclerotic lesions: Trial design and rationale. 2019

Mauri, Laura / Doros, Gheorghe / Rao, Sunil V / Cohen, David J / Yakubov, Steven / Lasala, John / Wong, S Chiu / Zidar, James / Kereiakes, Dean J. ·Harvard Medical School. · Baim Institute for Clinical Research; Department of Biostatistics, Boston University. · The Duke Clinical Research Institute. · Saint Luke's Mid America Heart Institute, Kansas City, MO. · OhioHealth Riverside Methodist Hospital. · Washington University School of Medicine in St. Louis. · Weil Cornell Medicine. · University of North Carolina. · The Christ Hospital and Lindner Research Center. Electronic address: Lindner@thechristhospital.com. ·Am Heart J · Pubmed #31415994.

ABSTRACT: Coronary stenting without angioplasty pretreatment (direct stenting) may simplify procedures in appropriate lesions. Direct stenting is facilitated by smaller profile coronary stent platforms. The present study was designed for regulatory approval of a novel drug-eluting coronary stent and incorporates both randomized comparison for non-inferiority to an approved predicate device as well as a nested evaluation of subjects eligible for direct stenting. STUDY DESIGN AND OBJECTIVES: Prospective, single-blind, randomized, active-control, multi-center study designed to assess the safety and efficacy of the novel Svelte sirolimus-eluting stent (SES) systems. A total of 1630 subjects with up to 3 target lesions will be randomized 1:1 to the Svelte SES versus either the Xience or Promus everolimus-eluting stents (control). Randomization will be stratified by whether or not a direct stenting strategy is planned by the investigator. The primary endpoint is target lesion failure (TLF) at 12 months post index procedure, defined as cardiac death, target vessel myocardial infarction, or clinically driven target lesion revascularization, and the primary analysis is a non-inferiority test with a non-inferiority margin of 3.58%. Secondary clinical endpoints include individual components of TLF, stent thrombosis and measures of procedural resource utilization including contrast administration, fluoroscopy exposure and procedural resource utilization as well as costs. CONCLUSION: The OPTMIZE Trial will evaluate the safety, efficacy and clinical value of the novel Svelte SES in subjects with up to 3 lesions, and will provide a comparison of direct stenting between randomized devices.

27 Article Benefit and Risk of Prolonged DAPT After Coronary Stenting in Women. 2018

Berry, Natalia C / Kereiakes, Dean J / Yeh, Robert W / Steg, P Gabriel / Cutlip, Donald E / Jacobs, Alice K / Abbott, J Dawn / Hsieh, Wen-Hua / Massaro, Joseph M / Mauri, Laura / Anonymous3030966. ·Department of Cardiovascular Medicine, Brigham and Women's Hospital, Boston, MA (N.C.B., L.M.). · Harvard Medical School, Boston, MA (N.C.B., L.M., D.E.C., R.W.Y.). · Baim Institute for Clinical Research, Boston, MA (N.C.B., L.M., D.E.C., R.W.Y., W.-H.H., J.M.M.). · The Christ Hospital Heart and Vascular Center and The Lindner Center for Research and Education, Cincinnati, OH (D.J.K). · The Smith Center for Outcomes Research in Cardiology (R.W.Y.), Beth Israel Deaconess Medical Center, Boston, MA. · Université Paris-Diderot, Sorbonne Paris Cité, INSERM Unité-1148, Département Hospitalo-Universitaire Fibrosis Inflammation Remodeling, and Hôpital Bichat, Assistance Publique-Hôpitaux de Paris, France (P.G.S.). · National Heart and Lung Institute, Institute of Cardiovascular Medicine and Science, Royal Brompton Hospital, Imperial College, London, United Kingdom (P.G.S.). · Division of Cardiology, Department of Medicine (D.E.C.). · Boston University School of Medicine, Boston, MA (A.K.J.). · Rhode Island Hospital, Brown University School of Medicine (J.D.A.). · Boston University School of Public Health, MA (J.M.M.). ·Circ Cardiovasc Interv · Pubmed #30354781.

ABSTRACT: BACKGROUND: Women may derive differential benefit from prolonged DAPT (dual antiplatelet therapy) after coronary stenting than men. We assessed whether the risks/benefits of prolonged DAPT differ between women and men. METHODS AND RESULTS: The DAPT study was a randomized double-blind, placebo-controlled trial comparing continued thienopyridine versus placebo beyond 12 months after coronary stenting. We compared rates of myocardial infarction, stent thrombosis, major adverse cardiovascular and cerebrovascular events, and bleeding by sex and randomized treatment. Of 11 648 patients, women (N=2925) were older, with higher prevalence of diabetes mellitus and lower rates of acute coronary syndrome than men. At 12 to 30 months, women had similar adjusted ischemic and bleeding events as men. The effects of continued thienopyridine therapy did not differ significantly by sex for stent thrombosis (women: hazard ratio [HR], 0.54; 95% confidence interval [CI], 0.22-1.36; men: HR, 0.26; 95% CI, 0.15-0.44; interaction P=0.17), myocardial infarction (women: HR, 0.75; 95% CI, 0.50-1.14; men: HR, 0.46; 95% CI, 0.36-0.60; interaction P=0.052), major adverse cardiovascular and cerebrovascular events (women: HR, 0.87; 95% CI, 0.62-1.22; men: HR, 0.70; 95% CI, 0.58-0.85; interaction P=0.26), and bleeding (women: HR, 1.45; 95% CI, 0.88-2.40; men: HR, 1.78; 95% CI, 1.28-2.49; interaction P=0.50). CONCLUSIONS: Women had similar late risks of ischemia and bleeding as men after coronary stent procedures. CLINICAL TRIAL REGISTRATION: URL: https://www.clinicaltrials.gov . Unique identifier: NCT00977938.

28 Article Rationale and design of the EVOLVE Short DAPT Study to assess 3-month dual antiplatelet therapy in subjects at high risk for bleeding undergoing percutaneous coronary intervention. 2018

Mauri, Laura / Kirtane, Ajay J / Windecker, Stephan / Yeh, Robert W / Dauerman, Harold L / Price, Matthew J / Christen, Thomas / Allocco, Dominic J / Meredith, Ian T / Kereiakes, Dean J. ·Division of Cardiovascular Medicine/Brigham and Women's Hospital, Harvard Medical School, Boston, MA, USA. Electronic address: laura.mauri@gmail.com. · Division of Cardiology, Columbia University/NewYork-Presbyterian Hospital and the Cardiovascular Research Foundation, New York, NY, USA. · Bern University Hospital, Bern, Switzerland. · Beth Israel Deaconess Medical Center, Boston, MA, USA. · University of Vermont Larner College of Medicine, Burlington, VT, USA. · Scripps Clinic, La Jolla, CA, USA. · Boston Scientific Corporation, Marlborough, MA, USA. · The Christ Hospital Heart and Vascular Center/The Lindner Research Center, Cincinnati, OH, USA. Electronic address: lindner@thechristhospital.com. ·Am Heart J · Pubmed #30218844.

ABSTRACT: BACKGROUND: While extended dual antiplatelet therapy (DAPT) with aspirin and a platelet (P2Y TRIAL DESIGN: EVOLVE Short DAPT is a prospective, single-arm, international study that enrolled 2009 high risk bleeding subjects (defined as age ≥75 years, chronic anticoagulation, major bleeding within 12 months, history of stroke, renal insufficiency/failure, or thrombocytopenia) who underwent PCI with the SYNERGY stent. Subjects presenting with acute MI or complex lesions were excluded. After 3 months treatment with DAPT (except those on anticoagulant in whom aspirin is optional), subjects free from stroke, MI, revascularization or ST will be eligible to discontinue P2Y CONCLUSION: The EVOLVE Short DAPT study will prospectively define the safety of DAPT discontinuation at 3 months in high bleeding risk patients treated with the SYNERGY stent.

29 Article Lesion Complexity and Outcomes of Extended Dual Antiplatelet Therapy After Percutaneous Coronary Intervention. 2017

Yeh, Robert W / Kereiakes, Dean J / Steg, P Gabriel / Cutlip, Donald E / Croce, Kevin J / Massaro, Joseph M / Mauri, Laura / Anonymous6160924. ·Richard A. and Susan F. Smith Center for Outcomes Research in Cardiology, Beth Israel Deaconess Medical Center, Boston, Massachusetts; Baim Institute for Clinical Research, Boston, Massachusetts. Electronic address: ryeh@bidmc.harvard.edu. · Christ Hospital Heart and Vascular Center and the Lindner Center for Research and Education, Cincinnati, Ohio. · Université Paris-Diderot, INSERM U-1148, Paris, France; Hôpital Bichat, Département Hospitalo-Universitaire FIRE, Assistance Publique-Hôpitaux de Paris, Paris, France; NHLI, Imperial College, Royal Brompton Hospital, London, United Kingdom. · Richard A. and Susan F. Smith Center for Outcomes Research in Cardiology, Beth Israel Deaconess Medical Center, Boston, Massachusetts; Baim Institute for Clinical Research, Boston, Massachusetts. · Brigham and Women's Hospital, Boston, Massachusetts. · Baim Institute for Clinical Research, Boston, Massachusetts; Boston University School of Public Health, Boston, Massachusetts. · Baim Institute for Clinical Research, Boston, Massachusetts; Brigham and Women's Hospital, Boston, Massachusetts. ·J Am Coll Cardiol · Pubmed #29073947.

ABSTRACT: BACKGROUND: Subjects undergoing coronary stenting with complex lesion anatomy may experience different risks and benefits with prolonged dual antiplatelet therapy. OBJECTIVES: The authors assessed the effect of 30 months versus 12 months of dual antiplatelet therapy (DAPT) after percutaneous coronary intervention (PCI) based on the presence or absence of anatomically-complex target lesions. METHODS: In the DAPT Study, combined myocardial infarction (MI) or stent thrombosis and moderate/severe bleeding were assessed in enrolled (n = 25,416) and randomized (n = 11,554) subjects. Complex lesions had any of the following characteristics: unprotected left main, >2 lesions/vessel, length ≥30 mm, bifurcation with side branch ≥2.5 mm, vein bypass graft, or thrombus-containing lesion. Events were evaluated according to increasing number of complexity characteristics and compared according to DAPT score. RESULTS: Enrolled subjects with more complex target lesions had higher rates of MI or stent thrombosis in the first 12 months after PCI (3.9% vs. 2.4%; p < 0.001). Among those who were event-free at 12 months, rates of MI or stent thrombosis between 12 and 30 months were similar between those with versus without complex anatomy (3.5% vs. 2.9%; p = 0.07). Reduction of MI or stent thrombosis with continued thienopyridine beyond 12 months versus placebo was similar for subjects with (2.5% vs. 4.5%; hazard ratio: 0.55; 95% confidence interval: 0.38 to 0.79; p = 0.001) and without (2.0% vs. 3.8%; hazard ratio: 0.52; 95% confidence interval: 0.39 to 0.69; p < 0.001) anatomic complexity (p CONCLUSIONS: Complex target-lesion anatomy is associated with increased ischemic events, particularly within the first year after PCI. Among those without events in the first 12 months, the benefits of extending DAPT were similar in subjects with and without complex lesions. A high DAPT score identified those experiencing the most benefit from extended treatment among patients with and without complex anatomy. (The Dual Antiplatelet Therapy Study [DAPT Study]; NCT00977938).

30 Article Ultrathin, bioresorbable polymer sirolimus-eluting stents versus thin, durable polymer everolimus-eluting stents in patients undergoing coronary revascularisation (BIOFLOW V): a randomised trial. 2017

Kandzari, David E / Mauri, Laura / Koolen, Jacques J / Massaro, Joseph M / Doros, Gheorghe / Garcia-Garcia, Hector M / Bennett, Johan / Roguin, Ariel / Gharib, Elie G / Cutlip, Donald E / Waksman, Ron / Anonymous4350917. ·Piedmont Heart Institute, Atlanta, GA, USA. Electronic address: david.kandzari@piedmont.org. · Divison of Cardiovascular Medicine, Brigham and Women's Hospital, Boston, MA, USA. · Catharina Hospital, Eindhoven, Netherlands. · Department of Biostatistics and Epidemiology, Boston University School of Public Health, Boston, MA, USA. · Department of Biostatistics and Epidemiology, Boston University School of Public Health, Boston, MA, USA; Baim Institute for Clinical Research, Boston, MA, USA. · Division of Interventional Cardiology, MedStar Cardiovascular Research Network, MedStar Washington Hospital Center, Washington, DC, USA. · Department of Cardiovascular Medicine, University Hospitals Leuven, Leuven, Belgium. · Department of Cardiology, Rambam Medical Center, Haifa, Israel. · Charleston Area Medical Center, Charleston, WV, USA. · Beth Israel Deaconess Medical Center, Baim Institute for Clinical Research, Boston, MA, USA. ·Lancet · Pubmed #28851504.

ABSTRACT: BACKGROUND: The development of coronary drug-eluting stents has included use of new metal alloys, changes in stent architecture, and use of bioresorbable polymers. Whether these advancements improve clinical safety and efficacy has not been shown in previous randomised trials. We aimed to examine the clinical outcomes of a bioresorbable polymer sirolimus-eluting stent compared with a durable polymer everolimus-eluting stent in a broad patient population undergoing percutaneous coronary intervention. METHODS: BIOFLOW V was an international, randomised trial done in patients undergoing elective and urgent percutaneous coronary intervention in 90 hospitals in 13 countries (Australia, Belgium, Canada, Denmark, Germany, Hungary, Israel, the Netherlands, New Zealand, South Korea, Spain, Switzerland, and the USA). Eligible patients were those aged 18 years or older with ischaemic heart disease undergoing planned stent implantation in de-novo, native coronary lesions. Patients were randomly assigned (2:1) to either an ultrathin strut (60 μm) bioresorbable polymer sirolimus-eluting stent or to a durable polymer everolimus-eluting stent. Randomisation was via a central web-based data capture system (mixed blocks of 3 and 6), and stratified by study site. The primary endpoint was 12-month target lesion failure. The primary non-inferiority comparison combined these data from two additional randomised trials of bioresorbable polymer sirolimus-eluting stent and durable polymer everolimus-eluting stent with Bayesian methods. Analysis was by intention to treat. The trial is registered with ClinicalTrials.gov, number NCT02389946. FINDINGS: Between May 8, 2015, and March 31, 2016, 4772 patients were recruited into the study. 1334 patients met inclusion criteria and were randomly assigned to treatment with bioresorbable polymer sirolimus-eluting stents (n=884) or durable polymer everolimus-eluting stents (n=450). 52 (6%) of 883 patients in the bioresorbable polymer sirolimus-eluting stent group and 41 (10%) of 427 patients in the durable polymer everolimus-eluting stent group met the 12-month primary endpoint of target lesion failure (95% CI -6·84 to -0·29, p=0·0399), with differences in target vessel myocardial infarction (39 [5%] of 831 patients vs 35 [8%] of 424 patients, p=0·0155). The posterior probability that the bioresorbable polymer sirolimus-eluting stent is non-inferior to the durable polymer everolimus-eluting stent was 100% (Bayesian analysis, difference in target lesion failure frequency -2·6% [95% credible interval -5·5 to 0·1], non-inferiority margin 3·85%, n=2208). INTERPRETATION: The outperformance of the ultrathin, bioresorbable polymer sirolimus-eluting stent over the durable polymer everolimus-eluting stent in a complex patient population undergoing percutaneous coronary intervention suggests a new direction in improving next generation drug-eluting stent technology. FUNDING: BIOTRONIK.

31 Article Usefulness of Intracoronary Brachytherapy for Patients With Resistant Drug-Eluting Stent Restenosis. 2017

Mangione, Fernanda M / Jatene, Tannas / Badr Eslam, Roza / Bergmark, Brian A / Gallagher, Jacob R / Shah, Pinak B / Mauri, Laura / Leopold, Jane A / Sobieszczyk, Piotr S / Faxon, David P / Croce, Kevin J / Bhatt, Deepak L / Devlin, Phillip M. ·Brigham and Women's Hospital Heart & Vascular Center and Harvard Medical School, Boston, Massachusetts; Beneficência Portuguesa de São Paulo Hospital, São Paulo, Brazil. · Brigham and Women's Hospital Heart & Vascular Center and Harvard Medical School, Boston, Massachusetts. · Division of Cardiology, Department of Internal Medicine II, Medical University of Vienna, Vienna, Austria. · Brigham and Women's Hospital Heart & Vascular Center and Harvard Medical School, Boston, Massachusetts. Electronic address: dlbhattmd@post.harvard.edu. ·Am J Cardiol · Pubmed #28583681.

ABSTRACT: In-stent restenosis (ISR) remains a concern even in the drug-eluting stent (DES) era and carries a high risk of recurrence. Brachytherapy is being used as an alternative treatment for resistant ISR, yet the safety and efficacy of this approach has not been well studied. We analyzed the outcomes of 101 patients who underwent coronary brachytherapy for resistant DES ISR. Baseline demographic, clinical, procedural, and outcome data were collected by phone and from electronic records. Comorbidities and overt cardiovascular disease were highly prevalent. Median previous stent layers were 2 with a maximum of 5 layers. Procedural angiographic success rate was 97% and median time to discharge was 1 day after brachytherapy. The primary outcome of target vessel revascularization was 24% at 1 year, 32% at 2 years, and 42% at 3 years. The rate of nonfatal myocardial infarction was 0% at 1 year, 3.5% at 2 years, and 6% at 3 years. The rate of all-cause mortality was 8.5% at 1 year, 12% at 2 years, and 16% at 3 years. We observed only 1 case of late stent thrombosis. After multivariable adjustment, female gender (hazard ratio 2.37, 95% confidence interval 1.02 to 5.52, p = 0.04) and diffuse ISR pattern (hazard ratio 2.95, 95% confidence interval 1.21 to 7.17, p = 0.01) were independently associated with the primary outcome. In conclusion, brachytherapy is feasible for the treatment of resistant DES ISR and is associated with high immediate procedural success and reasonable efficacy in a complex patient population. This approach might be used as an alternative for these patients.

32 Article Extended Duration Dual Antiplatelet Therapy After Coronary Stenting Among Patients With Peripheral Arterial Disease: A Subanalysis of the Dual Antiplatelet Therapy Study. 2017

Secemsky, Eric A / Yeh, Robert W / Kereiakes, Dean J / Cutlip, Donald E / Steg, P Gabriel / Massaro, Joseph M / Apruzzese, Patricia K / Mauri, Laura / Anonymous3080905. ·Division of Cardiology, Department of Medicine, Massachusetts General Hospital, Boston, Massachusetts; Division of Cardiology and Center for Clinical Biometrics, Department of Medicine, Brigham and Women's Hospital, Boston, Massachusetts; Baim Institute for Clinical Research, Boston, Massachusetts; Smith Center for Outcomes Research in Cardiology, Beth Israel Deaconess Medical Center, Boston, Massachusetts. · Baim Institute for Clinical Research, Boston, Massachusetts; Smith Center for Outcomes Research in Cardiology, Beth Israel Deaconess Medical Center, Boston, Massachusetts. · The Christ Hospital Heart and Vascular Center and The Lindner Center for Research and Education, Cincinnati, Ohio. · Baim Institute for Clinical Research, Boston, Massachusetts. · Université Paris-Diderot, INSERM U-1148, Hôpital Bichat, Département Hospitalo-Universitaire Fibrosis, Inflammation, and Remodelling, Assistance Publique-Hôpitaux de Paris, Paris, France; National Heart and Lung Institute, Institute of Cardiovascular Medicine and Science, Royal Brompton Hospital, Imperial College, London, United Kingdom. · Division of Cardiology and Center for Clinical Biometrics, Department of Medicine, Brigham and Women's Hospital, Boston, Massachusetts; Baim Institute for Clinical Research, Boston, Massachusetts. Electronic address: lmauri1@partners.org. ·JACC Cardiovasc Interv · Pubmed #28473118.

ABSTRACT: OBJECTIVES: This study sought to determine whether patients with peripheral arterial disease (PAD) experience different reductions in ischemic event and increases in bleeding events with extended duration dual antiplatelet therapy versus those without PAD. BACKGROUND: Patients with PAD have increased ischemic and bleeding risks after coronary stenting. METHODS: The DAPT (Dual Antiplatelet Therapy) study randomized 11,648 patients free from ischemic and bleeding events 12 months after coronary stenting to continued thienopyridine plus aspirin therapy for an additional 18 months versus aspirin therapy alone. The effects of continued thienopyridine on myocardial infarction (MI) or stent thrombosis, major adverse cardiovascular and cerebrovascular events (death, MI, or stroke) and bleeding (GUSTO [Global Utilization of t-PA and Streptokinase for Occluded Coronary Arteries] moderate or severe) were assessed among those with versus without PAD. RESULTS: Among 11,648 randomized patients, 649 (5.57%) had PAD. Between 12 and 30 months, randomized patients with PAD had higher rates of MI/stent thrombosis (6.03% vs. 2.92%; p < 0.001), major adverse cardiovascular and cerebrovascular events (11.65% vs. 4.62%; p < 0.001), and bleeding (4.86% vs. 1.74%; p < 0.001). Continued thienopyridine versus placebo was associated with consistent treatment effects for MI/stent thrombosis (with PAD, HR: 0.63; 95% CI: 0.32 to 1.22; without PAD, HR: 0.53; 95% CI: 0.42, 0.66; interaction p = 0.631), major adverse cardiovascular and cerebrovascular events (with PAD, HR: 1.06; 95% CI: 0.67 to 1.67; without PAD, HR: 0.70; 95% CI: 0.59 to 0.84; interaction p = 0.103), and bleeding (with PAD, HR, 1.82; 95% CI: 0.87 to 3.83; without PAD, HR: 1.66; 95% CI: 1.23 to 2.24; interaction p = 0.811). CONCLUSIONS: Among patients undergoing coronary stenting, those with PAD have more ischemic and bleeding events versus those without PAD. Extended duration dual antiplatelet therapy is associated with consistent ischemic benefit and bleeding harm among patients with and without PAD.

33 Article Long-Term Outcomes of Stenting the Proximal Left Anterior Descending Artery in the PROTECT Trial. 2017

Roguin, Ariel / Camenzind, Edoardo / Kerner, Arthur / Beyar, Rafael / Boersma, Eric / Mauri, Laura / Steg, Ph Gabriel / Wijns, William. ·Rambam Medical Center, Haifa, Israel; Technion-Israel Institute of Technology, Haifa, Israel. Electronic address: aroguin@technion.ac.il. · Institut Lorrain du Coeur et des Vaisseaux, Vandoeuvre-les-Nancy, France; Université de Lorraine, Nancy, France. · Rambam Medical Center, Haifa, Israel; Technion-Israel Institute of Technology, Haifa, Israel. · Erasmus Medical Center, Rotterdam, the Netherlands. · Harvard Medical School, and Brigham and Women's Hospital, Boston, Massachusetts. · Département Hospitalo-Universitaire FIRE, Paris, France; Université Paris-Diderot, Sorbonne-Paris Cité, Paris, France; Assistance Publique - Hôpitaux de Paris, Hôpital Bichat, Paris, France; NHLI Imperial College, ICMS, Royal Brompton Hospital, London, United Kingdom. · Cardiovascular Research Center, OLV Hospital, Aalst, Belgium. ·JACC Cardiovasc Interv · Pubmed #28335893.

ABSTRACT: OBJECTIVES: This study sought to compare the outcomes of patients undergoing drug-eluting stent implantation according to lesion location within or outside the proximal left anterior descending (LAD) artery. BACKGROUND: Proximal LAD artery involvement is considered uniquely in revascularization guidelines. The impact of LAD lesion location on long-term outcomes after revascularization is poorly understood in context of current percutaneous coronary intervention and medical therapy. METHODS: Among 8,709 patients enrolled in PROTECT (Patient Related Outcomes with Endeavor Versus Cypher Stenting Trial), a multicenter percutaneous coronary intervention trial, we compared the outcomes of 2,534 patients (29.1%) (3,871 lesions [31.5%]) with stents implanted in the proximal LAD to 6,172 patients (70.9%) (8,419 lesions [68.5%]) with stents implanted outside the proximal LAD. RESULTS: At the 4-year follow-up, death rates were the same (5.8% vs. 5.8%; p > 0.999), but more myocardial infarctions occurred in the proximal LAD group (6.2% vs. 4.9%; p = 0.015). The rate of clinically driven target vessel failure (TVF) (14.8% vs. 13.5%; p = 0.109), major adverse cardiac event(s) (MACE) (15.0% vs. 13.7%; hazard ratio: 1.1; 95% confidence interval: 0.97 to 1.31; p = 0.139), and stent thrombosis (2.1% vs. 2.0%; p = 0.800) were similar. Drug-eluting stent type had no interaction with MACE or TVF. In multivariate analysis, the proximal LAD was a predictor of myocardial infarction (p = 0.038) but not of TVF (p = 0.149) or MACE (p = 0.069). CONCLUSIONS: In this study of contemporary percutaneous coronary intervention, proximal LAD location was associated with higher rates of myocardial infarction during the long-term follow-up, but there were no differences in stent thrombosis, death, TVF, or overall MACE. This finding may suggest that, in the drug-eluting stent era, proximal LAD no longer confers a different prognosis than other lesion sites. (Randomized Study Comparing Endeavor With Cypher Stents [PROTECT]; NCT00476957).

34 Article Mortality Following Cardiovascular and Bleeding Events Occurring Beyond 1 Year After Coronary Stenting: A Secondary Analysis of the Dual Antiplatelet Therapy (DAPT) Study. 2017

Secemsky, Eric A / Yeh, Robert W / Kereiakes, Dean J / Cutlip, Donald E / Cohen, David J / Steg, P Gabriel / Cannon, Christopher P / Apruzzese, Patricia K / D'Agostino, Ralph B / Massaro, Joseph M / Mauri, Laura / Anonymous5140899. ·Division of Cardiology, Massachusetts General Hospital, Boston 2Harvard Medical School, Boston, Massachusetts 3Center for Clinical Biometrics, Department of Medicine, Brigham and Women's Hospital, Boston, Massachusetts 4Smith Center for Outcomes Research in Cardiology, Beth Israel Deaconess Medical Center, Boston, Massachusetts 5Baim Institute for Clinical Research, Boston, Massachusetts. · Harvard Medical School, Boston, Massachusetts 4Smith Center for Outcomes Research in Cardiology, Beth Israel Deaconess Medical Center, Boston, Massachusetts 5Baim Institute for Clinical Research, Boston, Massachusetts 6Division of Cardiology, Beth Israel Deaconess Medical Center, Boston, Massachusetts. · Christ Hospital Heart and Vascular Center, Cincinnati, Ohio 8Lindner Center for Research and Education, Cincinnati, Ohio. · Harvard Medical School, Boston, Massachusetts 5Baim Institute for Clinical Research, Boston, Massachusetts 6Division of Cardiology, Beth Israel Deaconess Medical Center, Boston, Massachusetts. · Saint Luke's Mid America Heart Institute, Kansas City, Missouri10University of Missouri-Kansas City School of Medicine, Kansas City, Missouri. · Université Paris-Diderot, Institut National de la Santé et de la Récherche Médicale U-1148, Hôpital Bichat, Paris, France 12Département Hospitalo-Universitaire Fibrosis, Inflammation, and Remodeling, Assistance Publique, Hôpitaux de Paris, Paris, France 13National Heart and Lung Institute, Institute of Cardiovascular Medicine and Science, Royal Brompton Hospital, Imperial College, London, England. · Harvard Medical School, Boston, Massachusetts 5Baim Institute for Clinical Research, Boston, Massachusetts 14Division of Cardiology, Brigham and Women's Hospital, Boston, Massachusetts. · Baim Institute for Clinical Research, Boston, Massachusetts. · Baim Institute for Clinical Research, Boston, Massachusetts 15Boston University School of Public Health, Boston, Massachusetts. · Harvard Medical School, Boston, Massachusetts 3Center for Clinical Biometrics, Department of Medicine, Brigham and Women's Hospital, Boston, Massachusetts 5Baim Institute for Clinical Research, Boston, Massachusetts 14Division of Cardiology, Brigham and Women's Hospital, Boston, Massachusetts. ·JAMA Cardiol · Pubmed #28297015.

ABSTRACT: Importance: Early cardiovascular and bleeding events after coronary stenting are associated with high risk of morbidity and mortality. Objective: To assess the prognosis of cardiovascular and bleeding events occurring beyond 1 year after coronary stenting. Design, Setting, and Participants: This secondary analysis is derived from data from the Dual Antiplatelet Therapy (DAPT) Study, a multicenter trial involving 220 US and international clinical sites from 11 countries. The study dates were August 2009 to May 2014. Individuals who underwent coronary stenting and completed 12 months of thienopyridine plus aspirin therapy without ischemic or bleeding events remained on an aspirin regimen and were randomized to continued thienopyridine therapy vs placebo for 18 additional months. Individuals were then followed up for 3 additional months while receiving aspirin therapy alone. The analysis began in August 2015. Exposures: Ischemic events (myocardial infarction not related to stent thrombosis, stent thrombosis, and ischemic stroke) and bleeding events (Global Utilization of Streptokinase and Tissue Plasminogen Activator for Occluded Arteries [GUSTO] classification moderate or severe bleeding). Main Outcomes and Measures: Ischemic events (myocardial infarction not related to stent thrombosis, stent thrombosis, and ischemic stroke) and bleeding events (GUSTO classification moderate or severe bleeding). Death at 21 months after randomization (33 months after coronary stenting). Results: In total, 25 682 individuals older than 18 years with an indication for coronary stenting were enrolled, and 11 648 (mean age, 61.3 years; 25.1% female) were randomized. After randomization, 478 individuals (4.1%) had 502 ischemic events (306 with myocardial infarction, 113 with stent thrombosis, and 83 with ischemic stroke), and 232 individuals (2.0%) had 235 bleeding events (155 with moderate and 80 with severe bleeding). Among individuals with ischemic events, 52 (10.9%) died. The annualized mortality rate after an ischemic event was 27.2 (95% CI, 20.3-35.7) per 100 person-years. The cumulative incidence of death after an ischemic event among the total randomized study population was 0.5% (0.3% with myocardial infarction, 0.1% with stent thrombosis, and 0.1% with ischemic stroke). Among individuals with bleeding events, 41 (17.7%) died. The annualized mortality rate after a bleeding event was 21.5 (95% CI, 15.4-29.1) per 100 person-years. The cumulative incidence of death after a bleeding event among the total randomized study population was 0.3% (0.1% with moderate and 0.2% with severe bleeding). Conclusions and Relevance: In patients treated with dual antiplatelet therapy for at least 1 year after coronary stenting, ischemic events were more frequent than bleeding events, and both events were associated with high risk of mortality. Trial Registration: clinicaltrials.gov Identifier: NCT00977938.

35 Article Myocardial Infarction Risk After Discontinuation of Thienopyridine Therapy in the Randomized DAPT Study (Dual Antiplatelet Therapy). 2017

Stefanescu Schmidt, Ada C / Kereiakes, Dean J / Cutlip, Donald E / Yeh, Robert W / D'Agostino, Ralph B / Massaro, Joseph M / Hsieh, Wen-Hua / Mauri, Laura / Anonymous3970897. ·From Massachusetts General Hospital, Boston (A.C.S.S.) · Baim Institute for Clinical Research (formerly Harvard Clinical Research Institute), Boston, MA (A.C.S.S., D.E.C., R.W.Y., R.B.D'A., J.M.M., W.-H.H., L.M.) · Brigham and Women's Hospital, Boston, MA (A.C.S.S., L.M.) · Christ Hospital, Heart and Vascular Center and Lindner Center for Research and Education, Cincinnati, OH (D.J.K.) · and Beth Israel Deaconess Medical Center, Boston, MA (D.E.C., R.W.Y.). ·Circulation · Pubmed #28228427.

ABSTRACT: BACKGROUND: Thienopyridine plus aspirin beyond 1 year after coronary stenting reduces myocardial infarction (MI) risk and increases bleeding risk in comparison with aspirin alone. The hazard associated with late thienopyridine discontinuation and risk factors for MI after discontinuation are poorly defined. METHODS: In the DAPT Study (Dual Antiplatelet Therapy), after percutaneous coronary intervention and 12 months of thienopyridine (clopidogrel or prasugrel) plus aspirin, eligible patients remained on aspirin and were randomly assigned to continued thienopyridine versus placebo for 18 months. At 30 months, patients stopped the study drug and were observed for 3 months. Cumulative incidence of MI was assessed over 3 months after randomization (months 12-15) and 3 months after study drug discontinuation (months 30-33). The MI hazard for each of these periods was assessed across randomized treatment arms and by DAPT score values <2 or ≥2. RESULTS: Among the 11 648 randomly assigned patients, the monthly cumulative incidence of MI was lower with continued thienopyridine versus placebo at 12 to 15 months (0.12% versus 0.37%, CONCLUSIONS: Discontinuing thienopyridine after either 12 or 30 months is associated with an early increase in MI risk, mainly unrelated to stent thrombosis; the magnitude of risk is highest in the earlier time frame, and lower in patients not treated with paclitaxel-eluting stents. Although higher DAPT scores identify patients with greater absolute ischemic benefit (relative to bleeding harm) with continued thienopyridine therapy, discontinuation at 12 months increases MI hazard regardless of DAPT score group. CLINICAL TRIAL REGISTRATION: URL: http://www.clinicaltrials.gov. Unique identifier: NCT00977938.

36 Article 5-Year Safety and Efficacy of Resolute Zotarolimus-Eluting Stent: The RESOLUTE Global Clinical Trial Program. 2017

Yeh, Robert W / Silber, Sigmund / Chen, Lianglong / Chen, Shaoliang / Hiremath, Shirish / Neumann, Franz-Josef / Qiao, Shubin / Saito, Shigeru / Xu, Bo / Yang, Yuejin / Mauri, Laura. ·Smith Center for Outcomes Research in Cardiology, Beth Israel Deaconess Medical Center, Boston, Massachusetts. Electronic address: ryeh@bidmc.harvard.edu. · Department of Cardiology, Heart Centre at the Isar, Munich, Germany. · Union Hospital, Fujian Medical University, Fujian, China. · Nanjing First Hospital, Jiangshu, China. · Ruby Hall Clinic, Pune, India. · University Heart Center Freiburg-Bad Krozingen, Bad Krozingen, Germany. · Fu Wai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences, Beijing, China. · Shonan Kamakura General Hospital, Kamakura, Japan. · Division of Cardiovascular Medicine, Baim Institute for Clinical Research, Brigham and Women's Hospital, and Harvard Medical School, Boston, Massachusetts. ·JACC Cardiovasc Interv · Pubmed #28109872.

ABSTRACT: OBJECTIVES: The authors evaluated the 5-year cumulative incidence of cardiovascular events following Resolute zotarolimus-eluting stent (R-ZES) implantation. BACKGROUND: Individual trials are often underpowered to show differences for low-frequency adverse events. The R-ZES was studied in 10 prospective clinical trials, designed with identical adverse event definitions, ascertainment, and adjudication. METHODS: The RESOLUTE Global Clinical Trial Program includes 7,618 patients treated with R-ZES: RESOLUTE first-in-human study (N = 139), RESOLUTE All Comers (N = 1,140), RESOLUTE International (N = 2,349), RESOLUTE US (N = 1,402), RESOLUTE US 38 mm (N = 114), RESOLUTE Japan (N = 100), RESOLUTE Japan Small Vessel Study (N = 65), RESOLUTE Asia (N = 311), RESOLUTE China Randomized Controlled Trial (N = 198), and RESOLUTE China Registry (N = 1,800). The 5-year cumulative incidence of events was calculated. RESULTS: The 5-year cumulative incidence of cardiac events was 13.4% for target lesion failure and included 5.0% cardiac death, 4.4% target vessel myocardial infarction, and 6.3% clinically driven target lesion revascularization. Dual-antiplatelet therapy at 1, 3, and 5 years was 91%, 37%, and 32%, respectively. The 5-year cumulative incidence of definite or probable stent thrombosis was 1.2%, which comprised 0.7% at 1 year and an annualized rate of 0.1% thereafter. Five-year use of dual-antiplatelet therapy varied geographically from 63% in Japan to 11% in Europe. CONCLUSIONS: In the largest group of R-ZES patients examined to date, the majority of stent-related events, including target vessel myocardial infarction and stent thrombosis, occurred within the first year of implantation with much lower risks of these events out to 5 years.

37 Article Prevention of Stroke with Ticagrelor in Patients with Prior Myocardial Infarction: Insights from PEGASUS-TIMI 54 (Prevention of Cardiovascular Events in Patients With Prior Heart Attack Using Ticagrelor Compared to Placebo on a Background of Aspirin-Thrombolysis in Myocardial Infarction 54). 2016

Bonaca, Marc P / Goto, Shinya / Bhatt, Deepak L / Steg, P Gabriel / Storey, Robert F / Cohen, Marc / Goodrich, Erica / Mauri, Laura / Ophuis, Ton Oude / Ruda, Mikhail / Špinar, Jindřich / Seung, Ki-Bae / Hu, Dayi / Dalby, Anthony J / Jensen, Eva / Held, Peter / Morrow, David A / Braunwald, Eugene / Sabatine, Marc S. ·From TIMI Study Group, Brigham and Women's Hospital, Harvard Medical School, Boston, MA (M.P.B., D.L.B., E.G., D.A.M., E.B., M.S.) · Tokai University School of Medicine · Institute of Medical Science, Isehara, Japan (S.G.) · FACT, DHU-FIRE INSERM Unité 1148, Assistance Publique-Hôpitaux de Paris and Université Paris Diderot, Paris, France, and NHLI Imperial College, Royal Brompton Hospital, London, UK (P.G.S.) · University of Sheffield, United Kingdom (R.F.S.) · Division of Cardiology, Newark Beth Israel Medical Center, Rutgers-New Jersey Medical School, Newark (M.C.) · Brigham and Women's Hospital and Harvard Clinical Research Institute, Harvard Medical School, Boston, MA (L.M.) · CWZ Hospital, Nijmegen, The Netherlands (T.O.O.) · Cardiology Research and Production complex MH RF, Moscow, Russia (M.R.) · Internal Cardiology Department, University Hospital and Medical faculty, Brno, Czech Republic (J.S.) · Seoul St. Mary's Hospital, College of Medicine, The Catholic University of Korea (K.-B.S.) · Heart Institute, Intervention Center, People Hospital of Peking University, China (D.H.) · Life Fourways Hospital, Randburg, South Africa (A.J.D.) · and AstraZeneca, Mölndal, Sweden (E.J., P.H.). ·Circulation · Pubmed #27576775.

ABSTRACT: BACKGROUND: In the PEGASUS-TIMI 54 trial (Prevention of Cardiovascular Events in Patients With Prior Heart Attack Using Ticagrelor Compared to Placebo on a Background of Aspirin-Thrombolysis in Myocardial Infarction 54), ticagrelor reduced the risk of major adverse cardiovascular events when added to low-dose aspirin in stable patients with prior myocardial infarction, resulting in the approval of ticagrelor 60 mg twice daily for long-term secondary prevention. We investigated the incidence of stroke, outcomes after stroke, and the efficacy of ticagrelor focusing on the approved 60 mg twice daily dose for reducing stroke in this population. METHODS: Patients were followed for a median of 33 months. Stroke events were adjudicated by a central committee. Data from similar trials were combined using meta-analysis. RESULTS: Of 14 112 patients randomly assigned to placebo or ticagrelor 60 mg, 213 experienced a stroke; 85% of these strokes were ischemic. A total of 18% of strokes were fatal and another 15% led to either moderate or severe disability at 30 days. Ticagrelor significantly reduced the risk of stroke (hazard ratio, 0.75; 95% confidence interval, 0.57-0.98; P=0.034), driven by a reduction in ischemic stroke (hazard ratio, 0.76; 95% confidence interval, 0.56-1.02). Hemorrhagic stroke occurred in 9 patients on placebo and 8 patients on ticagrelor. A meta-analysis across 4 placebo-controlled trials of more intensive antiplatelet therapy in 44 816 patients with coronary disease confirmed a marked reduction in ischemic stroke (hazard ratio, 0.66; 95% confidence interval, 0.54-0.81; P=0.0001). CONCLUSIONS: High-risk patients with prior myocardial infarction are at risk for stroke, approximately one-third of which are fatal or lead to moderate-to-severe disability. The addition of ticagrelor 60 mg twice daily significantly reduced this risk without an excess of hemorrhagic stroke but with more major bleeding. In high-risk patients with coronary disease, more intensive antiplatelet therapy should be considered not only to reduce the risk of coronary events, but also of stroke. CLINICAL TRIAL REGISTRATION: URL: http://www.clinicaltrials.gov. Unique Identifier: NCT01225562.

38 Article Impact of Optimal Medical Therapy in the Dual Antiplatelet Therapy Study. 2016

Resor, Charles D / Nathan, Ashwin / Kereiakes, Dean J / Yeh, Robert W / Massaro, Joseph M / Cutlip, Donald E / Gabriel Steg, P / Hsieh, Wen-Hua / Mauri, Laura / Anonymous6290879. ·From Division of Cardiology and Center for Clinical Biometrics, Department of Medicine, Brigham and Women's Hospital, Boston, MA (C.D.R., L.M.) · Harvard Clinical Research Institute, Boston, MA (R.W.Y., D.E.C., W.-H.H., L.M.) · Harvard Medical School, Boston, MA (R.W.Y., L.M.) · Division of Cardiology, University of Pennsylvania Medical Center, Philadelphia (A.N.) · Smith Center for Outcomes Research in Cardiology, Beth Israel Deaconess Medical Center, Boston, MA (R.W.Y., D.E.C.) · Department of Biostatistics, Boston University School of Public Heath, MA (J.M.M.) · The Christ Hospital Heart and Vascular Center and The Lindner Center for Research and Education, Cincinnati, OH (D.J.K.) · Université Paris-Diderot, INSERM U-1148, Hôpital Bichat, Département Hospitalo-Universitaire Fibrosis, Inflammation, and Remodeling, Assistance Publique-Hôpitaux de Paris, Paris, France (P.G.S.) · and National Heart and Lung Institute, Institute of Cardiovascular Medicine and Science, Royal Brompton Hospital, Imperial College, London, UK (P.G.S.). ·Circulation · Pubmed #27576774.

ABSTRACT: BACKGROUND: Continued dual antiplatelet therapy and optimal medical therapy (OMT) improve outcomes in selected patient populations with established coronary heart disease, but whether OMT modifies the treatment effect of dual antiplatelet therapy is unknown. METHODS: The DAPT (Dual Antiplatelet Therapy) Study, a double-blind trial, randomly assigned 11 648 patients who had undergone coronary stenting and completed 1 year of dual antiplatelet therapy without major bleeding or ischemic events to an additional 18 months of continued thienopyridine or placebo. OMT was defined as a combination of statin, β-blocker, and angiotensin-converting enzyme inhibitor/angiotensin receptor blocker use in patients with an American College of Cardiology/American Heart Association class I indication for each medication. Per protocol, all patients were treated with 75 to 325 mg aspirin daily. End points included myocardial infarction, major adverse cardiovascular and cerebrovascular events, and Global Utilization of Streptokinase and Tissue Plasminogen Activator for Occluded Arteries moderate or severe bleeding events. RESULTS: Of 11 643 randomly assigned patients with complete medication data, 63% were on OMT. Between 12 and 30 months, continued thienopyridine reduced myocardial infarction in comparison with placebo in both groups (on OMT 2.1% versus 3.3%, hazard ratio [HR], 0.64; 95% confidence interval [CI], 0.48-0.86; P=0.003; off OMT 2.2% versus 5.2%, HR, 0.41; CI, 0.29-0.58; P<0.001; interaction P=0.103). Comparing continued thienopyridine versus placebo, rates of major adverse cardiovascular and cerebrovascular events were 4.2% versus 5.0% among patients on OMT (HR, 0.82; CI, 0.66-1.02; P=0.077) and 4.5% versus 7.0% among those off OMT (HR, 0.63; CI, 0.49-0.82; P<0.001; interaction P=0.250); rates of bleeding for thienopyridine versus placebo in patients on OMT were 2.2% versus 1.0% (HR, 2.13; CI, 1.43-3.17; P<0.001), and in patients off OMT were 2.8% versus 2.2% (HR, 1.30; CI, 0.88-1.92; P=0.189; interaction P=0.073). Overall, patients on OMT had lower rates of myocardial infarction (2.7% versus 3.7%, P=0.003), major adverse cardiovascular and cerebrovascular events (4.6% versus 5.7%, P=0.007), and bleeding (1.6% versus 2.5%, P<0.001) in comparison with patients off OMT. Rates of stent thrombosis (0.8% versus 1.0%, P=0.171) and death (1.6% versus 1.9%, P=0.155) did not differ. CONCLUSIONS: Continued thienopyridine therapy reduced the rate of myocardial infarction regardless of OMT status and had consistent effects on reduction in major adverse cardiovascular and cerebrovascular events and increased bleeding. CLINICAL TRIAL REGISTRATION: URL: http://clinicaltrials.gov. Unique identifier: NCT00977938.

39 Article Frequency of Stent Thrombosis Risk at 5 Years in Women Versus Men With Zotarolimus-Eluting Compared With Sirolimus-Eluting Stent. 2016

Ten Haaf, Monique / Appelman, Yolande / Wijns, William / Steg, Gabriel / Mauri, Laura / Rademaker-Havinga, Tessa / Wetzels, Gwenn / Bousquette, Lisa / Camenzind, Edoardo / Boersma, Eric / Anonymous4110879. ·Department of Cardiology, VU University Medical Center, Amsterdam, The Netherlands; Netherlands Heart Institute, Utrecht, The Netherlands. · Department of Cardiology, VU University Medical Center, Amsterdam, The Netherlands. · Cardiovascular Center, OLV Hospital, Aalst, Belgium. · Department of Cardiology, Hopital Bichat Assistance Publique, Paris, France. · Department of Cardiology, Harvard Medical School and Brigham and Women's Hospital, Boston, Massachusetts. · Cardialysis BV, Rotterdam, The Netherlands. · Medtronic Bakken Research Center, Medtronic Cardiovascular, Maastricht, The Netherlands. · Medtronic Cardiovascular, Santa Rosa, California. · Department of Cardiology, University Hospital of Nancy, Vandoeuvre-lès-Nancy, France. · Department of Cardiology, Erasmus MC, Rotterdam, The Netherlands; Cardiovascular research school COEUR, Erasmus MC, Rotterdam, The Netherlands. Electronic address: h.boersma@erasmusmc.nl. ·Am J Cardiol · Pubmed #27569387.

ABSTRACT: The prevalence of factors that are associated with an increased risk of stent thrombosis (ST), including smoking, diabetes mellitus, and small stent size, is different in women and men who underwent percutaneous coronary intervention. Thus, gender may potentially modify the relation between stent type and the incidence of ST during long-term follow-up. We explored the data of Patient Related Outcomes With Endeavor Versus Cypher stenting Trial (PROTECT) to evaluate this hypothesis. PROTECT randomized 2,061 women and 6,648 men who underwent percutaneous coronary intervention for various indications to Endeavor zotarolimus-eluting stenting (E-ZES) or Cypher sirolimus-eluting stenting (C-SES). Dual antiplatelet therapy was prescribed for at least 3 months. Data on study end points were collected until 5 years after randomization, including ST, death, and cardiovascular events. We analyzed end points and treatment effect (E-ZES vs C-SES) in relation to gender. Women were on average 4.7 years older (65.8 vs 61.1), had a higher prevalence of insulin-dependent diabetes mellitus, were less often smokers, and had a shorter total stent length than men. At discharge and throughout follow-up, a slightly lower fraction of women were using dual antiplatelet therapy. During 5-year follow-up, definite or probable ST was observed in 36 women (1.8%) and 152 men (2.4%; log-rank p = 0.15). E-ZES reduced the incidence of ST compared with C-SES in women (hazard ratio 0.58) and men (hazard ratio 0.61), with no evidence of heterogeneity (p = 0.89). In conclusion, in PROTECT, women and men had similar cumulative incidence of ST at 5 years after stent placement. The favorable effect of the study stent E-ZES over C-SES was not modified by gender.

40 Article Focused Update on Duration of Dual Antiplatelet Therapy for Patients With Coronary Artery Disease. 2016

Mauri, Laura / Smith, Sidney C. ·Brigham and Women's Hospital, Department of Cardiovascular Medicine, Harvard Medical School, Boston, Massachusetts2Harvard Clinical Research Institute, Boston, Massachusetts. · University of North Carolina School of Medicine, Chapel Hill, North Carolina4University of North Carolina Center for Heart and Vascular Care, Chapel Hill, North Carolina. ·JAMA Cardiol · Pubmed #27548911.

ABSTRACT: -- No abstract --

41 Article Temporal Trends in the Risk Profile of Patients Undergoing Outpatient Percutaneous Coronary Intervention: A Report from the National Cardiovascular Data Registry's CathPCI Registry. 2016

Vora, Amit N / Dai, Dadi / Gurm, Hitinder / Amin, Amit P / Messenger, John C / Mahmud, Ehtisham / Mauri, Laura / Wang, Tracy Y / Roe, Matthew T / Curtis, Jeptha / Patel, Manesh R / Dauerman, Harold L / Peterson, Eric D / Rao, Sunil V. ·From the Duke Clinical Research Institute, Duke University Medical Center, Durham, NC (A.N.V., D.D., T.Y.W., M.T.R., M.R.P., E.D.P., S.V.R.) · Department of Cardiovascular Medicine, University of Michigan, Ann Arbor (H.G.) · Division of Cardiology, Washington University School of Medicine, St. Louis, MO (A.P.A.) · Department of Medicine, University of Colorado Anschutz Medical Campus, Aurora (J.C.M.) · Division of Cardiovascular Medicine, Department of Medicine, University of California-San Diego (E.M.) · Division of Cardiovascular Medicine, Department of Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, MA (L.M.) · Harvard Clinical Research Institute, Boston, MA (L.M.) · Section of Cardiovascular Medicine, Yale University School of Medicine, New Haven, CT (J.C.) · and University of Vermont Cardiovascular Research Institute, Burlington, VT (H.L.D.). ·Circ Cardiovasc Interv · Pubmed #26957417.

ABSTRACT: BACKGROUND: Because of recent changes in criteria for coverage for inpatient hospital stays, most nonacute percutaneous coronary intervention (PCI) procedures are reimbursed on an outpatient basis regardless of underlying patient risk. Downstream effects of these changes on the risk profile of patients undergoing outpatient PCI have not been evaluated. METHODS AND RESULTS: Using the American College of Cardiology National Cardiovascular Data Registry's CathPCI Registry, we assessed temporal trends in risk profiles and rates of hospital admission among 999 279 patients undergoing PCI qualifying for outpatient reimbursement. We estimated mortality and bleeding risk using validated models from the registry. From 2009 to 2014, the proportion of outpatients not admitted to a hospital after PCI increased from 32.8% to 66.3% (P<0.001). Patients who were admitted after PCI were older, had greater comorbidities, and experienced more post-PCI complications (all P<0.001). Among those not admitted, the proportion of patients at high risk for predicted mortality increased significantly from 17.0% to 19.8% during the study period (P<0.001). In contrast, 16.7% of patients admitted after PCI were at low risk for mortality. CONCLUSIONS: Among patients undergoing PCI procedures that qualify for outpatient reimbursement, there has been a temporal decrease in postprocedure hospital admission. Concomitantly, the proportion of these outpatients at high risk for mortality has significantly increased over time. These data suggest that current reimbursement classification could be improved by incorporating patient risk to appropriately match the necessary resources to the needed level of care.

42 Article Benefits and Risks of Extended Dual Antiplatelet Therapy After Everolimus-Eluting Stents. 2016

Hermiller, James B / Krucoff, Mitchell W / Kereiakes, Dean J / Windecker, Stephan / Steg, P Gabriel / Yeh, Robert W / Cohen, David J / Cutlip, Donald E / Massaro, Joseph M / Hsieh, Wen-Hua / Mauri, Laura / Anonymous5180855. ·St. Vincent Heart Center, Indianapolis, Indiana. · Department of Medicine, Duke University Medical Center, Durham, North Carolina. · The Christ Hospital Heart and Vascular Center and The Lindner Center for Research and Education, Cincinnati, Ohio. · Department of Cardiology, Bern University Hospital, Bern, Switzerland. · Université Paris-Diderot, INSERM U-1148, and Hôpital Bichat, Département Hospitalo-Universitaire FIRE, Assistance Publique-Hôpitaux de Paris, Paris, France; National Heart & Lung Institute, Imperial College, Royal Brompton Hospital, London, United Kingdom. · The Smith Center for Outcomes Research in Cardiology, Beth Israel Deaconess Medical Center, Boston, Massachusetts; Harvard Medical School, Boston, Massachusetts; Harvard Clinical Research Institute, Boston, Massachusetts. · Department of Cardiology, Saint Luke's Mid America Heart Institute, University of Missouri-Kansas City School of Medicine, Kansas City, Missouri. · Harvard Medical School, Boston, Massachusetts; Harvard Clinical Research Institute, Boston, Massachusetts; Department of Medicine, Cardiology Division, Beth Israel Deaconess Medical Center, Boston, Massachusetts. · Harvard Clinical Research Institute, Boston, Massachusetts; School of Public Health, Boston University School of Medicine, Boston, Massachusetts. · Harvard Clinical Research Institute, Boston, Massachusetts. · Harvard Medical School, Boston, Massachusetts; Harvard Clinical Research Institute, Boston, Massachusetts; Division of Cardiovascular Medicine, Brigham and Women's Hospital, Boston, Massachusetts. Electronic address: lmauri1@partners.org. ·JACC Cardiovasc Interv · Pubmed #26793956.

ABSTRACT: OBJECTIVES: The purpose of this study was to characterize outcomes for everolimus-eluting stent (EES)-treated subjects according to treatment with continued thienopyridine plus aspirin versus aspirin alone 12 to 30 months after stenting. BACKGROUND: In the DAPT (Dual Antiplatelet Therapy) study, continued thienopyridine plus aspirin beyond 1 year after coronary stenting reduced ischemic events. Given low rates of stent thrombosis and myocardial infarction (MI) for current drug-eluting stents, we examined outcomes among EES-treated subjects in the DAPT study. METHODS: The DAPT study enrolled 25,682 subjects (11,308 EES-treated) after coronary stenting. Following 12 months of treatment with thienopyridine and aspirin, eligible subjects continued treatment with aspirin and 9,961 (4,703 with EES) were randomized to 18 months of continued thienopyridine or placebo. Stent type was not randomized, and the EES subset analysis was post hoc. RESULTS: Among EES-treated patients, continued thienopyridine reduced stent thrombosis (0.3% vs. 0.7%, hazard ratio [HR]: 0.38, 95% confidence interval [CI]: 0.15 to 0.97; p = 0.04) and MI (2.1% vs. 3.2%, HR: 0.63, 95% CI: 0.44 to 0.91; p = 0.01) versus placebo but did not reduce a composite of death, MI, and stroke (4.3% vs. 4.5%, HR: 0.89, 95% CI: 0.67 to 1.18; p = 0.42), and increased moderate/severe bleeding (2.5% vs. 1.3%, HR: 1.79, 95% CI: 1.15 to 2.80; p = 0.01), and death (2.2% vs. 1.1%, HR: 1.80, 95% CI: 1.11 to 2.92; p = 0.02). Death due to cancer and not related to bleeding was increased (0.64% vs. 0.17%; p = 0.01). CONCLUSIONS: In EES-treated subjects, significant reductions in stent thrombosis and MI and an increase in bleeding were observed with continued thienopyridine beyond 1 year compared with aspirin alone. (The Dual Antiplatelet Therapy Study [DAPT Study]); NCT00977938).

43 Article Stent Thrombosis in Drug-Eluting or Bare-Metal Stents in Patients Receiving Dual Antiplatelet Therapy. 2015

Kereiakes, Dean J / Yeh, Robert W / Massaro, Joseph M / Driscoll-Shempp, Priscilla / Cutlip, Donald E / Steg, P Gabriel / Gershlick, Anthony H / Darius, Harald / Meredith, Ian T / Ormiston, John / Tanguay, Jean-François / Windecker, Stephan / Garratt, Kirk N / Kandzari, David E / Lee, David P / Simon, Daniel I / Iancu, Adrian Corneliu / Trebacz, Jaroslaw / Mauri, Laura / Anonymous5020846. ·Christ Hospital Heart and Vascular Center and The Lindner Center for Research and Education, Cincinnati, Ohio. · Harvard Clinical Research Institute, Boston, Massachusetts; Massachusetts General Hospital, Boston, Massachusetts. · Harvard Clinical Research Institute, Boston, Massachusetts; Boston University School of Public Health, Boston, Massachusetts. · Harvard Clinical Research Institute, Boston, Massachusetts. · Harvard Clinical Research Institute, Boston, Massachusetts; Beth Israel Deaconess Medical Center, Department of Medicine, Cardiology Division, Boston, Massachusetts. · Université Paris-Diderot, Paris, France, INSERM U-1148, Paris, France; Hôpital Bichat, Département Hospitalo-Universitaire FIRE, Assistance Publique-Hôpitaux de Paris, Paris, France; NHLI, Imperial College, Royal Brompton Hospital, London, United Kingdom. · Department of Cardiovascular Sciences, University of Leicester and National Institute of Health Research Leicester Cardiovascular Biomedical Research Unit, University Hospitals of Leicester, Leicester, United Kingdom. · Vivantes Neukoelln Medical Center, Department of Cardiology, Angiology, Nephrology and Intensive Care Medicine, Berlin, Germany. · Monash Heart, Monash Health, Monash University, Victoria, Australia. · Mercy Hospital, Auckland, New Zealand. · Montreal Heart Institute, Department of Medicine/Division of Interventional Cardiology, Université de Montréal, Department of Medicine, Montreal, Canada. · Bern University Hospital, Department of Cardiology, Bern, Switzerland. · Center for Heart and Vascular Health, Christiana Care, Wilmington, Delaware. · Piedmont Heart Institute, Atlanta, Georgia. · Stanford University, Department of Medicine, Division of Cardiovascular Medicine, Stanford, California. · University Hospitals Case Medical Center, Harrington Heart and Vascular Institute, Cleveland, Ohio. · Heart Institute, University of Medicine Iuliu Hatieganu, Cluj Napoca, Romania. · Jan Pawel II Hospital Krakow, Krakow, Poland. · Harvard Clinical Research Institute, Boston, Massachusetts; Brigham and Women's Hospital, Division of Cardiovascular Medicine, Boston, Massachusetts. Electronic address: lmauri1@partners.org. ·JACC Cardiovasc Interv · Pubmed #26493248.

ABSTRACT: OBJECTIVES: This study sought to compare rates of stent thrombosis and major adverse cardiac and cerebrovascular events (MACCE) (composite of death, myocardial infarction, or stroke) after coronary stenting with drug-eluting stents (DES) versus bare-metal stents (BMS) in patients who participated in the DAPT (Dual Antiplatelet Therapy) study, an international multicenter randomized trial comparing 30 versus 12 months of dual antiplatelet therapy in subjects undergoing coronary stenting with either DES or BMS. BACKGROUND: Despite antirestenotic efficacy of coronary DES compared with BMS, the relative risk of stent thrombosis and adverse cardiovascular events is unclear. Many clinicians perceive BMS to be associated with fewer adverse ischemic events and to require shorter-duration dual antiplatelet therapy than DES. METHODS: Prospective propensity-matched analysis of subjects enrolled into a randomized trial of dual antiplatelet therapy duration was performed. DES- and BMS-treated subjects were propensity-score matched in a many-to-one fashion. The study design was observational for all subjects 0 to 12 months following stenting. A subset of eligible subjects without major ischemic or bleeding events were randomized at 12 months to continued thienopyridine versus placebo; all subjects were followed through 33 months. RESULTS: Among 10,026 propensity-matched subjects, DES-treated subjects (n = 8,308) had a lower rate of stent thrombosis through 33 months compared with BMS-treated subjects (n = 1,718, 1.7% vs. 2.6%; weighted risk difference -1.1%, p = 0.01) and a noninferior rate of MACCE (11.4% vs. 13.2%, respectively, weighted risk difference -1.8%, p = 0.053, noninferiority p < 0.001). CONCLUSIONS: DES-treated subjects have long-term rates of stent thrombosis that are lower than BMS-treated subjects. (The Dual Antiplatelet Therapy Study [DAPT study]; NCT00977938).

44 Article Balancing Long-Term Risks of Ischemic and Bleeding Complications After Percutaneous Coronary Intervention With Drug-Eluting Stents. 2015

Matteau, Alexis / Yeh, Robert W / Camenzind, Edoardo / Steg, P Gabriel / Wijns, William / Mills, Joseph / Gershlick, Anthony / de Belder, Mark / Ducrocq, Gregory / Mauri, Laura. ·Division of Cardiovascular Medicine, Department of Medicine, Brigham and Women's Hospital, Boston, Massachusetts. · Cardiology Division, Department of Medicine, Massachusetts General Hospital, Boston, Massachusetts. · Cardiology Department, University of Geneva, Geneva, Switzerland. · Cardiology Department, DHU-FIRE, Hôpital Bichat, Paris, France; Université Paris-Diderot, Paris, France; INSERM U1148, Paris, France. · Cardiology Department, Cardiovascular Research Center Aalst, OLV Hospital, Aalst, Belgium. · Cardiology Department, Cardiothoracic Centre, Liverpool, United Kingdom. · Department of Cardiovascular Sciences, University of Leicester, Leicester, United Kingdom; NIHR Leicester Cardiovascular Biomedical Research Unit, University Hospitals of Leicester Glenfield Hospital, Leicester, United Kingdom. · Cardiology Department, The James Cook University Hospital, Middlesbrough, United Kingdom. · Division of Cardiovascular Medicine, Department of Medicine, Brigham and Women's Hospital, Boston, Massachusetts. Electronic address: lmauri1@partners.org. ·Am J Cardiol · Pubmed #26187674.

ABSTRACT: Although trials comparing antiplatelet strategies after percutaneous coronary intervention report average risks of bleeding and ischemia in a population, there is limited information to guide choices based on individual patient risks, particularly beyond 1 year after treatment. Patient-level data from Patient Related Outcomes With Endeavor vs Cypher Stenting Trial (PROTECT), a broadly inclusive trial enrolling 8,709 subjects treated with drug-eluting stents (sirolimus vs zotarolimus-eluting stent), and PROTECT US, a single-arm study including 1,018 subjects treated with a zotarolimus-eluting stent, were combined. The risk of ischemic events, cardiovascular death/non-periprocedural myocardial infarction (MI)/definite or probable stent thrombosis, and bleeding events, Global Use of Strategies to Open Occluded Arteries moderate or severe bleed, were predicted using logistic regression. At median follow-up of 4.1 years, major bleeding occurred in 260 subjects (2.8%) and ischemic events in 595 (6.3%). Multivariate predictors of bleeding were older age, smoking, diabetes mellitus, congestive heart failure, and chronic kidney disease (all p <0.05). Ischemic events shared all the same predictors with bleeding events and gender, body mass index, previous MI, previous coronary artery bypass graft surgery, ST-segment elevation MI on presentation, stent length, and sirolimus-eluting stent use (all p <0.05). Within individual subjects, bleeding and ischemic risks were strongly correlated; 97% of subjects had a greater risk of ischemic events than bleeding. In conclusion, individual patient risks of ischemia and bleeding are related to many common risk factors, yet the predicted risks of ischemic events are greater than those of major bleeding in the large majority of patients in long-term follow-up.

45 Article Impact of body mass index on long-term clinical outcomes after second-generation drug eluting stent implantation: Insights from the international global RESOLUTE program. 2015

Diletti, Roberto / Garcia-Garcia, Hector M / Bourantas, Christos / Van Mieghem, Nicolas M / van Geuns, Robert Jan / Muramatsu, Takashi / Zhang, Yao-Jun / Mauri, Laura / Belardi, Jorge / Silber, Sigmund / Widimsky, Petr / Leon, Martin / Windecker, Stephan / Meredith, Ian / Neumann, Franz-Josef / Yeung, Alan C / Saito, Shigeru / Liu, Minglei / van Leeuwen, Frank / Serruys, Patrick W. ·Department of Interventional Cardiology, Thoraxcenter, Erasmus MC, Rotterdam, The Netherlands. ·Catheter Cardiovasc Interv · Pubmed #25689692.

ABSTRACT: BACKGROUND: An increased body mass index (BMI) is associated with a high risk of cardiovascular disease and reduction in life expectancy. However, several studies reported improved clinical outcomes in obese patients treated for cardiovascular diseases. The aim of the present study is to investigate the impact of BMI on long-term clinical outcomes after implantation of zotarolimus eluting stents. METHODS: Individual patient data were pooled from the RESOLUTE Clinical Program comprising five trials worldwide. The study population was sorted according to BMI tertiles and clinical outcomes were evaluated at 2-year follow-up. RESULTS: Data from a total of 5,127 patients receiving the R-ZES were included in the present study. BMI tertiles were as follow: I tertile (≤ 25.95 kg/m(2) -Low or normal weight) 1,727 patients; II tertile (>25.95 ≤ 29.74 kg/m(2) -overweight) 1,695 patients, and III tertile (>29.74 kg/m(2) -obese) 1,705 patients. At 2-years follow-up no difference was found for patients with high BMI (III tertile) compared with patients with normal or low BMI (I tertile) in terms of target lesion failure (I-III tertile, HR [95% CI] = 0.89 [0.69, 1.14], P = 0.341; major adverse cardiac events (I-III tertile, HR [95% CI] = 0.90 [0.72, 1.14], P = 0.389; cardiac death (I-III tertile, HR [95% CI] = 1.20 [0.73, 1.99], P = 0.476); myocardial infarction (I-III tertile, HR [95% CI] = 0.86 [0.55, 1.35], P = 0.509; clinically-driven target lesion revascularization (I-III tertile, HR [95% CI] = 0.75 [0.53, 1.08], P = 0.123; definite or probable stent thrombosis (I-III tertile, HR [95% CI] = 0.98 [0.49, 1.99], P = 0.964. CONCLUSIONS: In the present study, the patients' body mass index was found to have no impact on long-term clinical outcomes after coronary artery interventions.

46 Article Evaluating the generalizability of a large streamlined cardiovascular trial: comparing hospitals and patients in the dual antiplatelet therapy study versus the National Cardiovascular Data Registry. 2015

Yeh, Robert W / Czarny, Matthew J / Normand, Sharon-Lise T / Kereiakes, Dean J / Holmes, David R / Brindis, Ralph G / Weaver, W Douglas / Rumsfeld, John S / Roe, Matthew T / Kim, Sunghee / Driscoll-Shempp, Priscilla / Mauri, Laura. ·From the Cardiology Division, Department of Medicine, Massachusetts General Hospital (R.W.Y), Department of Health Care Policy (Biostatistics) (S.-L.T.N.), and Division of Cardiovascular Medicine, Department of Medicine, Brigham and Women's Hospital (L.M.), Harvard Medical School, Boston, MA (R.W.Y., S.-L.T.N., L.M.) · Harvard Clinical Research Institute, Boston, MA (R.W.Y., P.D.S., L.M.) · Cardiology Division, Department of Medicine, Johns Hopkins Hospital, Johns Hopkins University School of Medicine, Baltimore, MD (M.J.C.) · Department of Biostatistics, Harvard University School of Public Health, Boston, MA (S.-L.T.N.) · The Christ Hospital Heart and Vascular Center/The Lindner Research Center, Cincinnati, OH (D.J.K.) · Cardiology Division, Mayo Clinic, Rochester, MN (D.R.H., Jr) · Philip R. Lee Institute for Health Policy Studies, Department of Medicine, University of California, San Francisco (R.G.B.) · Heart and Vascular Institute, Henry Ford Health System, Detroit, MI (W.D.W.) · Cardiology Division, Denver VA Medical Center/Veterans Health Administration, CO (J.S.R.) · and Duke Clinical Research Institute, Durham, NC (M.T.R., S.K.). ·Circ Cardiovasc Qual Outcomes · Pubmed #25399847.

ABSTRACT: BACKGROUND: The Dual Antiplatelet Therapy Study is large streamlined clinical trial designed to evaluate antiplatelet treatment strategies in a broadly inclusive population of subjects treated with coronary stents. Whether large streamlined trials can successfully include a representative group of study sites and patients has not been formally assessed. METHODS AND RESULTS: Within the National Cardiovascular Data Registry CathPCI Registry, we compared characteristics and outcomes of hospitals participating versus not participating in the Dual Antiplatelet Therapy Study. We also compared clinical and procedural characteristics of trial subjects undergoing percutaneous coronary intervention (PCI) with drug-eluting stents to contemporaneous patients within the National Cardiovascular Data Registry CathPCI Registry. Standardized differences between groups were estimated. Between September 2009 and July 2011, 1.1 million PCIs were performed among 1276 hospitals, of which 309 (24.2%) participated in the Dual Antiplatelet Therapy Study. Participating hospitals were larger (468 versus 311 beds), more frequently located in urban settings (61.2% versus 42.6%), and had higher annual PCI volumes (858 versus 378) compared with nonparticipating hospitals, although hospital case mix and procedural outcomes were similar. Compared with CathPCI patients, trial patients undergoing PCI with drug-eluting stents were similar with respect to race, sex, and rates of diabetes mellitus, hypertension, and smoking, although they had lower rates of prior cardiovascular disease. CONCLUSIONS: Within the Dual Antiplatelet Therapy Study, clinical trial sites had similar patient case mix and clinical outcomes as nonparticipating sites. Although trial participants were representative of PCI patients with respect to race, sex and most comorbidities, they had a lower prevalence of chronic cardiovascular disease compared with registry patients. Although a streamlined cardiovascular clinical trial may successfully involve a large number of hospitals and rapidly enroll a diverse population of patients, differences between eligible patients and those actually enrolled remained. CLINICAL TRIAL REGISTRATION URL: http://www.clinicaltrials.gov. Unique identifier: NCT00977938.

47 Article Evolving antithrombotic strategies in patients with atrial fibrillation undergoing percutaneous coronary intervention: results from a survey among US cardiologists. 2014

Vardi, Moshe / Debidda, Marcella / Bhatt, Deepak L / Mauri, Laura / Cannon, Christopher P. · ·Clin Cardiol · Pubmed #24672813.

ABSTRACT: BACKGROUND: Many patients treated with oral anticoagulants for atrial fibrillation undergo percutaneous stent implantation, where dual antiplatelet therapy (DAPT) is also recommended. The current evidence to support triple oral antithrombotic therapy (TOAT) in these patients is limited, and new strategies are being discussed to optimize outcomes. HYPOTHESIS: There will be variation in antithrombotic strategies in patients with atrial fibrillation needing stenting. METHODS: We surveyed US-based cardiologists serving as clinical investigators in academic sites and posted an online "question of the month" on cardiosource.org. RESULTS: Seventy-five (10.7%) responses were received to the email survey and 119 to the online question. Bare-metal stenting (BMS) was a priori preferred over drug-eluting stenting (DES) for 50.6% of patients. Only 8.8% of the responders chose newer anticoagulants in addition to DAPT as the preferred oral anticoagulant. For duration of TOAT, 79.4% of physicians recommended stopping DAPT at 1 month when BMS was used in patients presenting without acute coronary syndrome (ACS) vs 57.4% in patients with ACS. In patients implanted with a DES, 73.5% and 76.5% preferred stopping DAPT at 6 to 12 months (no ACS vs ACS, respectively). When asked which of the 2 antiplatelet agents they would recommend stopping after the above durations, 50% chose to quit aspirin. CONCLUSIONS: The survey highlights an interest in the new strategy of dropping aspirin, but the lack of concrete evidence triggers undesired diversity in clinical approaches. High-quality data on the efficacy and safety of such interventions are needed to further consolidate these approaches.

48 Article Causes of short-term readmission after percutaneous coronary intervention. 2014

Wasfy, Jason H / Strom, Jordan B / O'Brien, Cashel / Zai, Adrian H / Luttrell, Jennifer / Kennedy, Kevin F / Spertus, John A / Zelevinsky, Katya / Normand, Sharon-Lise T / Mauri, Laura / Yeh, Robert W. ·From the Cardiology Division (J.H.W., C.O'B., R.W.Y.), Department of Medicine (J.H.W., C.O'B., R.W.Y., J.B.S.), and Laboratory of Computer Science (A.H.Z., J.L.), Massachusetts General Hospital, Harvard Medical School, Boston · Saint Luke's Mid America Heart Institute/UMKC, Kansas City, MO (K.F.K., J.A.S.) · Department of Biostatistics, Harvard School of Public Health, Boston, MA (K.Z., S.-L.T.N.) · Cardiovascular Division, Department of Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, MA (L.M.) · and Harvard Clinical Research Institute, Boston, MA (L.M., R.W.Y.). ·Circ Cardiovasc Interv · Pubmed #24425587.

ABSTRACT: BACKGROUND: Rehospitalization within 30 days after an admission for percutaneous coronary intervention (PCI) is common, costly, and a future target for Medicare penalties. Causes of readmission after PCI are largely unknown. METHODS AND RESULTS: To illuminate the causes of PCI readmissions, patients with PCI readmitted within 30 days of discharge between 2007 and 2011 at 2 hospitals were identified, and their medical records were reviewed. Of 9288 PCIs, 9081 (97.8%) were alive at the end of the index hospitalization. Of these, 893 patients (9.8%) were readmitted within 30 days of discharge and included in the analysis. Among readmitted patients, 341 patients (38.1%) were readmitted for evaluation of recurrent chest pain or other symptoms concerning for angina, whereas 59 patients (6.6%) were readmitted for staged PCI without new symptoms. Complications of PCI accounted for 60 readmissions (6.7%). For cases in which chest pain or other symptoms concerning for angina prompted the readmission, 21 patients (6.2%) met criteria for myocardial infarction, and repeat PCI was performed in 54 patients (15.8%). The majority of chest pain patients (288; 84.4%) underwent ≥1 diagnostic imaging test, most commonly coronary angiography, and only 9 (2.6%) underwent target lesion revascularization. CONCLUSIONS: After PCI, readmissions within 30 days were seldom related to PCI complications but often for recurrent chest pain. Readmissions with recurrent chest pain infrequently met criteria for myocardial infarction but were associated with high rates of diagnostic testing.

49 Article Safety and efficacy outcomes of first and second generation durable polymer drug eluting stents and biodegradable polymer biolimus eluting stents in clinical practice: comprehensive network meta-analysis. 2013

Navarese, Eliano P / Tandjung, Kenneth / Claessen, Bimmer / Andreotti, Felicita / Kowalewski, Mariusz / Kandzari, David E / Kereiakes, Dean J / Waksman, Ron / Mauri, Laura / Meredith, Ian T / Finn, Aloke V / Kim, Hyo-Soo / Kubica, Jacek / Suryapranata, Harry / Aprami, Toni Mustahsani / Di Pasquale, Giuseppe / von Birgelen, Clemens / Kedhi, Elvin. ·Department of Cardiology and Internal Medicine, Ludwik Rydygier Collegium Medicum, Nicolaus Copernicus University, Bydgoszcz, Poland. ·BMJ · Pubmed #24196498.

ABSTRACT: OBJECTIVES: To investigate the safety and efficacy of durable polymer drug eluting stents (DES) and biodegradable polymer biolimus eluting stents (biolimus-ES). DESIGN: Network meta-analysis of randomised controlled trials. DATA SOURCES AND STUDY SELECTION: Medline, Google Scholar, Embase, and Cochrane Central Register of Controlled Trials (CENTRAL) database search for randomised controlled trials comparing at least two of durable polymer sirolimus eluting stents (sirolimus-ES) and paclitaxel eluting stents (paclitaxel-ES), newer durable polymer everolimus eluting stents (everolimus-ES), Endeavor and Resolute zotarolimus eluting stents (zotarolimus-ES), and biodegradable polymer biolimus-ES. PRIMARY OUTCOMES: Safety (death, myocardial infarction, definite or probable stent thrombosis) and efficacy (target lesion and target vessel revascularisation) assessed at up to one year and beyond. RESULTS: 60 randomised controlled trials were compared involving 63,242 patients with stable coronary artery disease or acute coronary syndrome treated with a DES. At one year, there were no differences in mortality among devices. Resolute and Endeavor zotarolimus-ES, everolimus-ES, and sirolimus-ES, but not biodegradable polymer biolimus-ES, were associated with significantly reduced odds of myocardial infarction (by 29-34%) compared with paclitaxel-ES. Compared with everolimus-ES, biodegradable polymer biolimus-ES were associated with significantly increased odds of myocardial infarction (by 29%), while Endeavor zotarolimus-ES and paclitaxel-ES were associated with significantly increased odds of stent thrombosis. All investigated DES were similar with regards to efficacy endpoints, except for Endeavor zotarolimus-ES and paclitaxel-ES, which were associated with significantly increased the odds of target lesion and target vessel revascularisations compared with other devices. Direction of results beyond one year did not diverge from the findings for up to one year follow-up. Bayesian probability curves showed a gradient in the magnitude of effect, with everolimus-ES and Resolute zotarolimus-ES offering the highest safety profiles. CONCLUSIONS: The newer durable polymer everolimus-ES and Resolute zotarolimus-ES and the biodegradable polymer biolimus-ES maintain the efficacy of sirolimus-ES; however, for safety endpoints, differences become apparent, with everolimus-ES and Resolute zotarolimus-ES emerging as the safest stents to date.

50 Article Long-term efficacy and safety of Zotarolimus-eluting stent in patients with diabetes mellitus: pooled 5-year results from the ENDEAVOR III and IV trials. 2013

Vardi, Moshe / Burke, David A / Bangalore, Sripal / Pencina, Michael J / Mauri, Laura / Kandzari, David E / Leon, Martin B / Cutlip, Donald E. ·Harvard Clinical Research Institute, Boston, Massachusetts; Cardiology Division, Beth Israel Deaconess Medical Center, Boston, Massachusetts. ·Catheter Cardiovasc Interv · Pubmed #23737390.

ABSTRACT: OBJECTIVE: To assess long-term outcomes of Endeavor Zotarolimus-eluting stent (E-ZES) implantation in patients with diabetes mellitus (DM). BACKGROUND: Patients with DM and coronary artery disease have lower restenosis with drug-eluting stent (DES) compared with bare-metal stents. Recent data suggest that the E-ZES is inferior to other DES in this population. METHODS: Patient-level data for 601 patients with DM from the ENDEAVOR III and ENDEAVOR IV trials were pooled, of which 337 were treated with E-ZES and 264 were treated with other DES. The primary outcome was target vessel failure (TVF) in the course of 5 years. Outcomes are reported as rates using Kaplan-Meier (KM) survival method and differences between E-ZES and other stent types (sirolimus-eluting stent or paclitaxel-eluting stent) were compared using the log-rank statistic. The independent effect of stent type on TVF was assessed using Cox proportional hazards regression. RESULTS: Baseline characteristics were similar between the groups. Five-year TVF KM rate estimate was numerically lower for E-ZES, but the difference did not reach statistical significance (20.2 vs. 26.9%, P = 0.065). The 5-year KM rate estimates of major adverse cardiac events (17.7 vs. 26.6%, P = 0.012), death (7.6 vs. 15.0%, P = 0.004), and myocardial infarction (1.3 vs. 5.1%, P = 0.011) were also lower for E-ZES versus other DES. CONCLUSIONS: Patients with DM implanted with E-ZES have favorable long-term outcomes compared to first-generation DES. Long-term performance of DES should be assessed routinely and may differ from initial performance.

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