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Original Investigation
August 2017

Long-term Safety and Efficacy of New-Generation Drug-Eluting Stents in Women With Acute Myocardial InfarctionFrom the Women in Innovation and Drug-Eluting Stents (WIN-DES) Collaboration

Author Affiliations
  • 1The Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of Medicine at Mount Sinai, New York, New York
  • 2Columbia University Medical Center, New York, New York
  • 3Bern University Hospital, Bern, Switzerland
  • 4Erasmus MC, Rotterdam, the Netherlands
  • 5Herzzentrum, Munich, Germany
  • 6Thoraxcentrum Twente, Enschede, the Netherlands
  • 7Kyoto University Graduate School of Medicine, Kyoto, Japan
  • 8Humanitas Research Hospital, Rozzano, Milan, Italy
  • 9Cardiovascular Center Aalst, Onze-Lieve-Vrouwziekenhuis Ziekenhuis, Aalst, Belgium
  • 10Département Hospitalo Universitaire Fibrose, Inflammation et REmodelage, Assistance Publique-Hôpitaux de Paris, Université Paris Diderot, INSERM U114, Paris, France
  • 11Department of Cardiology and Cardiovascular Surgery, Institut Cardiovasculaire Paris Sud, Paris, France
  • 12Institut Lorrain du Coeur et des Vaisseaux University Hospital Nancy–Brabois Vandoeuvre-lès-Nancy, France
  • 14Maasstad Hospital, Rotterdam, the Netherlands
  • 15Piedmont Heart Institute, Atlanta, Georgia
  • 16Gentofte University Hospital, Hellerup, Denmark
  • 17University Hospital Basel, Basel, Switzerland
  • 18Hoag Memorial Hospital Presbyterian, Newport Beach, California
  • 19Ohio State University Medical Center, Columbus
  • 20Seoul National University Main Hospital, Seoul, Korea
  • 21San Raffaele Scientific Institute, Milan, Italy
JAMA Cardiol. 2017;2(8):855-862. doi:10.1001/jamacardio.2017.1978
Key Points

Question  What is the long-term safety and efficacy of new-generation drug-eluting stents (DES) vs early-generation DES in women presenting with acute myocardial infarction (MI)?

Findings  In this international, collaborative, patient-level pooled analysis of women in 26 randomized clinical trials of DES, new-generation DES were associated with a 3-year lower risk of death, MI or target lesion revascularization, and definite or probable stent thrombosis in women with acute MI. The absolute magnitude of these benefits appears to be greater per increase in severity across the spectrum of acute coronary syndromes.

Meaning  New-generation DES are associated with consistent and durable benefits over 3 years in women presenting with acute MI.

Abstract

Importance  Women with acute myocardial infarction (MI) undergoing mechanical reperfusion remain at increased risk of adverse cardiac events and mortality compared with their male counterparts. Whether the benefits of new-generation drug-eluting stents (DES) are preserved in women with acute MI remains unclear.

Objective  To investigate the long-term safety and efficacy of new-generation DES vs early-generation DES in women with acute MI.

Design, Setting, and Participants  Collaborative, international, individual patient-level data of women enrolled in 26 randomized clinical trials of DES were analyzed between July and December 2016. Only women presenting with an acute coronary syndrome were included. Study population was categorized according to presentation with unstable angina (UA) vs acute MI. Acute MI included non–ST-segment elevation MI (NSTEMI) or ST-segment elevation MI (STEMI).

Interventions  Randomization to early- (sirolimus- or paclitaxel-eluting stents) vs new-generation (everolimus-, zotarolimus-, or biolimus-eluting stents) DES.

Main Outcomes and Measures  Composite of death, MI or target lesion revascularization, and definite or probable stent thrombosis at 3-year follow-up.

Results  Overall, the mean age of participants was 66.8 years. Of 11 577 women included in the pooled data set, 4373 (37.8%) had an acute coronary syndrome as clinical presentation. Of these 4373 women, 2176 (49.8%) presented with an acute MI. In women with acute MI, new-generation DES were associated with lower risk of death, MI or target lesion revascularization (14.9% vs 18.4%; absolute risk difference, −3.5%; number needed to treat [NNT], 29; adjusted hazard ratio, 0.78; 95% CI, 0.61-0.99), and definite or probable stent thrombosis (1.4% vs 4.0%; absolute risk difference, −2.6%; NNT, 46; adjusted hazard ratio, 0.36; 95% CI, 0.19-0.69) without evidence of interaction for both end points compared with women without acute MI (P for interaction = .59 and P for interaction = .31, respectively). A graded absolute benefit with use of new-generation DES was observed in the transition from UA, to NSTEMI, and to STEMI (for death, MI, or target lesion revascularization: UA, −0.5% [NNT, 222]; NSTEMI, −3.1% [NNT, 33]; STEMI, −4.0% [NNT, 25] and for definite or probable ST: UA, −0.4% [NNT, 278]; NSTEMI, −2.2% [NNT, 46]; STEMI, −4.0% [NNT, 25]).

Conclusions and Relevance  New-generation DES are associated with consistent and durable benefits over 3 years in women presenting with acute MI. The magnitude of these benefits appeared to be greater per increase in severity of acute coronary syndrome.

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