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. 2017 Aug 1;2(8):855-862.
doi: 10.1001/jamacardio.2017.1978.

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

Gennaro Giustino  1 , Rafael Harari  1 , Usman Baber  1 , Samantha Sartori  1 , Gregg W Stone  2 , Martin B Leon  2 , Stephan Windecker  3 , Patrick W Serruys  4 , Adnan Kastrati  5 , Clemens Von Birgelen  6 , Takeshi Kimura  7 , Giulio G Stefanini  8 , George D Dangas  1 , William Wijns  9 , P Gabriel Steg  10 , Marie-Claude Morice  11 , Edoardo Camenzind  12 , Giora Weisz  2 , Pieter C Smits  13 , Sabato Sorrentino  1 , Madhav Sharma  1 , Serdar Farhan  1 , Michela Faggioni  1 , David Kandzari  14 , Soren Galatius  15 , Raban V Jeger  16 , Marco Valgimigli  3 , Dipti Itchhaporia  17 , Laxmi Mehta  18 , Hyo-Soo Kim  19 , Alaide Chieffo  20 , Roxana Mehran  1
Affiliations

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

Gennaro Giustino et al. JAMA Cardiol. .

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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Conflict of interest statement

Conflict of Interest Disclosures: All authors have submitted the ICMJE Form for Disclosure of Potential Conflicts of Interest. Dr Windecker has received research contracts to the institution from Abbott, Boston Scientific, Biosensors, Cordis, and Medtronic. Dr Kastrati has received honoraria from Abbott, Biosensors, Biotronik, Cordis, and Medtronic and a patent application in respect of a biodegradable polymer stent coating. Dr Von Birgelen is a consultant to and has received lecture fees or travel expenses from Abbott Vascular, Biotronik, Boston Scientific, Medtronic, and Merck Sharp and Dohme. Dr Von Birgelen’s research department Thoraxcentrum Twente has received educational or research grants from Abbott Vascular, Biotronik, Boston Scientific, and Medtronic. Dr Stefanini has received speaker fees from Abbott Vascular, AstraZeneca, Biosensors, and Biotronik. Dr Wijns has received institutional research grants from Boston Scientific, Medtronic, Abbott, Terumo, and Biosensors and is an investigator for sponsored trials by Boston Scientific, Medtronic, Abbott, Terumo, and Biosensors. Fees or honoraria on behalf of Dr Wijns from Boston Scientific, Medtronic, Abbott, Terumo, and Biosensors go to the Cardiovascular Center Aalst. Dr Steg received research grants (to INSERM U1148) from Servier and Sanofi and served as a speaker or consultant for Amarin, AstraZeneca, Bayer, Boehringer-Ingelheim, Bristol-Myers Squibb, Daiichi-Sankyo, GlaxoSmithKline, Janssen, Lilly, Medtronic, Merck Sharpe and Dohme, Novartis, Orexigen, Pfizer, Regado, Sanofi, Servier, and The Medicines Company and is stockholder of Aterovax. Dr Smits has received institutional research grants from Abbott Vascular, Boston Scientific, St Jude, and Terumo. Dr Kandzari has received research or grant support from Medtronic, Abbott, and Boston Scientific and consulting honoraria from Medtronic and Boston Scientific. Dr Galatius has received grant support from St Jude, Abbott, Terumo, and Biotronik, and advisory board honorarium from Eli Lilly and Servier. Dr Valgimigli has received honoraria for lectures or advisory board and research grants from Merck, Iroko, Eli Lilly, and Medtronic; honoraria for advisory board and lectures from The Medicines Company, Eli Lilly, Daiichi Sankyo, St Jude, and Abbott Vascular; and honoraria for lectures from Cordis, Carbostent and Implantable Devices, and Terumo. Dr Mehran has received institutional research grant support from The Medicines Company, Bristol-Myers Squibb, Sanofi-Aventis, Eli Lilly, and AstraZeneca and consulting fees from AstraZeneca, Bayer, CSL Behring, Janssen Pharmaceuticals Inc, Merck & Co, Osprey Medical Inc, and Watermark Research Partners and serves on the advisory board of Abbott Laboratories, Boston Scientific Corporation, Covidien, Janssen Pharmaceuticals, The Medicines Company, and Sanofi-Aventis. No other disclosures were reported.

Figures

Figure 1.
Figure 1.. Study Population Flow Diagram
ACS indicates acute coronary syndrome; DES, drug-eluting stent; MI, myocardial infarction; NSTEMI, non–ST-segment elevation myocardial infarction; RCTs, randomized clinical trials; STEMI, ST-segment-elevation myocardial infarction; and UA, unstable angina.
Figure 2.
Figure 2.. New-Generation vs Early-Generation Drug-Eluting Stents (DES) In Women With and Without Acute Myocardial Infarction (MI)
NNT indicates number needed to treat; TLR, target lesion revascularization; and UA, unstable angina.
Figure 3.
Figure 3.. Kaplan-Meier Curves for Women Treated With New-Generation Drug-Eluting Stents (DES) vs Early-Generation DES Across the Spectrum of Acute Coronary Syndromes
HR indicates hazard ratio; NSTEMI, non–ST-segment elevation myocardial infarction; and STEMI, ST-segment elevation myocardial infarction. aP for interaction = .59. bP for interaction = .64. cP for interaction = .91. dP for interaction = .31.
Figure 4.
Figure 4.. Absolute Risk Differences Between New-Generation Drug-Eluting Stents (DES) vs Early-Generation DES Across the Spectrum of Acute Coronary Syndromes
NNT indicates number needed to treat; NSTEMI, non–ST-segment elevation myocardial infarction; and STEMI, ST-segment elevation myocardial infarction.
See this image and copyright information in PMC

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