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)?
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.
New-generation DES are associated with consistent and durable benefits over 3 years in women presenting with acute MI.
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.
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).
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.
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.
Giustino G, Harari R, Baber U, Sartori S, Stone GW, Leon MB, Windecker S, Serruys PW, Kastrati A, Von Birgelen C, Kimura T, Stefanini GG, Dangas GD, Wijns W, Steg PG, Morice M, Camenzind E, Weisz G, Smits PC, Sorrentino S, Sharma M, Farhan S, Faggioni M, Kandzari D, Galatius S, Jeger RV, Valgimigli M, Itchhaporia D, Mehta L, Kim H, Chieffo A, Mehran R. 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. JAMA Cardiol. Published online June 28, 2017. doi:10.1001/jamacardio.2017.1978