Long-term Safety and Efficacy of New-Generation Drug-Eluting Stents in Women With Acute Myocardial Infarction

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. INTERVENTIONS Randomization to early-(sirolimus-or paclitaxel-eluting stents) vs new-generation (everolimus-, zotarolimus-, or biolimus-eluting stents) DES. MAIN OUTCOMES AND MEASURESComposite 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.

Sex disparities in acute myocardial infarction care and outcomes

“…Similar to contemporary studies [21], women with AMI undergoing percutaneous coronary intervention (PCI) exhibited increased mortality in our study. However, as demonstrated in prior studies [22], this was not related to stent failure, as device related outcomes (TVF, TLR, TVMI) were similar between sexes, but rather related to an increase in major bleeding which occurred for both sexes most commonly between day 31 and 365. This finding confirms prior studies that emphasize the implications of bleeding on mortality and highlight the importance of reducing this complication.…”

Sex-Based Differences in Coronary and Structural Percutaneous Interventions

“…As stent technology advances to reduce short- and long-term complications, it is unknown whether these adverse outcomes are affected by sex. There has been improved insight into this subject from work supported through the Society for Cardiovascular Angiography and Intervention (SCAI) [ 31 ]. As part of their women’s initiative, Women in Innovation and Drug-Eluting Stents (WIN-DES) was created to gather and analyze data regarding PCI in women [ 31 ].…”

“…There has been improved insight into this subject from work supported through the Society for Cardiovascular Angiography and Intervention (SCAI) [ 31 ]. As part of their women’s initiative, Women in Innovation and Drug-Eluting Stents (WIN-DES) was created to gather and analyze data regarding PCI in women [ 31 ]. A large multicentered registry sponsored by WIN-DES assessed differences in outcomes of DES in women [ 32 ].…”

Outcomes After Percutaneous Coronary Intervention in Women: Are There Differences When Compared with Men?

“…Recently published data demonstrates the safety and efficacy of the use of contemporary DES in 2,176 women after acute MI. [25] At 3 years, the use of new-generation DES was associated with lower risk of death, MI or target lesion revascularisation (14.9% versus 18.4%; adjusted HR 0.78; 95% CI [0.61–0.99]) compared with first generation DES, as well as definite or probable stent thrombosis (1.4% versus 4.0%; adjusted HR 0.36; 95% CI [0.19–0.69]).…”