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New-generation DES consistent, durable over 3 years in women with acute MI
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New-generation drug-eluting stents were associated with significantly lower risk for death, MI, target lesion revascularization and stent thrombosis over 3 years vs. early-generation stents in women who presented with acute MI, according to a new analysis from the Women in Innovation and Drug-Eluting Stents Collaboration.
In addition, “the magnitude of these benefits appeared to be greater per increase in severity of ACS,” Gennaro Giustino, MD, resident physician at the Icahn School of Medicine at Mount Sinai, and colleagues wrote in JAMA Cardiology.
The new-generation DES studied included those that elute everolimus, zotarolimus or biolimus, whereas the older-generation stents included those that elute sirolimus or paclitaxel.
The study was conducted to investigate long-term safety and efficacy of the new-generation DES among women with acute MI. The researchers analyzed women with ACS enrolled in 26 randomized clinical trials of DES; the women were stratified by presentation of unstable angina vs. acute MI, including non-STEMI and STEMI.
In total, the pooled data set included 11,577 women (mean age, 67 years), 37.8% of whom presented with ACS. Of those, 50% presented with acute MI.
The primary endpoint was MACE at 3-year patient follow-up, which was defined as a composite of all-cause mortality, MI and TLR. Secondary endpoints included a composite endpoint of death, MI and definite/probable stent thrombosis; stent thrombosis; and TLR.
At 3 years, the rate of death, MI or TLR was 14.9% among women who received new-generation DES vs. 18.4% among women who received earlier-generation DES (absolute risk difference, –3.5%; number needed to treat = 29; adjusted HR = 0.78; 95% CI, 0.61-0.99), according to the researchers. The risk for definite/probable stent thrombosis was also lower with new-generation DES: 1.4% vs. 4% (absolute risk difference, –2.6%; number needed to treat = 46; adjusted HR = 0.36; 95% CI, 0.19-0.69). These findings were observed without evidence of interaction for both endpoints vs. women without acute MI (new-generation DES: P for interaction = .59; earlier-generation DES: P for interaction = .31).
Moreover, the benefits of new-generation DES were observed consistently across the spectrum of ACS, including in the transition from unstable angina to non-STEMI and to STEMI (MACE: absolute risk difference, –0.45% vs. –3.07% vs. –3.97%; stent thrombosis: absolute risk difference, –0.46% vs. –2.06% vs. –3.53%, respectively), according to the study results.
“The clinical implications of our observation are that the benefits of new-generation DES are likely to be observed in higher-risk populations. First, this information gives reassurance regarding the performances of currently approved devices in clinical practice. Second, the enhanced antithrombotic properties of currently used DES may allow for more flexible use of [dual antiplatelet therapy] for prevention of stent-related thrombotic complications,” Giustino and colleagues wrote.
The researchers noted that additional research is warranted to confirm these data in women. However, they wrote, “the results of the current large-scale analysis confirm the results of [randomized controlled trials] performed in predominantly male populations and consolidate new-generation DES as the standard of care for women with ACS.” – by Dave Quaile
Disclosures: Giustino reports no relevant financial disclosures. Please see the full study for a list of the other researchers’ relevant financial disclosures.
Perspective
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Ki Park, MD, MS, FSCAI
Studies of DES efficacy and safety have been performed primarily in male-dominated cohorts. A study by Giustino et al published in JAMA Cardiology aimed to assess the relative efficacy and safety of newer-generation DES in women by using data gathered as part of the Women in Innovation and Drug-Eluting Stents (WIN-DES) collaboration. The authors found that use of the newest-generation DES in women presenting with acute MI — who tend to have worse outcomes compared to their male counterparts overall — was associated with durable benefit (composite outcome of death, MI, TLR) and safety over 3 years compared with first-generation DES. Of note, there appeared to be a graded effect of this association, as patients with the most severe presentation of STEMI appeared to gain the most benefit as compared with those women with either unstable angina or non-STEMI.
The findings of this study are important in several aspects. As women with acute MI represent a particularly high-risk group, this analysis affirms the consistent benefit of DES independent of sex/gender. Additionally, as women tend to have smaller-diameter coronary arteries, assessing the risk for restenosis and stent thrombosis is particularly important as stent diameter is correlated with the risk for these complications. This study also continues to highlight the need for dedicated collaborative data such as that collected through WIN-DES. Analyses such as these should prompt further consideration of improving enrollment of women into clinical device trials as well as dedicated large-scale registries.
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