New-Generation DES Work Just Fine in Women With Acute MI

Addressing some uncertainty stemming from the underrepresentation of women in randomized trials of drug-eluting stents, a new patient-level meta-analysis shows that 3-year outcomes are better with new- versus early-generation devices.

Among women with acute MI, use of new-generation DES was associated with lower 3-year risks of MACE (14.6% vs 18.1%; adjusted HR 0.78; 95% CI 0.61-0.99) and definite/probable stent thrombosis (1.4% vs 4.0%; adjusted HR 0.36; 95% CI 0.19-0.69), according to lead author Gennaro Giustino, MD (Icahn School of Medicine at Mount Sinai, New York, NY), and colleagues.

Newer stents had an advantage over older ones across the spectrum of ACS, but the benefits were greatest for women with STEMI, they report in a study published online June 28, 2017, ahead of print in JAMA Cardiology.

“The results of the current large-scale analysis confirm the results of RCTs performed in predominantly male populations and consolidate new-generation DES as the standard of care for women with ACS,” the authors conclude.

Senior author Roxana Mehran, MD (Icahn School of Medicine at Mount Sinai), told TCTMD that “there should never be a [thought] that we shouldn’t use drug-eluting stents in women, even in women with an acute coronary syndrome.”

Introduction of DES, and particularly new-generation stents, have led to improvements in PCI outcomes, but women have typically made up only 15% to 25% of the participants in trials evaluating their safety and efficacy. Thus, there is very little data on use in women with ACS, particularly STEMI, Mehran said.

The current meta-analysis, which pooled patient-level data from 26 randomized trials, came out of the Women in Innovation and Drug-Eluting Stents (WIN-DES) Collaboration. The investigators focused on 4,373 women presenting with ACS, roughly half with acute MI and half with unstable angina.

An advantage for new- versus early-generation DES through 3 years was seen across various composite and individual outcomes, although not every relationship reached statistical significance.

The magnitude of benefit appeared to increase as the severity of presentation worsened. Regarding MACE (death, MI, and TLR), for example, the number needed to treat was 222 in women with unstable angina, 33 in those with NSTEMI, and 25 in those with STEMI. A similar trend was seen for other outcomes, including definite/probable stent thrombosis.

“First, this information gives reassurance regarding the performances of currently approved devices in clinical practice,” the authors conclude. “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.”

Commenting for TCTMD, Harmony Reynolds, MD (NYU Langone Medical Center, New York, NY), noted that for “every treatment that we use, there’s the potential for a sex difference because there are sex differences in the pathophysiology of acute coronary syndromes, there are sex differences in coronary artery disease in general, and there are sex differences in the outcomes. So it is quite plausible that there would be sex differences in how efficacious our treatments are and we need those data.”

Analyses like this one are critical “to understand how treatments that we use commonly in cardiovascular disease work in women,” who have been underrepresented in clinical trials, Reynolds added. “I think that it was wonderful and a great innovation to pool patient-level data to get these results, and I’m convinced that newer-generation drug-eluting stents are better for women.”