Further data to support use of new-generation drug-eluting stents in women

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A new study from the Women in Innovation Initiative and Drug-Eluting Stents (WIN-DES) collaborative has found that the use of new-generation drug-eluting stents is associated with durable and consistent benefits, compared with early-generation stents, in women with acute myocardial infarction. Previous findings from the collaborative have shown that new-generation drug-eluting stents provide benefits for women undergoing percutaneous coronary intervention (PCI).

Gennaro Giustino (The Zena and Michael A Wiener Cardiovascular Institute, Ichan School of Medicine at Mount Sinai, New York, USA) write in JAMA Cardiology that the safety and efficacy of new-generation drug-eluting stents in women with acute myocardial infarction “remain unclear” because of women being “historically under-represented” in randomised clinical trials and because women are less likely than men to present with ST-segment elevation myocardial infarction (STEMI) or non-STEMI (NSTEMI). They add that the WIN-DES collaborative, which comes the under the umbrella of the Society for Cardiovascular Angiography and Interventions (SCAI), aimed to address this gap in knowledge by analysing pooled patient-level data from women enrolled in (26) randomised controlled trials of drug-eluting stents.

“In the present study, we sought to investigate the efficacy and safety of new-generation drug-eluting stents across the spectrum of acute coronary syndromes,” Giustino et al report. They add that the primary endpoint was the three-year rate of major adverse cardiac events (MACE), which was defined as the “composite of all-cause mortality, myocardial infarction, and target lesion revascularisation”. Secondary endpoints included the composite of death, myocardial infarction, and definite or probable stent thrombosis, stent thrombosis and target lesion revascularisation.

Of 11,577 women in the dataset, 4,373 presented with acute coronary syndrome—of whom, 2,176 had an acute myocardial infarction. At three years, the use of new-generation drug-eluting stents was associated with a significantly lower risk of MACE than was the use of early-generation drug-eluting stents: 12% vs. 16.6% respectively; this benefit was observed across all composite and single endpoints.

However, the authors comment: “Of note, the absolute benefits of new-generation drug-eluting stents appeared to be greater for women presenting with acute myocardial infarction compared with those without acute myocardial infarction.” They explain that the numbers needed to treat to prevent death, myocardial infarction or target lesion revascularisation, with new-generation drug-eluting stents, was 222 for unstable angina compared with 25 for STEMI. “The public health impact of such intervention is greater or comparable with that observed with statins or dual antiplatelet therapy on similar endpoints and patient populations,” Giustino et al note.

Concluding, the authors say that their results provide “reassurance” about the performance of currently approved devices in clinical practice and add: “The results of the current large-scale analysis confirm the results of randomised control trials performed in predominantly male populations and consolidate new-generation drug-eluting stents as the standard of care for women with acute coronary syndromes.”

Study author Roxana Mehran (The Zena and Michael A Wiener Cardiovascular Institute, Ichan School of Medicine at Mount Sinai, New York, USA) told Cardiovascular News: “This work is another example of why we need to continue our work on trials concentrating on women and minorities.  This is the only way we can level the playing field for this population.”

 

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