Impact of Sex on Clinical and Angiographic Outcomes Among Patients Undergoing Revascularization With Drug-Eluting Stents

Study Questions:

Are there sex-based differences in long-term clinical and angiographic outcomes after coronary revascularization with drug-eluting stents (DES)?

Methods:

Data from three randomized DES trials were pooled and used for the present study. The studies were: SIRTAX (Sirolimus-Eluting Versus Paclitaxel-Eluting Stents for Coronary Revascularization), LEADERS (Limus Eluted From A Durable Versus ERodable Stent Coating), and RESOLUTE All-Comers (Randomized Comparison of a Zotarolimus-Eluting Stent With an Everolimus Eluting Stent for Percutaneous Coronary Intervention) trials. All trials were conducted between 2004 and 2009 at European institutions, with the exclusive use of DES and an all-comers study design. Inclusion criteria were broad to reflect routine clinical practice. Protocol-mandated angiographic follow-up was available for 1,561 lesions (351 among women; 1,210 among men). The primary endpoint was the composite of cardiac death and myocardial infarction (MI) at 2 years.

Results:

A total of 5,011 patients were included in the three studies: 4,885 subjects (1,164 women, 3,721 men) completed 2 years of follow-up. Women were older than the men and were more likely to have diabetes, obesity, and hypertension, but less likely to be smokers, or have a prior history of MI or prior surgical revascularization. Women were also more likely to have a smaller reference diameter of the target vessel and a lower SYNTAX score. After adjustment for baseline differences, women and men had a similar risk of cardiac death or MI (odds ratio [OR], 1.13; 95% CI, 0.82-1.56; p = 0.44), cardiac death (OR, 1.04; 95% CI, 0.61-1.80; p = 0.87), and MI (OR, 1.07; 95% CI, 0.75-1.53; p = 0.71) at 2 years. Similarly, risks of target lesion revascularization (OR, 1.09; 95% CI, 0.77-1.54; p = 0.62), target vessel revascularization (OR, 0.88; 95% CI, 0.63-1.22; p = 0.43), and definite or probable stent thrombosis (OR, 0.73; 95% CI, 0.38-1.38; p = 0.33) were comparable for women and men. Follow-up angiography showed no differences in terms of in-stent late loss and in-segment binary restenosis (8.5% vs. 8.5%, p = 0.76).

Conclusions:

The investigators concluded that unrestricted use of DES is associated with similar long-term safety and efficacy among women and men.

Perspective:

These data from three trials suggest that long-term outcomes related to DES are similar among women and men.

Clinical Topics: Invasive Cardiovascular Angiography and Intervention, Prevention, Hypertension

Keywords: Odds Ratio, Myocardial Infarction, Follow-Up Studies, Drug-Eluting Stents, Sirolimus, Percutaneous Coronary Intervention, Paclitaxel, Thrombosis, Research Personnel, Obesity, Diabetes Mellitus, Hypertension


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