Courtesy of Dr. Agustín Vecchia.
Currently, the duration of dual antiplatelet therapy (DAPT) after stent placement is one of the most highly debated topics in Cardiology. On the one hand, women are usually underrepresented in trials in our specialty; on the other, the fact that symptoms of coronary disease are different in women is well-known.
The aim of the following PRODIGY substudy was to assess the impact of sex on 2-year outcomes after percutaneous coronary intervention (PCI) in patients randomized to 6-month versus 12-month DAPT.
PRODIGY was a multicenter study including 2013 all-comer patients undergoing PCI with 4 different stent types (bare metal stents [BMS] and zotarolimus-, paclitaxel- or everolimus-eluting stents) randomized to 6- or 12-month DAPT with clopidogrel and aspirin.
Women (n = 459 [23.3%]) were older and presented a higher prevalence of hypertension, lower creatinine clearance, and, more frequently, acute coronary syndrome. However, they presented a lower severity of coronary artery disease.
After a multivariate analysis, prolonged DAPT did not reduce the primary outcome in men (hazard ratio [HR]: 1.080; 95% confidence interval [CI]: 0.766 to 1.522; p = 0.661) or women (HR: 1.013; 95% CI: 0.588 to 1.748; p = 0.962, interaction p = 0.785).
No sex disparity was identified across multiple ischemic outcomes, including overall or cardiovascular mortality, infarction, or stent thrombosis. There were no clear differences between men and women regarding bleeding (Bleeding Academic Research Consortium [BARC] and Global Use of Strategies to Open Occluded Coronary Arteries [GUSTO]).
Conclusion
Authors conclude that both groups have similar ischemic and bleeding outcomes, despite being characterized by different clinical presentation. Sex was not a treatment modifier as regards dual antiplatelet therapy duration.
Editorial
Existing evidence including sex as a relevant variable for the definition of DAPT duration is limited. In a recently published “state of the art review”, Montalescot (1) observed that women constituted a group that might benefit from shorter DAPT duration, probably due to more comorbidities and older age at presentation.
The DAPT trial showed that more prolonged treatment duration reduces the rate of myocardial infarction and probable or definite stent thrombosis in men, but not in women. Conversely, analyses by sex in the ARCTIC and PEGASUS trials showed no differences in outcome between genders.
As a conclusion, women present a different risk profile compared to men; however, after adjusting these variables, ischemic and bleeding risks do not seem to differ between genders.
1: Montalescot G, Brieger D, Dalby AJ, Park SJ, Mehran R. Duration of dual antiplatelet therapy after coronary stenting: a review of the evidence. J Am Coll Cardiol Intv 2015;66:832-47.
Original title: Impact of Sex on 2-Year Clinical Outcomes in Patients Treated With 6-Month or 24-Month Dual Antiplatelet. Therapy Duration A PreSpecified Analysis From the PRODIGY Trial.
Reference: Giuseppe Gargiulo et al. J Am Coll Cardiol Intv. 2016;9(17):1780-1789.
Courtesy of Dr. Agustín Vecchia. Buenos Aires German Hospital, Argentina.
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