DAPT trial

Gender No Predictor of Prolonged DAPT Benefit

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Prolonged dual antiplatelet therapy (DAPT) after percutaneous coronary intervention (PCI) effects don’t differ by gender, the PRODIGY investigators suggested.

On multivariable adjustment, recipients of extended and 6-month DAPT experienced similar rates of combined death, myocardial infarction, and cerebrovascular accidents at 2 years. This was true whether they were male (HR 1.08, 95% CI 0.766 to 1.522) or female (HR 1.013, 95% CI 0.588 to 1.748), reported Marco Valgimigli, MD, PhD, of Bern University Hospital in Switzerland, and colleagues.

 According to their study, published online in JACC: Cardiovascular Interventions, sex did not appear to play a role in the frequency of individual adverse outcomes. Notably, major bleeding occurred at similar rates across groups regardless of the definition used (included were the Bleeding Academic Research Consortium, Thrombolysis in Myocardial Infarction, and Global Use of Strategies to Open Occluded Coronary Arteries scales).

“Gender failed to emerge as a treatment modifier with respect to DAPT durationsuggesting that the decision-making on DAPT duration in female patients should weigh ischemic versus bleeding risks,” the authors concluded.

They noted that the longer duration won out in the landmark DAPT trial likely because of the selection of endpoints — stent thrombosis and the combination of MI and stroke.

While the secondary analysis of the PRODIGY trial, which randomized 1,970 patients to 6- or 24-month DAPT consisting of clopidogrel (Plavix) and aspirin, was only powered to find a 40% difference, it was in line with other trials that haven’t shown a significant impact on death or cardiovascular death, the researchers noted.

“When taken together, currently available studies suggest that the decision-making over DAPT duration towards either shorter or longer than conventional 12-month time frame should be a ‘patient by patient’ approach, aiming at balancing ischemic versus bleeding risks,” they concluded. “With that respect, whether gender per se should be taken into account in tailoring patient’s therapy is still unclear.”

 But what was clear from PRODIGY was that “gender should not be a primary covariate to be considered in the decision-making on DAPT duration after coronary stenting,” they added.

In the trial, women (n=459) were older and more likely to have hypertension, lower creatinine clearance, and acute coronary syndrome. Men, however, had a higher severity of coronary artery disease.

“The current findings suggest that men and women undergoing PCI have similar adjusted 2-year ischemic and bleeding outcomes, despite being characterized by different clinical presentation,” according to Valgimigli’s group.