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Women, men undergoing PCI have similar outcomes after short vs. prolonged DAPT
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In a subanalysis of the PRODIGY trial, women and men who were assigned to receive 6 months or 24 months of dual antiplatelet therapy after undergoing PCI had similar ischemic and bleeding outcomes at 2 years.
“[Sex] failed to emerge as a treatment modifier with respect to [dual antiplatelet therapy] duration, suggesting that the decision-making on [dual antiplatelet therapy] duration in female patients should weigh ischemic vs. bleeding risks,” Giuseppe Gargiulo, MD, and colleagues wrote in JACC: Cardiovascular Interventions.
The PRODIGY trial enrolled 2,013 all-comers scheduled for elective, urgent or emergent angioplasty who were randomly assigned to receive an everolimus-eluting stent, paclitaxel-eluting stent, zotarolimus-eluting stent or third-generation thin-strut bare-metal stent. Thirty days after PCI, patients in each stent group were then randomly assigned to receive 6 or 24 months of dual antiplatelet therapy (DAPT) consisting of clopidogrel and aspirin.
Of those enrolled, 459 (23%) were men. At baseline, women were older and more likely to have ACS, hypertension and lower creatinine clearance and a lower severity of CAD.
The primary efficacy endpoint of the overall PRODIGY trial was a composite of death, MI or cerebrovascular accident at 24 months. According to the findings of the new analysis, 24 months of DAPT did not reduce the primary endpoint in women (adjusted HR = 1.013; 95% CI, 0.588-1.748) or men (adjusted HR = 1.08; 95% CI, 0.766-1.522) compared with 6 months of DAPT.
The researchers also observed no sex disparity after evaluation of secondary ischemic endpoints, including CV or overall death, MI and stent thrombosis, and clinically relevant bleeding, including BARC 3 or 5, GUSTO or TIMI scales, according to the results.
“This is the first dedicated [sex]-based analysis of a randomized trial comparing a short [vs.] a prolonged DAPT regimen. Our analysis suggests that the overall results of the PRODIGY trial can be extended with confidence to both [sexes],” the researchers concluded. – by Katie Kalvaitis
Disclosure: The researchers report no relevant financial disclosures.
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