After percutaneous coronary intervention (PCI), dual therapy with a direct oral anticoagulant (DOAC) plus a P2Y12 inhibitor was associated with reduced risk for major bleeding versus triple therapy with a vitamin K antagonist (VKA) plus aspirin and a P2Y12 inhibitor in patients with nonvalvular atrial fibrillation, according to a recent systematic review and meta-analysis.
Researchers reviewed four randomized controlled trials of 7,953 patients that compared the effects of dual versus triple therapy on bleeding, mortality, and ischemic events after PCI in adults with atrial fibrillation. All of the included trials were industry-funded and used an open-label design. The main outcomes of the meta-analysis were all-cause mortality and major bleeding events that met TIMI (Thrombolysis in Myocardial Infarction) criteria. Other end points were major and minor bleeding, intracerebral hemorrhage, trial-defined bleeding events, cardiovascular mortality, myocardial infarction (MI), stent thrombosis, stroke, and major adverse cardiovascular events. Results were published March 18 by Annals of Internal Medicine.
Mean patient age was 68.6 to 71.7 years, and most were men. At the median follow-up of one year, high-certainty evidence showed that dual therapy was associated with reduced risk for major bleeding compared with triple therapy (risk difference [RD], −0.013; 95% CI, −0.025 to −0.002), the authors wrote. Low-certainty evidence showed inconclusive effects of dual versus triple therapy on risks for all-cause mortality (RD, 0.004; 95% CI, −0.010 to 0.017), cardiovascular death (RD, 0.001; 95% CI, −0.011 to 0.013), MI (RD, 0.003; 95% CI, −0.010 to 0.017), stent thrombosis (RD, 0.003; 95% CI, −0.005 to 0.010), and stroke (RD, −0.003; 95% CI, −0.010 to 0.005). The authors noted that while the upper bounds of the confidence intervals for these effects were compatible with possible increased risks with dual therapy, the results including sensitivity analyses showed a possible increased risk for ischemic end points with use of dual versus triple therapy.
An accompanying editorial noted that there is high-certainty evidence that use of dual therapy compared with triple therapy is associated with a reduction in major bleeding events and low-certainty evidence of inconclusive effects with a possible increased risk of dual therapy compared with triple therapy on all-cause mortality, cardiovascular mortality, MI, stent thrombosis, and stroke.
“Lesion complexity, patient-specific bleeding risk, and whether stenting is elective or emergent are factors to weigh in determining the duration and intensity of combined anticoagulant and antiplatelet therapy,” the editorial stated. “Navigating the competing risks remains a challenge. Stent technology is maturing, and which P2Y12 inhibitor to prescribe remains a question, especially when treatment with clopidogrel is unsuccessful.”