Abstract
Background: Several randomized clinical trials (RCTs) have compared the use of dual therapy (DT), or one of the non-vitamin K antagonist oral anticoagulants (NOAC) with a P2Y12 agent, versus triple therapy (TT), consisting of a vitamin-K antagonist (VKA) along with dual antiplatelet therapy, in patients with concomitant atrial fibrillation after percutaneous coronary intervention (PCI) or acute coronary syndrome (ACS). We performed a meta-analysis and systematic review of RCTs to evaluate the safety and efficacy of NOAC-based DT in such patients. Methods: The major efficacy outcome was major adverse cardiovascular and cerebrovascular events (MACCE), defined as a composite of mortality, myocardial infarction, stroke, stent thrombosis (ST), and urgent revascularization. The International Society on Thrombosis and Hemostasis (ISTH) major or clinically relevant non-major bleeding (CRNM) was the major primary safety outcome. Results: A total of 4 RCTs were included in the meta-analysis with 7942 total patients for analysis (DT: 4377 & TT: 3565). Compared to TT, DT resulted in similar risk of MACCE (OR: 1.12; 95% CI: 0.94–1.34; P = 0.20) and other efficacy endpoints with a trend in increased risk of ST in the DT group (1.55; 0.99–2.44; P = 0.06). DT resulted in lower risk of ISTH major or CRNM bleeding (0.56; 0.41–0.76; P < 0.01), and all other bleeding outcomes except for a trend of reduced risk of TIMI minor bleeding. Conclusion: In conclusion, patients with atrial fibrillation who undergo PCI or develop ACS, NOAC-based dual therapy reduces bleeding outcomes without significantly increasing ischemic outcomes. Future trials should explore the possible differences in stent thrombosis.