Abstract
Background: Our study aims to perform a meta-analysis of benefits and risks associated with the use of non-vitamin K oral anticoagulants (NOAC) versus vitamin K antagonists (VKA) in patients with a percutaneous coronary intervention (PCI) with a particular focus on the combination type: dual vs. dual antithrombotic therapy (DAT: NOAC + single antiplatelet therapy (SAPT) vs. DAT: VKA + SAPT), dual vs. triple antithrombotic therapy (DAT: NOAC + SAPT vs. TAT: VKA + dual antiplatelet therapy (DAPT)) or triple vs. triple antithrombotic therapy (TAT: NOAC+DAPT vs. TAT: VKA+DAPT). Methods: PubMed, EMBASE, and Cochrane databases were searched to identify randomized controlled trials comparing antithrombotic regimens. Four randomized studies (n = 10.969; PIONEER AF-PCI, RE-DUAL PCI, AUGUSTUS, and ENTRUST-AF PCI) were included. The primary outcome was the composite of major bleeding defined by the International Society on Thrombosis and Hemostasis (ISTH) and clinically relevant bleeding requiring medical intervention (CRNM). Secondary outcomes included all-cause mortality, major adverse cardiovascular events (MACE), myocardial infarction (MI), stroke, and stent thrombosis (ST). Results: Combination strategies with NOACs were associated with reduced risk of major bleeding events across different combination strategies as compared to VKA, with the most significant risk reduction when DAT was compared with TAT, namely DAT with NOAC + SAPT was associated with a 37% relative risk reduction (RRR) of major bleeding events as compared to TAT with VKA + DAPT (RR 0.63; 95% CI, 0.50–0.80). The reduction of major bleeding risks is a class effect of NOACs. Combination strategies of NOACs vs. VKAs resulted in a comparable risk of MACE, MI, stroke, ST, or death. Conclusions: Antithrombotic combinations of NOACs (as DAT or TAT) are safer than VKAs with respect to bleeding risk and result in a satisfactory efficacy with no increase of ischemic or thrombotic events in patients undergoing PCI.
Highlights
Atrial fibrillation (AF) is a global health problem and a common arrhythmia that increases the risk of thromboembolic complications, including stroke and other cardiovascular events [1]
Our meta-analysis in over ten thousand patients confirms that non–vitamin K antagonist oral anticoagulants (NOAC) as part of diverse antithrombotic combinations are safer than vitamin K antagonists (VKA) with respect to major bleeding events
The magnitude of the effect was larger when NOACs were used as part of a dual antithrombotic therapy (DAT) than triple antithrombotic therapy (TAT); NOACs as part of DAT were associated with a 37% relative risk reduction (RRR) of major bleeding events as compared to VKA as a part of TAT
Summary
Atrial fibrillation (AF) is a global health problem and a common arrhythmia that increases the risk of thromboembolic complications, including stroke and other cardiovascular events [1]. In order to reduce the risk of both stroke and coronary ischemic events in this vulnerable population of patients with AF who concomitantly received coronary stents, triple antithrombotic therapies (TAT i.e., a combination of oral anticoagulants (OAC) and DAPT) have been used for the last decade [5]. Randomized controlled trials (RCTs) have been conducted to compare the safety and efficacy of NOACs versus VKA as a combination with single or dual antiplatelet agents (SAPT/DAPT) in patients with AF undergoing PCI or presenting with ACS [9,10,11,12,13]. To summarize the existing evidence, we performed a meta-analysis evaluating the safety and efficacy of NOAC vs VKA with different antiplatelet combination strategies in patients with AF following elective or urgent PCI. A particular focus of this meta-analysis was to perform subgroup analyses focusing on various combinations of antithrombotic strategies as dual or triple antithrombotic therapies (DAT or TAT) while always comparing NOAC vs. VKA
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