Eyileten Ceren, Postula Marek, Jakubik Daniel, Toma Aurel, Mirowska-Guzel Dagmara, Patti Giuseppe, Renda Giulia, Siller-Matula Jolanta M
Department of Experimental and Clinical Pharmacology, Centre for Preclinical Research and Technology (CEPT), Medical University of Warsaw, 02097 Warsaw, Poland.
Department of Internal Medicine II, Division of Cardiology, Medical University of Vienna, 1090 Vienna, Austria.
J Clin Med. 2020 Apr 14;9(4):1120. doi: 10.3390/jcm9041120.
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).
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).
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.
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.
我们的研究旨在对经皮冠状动脉介入治疗（PCI）患者使用非维生素K口服抗凝剂（NOAC）与维生素K拮抗剂（VKA）相关的获益和风险进行荟萃分析，特别关注联合类型：双联与双联抗栓治疗（DAT：NOAC + 单药抗血小板治疗（SAPT）与DAT：VKA + SAPT）、双联与三联抗栓治疗（DAT：NOAC + SAPT与TAT：VKA + 双联抗血小板治疗（DAPT））或三联与三联抗栓治疗（TAT：NOAC + DAPT与TAT：VKA + DAPT）。
检索PubMed、EMBASE和Cochrane数据库，以识别比较抗栓方案的随机对照试验。纳入四项随机研究（n = 10969；PIONEER AF - PCI、RE - DUAL PCI、AUGUSTUS和ENTRUST - AF PCI）。主要结局是由国际血栓与止血学会（ISTH）定义的大出血与需要医疗干预的临床相关出血（CRNM）的复合结局。次要结局包括全因死亡率、主要不良心血管事件（MACE）、心肌梗死（MI）、卒中及支架血栓形成（ST）。
与VKA相比，不同联合策略下使用NOAC的联合策略与大出血事件风险降低相关，当比较DAT与TAT时风险降低最为显著，即与VKA + DAPT的TAT相比，NOAC + SAPT的DAT大出血事件相对风险降低37%（RRR）（RR 0.63；95% CI，0.50 - 0.80）。大出血风险降低是NOAC的类效应。NOAC与VKA的联合策略导致MACE、MI、卒中、ST或死亡风险相当。
就出血风险而言，NOAC的抗栓联合治疗（作为DAT或TAT）比VKA更安全，并且在接受PCI的患者中产生令人满意的疗效，而不会增加缺血或血栓形成事件。
