Department of Cardiovascular and Thoracic Sciences, Fondazione Policlinico A. Gemelli IRCCS, Largo F. Vito 1, 00168 Rome, Italy.
Università Cattolica del Sacro Cuore, Rome, Italy.
Europace. 2020 Apr 1;22(4):538-546. doi: 10.1093/europace/euz345.
To assess the efficacy-safety profile of dual antithrombotic therapy (DAT) including direct oral anticoagulant (DOAC) vs. triple antithrombotic therapy (TAT) in patients with atrial fibrillation (AF) and acute coronary syndrome (ACS) or undergoing percutaneous coronary intervention (PCI).
Randomized trials of AF patients with ACS/PCI, comparing DAT using DOACs against TAT, were selected. Overall, 11 161 studies were screened, 458 trials assessed, and four included, comprising 10 234 patients followed for a mean of 11 months. DAT compared to TAT resulted in significant reductions of trial-defined primary safety outcome [odds ratio (OR) 0.63, 95% confidence interval (CI) 0.50-0.79, number needed to treat (NNT) 17] and of thrombolysis in myocardial infarction (TIMI) major bleeding (OR 0.54, 95% CI 0.41-0.70, NNT 76) and in a numerical reduction of intracranial haemorrhage (OR 0.50, 95% CI 0.21-1.19, NNT 314), which became significant after exclusion of DOACs from TAT and vitamin K antagonist from DAT arms (OR 0.31, 95% CI 0.15-0.64). There were no significant differences in the risks of cardiovascular or any deaths or stroke, but with DAT, there was a numerical increase in myocardial infarctions (MIs) (OR 1.23, 95% CI 0.99-1.54, estimated NNT for an additional harmful outcome (NNTH) 151), which became significant in the ACS/PCI subgroup (OR 1.43, 95% CI 1.02-2.00), and a 60% significant increase in stent thrombosis risk (OR 1.60, 95% CI 1.02-2.52; NNTH 274).
Dual antithrombotic therapy, compared to TAT, conferred a significantly reduced risk of overall bleeding but with a significant increase of stent thrombosis risk in the overall population and a significant 43% increase of MI in the ACS/PCI subgroup.
评估房颤（AF）合并急性冠脉综合征（ACS）或行经皮冠状动脉介入治疗（PCI）患者双联抗栓治疗（DAT）与三联抗栓治疗（TAT）的疗效-安全性特征。
筛选了 AF 合并 ACS/PCI 患者的随机试验，比较了 DAT 使用直接口服抗凝剂（DOAC）与 TAT。共筛选了 11161 项研究，评估了 458 项试验，纳入了 4 项研究，共纳入 10234 例患者，平均随访 11 个月。与 TAT 相比，DAT 显著降低了试验定义的主要安全性结局[比值比（OR）0.63，95%置信区间（CI）0.50-0.79，需要治疗的人数（NNT）17]和心肌梗死溶栓治疗（TIMI）大出血（OR 0.54，95%CI 0.41-0.70，NNT 76），并在数值上降低了颅内出血（OR 0.50，95%CI 0.21-1.19，NNT 314），但在排除 TAT 中的 DOAC 和 DAT 中的维生素 K 拮抗剂后，差异具有统计学意义（OR 0.31，95%CI 0.15-0.64）。心血管或任何死亡或卒中等结局的风险无显著差异，但 DAT 组心肌梗死（MI）发生率略有增加（OR 1.23，95%CI 0.99-1.54，估计额外有害结局的需要治疗人数（NNTH）为 151），ACS/PCI 亚组差异具有统计学意义（OR 1.43，95%CI 1.02-2.00），支架血栓形成风险增加 60%（OR 1.60，95%CI 1.02-2.52；NNTH 274）。
与 TAT 相比，DAT 可显著降低总体出血风险，但在总体人群中支架血栓形成风险显著增加，ACS/PCI 亚组 MI 增加 43%。
