Department of Medicine, West Virginia University, 1 Medical Center Drive, Morgantown, WV, 26505, USA.
Department of Cardiovascular Disease, University of Oklahoma, Norman, OK, USA.
J Thromb Thrombolysis. 2020 Nov;50(4):913-920. doi: 10.1007/s11239-020-02114-7.
The mortality effects and risk-benefit profile of low dose rivaroxaban (2.5 mg twice daily) in patients with coronary heart disease are not completely understood. Five randomized controlled trials (26,110 patients) were selected using PubMed and Cochrane library till April 2019. The background antiplatelet therapy was aspirin in 3 trials, P2Y12 inhibitor in 1 trial, and in 1 trial 65% patients received aspirin and 35% were on dual antiplatelet therapy (DAPT). The outcomes of interest were cardiovascular mortality, all-cause mortality, myocardial infarction (MI), stroke and major bleeding events. Random effects hazard ratios (HR) with 95% confidence intervals (CI) were calculated. Low dose rivaroxaban did not reduce the risk of cardiovascular mortality (HR 0.90, 95% CI 0.73-1.11, P = 0.34) or all-cause mortality (HR 0.91, 95% CI 0.74-1.12, P = 0.38) compared with control. However, low dose rivaroxaban was associated with reduction in MI (HR 0.85, 95% CI 0.73-0.99, P = 0.04), and stroke (HR 0.59, 95%CI 0.48-0.73, P < 0.001) at the expense of major bleeding (HR 1.64, 95% CI 1.39-1.94, P < 0.001) compared with control. These effects did not vary according to acute coronary syndrome or stable coronary heart disease (P-interaction > 0.05). The use of low dose rivaroxaban in patients with coronary heart disease predominantly receiving antiplatelet monotherapy did not reduce cardiovascular or all-cause mortality. The benefits of preventing MI and stroke were balanced by increased risk of major bleeding.
低剂量利伐沙班（每日两次 2.5 毫克）在冠心病患者中的死亡率影响和风险效益情况尚不完全清楚。使用 PubMed 和 Cochrane 图书馆，截至 2019 年 4 月，选择了 5 项随机对照试验（26110 例患者）。3 项试验的背景抗血小板治疗为阿司匹林，1 项试验为 P2Y12 抑制剂，1 项试验中 65%的患者接受阿司匹林治疗，35%的患者接受双联抗血小板治疗（DAPT）。感兴趣的结局是心血管死亡率、全因死亡率、心肌梗死（MI）、卒中和主要出血事件。使用 95%置信区间（CI）计算随机效应危害比（HR）。与对照组相比，低剂量利伐沙班并未降低心血管死亡率（HR 0.90，95%CI 0.73-1.11，P=0.34）或全因死亡率（HR 0.91，95%CI 0.74-1.12，P=0.38）的风险。然而，与对照组相比，低剂量利伐沙班与降低 MI（HR 0.85，95%CI 0.73-0.99，P=0.04）和卒（HR 0.59，95%CI 0.48-0.73，P<0.001）相关，但以增加大出血风险为代价（HR 1.64，95%CI 1.39-1.94，P<0.001）。这些影响在急性冠脉综合征或稳定型冠心病患者中没有差异（P 交互作用>0.05）。在主要接受抗血小板单药治疗的冠心病患者中使用低剂量利伐沙班并未降低心血管或全因死亡率。预防 MI 和卒中等益处与大出血风险增加相平衡。
