Branch Kelley R H, Probstfield Jeffrey L, Bosch Jackie, Bhatt Deepak L, Maggioni Aldo P, Muehlhofer Eva, Avezum Alvaro, Widimsky Petr, Connolly Stuart J, Yi Quilong, Shestakovska Olga, Yusuf Salim, Eikelboom John W
University of Washington, Division of Cardiology, Seattle, WA.
University of Washington, Division of Cardiology, Seattle, WA.
Am Heart J. 2023 Apr;258:60-68. doi: 10.1016/j.ahj.2023.01.008. Epub 2023 Jan 14.
Low dose rivaroxaban with aspirin reduced major cardiovascular events (MACE) compared to aspirin alone in patients with cardiovascular disease although effects on total events are unknown.
The COMPASS clinical trial randomized 27,395 participants with chronic coronary and/or peripheral artery disease to rivaroxaban 2.5 mg twice daily plus aspirin 100 mg daily, rivaroxaban 5 mg twice daily alone, or aspirin 100 mg daily. We analyzed total (first and recurrent) MACE outcomes of cardiovascular death, stroke, or myocardial infarction, and the primary safety outcome of major bleeding. Exploratory analyses included on-treatment and net clinical benefit. Total MACE and safety events were modeled for each treatment.
MACE events were lowest in rivaroxaban with aspirin (379 first MACE, 432 total MACE) compared with rivaroxaban (448 first, 508 total) or aspirin alone (496 first, 574 total). Rivaroxaban and aspirin reduced total MACE events compared with aspirin alone [HR 0.75, 95% CI 0.66-0.85, P < .0001, number needed to treat for 2 years (NNT) of 63]. Total major bleeding was higher for rivaroxaban with aspirin compared to aspirin, but severe bleeding was not increased. The net clinical benefit of rivaroxaban plus aspirin was 20% higher compared with aspirin alone [HR 0.80 (95% CI 16.3%-31.6%)]. Rivaroxaban alone had no benefit on MACE outcomes compared with aspirin alone. MACE outcomes were similar for those on and off randomized treatment.
Low dose rivaroxaban with aspirin significantly reduces first and total cardiovascular events compared with aspirin alone with a NNT of 63 and a 20% net clinical benefit.
NCT01776424. https://clinicaltrials.gov/ct2/show/NCT01776424.
在心血管疾病患者中，与单独使用阿司匹林相比，低剂量利伐沙班联合阿司匹林可降低主要心血管事件（MACE），但对总事件的影响尚不清楚。
COMPASS临床试验将27395例慢性冠状动脉和/或外周动脉疾病患者随机分为三组，分别接受每日两次2.5mg利伐沙班联合每日100mg阿司匹林治疗、每日两次5mg利伐沙班单药治疗或每日100mg阿司匹林单药治疗。我们分析了心血管死亡、中风或心肌梗死的总（首次和复发）MACE结局，以及主要出血的主要安全性结局。探索性分析包括治疗期间和净临床获益情况。对每种治疗的总MACE和安全性事件进行建模。
与利伐沙班单药治疗（首次448例，总计508例）或单独使用阿司匹林（首次496例，总计574例）相比，利伐沙班联合阿司匹林组的MACE事件最低（首次MACE 379例，总MACE 432例）。与单独使用阿司匹林相比，利伐沙班联合阿司匹林可降低总MACE事件[风险比（HR）0.75，95%置信区间（CI）0.66 - 0.85，P <.0001，2年治疗所需人数（NNT）为63]。与阿司匹林相比，利伐沙班联合阿司匹林组的总主要出血发生率更高，但严重出血并未增加。与单独使用阿司匹林相比，利伐沙班联合阿司匹林的净临床获益高20%[HR 0.80（95%CI 16.3% - 31.6%）]。与单独使用阿司匹林相比，利伐沙班单药治疗对MACE结局无益处。随机治疗组和非随机治疗组的MACE结局相似。
与单独使用阿司匹林相比，低剂量利伐沙班联合阿司匹林可显著降低首次和总的心血管事件，NNT为63，净临床获益为20%。
NCT01776424。https://clinicaltrials.gov/ct2/show/NCT01776424。
