Yamada Norikazu, Fu Weiguo, Shi Zhenyu, Park Ki-Hyuk, Kim Hyo-Soo, Dai Xiangchen, Lensing Anthonie Wa, Pap Akos F, Kohno Tomoko, Tajima Tsubasa, Watakabe Tadashi, Mitsumori Tomoyuki
Kuwana City Medical Center, Kotobuki-Cho 3- 11, 511-0061, Kuwana City, Mie, Japan.
Departments of Vascular Surgery, Zhongshan Hospital, Fudan University, Shanghai, China.
Thromb J. 2024 Jun 6;22(1):48. doi: 10.1186/s12959-024-00609-4.
Risks of recurrence and major bleeding with extended anticoagulation in Asian patients with venous thromboembolism (VTE) are similar to those in non-Asian patients but risks according to baseline risk factor profiles is not well documented.
Subgroup analysis of two randomized trials, which compared once-daily rivaroxaban (20 mg or 10 mg) with placebo or aspirin (100 mg) for extended treatment in Asian patients with VTE who had completed 6-12 months of anticoagulation. Index events were classified as unprovoked, provoked by major persistent risk factors, minor persistent risk factors, minor transient risk factors, or major transient risk factors. One-year cumulative risks of recurrent VTE were calculated for these risk factor profiles.
367 patients received rivaroxaban, 159 aspirin, and 48 placebo. For patients with unprovoked VTE, one-year cumulative incidences of recurrence in the 202 patients given rivaroxaban, the 89 given aspirin and the 28 given placebo were 1.6%, 5.8%, and 14.8%, respectively. For patients with VTE provoked by minor persistent risk factors, these incidences were 0% in the 74 patients given rivaroxaban, 9.3% in the 36 given aspirin, and 0% in the 12 given placebo. No recurrent VTE occurred in patients with VTE provoked by major persistent or transient risk factors or minor transient risk factors. Rivaroxaban was not associated with a significant increase in major bleeding.
Rivaroxaban seems to be an effective and safe option for extended treatment in Asian patients, especially those presenting with unprovoked VTE. Subgroups of patients with provoked risk factors were too small to draw meaningful conclusions.
NCT00439725 and NCT02064439.
亚洲静脉血栓栓塞症（VTE）患者延长抗凝治疗的复发风险和大出血风险与非亚洲患者相似，但根据基线风险因素概况的风险情况尚无充分记录。
对两项随机试验进行亚组分析，这两项试验比较了每日一次利伐沙班（20毫克或10毫克）与安慰剂或阿司匹林（100毫克）用于已完成6至12个月抗凝治疗的亚洲VTE患者的延长治疗。指标事件分为不明原因、由主要持续性风险因素诱发、次要持续性风险因素诱发、次要短暂性风险因素诱发或主要短暂性风险因素诱发。计算这些风险因素概况的复发性VTE的一年累积风险。
367例患者接受利伐沙班治疗，159例接受阿司匹林治疗，48例接受安慰剂治疗。对于不明原因VTE患者，202例接受利伐沙班治疗、89例接受阿司匹林治疗和28例接受安慰剂治疗的患者的一年复发累积发生率分别为1.6%、5.8%和14.8%。对于由次要持续性风险因素诱发VTE的患者，74例接受利伐沙班治疗、36例接受阿司匹林治疗和12例接受安慰剂治疗的患者的这些发生率分别为0%、9.3%和0%。由主要持续性或短暂性风险因素或次要短暂性风险因素诱发VTE的患者未发生复发性VTE。利伐沙班与大出血的显著增加无关。
利伐沙班似乎是亚洲患者延长治疗的有效且安全的选择，尤其是那些不明原因VTE患者。有诱发风险因素的患者亚组规模过小，无法得出有意义的结论。
NCT00439725和NCT02064439。
