Yamashita Takeshi, Fukuda Ikuo, Nakamura Mashio, Yamada Norikazu, Takayama Morimasa, Maeda Hideaki, Ikeda Takanori, Mo Makoto, Yamazaki Tsutomu, Okumura Yasuo, Hirayama Atsushi
Department of Cardiovascular Medicine, The Cardiovascular Institute Tokyo Japan.
Department of Cardiovascular Surgery, Suita Tokushukai Hospital Suita Japan.
Circ Rep. 2022 Jul 13;4(8):371-377. doi: 10.1253/circrep.CR-22-0011. eCollection 2022 Aug 10.
Rivaroxaban, a direct oral anticoagulant, is used as first-line treatment to prevent venous thromboembolism (VTE), including deep vein thrombosis (DVT) and pulmonary embolism (PE). However, the frequency of rivaroxaban discontinuation and the subsequent clinical outcomes remain unclear. The study was a subanalysis of the prospective, multicenter, observational J'xactly study, conducted in Japan, and included patients who underwent anticoagulant discontinuation without major bleeding and recurrent VTE. The modified intention-to-treat population (n=1,016) included 579 patients (57%) who underwent anticoagulant discontinuation during a mean follow-up period of 20.2 months (mean [±SD] anticoagulation period 6.9±6.2 months). Patients were divided into 3 groups: those with active cancer, those without active cancer and a transient risk factor for VTE, and those without active cancer or a transient risk factor and/or with previous VTE (unprovoked group). After discontinuation, VTE recurrence occurred in 4.1% of patients, with an annual incidence of 4.6%/year and an increased tendency in the unprovoked group; major bleeding occurred in 8 patients (1.4%; annual incidence 1.1%/year), of whom half were in the cancer group. This analysis of a real-world observational study provides data on VTE recurrence after rivaroxaban discontinuation, which will facilitate anticoagulant discontinuation according to individual risk-benefit considerations.
利伐沙班是一种直接口服抗凝剂，用作预防静脉血栓栓塞（VTE）的一线治疗药物，包括深静脉血栓形成（DVT）和肺栓塞（PE）。然而，利伐沙班停药的频率及其后续临床结果仍不明确。该研究是对在日本进行的前瞻性、多中心观察性J'xactly研究的亚分析，纳入了在无大出血和复发性VTE情况下停用抗凝剂的患者。改良意向性治疗人群（n = 1016）包括579例患者（57%），他们在平均20.2个月的随访期内停用了抗凝剂（平均[±标准差]抗凝期为6.9±6.2个月）。患者分为3组：患有活动性癌症的患者、没有活动性癌症但有VTE短暂危险因素的患者，以及没有活动性癌症或短暂危险因素和/或有既往VTE的患者（无诱因组）。停药后，4.1%的患者发生了VTE复发，年发病率为4.6%/年，且无诱因组有上升趋势；8例患者发生大出血（1.4%；年发病率1.1%/年），其中一半在癌症组。这项对真实世界观察性研究的分析提供了利伐沙班停药后VTE复发的数据，这将有助于根据个体的风险效益考虑来停用抗凝剂。
