Department of Medicine (Division of Hematology) and the Ottawa Hospital Research Institute, University of Ottawa, Ottawa, Ontario, Canada.
Department of Research, Ostfold Hospital Trust, Institute of Clinical Medicine, University of Oslo, Oslo, Norway.
J Thromb Haemost. 2022 Jan;20(1):126-132. doi: 10.1111/jth.15537. Epub 2021 Oct 19.
Statins may reduce the risk for recurrent venous thromboembolism (VTE); however, no randomized trials have explored this hypothesis. We performed a pilot randomized trial to determine feasibility of recruitment for a larger trial of secondary VTE prevention with rosuvastatin.
Patients with a newly diagnosed symptomatic proximal deep vein thrombosis and/or pulmonary embolism, receiving standard anticoagulation, were randomly allocated to adjuvant rosuvastatin 20 mg once daily for 180 days or no rosuvastatin for 6 months.
Between November 2016 and December 2019, 3391 patients were assessed for eligibility in six centers. Of these patients, 1347 (39.7%) were eligible and approached for participation in the trial and 312 (23.1%) were randomized. The mean rate of randomization was 8.2 ± 4.3 patients per month. During follow-up, five recurrent VTE events were observed, three (1.9%) in the rosuvastatin group (two pulmonary embolism, one deep vein thrombosis), and two (1.3%) in the control group (two pulmonary embolism; P = 0.68). One major arterial event occurred in the rosuvastatin arm and none in the control arm (0.6% vs. 0%, P = 0.50).
This pilot trial supports the feasibility of a larger scale randomized controlled trial to determine the efficacy of adjuvant rosuvastatin for the secondary prevention of VTE.
他汀类药物可能降低复发性静脉血栓栓塞症（VTE）的风险；然而，尚无随机试验探讨这一假说。我们进行了一项先导性随机试验，以确定使用瑞舒伐他汀进行二级 VTE 预防的更大规模试验的招募可行性。
患有新诊断的有症状近端深静脉血栓形成和/或肺栓塞、接受标准抗凝治疗的患者被随机分配至辅助瑞舒伐他汀 20mg 每日一次治疗 180 天或不使用瑞舒伐他汀治疗 6 个月。
2016 年 11 月至 2019 年 12 月，在 6 个中心评估了 3391 例患者的入选资格。在这些患者中，有 1347 例（39.7%）符合入选条件并被邀请参与试验，有 312 例（23.1%）被随机分组。平均每月随机分组率为 8.2±4.3 例。在随访期间，观察到 5 例复发性 VTE 事件，瑞舒伐他汀组 3 例（1.9%）（2 例肺栓塞，1 例深静脉血栓形成），对照组 2 例（1.3%）（2 例肺栓塞；P=0.68）。瑞舒伐他汀组发生 1 例主要动脉事件，对照组无此类事件（0.6% vs. 0%，P=0.50）。
这项先导性试验支持开展更大规模随机对照试验的可行性，以确定辅助使用瑞舒伐他汀治疗 VTE 二级预防的疗效。
