Spyropoulos Alex C, Goldin Mark, Ageno Walter, Albers Gregory W, Elliott C Gregory, Hiatt William R, Halperin Jonathan L, Maynard Gregory, Steg P Gabriel, Weitz Jeffrey I, Spiro Theodore E, Lu Wentao, Marsigliano Jessica, Raskob Gary E, Barnathan Elliot S
The Donald and Barbara Zucker School of Medicine at Hofstra/Northwell, The Feinstein Institute for Medical Research, New York, New York, United States.
Department of Medicine, Anticoagulation and Clinical Thrombosis Services, Northwell Health at Lenox Hill Hospital, New York, New York, United States.
TH Open. 2022 Jul 11;6(3):e177-e183. doi: 10.1055/s-0042-1750379. eCollection 2022 Jul.
The MARINER trial evaluated whether postdischarge thromboprophylaxis with rivaroxaban could reduce the primary outcome of symptomatic venous thromboembolism (VTE) or VTE-related death in acutely ill medical patients at risk for VTE. Although aspirin use was not randomized, approximately half of the enrolled patients were receiving aspirin at baseline. We hypothesized that thromboprophylaxis with once-daily rivaroxaban (10 mg or, if creatinine clearance was 30-49 mL/min, 7.5 mg) plus aspirin (R/A) would be superior to placebo without aspirin (no thromboprophylaxis [no TP]). We compared the primary and major secondary outcomes in the intention-to-treat population in four subgroups defined at baseline: (1) R/A ( = 3,159); (2) rivaroxaban alone ( = 2,848); (3) aspirin alone ( = 3,046); and (4) no TP ( = 2,966). Major bleeding (MB) and nonmajor clinically relevant (NMCR) bleeding were assessed in the safety population on treatment plus 2 days. Patients on R/A had reduced symptomatic VTE and VTE-related death compared with no TP (0.76 vs 1.28%, = 0.042), and experienced less symptomatic VTE and all-cause mortality ( = 0.005) and all-cause mortality alone ( = 0.01) compared with no TP. Event incidences for rivaroxaban alone (0.91%) or aspirin alone (0.92%) were similar. MB was low in all groups but lowest in the no TP group. NMCR bleeding was increased with R/A compared with no TP ( = 0.009). Aspirin use was not randomized. Extended postdischarge thromboprophylaxis with R/A was associated with less symptomatic VTE and VTE-related death compared with no TP in previously hospitalized medical patients at risk for VTE. NMCR bleeding was increased with R/A compared with no TP. These post hoc findings need confirmation in a prospective trial.
MARINER试验评估了利伐沙班出院后血栓预防措施能否降低有静脉血栓栓塞（VTE）风险的急性病内科患者出现有症状VTE或VTE相关死亡的主要结局。尽管阿司匹林的使用未随机分组，但约一半的入组患者在基线时正在服用阿司匹林。我们假设，每日一次服用利伐沙班（10毫克，若肌酐清除率为30 - 49毫升/分钟则为7.5毫克）加阿司匹林（R/A）进行血栓预防优于不使用阿司匹林的安慰剂（无血栓预防[无TP]）。我们在基线时定义的四个亚组的意向性治疗人群中比较了主要结局和主要次要结局：（1）R/A组（n = 3159）；（2）仅使用利伐沙班组（n = 2848）；（3）仅使用阿司匹林组（n = 3046）；以及（4）无TP组（n = 2966）。在治疗加2天的安全性人群中评估了大出血（MB）和非大出血的临床相关（NMCR）出血情况。与无TP组相比，R/A组有症状VTE和VTE相关死亡减少（0.76%对1.28%，P = 0.042），且与无TP组相比，有症状VTE和全因死亡率降低（P = 0.005）以及单独全因死亡率降低（P = 0.01）。仅使用利伐沙班组（0.91%）或仅使用阿司匹林组（0.92%）的事件发生率相似。所有组的MB发生率都较低，但无TP组最低。与无TP组相比，R/A组的NMCR出血增加（P = 0.009）。阿司匹林的使用未随机分组。与无TP相比，在先前住院的有VTE风险的内科患者中，延长出院后使用R/A进行血栓预防与较少的有症状VTE和VTE相关死亡相关。与无TP相比，R/A组的NMCR出血增加。这些事后分析结果需要在前瞻性试验中得到证实。
