Rivaroxaban Plus Aspirin for Extended Thromboprophylaxis in Acutely Ill Medical Patients: Insights from the MARINER Trial.
Alex C SpyropoulosMark GoldinWalter AgenoGregory W AlbersC Gregory ElliottWilliam R HiattJonathan L HalperinGregory MaynardP Gabriel StegJeffrey I WeitzTheodore E SpiroWentao LuJessica MarsiglianoGary E RaskobElliot S BarnathanPublished in: TH open : companion journal to thrombosis and haemostasis (2022)
Background 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]). Methods We compared the primary and major secondary outcomes in the intention-to-treat population in four subgroups defined at baseline: (1) R/A ( N = 3,159); (2) rivaroxaban alone ( N = 2,848); (3) aspirin alone ( N = 3,046); and (4) no TP ( N = 2,966). Major bleeding (MB) and nonmajor clinically relevant (NMCR) bleeding were assessed in the safety population on treatment plus 2 days. Results Patients on R/A had reduced symptomatic VTE and VTE-related death compared with no TP (0.76 vs 1.28%, p = 0.042), and experienced less symptomatic VTE and all-cause mortality ( p = 0.005) and all-cause mortality alone ( p = 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 ( p = 0.009). Limitations Aspirin use was not randomized. Conclusion 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.
Keyphrases
- venous thromboembolism
- direct oral anticoagulants
- end stage renal disease
- low dose
- ejection fraction
- atrial fibrillation
- chronic kidney disease
- newly diagnosed
- cardiovascular events
- healthcare
- clinical trial
- prognostic factors
- cardiovascular disease
- antiplatelet therapy
- pulmonary embolism
- open label
- randomized controlled trial
- metabolic syndrome
- double blind
- physical activity
- phase ii
- skeletal muscle
- coronary artery disease
- patient reported outcomes
- adipose tissue
- patient reported
- placebo controlled