Key result
Extended 28-day rivaroxaban shows no benefit over 7-day therapy for preventing post-surgical venous thromboembolism.
Why the study?
Venous thromboembolism is a leading cause of morbidity and mortality after bariatric surgery, but clinical end point studies on direct oral anticoagulant thromboprophylaxis in these patients are lacking.
Does extended thromboprophylaxis with rivaroxaban for 28 days prevent venous thromboembolism more effectively than a 7-day course in patients after bariatric surgery?
RCT (n=272)
Assessor-blinded
1:1 using an electronic online randomization system with different block sizes, stratified by surgical procedure, sex, and study center
Yes
Does extended thromboprophylaxis with rivaroxaban for 28 days prevent venous thromboembolism more effectively than a 7-day course in patients after bariatric surgery?
Absolute Event Rate: 0.8% vs 0%
A 7-day course of prophylactic rivaroxaban (10 mg daily) appears efficacious and safe for early postoperative VTE prevention after bariatric surgery, with no added benefit observed from extending treatment to 28 days.
Supports shorter-course rivaroxaban post-bariatric surgery; extends limited RCT data on optimal prophylaxis duration.
Importance: Venous thromboembolism (VTE) is a leading cause of morbidity and mortality after bariatric surgery. Clinical end point studies on thromboprophylaxis with direct oral anticoagulants in patients undergoing bariatric surgery are lacking. Objective: To assess the efficacy and safety of a prophylactic dose of 10 mg/d of rivaroxaban for both 7 and 28 days after bariatric surgery. Design, Setting, and Participants: This assessor-blinded, phase 2, multicenter randomized clinical trial was conducted from July 1, 2018, through June 30, 2021, with participants from 3 academic and nonacademic hospitals in Switzerland. Intervention: Patients were randomized 1 day after bariatric surgery to 10 mg of oral rivaroxaban for either 7 days (short prophylaxis) or 28 days (long prophylaxis). Main Outcomes and Measures: The primary efficacy outcome was the composite of deep vein thrombosis (symptomatic or asymptomatic) and pulmonary embolism within 28 days after bariatric surgery. Main safety outcomes included major bleeding, clinically relevant nonmajor bleeding, and mortality. Results: Of 300 patients, 272 (mean [SD] age, 40.0 [12.1] years; 216 women [80.3%]; mean body mass index, 42.2) were randomized; 134 received a 7-day and 135 a 28-day VTE prophylaxis course with rivaroxaban. Only 1 thromboembolic event (0.4%) occurred (asymptomatic thrombosis in a patient undergoing sleeve gastrectomy with extended prophylaxis). Major or clinically relevant nonmajor bleeding events were observed in 5 patients (1.9%): 2 in the short prophylaxis group and 3 in the long prophylaxis group. Clinically nonsignificant bleeding events were observed in 10 patients (3.7%): 3 in the short prophylaxis arm and 7 in the long prophylaxis arm. Conclusions and Relevance: In this randomized clinical trial, once-daily VTE prophylaxis with 10 mg of rivaroxaban was effective and safe in the early postoperative phase after bariatric surgery in both the short and long prophylaxis groups. Trial Registration: ClinicalTrials.gov Identifier: NCT03522259.
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Kröll et al. (2023) conducted an RCT in Severe obesity undergoing bariatric surgery (n=272). Rivaroxaban vs. Rivaroxaban for 7 days was evaluated on Composite of deep vein thrombosis (symptomatic or asymptomatic) and pulmonary embolism within 28 days. Rivaroxaban 10 mg daily for either 7 or 28 days resulted in very low rates of venous thromboembolism (1 event overall, 0.4%) with no significant difference in efficacy or bleeding between the short and long prophylaxis groups.
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