Is rivaroxaban safe and effective for thromboprophylaxis in adults after bariatric surgery?
Rivaroxaban 10 mg orally once daily is effective and safe for thromboprophylaxis after bariatric surgery. This study found no difference in VTE events or clinically relevant bleeding events in patients who received therapy for 7 days versus 28 days.
Plan de l'etude:
Randomized controlled trial (double-blinded)
Inpatient (any location) with outpatient follow-up
Patients undergoing bariatric surgery are at an increased risk for venous thromboembolism (VTE) because of severe obesity and perioperative immobility. Optimal VTE prophylaxis is uncertain. These investigators identified 272 adults, 18 years or older, undergoing bariatric surgery with a body mass index greater than 35 who were not at high risk for bleeding nor had a history of previous VTE. Eligible patients randomly received (concealed allocation assignment) rivaroxaban 10 mg orally once daily on postoperative day 1 for either 7 days (short group) or 28 days (long group) of thromboembolic prophylaxis. All patients underwent bilateral ultrasonography of both legs after 28 days by individuals masked to treatment group assignment. Spiral computed tomography was used to confirm pulmonary embolism when clinically suspected. Complete follow-up occurred for 98.9% of patients at 28 days.
Using intention-to-treat analysis, only one primary efficacy VTE end point (an asymptomatic DVT) occurred — in a patient in the long group (0.4%; 95% CI 0.02% - 2.2%). Major or clinically relevant nonmajor bleeding events occurred in 5 patients (1.9%), including 2 in the short group and 3 in the long group (difference not significant).
David C. Slawson, MD
Professor and Vice Chair of Family Medicine for Education and Scholarship
Professor of Family Medicine, UNC Chapel Hill