Discussion
bleedings, bleeding, VTE, DVT
THROMBOEMBOLIC EVENT, BLEEDING, POSTOPERATIVE COMPLICATIONS, EVENTS, DVT
To our knowledge, this is the first trial in which an oral factor Xa inhibitor has been prospectively investigated in patients after gastrointestinal surgery in general and in bariatric surgery in particular. The results of this randomized clinical trial indicate that thromboprophylaxis with 10 mg/d of rivaroxaban is efficacious and safe in the postoperative setting of bariatric surgery. The overall number of primary end point events was very low (1 single asymptomatic DVT in a patient undergoing SG with 28-day prophylactic treatment). Therefore, no significant difference between the 2 treatment groups regarding the primary composite end point (symptomatic or asymptomatic DVT and PE) could be detected. Although the altered anatomy after bariatric surgery is of some theoretical concern, no relevant effect on pharmacokinetic parameters could be observed in previous phase 1 studies.The subgroup analysis did not reveal any VTE difference among patients undergoing SG, Roux-en Y gastric bypass, and revisional surgery or within the same subgroup based on duration of prophylaxis (eTable 2 and eDiscussion 1 in Of note, this study was not designed to prove equivalence between the 2 treatment durations, and no equivalence testing has been planned or performed. Testing for equivalence would have required a larger study population.Given the very low number of thromboembolic events in both treatment groups, assessment of bleeding events was of special interest. The number of major bleeding events and clinically relevant nonmajor bleedings was low in the 7- and 28-day treatment groups (2 and 3 events, respectively), a difference that was not statistically significant. Although postoperative complications (including bleeding events) were more frequent in the long prophylaxis group, this difference was also not statistically significant.Low-molecular-weight heparins (LMWHs) are the most frequently prescribed pharmacologic prophylaxis for VTE in patients undergoing bariatric surgery.Our observations are consistent with those of 3 randomized clinical trialsIn a prospective trial of 308 patients undergoing bariatric surgery, Raftopoulos et alOur clinical trial results did not show a significant difference in thromboembolic events between the 2 treatment groups. Therefore, prophylaxis for 7 days after bariatric surgery might be sufficient to prevent thromboembolic events in most patients with a moderate risk of VTE. According to the recently published American Society for Metabolic and Bariatric Surgery recommendations on perioperative thromboprophylaxis in patients undergoing bariatric surgery, almost all patients are considered to be at least at moderate risk for VTE events.Data regarding prolonged use of prophylactic DOACs after surgical interventions are limited, except for data on major orthopedic surgery.Two previous phase 1 clinical trials