Strengths and Limitations
thromboembolic, thrombotic, DVT
EVENTS, ASYMPTOMATIC PULMONARY EMBOLISM, EVENT, DVT
A strength of this trial was detecting asymptomatic thrombotic events by CUS. This is important because 10% of untreated thrombotic events can result in symptomatic pulmonary embolism.This study has some limitations. The main limitation is the lack of an LMWH treatment arm. Therefore, a direct comparison of thromboembolic prophylaxis between rivaroxaban and LMWH is not possible. However, the results of this trial are comparable to those of trials investigating LMWH as thromboembolic prophylaxis regarding efficacy and safety. The very low number of primary outcome events was unexpected, especially because asymptomatic DVT was part of the composite end point. Because of the single primary composite outcome event, a direct comparison of the 2 treatment groups regarding efficacy is difficult. In addition, the number of patients investigated in this trial was relatively small, compared with a larger phase 3 trial. However, this is the first randomized clinical trial investigating thromboembolic prophylaxis with a DOAC in the context of bariatric surgery, and the inclusion of CUS to detect asymptomatic DVT increases the validity of the efficacy results.