Rivaroxaban Versus Enoxaparin for Prophylaxis of Venous Thromboembolism in Morbidly Obese Patients Undergoing Bariatric Surgery: An open_label Randomized Controlled Trial

Obesity is a public health issue that raises the risk of various diseases, including diabetes, cancer, gastrointestinal disorders, depression, atherosclerotic cardiovascular disease, hypertension, and venous thromboembolism (VTE).(1) Obesity increases the risk of pulmonary embolism, a major public health concern that has been investigated since 1927.(2) Within the previous three decades, the prevalence of obesity has tripled, and surgical approaches to reduce the incidence of obesity have been studied.(3) The World Obesity Atlas 2022 predicts that by 2030, one billion people would be obese, with one in every five women and one in every seven males.(4) Over the last two decades, bariatric surgery has reduced the risk of life-threatening weight-related health issues in the United States and elsewhere.(5) Nevertheless, bariatric surgery is not without problems and is associated with a mortality rate ranging from 0.1% to 1.1.(6) Although bariatric surgery is minimally invasive, it can cause post-operative problems like dumping syndrome, anastomic leakages, malnutrition, VTE, and sepsis.(7) VTE is a leading cause of post-discharge mortality following bariatric surgery.(8) Following bariatric surgery, the incidence of postdischarge VTE was 0.29% over the course of 30 days. Despite the fact that the incidence of VTE following bariatric surgery is not particularly high, it remains the most significant cause of postdischarge mortality, in addition to the increasing incidence of obesity.(9)

Thromboprophylaxis is the primary approach to reducing VTE-induced mortality following bariatric surgery.(10) The recommended duration of VTE prevention following BS is between 7 days and 4 weeks.(11) Low-molecular-weight heparin (Enoxaparin) is used to treat and prevent deep vein thrombosis and embolism during pregnancy and after certain surgeries such as SG and RYGB. Rivaroxaban is an oral drug that directly inhibits Factor Xa, providing an alternate treatment option. Rivaroxaban is quickly absorbed and reaches peak plasma concentrations within two to four hours after intake. Rivaroxaban exhibits exceptional oral bioavailability, with absorption rates ranging from 80% to 100% for a 10 mg dose, and is not influenced by food consumption.(12)

There is paucity in the studies that evaluate the outcome of use of different thromboprophylaxis medications among patients undergoing laparoscopic sleeve gastrectomy. So this study aims to compare the effect of use of prophylactic dose of rivaroxaban 10 mg once daily and enoxaparin 40 mg every 24 hours for 14 days against the development of VTE after bariatric surgery.

Aim of the work:

The present study aims to compare the effect of use of prophylactic dose of rivaroxaban 10 mg once daily and enoxaparin 40 mg every 24 hours for 14 days against the development of VTE after bariatric surgery.