BACKGROUND:Deep vein thrombosis (DVT) after varicose vein surgery (VVS) is not well recognized. Observational studies have yielded variable estimates of the risk, but evidence from randomized trials is lacking. Our aim was to compare the use of thromboprophylaxis with and without low-molecular-weight heparin (LMWH). METHODS: We prospectively randomized moderate-risk patients scheduled for VVS in two arms. The first group of patients received bemiparin for 10 days at a prophylactic dose, early ambulation, and compression therapy for 3 months; the second group received early ambulation and compression therapy alone. The primary efficacy outcome was the composite of DVT (symptomatic or asymptomatic detected by mandatory, bilateral duplex scan). Secondary efficacy and primary safety end points were superficial venous thrombosis, postoperative bleeding, and clinical pulmonary embolism (PE). We assessed transient and permanent risk factors for venous thromboembolism. RESULTS:Two-hundred sixty-two patients were eligible for evaluation. There were no cases of DVT. There were also no cases of clinical PE, death, or major bleeding. No significant differences were seen between groups in the rates of bleeding episodes. CONCLUSION: The data show no superiority of a short-term regimen of LMWH and early ambulation and compression therapy, as compared with early ambulation and compression therapy alone, in patients undergoing VVS in a moderate-risk population.
RCT Entities:
BACKGROUND:Deep vein thrombosis (DVT) after varicose vein surgery (VVS) is not well recognized. Observational studies have yielded variable estimates of the risk, but evidence from randomized trials is lacking. Our aim was to compare the use of thromboprophylaxis with and without low-molecular-weight heparin (LMWH). METHODS: We prospectively randomized moderate-risk patients scheduled for VVS in two arms. The first group of patients received bemiparin for 10 days at a prophylactic dose, early ambulation, and compression therapy for 3 months; the second group received early ambulation and compression therapy alone. The primary efficacy outcome was the composite of DVT (symptomatic or asymptomatic detected by mandatory, bilateral duplex scan). Secondary efficacy and primary safety end points were superficial venous thrombosis, postoperative bleeding, and clinical pulmonary embolism (PE). We assessed transient and permanent risk factors for venous thromboembolism. RESULTS: Two-hundred sixty-two patients were eligible for evaluation. There were no cases of DVT. There were also no cases of clinical PE, death, or major bleeding. No significant differences were seen between groups in the rates of bleeding episodes. CONCLUSION: The data show no superiority of a short-term regimen of LMWH and early ambulation and compression therapy, as compared with early ambulation and compression therapy alone, in patients undergoing VVS in a moderate-risk population.