Abstract
To analyze the necessity of venous thromboembolism (VTE) prophylaxis for patients undergoing high ligation and stripping of the great saphenous vein (GSV) and to estimate the efficacy and safety of different anticoagulant protocols in a single-center randomized controlled trial with large sample size. A total of 2196 patients undergoing high ligation and stripping of the GSV were randomized to one of the following postoperative VTE prophylaxis protocols: group A, no VTE prophylaxis (n=542); group B, subcutaneous low-dose unfractionated heparin (LDUH) hypodermic injection, 125 U/kg per day in three divided doses (n=531); group C, low-molecular-weight heparin (LMWH) 6000 IU once a day (n=573); and group D, LMWH 4000 IU twice daily (n=550). Groups were compared for the incidence of VTE and major hemorrhage within 1 month following surgery. Varicose vein severity was classified by CEAP (Clinical, Etiologic, Anatomic, Pathophysiologic elements) score. The clinical characteristics of the patients were equally matched between groups. Postoperative deep vein thrombosis (DVT) and pulmonary embolism (PE) were significantly higher in group A (DVT 5.17%, PE 1.48%) compared to groups B (0.56%, 0%), C (0.35%, 0%) and D (0.36%, 0%) (p<0.01). The incidence of VTE did not differ between the three active chemoprophylaxis arms. Hemorrhagic complications were low for each group but higher in group B (0.75%) compared to the other groups (group A 0.18%; group C 0.17%; group D 0.18%, p<0.01). Hemorrhagic complications did not differ amongst groups A, C and D. In conclusion, postoperative VTE chemoprophylaxis following high ligation and GSV stripping effectively reduces the venous thrombosis complications of this procedure. Of the three active strategies tested, no difference in efficacy was noted; however, thrice daily LDUH did increase bleeding complications.
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