Low-Molecular-Weight Heparin in Arterial Reconstructive Surgery: A Double-Blind, Randomized Dose-Finding Trial

Open Access
Publisher Website
Google Scholar
Abstract
Periprocedural and postprocedural anticoagulation during arterial reconstructive surgery (ARS) with intravenous heparin is standard of care. The general use and correct dosage of low-molecular-weight heparin, however, are still under debate. A prospective, randomized, double-blind trial was performed with a parallel group comparison of four dose regimen of a low-molecular-weight heparin, reviparin sodium, in patients undergoing major ARS. Sixty-five patients were randomly allocated to receive twice-daily subcutaneous injections of reviparin, 3500 (group A, n=17), 4200 (group B, n= 16), 5950 (group C, n= 16), and 7000 (group D, n= 16) anti-Xa IU per day. Patients were eligible for the trial if they had angiographically proven peripheral arterial obstructive disease with a planned arterial reconstruction of the infrarenal aorta, iliaca artery, or femoralis artery. Fifty-nine patients completed the trial. The goal was to determine the optimal dose of the low-molecular-weight heparin to achieve a minimum of early vascular events (less than 12%) with a minimum of major bleeding events (less than 10%) during a shortterm follow-up of up to 8 postoperative days. There was no reocclusion in the entire population. Patients randomized into the two lower dose groups (A and B), however, experienced a relatively high incidence of restenosis, whereas patients enrolled in group D, receiving the highest dose of reviparin, experienced an unacceptably high rate of bleeding events (all bleeds, 43%; major bleeding, 14.3%). Thus, the optimal dose of reviparin sodium to be administered in patients undergoing major ARS is half the therapeutic dose:5950 to 6300 anti Xa IU (75-85 anti Xa IU/kg body weight per day). Patients included in group C had no major bleeding event (95% confidence interval, 0% to 6.6%), a significant improvement of the doppler anklebrachial systolic pressure index (difference of 0.46 ± 0.29, P=.017), and a higher rate of responders with regard to the puls status measured at the tibialis posterior arteries (66.7%) compared to groups A and B (46.7% and 54.5%, respectively, P=.086). The efficacy and safety of this dosage regimen in comparison to standard of care should be further substantiated in larger trials.

This publication has 19 references indexed in Scilit: