An open-label randomized controlled trial of low molecular weight heparin compared to heparin and coumadin for the treatment of venous thromboembolic events in XXXX : the REVIVE trial.

@entity1 @entity932 @entity571 @entity548 @entity1372 @entity1211 @entity204
OBJECTIVE(S): @entity1211 ( @entity1211 ) are serious complications in @entity1 and for which the standard of care, unfractionated heparin followed by oral anticoagulation (UFH/ @entity571 ), is problematic. The objective of REVIVE was to compare the efficacy and safety of a low molecular weight heparin (reviparin- @entity1372 ) to UFH/ @entity571 for the treatment of @entity1211 in @entity1 . STUDY DESIGN: This multicenter, open-label study, with blinded central outcome adjudication, randomized @entity1 with objectively confirmed @entity1211 to receive either reviparin- @entity1372 or UFH/ @entity571 . Dose adjustments were made using nomograms. The efficacy outcome was based on recurrent @entity1211 and @entity204 due to @entity1211 during the 3-month treatment period. The safety outcomes were @entity548 , minor @entity548 and @entity204 . Due to slow @entity1 accrual, REVIVE was closed prematurely. RESULTS: At 3 months, with reviparin- @entity1372 , 2/36 @entity1 (5.6%) had recurrent @entity1211 or @entity204 compared to 4/40 @entity1 (10.0%) receiving UFH/ @entity571 (odds ratio=0.53; 95% CI=(0.05, 4.00); Fisher's exact test: 2P=0.677). There were 7 major @entity548 , 2/36 (5.6%) in the reviparin- @entity1372 group and 5/40 (12.5%) in UFH/ @entity571 group (odds ratio=0.41; 95% confidence interval 0.04, 2.76); Fisher's exact test: P=0.435). There were 5 deaths during the study period, 1 (2.8%) in the reviparin- @entity1372 group and 4 (10.0%) in the UFH/ @entity571 group. All five deaths were unrelated to @entity1211 but one was due to an @entity932 in the UFH/ @entity571 group. CONCLUSIONS: Although limited by small sample size, REVIVE provides valuable information on the incidence of recurrent @entity1211 , @entity548 and problematic issues associated with therapy of @entity1211 in @entity1 .
