Self-Managed Long-Term Low-Molecular-Weight Heparin Therapy: The Balance of Benefits and Harms

Participant flow chart.

Time to event analysis for patients who had recurrent venous thromboembolism At 3 months, of 737 patients, 18 of 369 patients receiving tinzaparin (4.9%) had recurrent venous thromboembolism compared with 21 of 368 (5.7%) receiving usual care (absolute difference, −0.8%, 95% CI, −4.1-2.4). IV = intravenous; LMWH = low-molecular-weight heparin.

Time to event analysis for patients who had hemorrhagic complications. A: All bleeding. Bleeding occurred in 48 of 369 patients (13.0%) receiving LMWH and 73 of 368 patients (19.8%) receiving heparin and warfarin (P = .011; risk ratio = 0.66). B: Major bleeding. Major bleeding occurred in 12 of 369 patients (3.3%) in the LMWH group and in 17 of 368 patients (4.6%) receiving heparin and warfarin (risk ratio = 0.70; absolute difference −1.4, 95% CI, −4.3-1.4). C: Minor bleeding. Minor bleeding occurred in 36 of 369 patients (9.8%) receiving LMWH and in 56 of 368 patients (15.2%) receiving heparin and warfarin (P = .022; risk ratio = 0.64). IV = intravenous; LMWH = low-molecular-weight heparin.

Prevalence of bleeding over time. The occurrence of bleeding according to time course of study therapy for each group is shown for major and minor bleeding complications. The pattern of the time of presentation of major bleeding differed significantly between groups (P = .034). New major bleeding events occurred throughout study treatment for patients in the usual-care group receiving warfarin but did not present after day 23 in the LMWH group (P = .034). New minor bleeding episodes occurred throughout the study treatment interval for both treatment groups. LMWH = low-molecular-weight heparin.

*Treatment duration 3 months. †Treatment duration 3 to 6 months. ‡Treatment duration 6 months. LMWH = low-molecular-weight heparin; CI = confidence interval; LMWH regimen: T = treatment dose; P = prophylactic dose; M = reduced maintenance dose.