November 10, 1997

The Importance of Initial Heparin Treatment on Long-term Clinical Outcomes of Antithrombotic Therapy

Structured PICO

Does the type and duration of initial heparin treatment affect the long-term rate of recurrent venous thromboembolism in patients with venous thromboembolism?

Population

746 patients with venous thromboembolism pooled from 3 consecutive, randomized, double-blind trials

Intervention

Various initial heparin regimens (continuous intravenous heparin, continuous intravenous heparin for 10 or 5 days, or once-daily subcutaneous low-molecular-weight heparin)

Comparator

Alternative initial heparin regimens (subcutaneous heparin, continuous intravenous heparin for different durations, or continuous intravenous heparin)

Outcome

Recurrent venous thromboembolism during long-term therapy with warfarin sodium at 3 months follow-uphard clinical

The specific strategy of initial heparin treatment significantly affects the long-term risk of recurrent venous thromboembolism.

Abstract

Background: Recent clinical trials of venous thromboembolism treatment suggest inadequate initial heparin therapy predisposes patients to late recurrence of thromboembolism. However, a recent review article was unable to demonstrate a relationship between initial heparin therapy and late recurrence. Objective: To evaluate the relationship between initial heparin treatment and long-term clinical outcome in 3 consecutive, randomized, double-blind trials that used similar study designs and patient populations and objective documentation of recurrent venous thromboembolism. Methods: The trials were performed sequentially and compared the use of continuous intravenous with subcutaneous heparin, continuous intravenous heparin for 10 or 5 days, and continuous intravenous heparin with once-daily subcutaneous low-molecular-weight heparin. All patients were followed up for 3 months to assess the a priori hypothesis that inadequate initial heparin therapy could lead to recurrent venous thromboembolism during long-term therapy with warfarin sodium. Results: The following were the observed rates of recurrent venous thromboembolism: continuous intravenous heparin, 3 (5.2%) of 58 patients vs subcutaneous heparin, 11 (19.3%) of 57 patients; continuous intravenous heparin for 10 days, 7 (7.0%) of 100 patients or for 5 days, 7 (7.1%) of 99 patients; and continuous intravenous heparin, 15 (6.9%) of 219 patients vs low-molecular-weight heparin, 6 (2.8%) of 213 patients. Pooled analysis of the patients treated with continuous intravenous heparin showed that of the total 32 patients with recurrent venous thromboembolism, in 6 patients thromboembolism occurred early (Conclusion: Our findings demonstrate that the initial heparin treatment affects the long-term outcome. This conclusion applies when these data are analyzed for each individual study by treatment group, observed difference in outcome, and pooled analysis. Arch Intern Med. 1997;157:2317-2321

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