Initial treatment with continuous intravenous heparin plus acenocoumarol reduced symptomatic extension or recurrence of venous thromboembolism compared to acenocoumarol alone (6.7% vs 20%; P=0.058).
RCT (n=120)
Double-blind
Randomized
Does continuous intravenous heparin plus acenocoumarol reduce confirmed symptomatic extension or recurrence of venous thromboembolism in outpatients with proximal-vein thrombosis compared to acenocoumarol alone?
Initial treatment of proximal-vein thrombosis requires full-dose heparin combined with oral anticoagulants, as oral anticoagulants alone result in an excess of symptomatic thromboembolic events.
Absolute Event Rate: 6.7% vs 20%
p-value: p=0.058
BACKGROUND: In most countries, heparin is used in the initial treatment of patients with deep-vein thrombosis. Well-designed studies establishing the efficacy of heparin therapy are lacking, however. Treatment with acenocoumarol alone, according to the hypothesis that high dosages of oral anticoagulants obviate the need for heparin, is considered an effective alternative in some countries. METHODS: In a randomized, double-blind study we compared the efficacy and safety of continuous intravenous heparin plus acenocoumarol with the efficacy and safety of acenocoumarol alone in the initial treatment of outpatients with proximal-vein thrombosis. The principal study end point was a confirmed symptomatic extension or recurrence of venous thromboembolism during six months of follow-up. In addition, we assessed asymptomatic extension or pulmonary embolism by repeating venography and lung scanning after the first week of treatment. The incidence of major bleeding was determined during three months of follow-up. RESULTS: The study was terminated early by the Data Safety and Monitoring Committee because of an excess of symptomatic events in the group that received acenocoumarol alone (in 12 of 60 patients 20 percent, as compared with 4 of 60 patients 6.7 percent in the combined-therapy group by intention-to-treat analysis; P = 0.058). Asymptomatic extension of venous thrombosis was observed in 39.6 percent of the patients in the acenocoumarol group and in 8.2 percent of patients treated with heparin plus acenocoumarol (P < 0.001). Major bleeding complications were infrequent and comparable in the two groups. CONCLUSIONS: Patients with proximal-vein thrombosis require initial treatment with full-dose heparin, which can safely be combined with acenocoumarol therapy.
Brandjes et al. (Thu,) conducted a rct in Proximal-vein thrombosis (n=120). Continuous intravenous heparin plus acenocoumarol vs. Acenocoumarol alone was evaluated on Confirmed symptomatic extension or recurrence of venous thromboembolism (p=0.058). Initial treatment with continuous intravenous heparin plus acenocoumarol reduced symptomatic extension or recurrence of venous thromboembolism compared to acenocoumarol alone (6.7% vs 20%; P=0.058).
Synapse has enriched 5 closely related papers on similar clinical questions. Consider them for comparative context: