DURAC II

DURation of AntiCoagulation II (1997)

Condition

Long-term prophylaxis after a second episode of VTE

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Objective

To compare 6 months of oral anticoagulant therapy after a second occurrence of DVT or PE to the same therapy continued indefinitely

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Trial design

Randomized, open study with parallel groups
Active treatment: warfarin or dicumarol, to target INR 2.0–2.85, continued indefinitely (follow-up period 4 years) (n=116)
Control treatment: warfarin or dicumarol, to target INR 2.0–2.85, for 6 months (n=111)

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Endpoints

Primary efficacy endpoint: recurrent thromboembolism during 4 years of follow-up
Primary safety endpoints: major hemorrhagic complications and death during the 4-year period 

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Trial participants

227 consecutive patients at least 15 years of age who had a second episode of VTE (acute PE or DVT in the leg, the iliac veins, or both)

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Results

Efficacy outcome: The primary endpoint of recurrent thromboembolic events during 4 years occurred in 23 of 116 patients (20.7%) who received 6-month oral anticoagulant therapy and in 3 of 111 patients (2.6%) who received indefinite anticoagulant therapy; the difference was statistically significant (p<0.001)
Safety outcome: The incidence of major bleeding was 2.7% (3/116) in the 6-month group and 8.6% (10/111) in the group assigned to indefinite anticoagulation. 16 patients (14.4%) with 6-months treatment and 10 patients (8.6%) receiving therapy indefinitely died. No cases of fatal pulmonary embolism could be confirmed

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Summary

Efficacy: Prophylactic oral anticoagulation that was continued for an indefinite period after a second episode of VTE was associated with a significantly lower rate of recurrence during 4 years of follow-up than oral anticoagulant treatment for 6 months
Safety: There was a trend toward more major hemorrhages in the group assigned to indefinite anticoagulation

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Reference

Schulman S, Granqvist S, Holmström M, Carlsson A, Lindmarker P, Nicol P, Eklund SG, Nordlander S, Lärfars G, Leijd B, Linder O, Loogna E, and the Duration of Anticoagulation Trial Study Group. The duration of oral anticoagulant therapy after a second episode of venous thromboembolism. N Engl J Med 1997;336:393-398

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Corresponding author

Sam Schulman, MD, Department of Internal Medicine, Karolinska Hospital, S-171 76 Stockholm, Sweden

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