GALLUS

Early start of warfarin in VTE treatment (1986)

Condition

Treatment of clinically submassive DVT or PE

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Objective

To define the most appropriate initial treatment schedule with heparin followed by warfarin

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Trial design

Randomized, open study with parallel groups
Active treatment: warfarin 10 mg followed by adjusted dosing (prothrombin time ratio 2.0–3.5), starting not before 7 days of initial i.v. aPTT-adjusted (50–60 s) heparin treatment (n=127)
Control treatment: warfarin 10 mg followed by adjusted dosing (prothrombin time ratio 2.0–3.5), starting within 3 days of initial i.v. aPTT-adjusted (50–60 s) heparin treatment (n=139)

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Endpoints

Primary efficacy endpoint: confirmed, probable, or possible, clinically apparent recurrent VTE during hospital stay
Secondary efficacy endpoints: symptomless I125-fibrinogen uptake proximal to the level of initially documented VT and symptomless new perfusion lung scan defects
Safety endpoints: major and minor bleeding episodes during hospital stay

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Trial participants

318 patients with confirmed VTE entered the study, 266 patients completed the trial

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Results

Efficacy outcome: During the hospital stay, recurrent VTE developed in 6 of 127 patients (4.7%) with late and in 11 of 139 patients (3.6%) with early start of warfarin treatment. On routine I125-fibrinogen leg scanning of patients presenting with distal thrombosis (n=55), symptomless proximal extension was found in 1 of 27 patients (3.6%) of the late start warfarin group compared to none of 28 patients in the early start warfarin group. Symptomless new perfusion defects in repeat lung scans were found in 8.5% of 118 patients in the late start and 3.9% of 128 patients in the early start warfarin group. During the follow-up of 29 months on average, mortality and symptomatic recurrence rates were similar in both groups
Safety outcome: During the hospital stay, major bleeding occurred in 2 patients in the late start warfarin (1.6%) and in 3 patients (3.9%) in the early start warfarin group. Minor bleeding episodes were observed in 31 (24%) vs. 19 (14%) in the late respectively early start warfarin group

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Summary

Efficacy: The frequency of symptomatic VTE recurrence during hospital stay was comparable in both groups
Safety: The incidence of major and minor bleeding was similar in both groups

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Reference

Gallus A, Jackaman J, Tillett J, Mills W, Wycherley A. Safety and efficacy of warfarin started early after submassive venous thrombosis or pulmonary embolism. Lancet 1986;2(8519):1293-1296

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Corresponding author

Alexander Gallus, MD, Department of Hematology, Flinders Medical Centre, Bedford Park, South Australia 5042, Australia

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