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F. Couturaud et al.
treated patients, respectively. In the warfarin group, INR was within the therapeutic range (2.0-3.0] for 70.3% of the time, being below and above this range for 19.1% and 10.6% of the time, respectively; corresponding figures for the sham INR in the placebo group were 75.9%, 14.6% and 9.6%, respectively (Online Supplementary Table S2).
Clinical outcomes during the study treatment period
During the 18-month study treatment period, the pri- mary outcome occurred in none of the 50 patients in the warfarin group and in 16 of 54 patients in the placebo
group (cumulative risk, 29.6%; 28.3 events per 100 per- son-years), resulting in a relative risk reduction of 97% in favor of warfarin (HR, 0.03; 95% CI: 0.01-0.51; P<0.001) (Table 2). As no major bleeding occurred in either group, the primary outcome was driven solely by the occurrence of symptomatic recurrent venous thromboembolism. All 16 episodes of symptomatic recurrent venous throm- boembolism reported in the placebo group were unpro- voked: one was fatal pulmonary embolism, 13 were iso- lated deep-vein thrombosis (2 contralateral and 11 ipsilat- eral) and two were non-fatal pulmonary embolism (1 was
Figure 1. Patients’ flow through the study.
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haematologica | 2019; 104(7)