News Finding: After randomization, 4 patients were lost to follow-up, all after month 18, and 1 withdrew due to an adverse event.
Paper Finding: Effective and relatively safe alternative options to vitamin K antagonist or no treatment were developing.
News Context: In this high-risk population, extending anticoagulation beyond 3 to 6 months is associated with a reduction in the risk of recurrence as long as treatment is continued. After randomization, 4 patients were lost to follow-up, all after month 18, and 1 withdrew due to an adverse event. During the 18-month treatment period, the primary outcome (the composite of recurrent venous thromboembolism or major bleeding at 18 months after randomization) occurred in 6 of 184 patients (3 percent) in the warfarin group and in 25 of 187 patients (13.5 percent) in the placebo group, resulting in a relative risk reduction of 78 percent in favor of warfarin.
Paper Context: Although we originally intended 42 months of follow-up and although the data and safety monitoring committee had not recommended ending the study early, the steering committee decided that by April 2014 the overall rates of recurrent venous thromboembolism (not segregated by allocation group) during the 18-month treatment period and the 24-month follow-up period provided sufficient data to end the follow-up on October 1, 2014, even though some patients had not completed the full follow-up period. Effective and relatively safe alternative options to vitamin K antagonist or no treatment were developing. 11, [21] [22] [23] Furthermore, because the trial metrics allowed for early termination without compromising study integrity, the steering committee considered that the termination date change would not interfere with the trial's objectives and would expedite sharing information that may alter routine practice (see page 4 in Supplement 3).