News Finding: 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 Finding: The first three patients were actively receiving warfarin therapy when major bleeding occurred, whereas in the fourth patient, the bleeding episode occurred 1 month after the patient decided to stop warfarin (without any medical rationale).
News Context: 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. This result was driven by a reduction in the risk of recurrent venous thromboembolism, with the risk of bleeding increasing to a minimal extent.
Paper Context: d Of these 4 patients, the first experienced serious epistaxis at 2 months, associated with a decrease in hemoglobin level of at least 2 g/dL and required embolization; the second had retroperitoneal bleeding at 4 months, associated with a decrease in hemoglobin level of at least 2 g/dL, resolving spontaneously after anticoagulation was stopped; the third presented with upper gastrointestinal tract bleeding at 13 months, associated with a decrease in hemoglobin level of at least 2 g/dL and required transfusion of 2 units of packed red cells; the fourth experienced intraocular bleeding at 18 months. The first three patients were actively receiving warfarin therapy when major bleeding occurred, whereas in the fourth patient, the bleeding episode occurred 1 month after the patient decided to stop warfarin (without any medical rationale). e One patient presented major bleeding 314 days after warfarin was initiated for recurrent venous thromboembolism.