Analysis of safety
Bleeding, bleeding, venous thrombosis
PULMONARY EMBOLISM, BLEEDING, THROMBOEMBOLIC EVENT, BLEEDING, EVENTS, VENOUS THROMBOSIS
The bleeding events within 30 days were 5.4% and 0.5% in the interventional and in the observational arms (Bleeding and thromboembolic events in the interventional and observational cohortsAt 30 days, four patients in the observational cohort had a thromboembolic event; of these two were venous thrombosis and two were pulmonary embolism. At 90 days, there were 3 thromboembolic events among patients in the interventional cohort; one patient had both venous thrombosis and pulmonary embolism, two patients had venous thrombosis only. Patients were not routinely evaluated for thromboembolic events in the observational cohort at 90 days.