Clinical outcomes after discontinuing anticoagulant therapy in patients with first unprovoked venous thromboembolism.

Background The duration of anticoagulation for a first episode of unprovoked venous thromboembolism (VTE) should balance the likelihood of VTE recurrence against the risk of major bleeding. Objectives Analyze rates and case-fatality rates (CFRs) of recurrent VTE and major bleeding after discontinuing anticoagulation in patients with a first unprovoked VTE after at least 3 months of anticoagulation. Patients/Methods We compared the rates and CFRs in patients of the RIETE and COMMAND-VTE registries. We used logistic regression models to identify predictors for recurrent pulmonary embolism (PE) and major bleeding. Results Of 8,261 patients with unprovoked VTE in RIETE, 4,012 (48.6%) had isolated deep vein thrombosis (DVT) and 4,250 had PE. Follow-up (median, 318 days) showed 543 recurrent DVTs, 540 recurrent PEs, 71 major bleeding episodes, and 447 deaths. The COMMAND VTE registry yielded similar results. Corresponding CFRs of recurrent DVT, PE, and major bleeding, were 0.4%, 4.6%, and 24%, respectively. On multivariable analyses, initial PE presentation (hazard ratio (HR): 3.03; 95%CI: 2.49-3.69), dementia (HR: 1.47; 95%CI: 1.01-2.13), and anemia (HR: 0.72; 95%CI: 0.57-0.91) predicted recurrent PE, whereas older age (HR: 2.11; 95%CI: 1.15-3.87), inflammatory bowel disease (HR: 4.39; 95%CI: 1.00-19.3) and anemia (HR: 2.24; 95%CI: 1.35-3.73) predicted major bleeding. Prognostic scores were formulated, with c-statistics of 0.63 for recurrent PE and 0.69 for major bleeding. Conclusions Recurrent DVT and PE were frequent but had low CFRs (0.4% and 4.6%, respectively) after discontinuing anticoagulation. Contrary, major bleeding was rare, but had high CFR (24%). A few clinical factors may predict these outcomes.