Key result
After discontinuing anticoagulation for a first unprovoked venous thromboembolism, the pooled incidence of major bleeding was 0.35 events per 100 person-years, with a 5-year cumulative incidence of 1.0%.
Why the study?
The long-term risk of major bleeding after discontinuing anticoagulant therapy for a first unprovoked venous thromboembolism is uncertain.
Meta-Analysis (n=8,740)
Effect estimate: 0.35 events per 100 person-years (95% CI 0.20-0.54)
The baseline risk of major bleeding after discontinuing anticoagulation for a first unprovoked VTE is approximately 0.35 per 100 person-years, providing a reference to help clinicians weigh the net clinical benefit of extended anticoagulation.
Supports anticoagulation discontinuation after unprovoked VTE in selected patients; extends meta-analytic evidence on low bleeding risk off therapy.
BACKGROUND: The long-term risk of major bleeding after discontinuing anticoagulant therapy for a first unprovoked venous thromboembolism (VTE) is uncertain. OBJECTIVES: To determine the incidence of major bleeding up to 5 years after discontinuing anticoagulation for a first unprovoked VTE. METHODS: We searched MEDLINE, EMBASE, and Cochrane CENTRAL (from inception to January 2021) to identify relevant randomized controlled trials (RCTs) and prospective cohort studies reporting major bleeding after discontinuing anticoagulation in patients with a first unprovoked or weakly provoked VTE who had completed (IMAGE_)3 months of initial treatment. Unpublished data on major bleeding events and person-years were obtained from authors of included studies to calculate study-level incidence rates. Random-effects meta-analysis was used to pool results across studies. RESULTS: = 7) per 100 person-years was 0.35 (95% confidence interval [CI]: 0.20-0.54) and 0.09 (95% CI: 0.05-0.15). The 5-year cumulative incidence of major bleeding was of 1.0% (95% CI: 0.4-2.4%). The case-fatality rate of major bleeding after discontinuing anticoagulation was 19.9% (95% CI: 10.6-31.1%). CONCLUSION: The risk of major bleeding once anticoagulants are discontinued in patients with a first unprovoked VTE is not zero. Estimates from this study can help clinicians counsel patients about the incremental risk of major bleeding with extended anticoagulation to guide decision making about treatment duration for unprovoked VTE.
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Khan et al. (2021) conducted a meta-analysis in First unprovoked or weakly provoked venous thromboembolism (n=8,740). Discontinuation of anticoagulation was evaluated on Incidence of major bleeding (0.35 events per 100 person-years, 95% CI 0.20-0.54). After discontinuing anticoagulation for a first unprovoked venous thromboembolism, the pooled incidence of major bleeding was 0.35 events per 100 person-years, with a 5-year cumulative incidence of 1.0%.
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