Long-term risk of major bleeding after discontinuing anticoagulation for unprovoked venous thromboembolism: a systematic review and meta-analysis.

Khan, Faizan; Rahman, Alvi; Tritschler, Tobias; Carrier, Marc; Kearon, Clive; Weitz, Jeffrey I; Schulman, Sam; Couturaud, Francis; Becattini, Cecilia; Agnelli, Giancarlo; Brighton, Timothy; Lensing, Anthonie Wa; Pinede, Laurent; Parpia, Sameer; Geersing, G J; Takada, Toshihiko; Bradbury, Charlotte; Andreozzi, Giuseppe Maria; Palareti, Gualtiero; Prandoni, Paolo; ... (2022). Long-term risk of major bleeding after discontinuing anticoagulation for unprovoked venous thromboembolism: a systematic review and meta-analysis. Thrombosis and haemostasis, 122(7), pp. 1186-1197. Thieme 10.1055/a-1690-8728

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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 VTE who had completed ≥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 Unpublished data on major bleeding events and person-years were obtained from authors of included studies to calculate study-level incidence rates.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

Of 1123 records identified by the search, 20 studies (17 RCTs) and 8740 patients were included in the analysis. During 13 011 person-years of follow-up after discontinuing anticoagulation, the pooled incidence of major bleeding (n=41) and fatal bleeding (n=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%).

CONCLUSIONS

Patients with a first unprovoked VTE have a non-trivial risk of major bleeding once anticoagulants are discontinued. 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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