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. 2023 Nov 26;8(1):102274.
doi: 10.1016/j.rpth.2023.102274. eCollection 2024 Jan.

Balancing risks of recurrent venous thromboembolism and bleeding with extended anticoagulation: a decision analysis

Maria A de Winter  1   2 , Kednapa Thavorn  3 , Steven H J Hageman  4 , Mathilde Nijkeuter  1 , Philip S Wells  3
Affiliations

Balancing risks of recurrent venous thromboembolism and bleeding with extended anticoagulation: a decision analysis

Maria A de Winter et al. Res Pract Thromb Haemost. .

Abstract

Background: A decision to stop or continue anticoagulation after 3 months of anticoagulation for venous thromboembolism (VTE) should be made by weighing individual risks of recurrence and bleeding.

Objectives: To determine the optimal ratio of recurrence risk reduction to increase the risk of bleeding in terms of maximizing quality-adjusted life years (QALYs) gained.

Methods: Using a microsimulation model, outcomes within 5 years were simulated after assigning extended treatment if absolute recurrence risk reduction outweighed absolute increase in clinically relevant bleeding risk (International Society on Thrombosis and Haemostasis definition), weighted by a certain ratio. Data were simulated based on the Bleeding Risk Study, a prospective cohort including patients after ≥3 months of anticoagulation for unprovoked VTE or provoked VTE with history of VTE. The VTE-PREDICT risk score was used to estimate 5-year risks of recurrent VTE and clinically relevant bleeding.

Results: Among 10,000 individuals (mean age, 60.2 years, 36% female), the ratio of 0.90 (95% CI, 0.51-3.40; ie, bleeding is considered 0.90 the severity of recurrent VTE), with 99% of patients assigned extended anticoagulation, was considered optimal and resulted in 93 (95% CI, -23 to 203) additional QALYs compared with the least favorable ratio (5.10, 0% extended anticoagulation). At the optimal ratio, treatment based on VTE-PREDICT yielded 44 (95% CI, -69 to 157) additional QALYs versus standard of care.

Conclusion: With the current evidence, the optimal ratio between relevant bleeding risk and absolute recurrence risk reduction remains uncertain. Our results confirm that clinical equipoise exists regarding the decision to stop or continue anticoagulation after initial VTE treatment, emphasizing the importance of shared decision-making.

Keywords: anticoagulation; bleeding; quality-adjusted life years; risk; venous thromboembolism.

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Figures

Figure 1
Figure 1
Simplified model schematic illustrating states and probabilities. CRNMB, clinically relevant, nonmajor bleeding; CTEPH, chronic thromboembolic pulmonary hypertension; DVT, deep venous thrombosis; ICH, intracranial hemorrhage; PE, pulmonary embolism; PTS, postthrombotic syndrome; VTE, venous thromboembolism.
Figure 2
Figure 2
Treatment assignment (A), number of events (B), and number of quality-adjusted life years (C) per 10,000 cases within 5 years for each of the assessed ratios between recurrence risk reduction and increase in risk of bleeding with VTE-PREDICT and usual care. Figures are based on probabilistic analysis using 1000 Monte Carlo simulations. ARI, absolute risk increase; ARR, absolute risk reduction; QALY, quality-adjusted life year.
Figure 3
Figure 3
Probabilistic analyses. Optimal ratio and number of quality-adjusted life years (QALYs) associated with the optimal ratio in each of the Monte Carlo simulations (n = 1000). ARI, absolute risk increase; ARR, absolute risk reduction.
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