Long-term risk of recurrence in patients with a first unprovoked venous thromboembolism managed according to D-dimer results; a cohort study
Kearon C, Parpia S, Spencer FA, Schulman S, Stevens SM, Shah V, Bauer KA, Douketis JD, Lentz SR, Kessler CM, Connors JM, Ginsberg JS, Spadafora L, and Julian JA. Long-term risk of recurrence in patients with a first unprovoked venous thromboembolism managed according to D-dimer results; a cohort study. J Thromb Haemost 2019; Epub ahead of print.
Journal of thrombosis and haemostasis : JTH
BACKGROUND: The long-tem risk of recurrence in patients with a first unprovoked venous thromboembolism (VTE) who have negative D-dimer results is uncertain. OBJECTIVES: To determine this risk, including in subgroups based on sex. PATIENTS AND METHODS: ln a prospective interventional cohort study of 410 patients with a first unprovoked VTE, anticoagulants were stopped if D-dimer was negative on therapy and 1 month after stopping therapy. Other patients remained on anticoagulant therapy. We previously reported findings after a mean of 2.2 years. The current report includes 3 years of additional follow-up in 293 of these patients. RESULTS: During a median follow-up of 5.0 years, recurrent VTE after stopping therapy in response to negative D-dimer testing was 5.1% (95% CI 3.6% to 6.5%) per patient-year overall, 7.5% (95% CI 5.5% to 10.0%) in men, 3.8% (95% CI 2.0% to 6.6%) in women with VTE not associated with estrogens, and 0.4% (95% CI 0.0% to 2.3%) in women with VTE associated with estrogens (p<0.001 for 3-group comparison). Risk of recurrence at 5 years was 21.5% (95% CI 16.4% to 26.5%) overall, 29.7% (95% CI 22.1% to 37.3%) in men, 17.0% (95% CI 8.1% to 25.9%) in non-estrogen women, and 2.3% (95% CI 0.0% to 6.8%) in estrogen-women. CONCLUSION: The long-term risk of recurrence in patients with a first unprovoked VTE who have negative D-dimer results is not low enough to justify stopping anticoagulant therapy in men, but appears to be low enough in women for many to choose stopping therapy (ClinicalTrials.gov; NCT00720915). This article is protected by copyright. All rights reserved.
ePub ahead of print