Premium
Long‐term risk of recurrence in patients with a first unprovoked venous thromboembolism managed according to d ‐dimer results; A cohort study
Author(s) -
Kearon Clive,
Parpia Sameer,
Spencer Frederick A.,
Schulman Sam,
Stevens Scott M.,
Shah Vinay,
Bauer Kenneth A.,
Douketis James D.,
Lentz Steven R.,
Kessler Craig M.,
Connors Jean M.,
Ginsberg Jeffrey S.,
Spadafora Luciana,
Julian Jim A.
Publication year - 2019
Publication title -
journal of thrombosis and haemostasis
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.947
H-Index - 178
eISSN - 1538-7836
pISSN - 1538-7933
DOI - 10.1111/jth.14458
Subject(s) - medicine , d dimer , venous thromboembolism , anticoagulant therapy , cohort , confidence interval , prospective cohort study , cohort study , lower risk , surgery , pediatrics , thrombosis
Essentials Long‐term recurrence risk after a first unprovoked VTE with negative d ‐dimer levels is uncertain. Anticoagulation was stopped if d ‐dimer was negative, and was continued if d ‐dimer was positive. Five years after stopping anticoagulants, recurrent VTE was 30% in men and 17% in women. Negative d ‐dimers do not justify stopping anticoagulants in most men but appear to in most women.Background The long‐term 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% confidence interval [CI] , 3.6‐6.5) per patient‐year overall, 7.5% (95% CI , 5.5‐10.0) in men, 3.8% (95% CI , 2.0‐6.6) in women with VTE not associated with estrogens, and 0.4% (95% CI, 0.0‐2.3) in women with VTE associated with estrogens ( P < 0.001 for three‐group comparison). Risk of recurrence at 5 years was 21.5% (95% CI , 16.4‐26.5) overall, 29.7% (95% CI, 22.1‐37.3) in men, 17.0% (95% CI, 8.1‐25.9) in non‐estrogen women, and 2.3% (95% CI, 0.0‐6.8) 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; NCT 00720915).