The risk of recurrent venous thromboembolism after discontinuing anticoagulation in patients with acute proximal deep vein thrombosis or pulmonary embolism. A prospective cohort study in 1,626 patients
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BACKGROUND AND OBJECTIVES: While it has long been recognized that patients with acute unprovoked deep vein thrombosis (DVT) or pulmonary embolism (PE) have a higher risk of recurrent venous thromboembolism (VTE) than that of patients with secondary thrombosis, whether other clinical parameters can help predict the development of recurrent events is controversial. The aim of this investigation was to assess the rate of recurrent VTE after withdrawal of vitamin K antagonists, and to identify clinical parameters associated with a higher likelihood of recurrence. DESIGN AND METHODS: We followed, up to a maximum of 10 years, 1626 consecutive patients who had discontinued anticoagulation after a first episode of clinically symptomatic proximal DVT and/or PE. All patients with clinically suspected recurrent VTE underwent objective tests to confirm or rule out the clinical suspicion. RESULTS: After a median follow-up of 50 months, 373 patients (22.9%) had had recurrent episodes of VTE. The cumulative incidence of recurrent VTE was 11.0% (95% CI, 9.5-12.5) after 1 year, 19.6% (17.5-21.7) after 3 years, 29.1% (26.3-31.9) after 5 years, and 39.9% (35.4-44.4) after 10 years. The adjusted hazard ratio for recurrent VTE was 2.30 (95% CI, 1.82-2.90) in patients whose first VTE was unprovoked, 2.02 (1.52-2.69) in those with thrombophilia, 1.44 (1.03-2.03) in those presenting with primary DVT, 1.39 (1.08-1.80) for patients who received a shorter (up to 6 months) duration of anticoagulation, and 1.14 (1.06-1.12) for every 10-year increase of age. When the analysis was confined to patients with unprovoked VTE the results did not change. INTERPRETATION AND CONCLUSIONS: Besides unprovoked presentation, other factors independently associated with a statistically significant increased risk of recurrent VTE are thrombophilia, clinical presentation with primary DVT, shorter duration of anticoagulation, and increasing age.
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For patients with unprovoked VTE, the risk of recurrent VTE after completing anticoagulant therapy is estimated to be 10% by 2 years and >30% by 10 years.
“For patients with unprovoked VTE, the risks of recurrent VTE after completing a course of anticoagulant therapy have been estimated to be 10% by 2 years and . 30% by 10 years. 11,12”
From American Society of Hematology 2020 guidelines for management of venous thromboembolism: treatment of deep vein thrombosis and pulmonary embolism (2020) · cites this paper as [12]
The Discussion’s unprovoked (idiopathic) VTE figure reports 52.6% cumulative recurrence at 10 years, supporting the >30% estimate. It reports 15.0% at one year, however, so an estimate of 10% by two years is too low; the figure does not give a two-year estimate. Page numbers are unavailable in our copy. (LLM, conf=0.90)
Experimental — accuracy not yet measuredTrials in the previous analysis were published before 2004, whereas since then additional prospective studies have reported on the risk for recurrent VTE after discontinuation of anticoagulant treatment in patients with a first episode of unprovoked VTE, with several of these studies having followed patients beyond 24 months and some up to 10 years.
“Furthermore, trials in that analysis were published before 2004, whereas since then additional prospective studies have reported on the risk for recurrent VTE after discontinuation of anticoagulant treatment in patients with a first episode of unprovoked VTE, with several of these studies having followed patients beyond 24 months and some up to 10 years.9 10 11 12 13”
From Long term risk of symptomatic recurrent venous thromboembolism after discontinuation of anticoagulant treatment for first unprovoked venous thromboembolism event: systematic review and meta-analysis (2019) · cites this paper as [11]
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- Authors
- Prandoni, P., Noventa, F., Ghirarduzzi, A., Pengo, V., Bernardi, E., Pesavento, R., Iotti, M., Tormene, D., Simioni, P., & Pagnan, A.
- Affiliations
- University of Padua (IT)
- Venue
- Haematologica
- Published
- 2007-02-01
- Volume
- 92
- Issue
- 2
- Pages
- 199-205
- ISSN
- 0390-6078 (ISSN-L)
- 1592-8721
- OpenAlex
- W2102778065
- Cited by
- 776
- References
- 37
- Citations by year
- 2026: 17 · 2025: 20 · 2024: 21 · 2023: 21 · 2022: 30 · 2021: 45 · 2020: 45 · 2019: 40 · 2018: 54 · 2017: 69 · 2016: 77 · 2015: 59 · 2014: 61 · 2013: 46 · 2012: 45
- FWCI
- 21.90
- Type
- journal article
- Language
- en
- Open access
- gold
- doi.org
- Locations
- Haematologica (publishedVersion)
- PubMed (publishedVersion)
- DOAJ (DOAJ: Directory of Open Access Journals) (submittedVersion)
- Padua Research Archive (University of Padova) (submittedVersion, other-oa)
- INFM-OAR (INFN Catania) (submittedVersion, other-oa)
- Topics
- Health Sciences › Medicine › Internal Medicine › Venous Thromboembolism Diagnosis and Management
- Health Sciences › Medicine › Hematology › Blood Coagulation and Thrombosis Mechanisms
- Health Sciences › Medicine › Neurology › Cerebral Venous Sinus Thrombosis
- Keywords
- recurrent venous thromboembolism, deep vein thrombosis, pulmonary embolism, anticoagulation discontinuation, vitamin K antagonists, unprovoked venous thromboembolism, thrombophilia, anticoagulation duration, recurrence risk factors, proximal deep vein thrombosis, long-term follow-up, cumulative incidence, age as risk factor
- MeSH terms
- Adolescent, Adult, Aged, Aged, 80 and over, Anticoagulants, Female, Heparin, Humans, Male, Middle Aged, Prospective Studies, Pulmonary Embolism, Thromboembolism, Warfarin, Cohort Studies, Thrombophilia, Venous Thrombosis, Secondary Prevention
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