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Dynamics of case-fatalilty rates of recurrent thromboembolism and major bleeding in patients treated for venous thromboembolism
Abstract
In patients with venous thromboembolism (VTE), assessment of the risk of fatal recurrent VTE and fatal bleeding during anticoagulation may help to guide intensity and duration of therapy. We aimed to provide estimates of the case-fatality rate (CFR) of recurrent VTE and major bleeding during anticoagulation in a 'real life' population, and to assess these outcomes according to the initial presentation of VTE and its etiology. The study included 41,826 patients with confirmed VTE from the RIETE registry who received different durations of anticoagulation (mean 7.8 ± 0.6 months). During 27,110 patient-years, the CFR was 12.1% (95% CI, 10.2-14.2) for recurrent VTE, and 19.7% (95% CI, 17.4-22.1) for major bleeding. During the first three months of anticoagulant therapy, the CFR of recurrent VTE was 16.1% (95% CI, 13.6-18.9), compared to 2.0% (95% CI, 0-4.2) beyond this period. The CFR of bleeding was 20.2% (95% CI, 17.5-23.1) during the first three months, compared to 18.2% (95% CI, 14.0-23.2) beyond this period. The CFR of recurrent VTE was higher in patients initially presenting with PE (18.5%; 95% CI, 15.3-22.1) than in those with DVT (6.3%; 95% CI, 4.5-8.6), and in patients with provoked VTE (16.3%; 95% CI, 13.6-19.4) than in those with unprovoked VTE (5.5%; 95% CI, 3.5-8.0). In conclusion, the CFR of recurrent VTE decreased over time during anticoagulation, while the CFR of major bleeding remained stable. The CFR of recurrent VTE was higher in patients initially presenting w…
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For patients with a nonsurgical transient risk factor, the estimated annualized risks of recurrent PE and DVT are 1.89 and 2.31 per 100 patient-years, respectively.
“Assuming that 45% of the VTE events are PEs and 55% are DVTs, 269 we estimated annualized risks of PE recurrence of 1.89 and of DVT recurrence of 2.31 per 100 patientyears for patients with a nonsurgical transient risk factor.”
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 [269]
For patients with unprovoked VTE, the estimated annualized risks of recurrent PE and DVT are 3.3 and 4.1 per 100 patient-years, respectively.
“Assuming that 45% of the VTE events are PEs and 55% are DVTs, 269 we estimated annualized risks of recurrent PE of 3.3 and of recurrent DVT of 4.1 per 100 patient-years for patients with unprovoked VTE.”
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 [269]
For patients with a chronic risk factor, the estimated annualized risks of recurrent PE and DVT are 4.4 and 5.3 per 100 patient-years, respectively.
“Assuming that 45% of the VTE events are PEs and 55% are DVTs, 269 we estimated annualized risks of recurrent PE of 4.4 and of recurrent DVT of 5.3 per 100 patient-years for patients with a chronic risk factor.”
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 [269]
For patients with chronic risk factors, indefinite antithrombotic therapy reduced the risk of PE (ARR, 31 fewer per 1000 patients; 95% CI, 37 fewer to 19 fewer; high-certainty evidence).
“as well as for patients with chronic risk factors 269,274 (ARR, 31 fewer per 1000 patients; 95% CI, 37 fewer to 19 fewer; high-certainty evidence).”
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 [269]
For patients with chronic risk factors at 1 year, indefinite antithrombotic therapy reduced the risk of DVT (ARR, 45 fewer per 1000 patients; 95% CI, 48 fewer to 41 fewer).
“as well as for patients with chronic risk factors at 1 year 269,274 (ARR, 45 fewer per 1000 patients; 95% CI, 48 fewer to 41 fewer).”
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 [269]
For patients with chronic risk factors, DOACs for indefinite anticoagulation reduced the risk of DVT (ARR, 45 fewer per 1000 patients; 95% CI, 48 fewer to 41 fewer; high-certainty evidence).
“as well as for patients with chronic risk factors (ARR, 45 fewer per 1000 patients; 95% CI, 48 fewer to 41 fewer; highcertainty evidence). 269,274”
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 [269]
For patients with unprovoked VTE, indefinite antithrombotic therapy reduced the risk of PE (ARR, 24 fewer per 1000 patients; 95% CI, 28 fewer to 15 fewer; high-certainty evidence).
“as well as for patients with unprovoked VTE 269,274 (ARR, 24 fewer per 1000 patients; 95% CI, 28 fewer to 15 fewer; high-certainty evidence).”
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 [269]
When using a DOAC for indefinite anticoagulation, the risk of DVT was reduced for patients with unprovoked VTE (ARR, 35 fewer per 1000 patients; 95% CI, 37 fewer to 31 fewer; high-certainty evidence).
“as well as for patients with unprovoked VTE 269,274 (ARR, 35 fewer per 1000 patients; 95% CI, 37 fewer to 31 fewer; high-certainty evidence).”
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 [269]
For patients with chronic risk factors, VKA or LMWH for indefinite anticoagulation reduced the risk of DVT (ARR, 44 fewer per 1000 patients; 95% CI, 51 fewer to 25 fewer; high-certainty evidence).
“as well as for patients with chronic risk factors 269,274 (ARR, 44 fewer per 1000 patients; 95% CI, 51 fewer to 25 fewer; high-certainty evidence).”
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 [269]
When using a VKA or LMWH for indefinite anticoagulation, the risk of DVT was likely reduced for patients with unprovoked VTE (ARR, 34 fewer per 1000 patients, 95% CI, 39 fewer to 19 fewer; high-certainty evidence).
“as well as for patients with unprovoked VTE (ARR, 34 fewer per 1000 patients, 95% CI, 39 fewer to 19 fewer; high-certainty evidence). 269,274”
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 [269]
For patients with a chronic risk factor, estimated annualized risks of PE and DVT recurrence are 4.4 and 5.3 per 100 patient-years, respectively.
“Assuming that 45% of the initial VTE events are PEs and 55% are DVTs, 269 we estimated annualized risks of 4.4 and 5.3 per 100 patient-years for PE and DVT recurrence, respectively, for patients with a chronic risk factor.”
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 [269]
For patients with unprovoked VTE at 1 year, indefinite antithrombotic therapy reduced the risk of DVT (ARR, 33 fewer per 1000 patients; 95% CI, 36 fewer to 27 fewer).
“as well as for patients with unprovoked VTE at 1 year 269,274 (ARR, 33 fewer per 1000 patients; 95% CI, 36 fewer to 27 fewer).”
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 [269]
Aspirin likely reduced the risk of DVT for patients with unprovoked VTE (ARR, 18 fewer per 1000 patients; 95% CI, 28 fewer to 1 fewer; moderate-certainty evidence).
“as well as for patients with unprovoked VTE (ARR, 18 fewer per 1000 patients; 95% CI, 28 fewer to 1 fewer; moderate-certainty evidence). 269,274”
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 [269]
For patients with chronic risk factors, aspirin reduced the risk of DVT (ARR, 24 fewer per 1000 patients; 95% CI, 37 fewer to 1 fewer; moderate-certainty evidence).
“as well as for patients with chronic risk factors 269,274 (ARR, 24 fewer per 1000 patients; 95% CI, 37 fewer to 1 fewer; moderate-certainty evidence).”
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 [269]
For patients with recurrent provoked VTE, the estimated risk of PE recurrence is 2.5 per 100 patient-years.
“For patients with recurrent provoked VTE, assuming that 45% of the VTE events are PEs and 55% are DVTs, 269 we estimated the risks of PE recurrence to be 2.5 per 100 patient-years and the risks of DVT recurrence to be 3.1 per 100 patient-years.”
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 [269]
Aspirin reduced the risk of DVT for patients with recurrent provoked VTE (ARR 14 fewer per 1000 patients; 95% CI 21 fewer to 1 fewer; moderate-certainty evidence).
“Aspirin reduced the risk of DVT in the study population (RR, 0.55; 95% CI, 0.31-0.98; ARR, 64 fewer per 1000 patients; 95% CI, 98 fewer to 3 fewer), as well as for patients with recurrent provoked VTE (ARR, 14 fewer per 1000 patients; 95% CI, 21 fewer to 1 fewer; moderate-certainty evidence). 269;324”
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 [269]
For patients with recurrent provoked VTE, the estimated risk of DVT recurrence is 3.1 per 100 patient-years.
“For patients with recurrent provoked VTE, assuming that 45% of the VTE events are PEs and 55% are DVTs, 269 we estimated the risks of PE recurrence to be 2.5 per 100 patient-years and the risks of DVT recurrence to be 3.1 per 100 patient-years.”
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 [269]
Indefinite antithrombotic therapy reduced the risk of DVT for patients with recurrent provoked VTE at 1 year (ARR 25 fewer per 1000 patients; 95% CI 27 fewer to 20 fewer).
“Indefinite antithrombotic therapy also reduced the risk of DVT for patients with recurrent provoked VTE at 1 year 269,324 (ARR, 25 fewer per 1000 patients; 95% CI, 27 fewer to 20 fewer).”
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 [269]
When using a VKA or LMWH for indefinite anticoagulation, the risk of recurrent DVT was reduced in the study population (RR 0.17; 95% CI 0.05-0.53; ARR 54 fewer per 1000 patients; high-certainty evidence).
“When using a VKA or LMWH for indefinite anticoagulation, we observed a reduction in the risk of recurrent DVT in the study population (RR, 0.17; 95% CI, 0.050.53; ARR, 54 fewer per 1000 patients; 95% CI, 61 fewer to 30 fewer), as well as for patients with recurrent provoked VTE (ARR, 26 fewer per 1000 patients; 95% CI, 29 fewer to 14 fewer; highcertainty evidence). 269,324”
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 [269]
Indefinite antithrombotic therapy reduced the risk of PE for patients with recurrent unprovoked VTE (ARR 38 fewer per 1000 patients; 95% CI 46 fewer to 24 fewer; high-certainty evidence).
“as well as for patients with recurrent unprovoked VTE 269,324 (ARR, 38 fewer per 1000 patients; 95% CI, 46 fewer to 24 fewer; high-certainty evidence).”
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 [269]
When using a DOAC for indefinite anticoagulation, the risk of DVT was reduced for patients with recurrent provoked VTE (ARR 26 fewer per 1000 patients; 95% CI 28 fewer to 24 fewer; high-certainty evidence).
“as well as for patients with recurrent provoked VTE 269,324 (ARR, 26 fewer per 1000 patients; 95% CI, 28 fewer to 24 fewer; high-certainty evidence).”
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 [269]
Aspirin reduced the risk of DVT in the study population (RR 0.55; 95% CI 0.31-0.98; ARR 64 fewer per 1000 patients; moderate-certainty evidence).
“Aspirin reduced the risk of DVT in the study population (RR, 0.55; 95% CI, 0.31-0.98; ARR, 64 fewer per 1000 patients; 95% CI, 98 fewer to 3 fewer), as well as for patients with recurrent provoked VTE (ARR, 14 fewer per 1000 patients; 95% CI, 21 fewer to 1 fewer; moderate-certainty evidence). 269;324”
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 [269]
Indefinite antithrombotic therapy reduced the risk of PE for patients with recurrent provoked VTE (ARR 18 fewer per 1000 patients; 95% CI 21 fewer to 11 fewer; high-certainty evidence).
“as well as for patients with recurrent provoked VTE 269,324 (ARR, 18 fewer per 1000 patients; 95% CI, 21 fewer to 11 fewer; high-certainty evidence).”
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 [269]
For patients with recurrent unprovoked VTE, the estimated risk of DVT recurrence is 6.6 per 100 patient-years.
“Assuming that 45% of the VTE events are PEs and 55% are DVTs, 269 we estimated the risks of PE recurrence to be 5.4 per 100 patient-years and the risks of DVT recurrence to be 6.6 per 100 patient-years for patients with recurrent unprovoked VTE.”
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 [269]
For patients with recurrent unprovoked VTE, the estimated risk of PE recurrence is 5.4 per 100 patient-years.
“Assuming that 45% of the VTE events are PEs and 55% are DVTs, 269 we estimated the risks of PE recurrence to be 5.4 per 100 patient-years and the risks of DVT recurrence to be 6.6 per 100 patient-years for patients with recurrent unprovoked VTE.”
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 [269]
When using a VKA or LMWH for indefinite anticoagulation, the risk of recurrent DVT was reduced for patients with recurrent provoked VTE (ARR 26 fewer per 1000 patients; 95% CI 29 fewer to 14 fewer; high-certainty evidence).
“When using a VKA or LMWH for indefinite anticoagulation, we observed a reduction in the risk of recurrent DVT in the study population (RR, 0.17; 95% CI, 0.050.53; ARR, 54 fewer per 1000 patients; 95% CI, 61 fewer to 30 fewer), as well as for patients with recurrent provoked VTE (ARR, 26 fewer per 1000 patients; 95% CI, 29 fewer to 14 fewer; highcertainty evidence). 269,324”
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 [269]
When a VKA or LMWH was used for indefinite anticoagulation, the risk of DVT was reduced for patients with recurrent unprovoked VTE (ARR 55 fewer per 1000 patients; 95% CI 63 fewer to 31 fewer; high-certainty evidence).
“as well as for patients with recurrent unprovoked VTE (ARR, 55 fewer per 1000 patients; 95% CI, 63 fewer to 31 fewer; high-certainty evidence). 269,324”
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 [269]
Aspirin reduced the risk of recurrent DVT for patients with recurrent unprovoked VTE (ARR 30 fewer per 1000 patients; 95% CI 46 fewer to 1 fewer; moderate-certainty evidence).
“as well as for patients with recurrent unprovoked VTE (ARR, 30 fewer per 1000 patients; 95%CI, 46 fewer to 1 fewer; moderate-certainty evidence). 269,324”
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 [269]
Indefinite antithrombotic therapy reduced the risk of DVT for patients with recurrent unprovoked VTE at 1 year (ARR 53 fewer per 1000 patients; 95% CI 58 fewer to 44 fewer).
“For patients with recurrent unprovoked VTE at 1 year, 269,324 indefinite antithrombotic therapy also reduced the risk of DVT (ARR, 53 fewer per 1000 patients; 95% CI, 58 fewer to 44 fewer).”
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 [269]
When using a DOAC for indefinite anticoagulation, the risk of DVT was reduced for patients with recurrent unprovoked VTE (ARR 56 fewer per 1000 patients; 95% CI 59 fewer to 51 fewer; high-certainty evidence).
“as well as for patients with recurrent unprovoked VTE 269,324 (ARR, 56 fewer per 1000 patients; 95% CI, 59 fewer to 51 fewer; high-certainty evidence).”
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 [269]
Citations
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Metadata
- Authors
- Alfonso, A., Jiménez, D., Capitán, C. F., Prandoni, P., Wells, P. S., Vidal, G., Barillari, G., Monreal, M., Lecumberri, R., & and the RIETE Investigators
- Affiliations
- Hospital Universitario Ramón y Cajal (ES)
- Hospital Universitario La Paz (ES)
- University of Padua (IT)
- University of Ottawa (CA)
- Corporació Sanitària Parc Taulí (ES)
- University of Udine (IT)
- Clinica Universidad de Navarra (ES)
- Corresponding author
- Lecumberri, Ramón
- Venue
- Thrombosis and Haemostasis
- Publisher
- Georg Thieme Verlag KG
- Published
- 2013
- Volume
- 110
- Issue
- 10
- Pages
- 834-843
- ISSN
- 0340-6245 (ISSN-L)
- 2567-689X
- OpenAlex
- W2016907231
- Cited by
- 129
- References
- 33
- Citations by year
- 2026: 7 · 2025: 11 · 2024: 7 · 2023: 10 · 2022: 10 · 2021: 8 · 2020: 12 · 2019: 8 · 2018: 17 · 2017: 14 · 2016: 10 · 2015: 11 · 2014: 3 · 2013: 1
- FWCI
- 7.25
- Type
- journal article
- Language
- en
- Open access
- closed
- Locations
- Thrombosis and Haemostasis (publishedVersion)
- PubMed (publishedVersion)
- IRIS (submittedVersion)
- Institutional Research Information System (Università degli Studi di Trento) (submittedVersion)
- SERVAL (Université de Lausanne) (submittedVersion)
- Padua Research Archive (University of Padova) (submittedVersion)
- Funders
- Bayer
- Universidad Autónoma de Madrid
- Sanofi España
- Topics
- Health Sciences › Medicine › Internal Medicine › Venous Thromboembolism Diagnosis and Management
- Health Sciences › Medicine › Hematology › Blood Coagulation and Thrombosis Mechanisms
- Health Sciences › Medicine › Cardiology and Cardiovascular Medicine › Atrial Fibrillation Management and Outcomes
- Keywords
- venous thromboembolism, recurrent thromboembolism, major bleeding, case fatality rate, anticoagulation, anticoagulation duration, provoked venous thromboembolism, pulmonary embolism, deep vein thrombosis, RIETE registry
- MeSH terms
- Aged, Aged, 80 and over, Anticoagulants, Female, Hemorrhage, Humans, International Cooperation, Male, Middle Aged, Prospective Studies, Recurrence, Registries, Cohort Studies, Survival Analysis, Venous Thromboembolism
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