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Systematic Review: Case-Fatality Rates of Recurrent Venous Thromboembolism and Major Bleeding Events Among Patients Treated for Venous Thromboembolism

Marc Carrier, MD, MSc; Grégoire Le Gal, MD, PhD; Philip S. Wells, MD, MSc; and Marc A. Rodger, MD, MSc
[+] Article and Author Information

From University of Ottawa, Ottawa Hospital Research Institute, Ottawa, Ontario, Canada, and Brest University Hospital, Brest, France.


Grant Support: By a Canadian Institute for Health Research Randomized Controlled Trials Mentoring Program Award (Dr. Carrier) and a Career Scientist Award from the Heart and Stroke Foundation of Ontario (Dr. Rodger). Dr. Wells is a recipient of a Canada Research Chair.

Potential Conflicts of Interest: Disclosures can be viewed at www.acponline.org/authors/icmje/ConflictOfInterestForms.do?msNum=M09-0900.

Requests for Single Reprints: Marc A. Rodger, MD, MSc, Ottawa Health Research Institute, Ottawa Hospital, General Campus, 501 Smyth Road, Room W6116, Eye Institute, Ottawa, Ontario K1H 8L6, Canada; e-mail, mrodger@ohri.ca.

Current Author Addresses: Dr. Carrier: Ottawa Hospital, General Campus, 501 Smyth Road, Box 201, Ottawa, Ontario KK1H 8L6, Canada.

Dr. Le Gal: Département de Médecine Interne et de Pneumologie, Centre Hospitalier Universitaire de la Cavale Blanche, 29609 Brest, France.

Dr. Wells: The Ottawa Hospital, Civic Campus, F649-1053 Carling Avenue, Ottawa Ontario K1Y 4E9, Canada.

Dr. Rodger: Ottawa Health Research Institute, Ottawa Hospital, General Campus, 501 Smyth Road, Room W6116, Eye Institute, Ottawa, Ontario K1H 8L6, Canada.

Author Contributions: Conception and design: M. Carrier, G. Le Gal, P.S. Wells, M.A. Rodger.

Analysis and interpretation of the data: M. Carrier, G. Le Gal, P.S. Wells, M.A. Rodger.

Drafting of the article: M. Carrier, G. Le Gal, P.S. Wells, M.A. Rodger.

Critical revision of the article for important intellectual content: M. Carrier, M.A. Rodger.

Final approval of the article: M. Carrier, G. Le Gal, P.S. Wells, M.A. Rodger.

Statistical expertise: M. Carrier, G. Le Gal, M.A. Rodger.

Obtaining of funding: M. Carrier, M.A. Rodger.

Administrative, technical, or logistic support: M. Carrier, M.A. Rodger.

Collection and assembly of data: M. Carrier, G. Le Gal, P.S. Wells.


Ann Intern Med. 2010;152(9):578-589. doi:10.7326/0003-4819-152-9-201005040-00008
Text Size: A A A

Background: Case-fatality rates are important for assessing the risks and benefits of anticoagulation in patients with venous thromboembolism (VTE).

Purpose: To summarize case-fatality rates of recurrent VTE and major bleeding events during anticoagulation and recurrent VTE after anticoagulation.

Data Sources: MEDLINE, EMBASE, the Cochrane Central Register of Controlled Trials, and all evidence-based medicine reviews in the Ovid interface through the second quarter of 2008.

Study Selection: 69 articles (13 prospective cohort studies and 56 randomized, controlled trials) that reported on patients with symptomatic VTE who received anticoagulation therapy for at least 3 months and on the rate of fatal recurrent VTE and fatal major bleeding.

Data Extraction: Two reviewers independently extracted data onto standardized forms.

Data Synthesis: During the initial 3 months of anticoagulation, the rate of recurrent fatal VTE was 0.4% (95% CI, 0.3% to 0.6%), with a case-fatality rate of 11.3% (CI, 8.0% to 15.2%). The rate of fatal major bleeding events was 0.2% (CI, 0.1% to 0.3%), with a case-fatality rate of 11.3% (CI, 7.5% to 15.9%). After anticoagulation, the rate of fatal recurrent VTE was 0.3 per 100 patient-years (CI, 0.1% to 0.4%), with a case-fatality rate of 3.6% (CI, 1.9% to 5.7%).

Limitations: Estimates come from heterogeneous trial and cohort populations and are not derived from patient-level longitudinal data. Differences in case-fatality rates during and after anticoagulation may be attributable to unmeasured patient characteristics.

Conclusion: The case-fatality rates of recurrent VTE and major bleeding events are similar during the initial period of VTE treatment. The case-fatality rate of recurrent VTE decreases after completion of the initial period of anticoagulation. When combined with absolute rates of recurrent VTE and major bleeding events, case-fatality rates provide clinicians with a surrogate measure of mortality to balance the risks and benefits of anticoagulant therapy in patients with VTE.

Primary Funding Source: Canadian Institute for Health Research and Heart and Stroke Foundation of Ontario.

Figures

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Appendix Figure.
Study flow diagram.

* Citations include references 9 to 77.

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Comments

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A double- edged sword
Posted on May 7, 2010
Rajasree Pai RamachandraPai
University of connecticut health center
Conflict of Interest: None Declared

There is an increasing conflict among primary care physicians on intiating and stopping anticoagulation in events like thromboembolism. Sometimes, acute pulmonary embolism is treated with longer than desired duration of anticoagulation regardless of the patients general condition and functional status. The mortality and morbidity associated needs to be taken into account in these situations. The medications used which is often warfarin, has numerous drug interactions that makes it difficult to use in the geriatric population having multiple comorbidities. Also, the close monitoring of bleeding parameters increases the risk of medication noncompliance or even more dangerously, overdosage.

Conflict of Interest:

None declared

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