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Case Fatality Rates of Recurrent Thromboembolism and Bleeding in Patients Receiving Direct Oral Anticoagulants for the Initial and Extended Treatment of Venous Thromboembolism: A Systematic Review.
J Cardiovasc Pharmacol Ther. 2015 Sep; 20(5):490-500.JC

Abstract

BACKGROUND

In patients with venous thromboembolism (VTE), the study of the case fatality rate (CFR) of VTE recurrences and bleeding complications may be of help to balance the risks and benefits of anticoagulant therapy.

OBJECTIVE

To investigate the CFR with the direct oral anticoagulants (DOACs; dabigatran, rivaroxaban, apixaban, and edoxaban) in patients with VTE.

METHODS

We conducted a systematic review and meta-analysis of randomized clinical trials testing the DOACs versus standard initial treatment of VTE (parenteral anticoagulant for ≥5 days plus vitamin K antagonists [VKAs] for ≥3 months) and DOACs versus placebo or VKA for extended treatment. Two investigators independently extracted the data. A random effects meta-analysis was conducted using StatsDirect software.

RESULTS

Overall, 10 trials in 35 029 patients were included. During initial treatment, the rate of recurrent VTE per 100 patient-years (%/yr) and CFR (%) was similar in patients receiving DOACs or standard therapy (4.1%/yr vs 4.4%/yr; P = .21 and 16% vs 13%; P = .61, respectively). However, major bleeding (1.8%/yr vs 3.1%/yr; P = .003), fatal bleeding (0.1%/yr vs 0.3%/yr; P = .02), and CFR (6% vs 10%; P = .18) were lower with DOACs than with standard therapy. During extended treatment, both all-cause mortality and recurrent VTE per 100 patient-years were lower with DOACs than with placebo (0.6%/yr vs 1.1%/yr; P = .01 and 1.9%/yr vs 10.9%/yr; P < .0001, respectively), but there were no statistical differences between treatments on CFR of VTE recurrences (P = .17). No fatal bleeding events were reported during extended treatment.

CONCLUSION

The use of DOACs was associated with fewer major and fatal bleedings and corresponding CFR than standard initial treatment of VTE, and fewer recurrent VTEs and mortality than placebo during extended therapy, although the CFR of recurrent VTE was not reduced.

Authors+Show Affiliations

Division of Pharmacology and Clinical Evaluation, Spanish Agency for Medicines and Medical Devices (AEMPS), Madrid, Spain agomezo@aemps.es.Hematology Service, University Clinic of Navarra, Pamplona, Spain.Division of Pharmacology and Clinical Evaluation, Spanish Agency for Medicines and Medical Devices (AEMPS), Madrid, Spain.Department of Clinical Pharmacology, Hospital Clínico San Carlos, Madrid, Spain Department of Pharmacology, Universidad Complutense, Madrid, Spain.Department of Internal Medicine, Hospital Universitari Germans Trias i Pujol, Badalona, Barcelona, Spain.Department of Clinical Pharmacology, Hospital Clínico San Carlos, Madrid, Spain Department of Pharmacology, Universidad Complutense, Madrid, Spain.

Pub Type(s)

Journal Article
Meta-Analysis
Review
Systematic Review

Language

eng

PubMed ID

25802423

Citation

Gómez-Outes, Antonio, et al. "Case Fatality Rates of Recurrent Thromboembolism and Bleeding in Patients Receiving Direct Oral Anticoagulants for the Initial and Extended Treatment of Venous Thromboembolism: a Systematic Review." Journal of Cardiovascular Pharmacology and Therapeutics, vol. 20, no. 5, 2015, pp. 490-500.
Gómez-Outes A, Lecumberri R, Suárez-Gea ML, et al. Case Fatality Rates of Recurrent Thromboembolism and Bleeding in Patients Receiving Direct Oral Anticoagulants for the Initial and Extended Treatment of Venous Thromboembolism: A Systematic Review. J Cardiovasc Pharmacol Ther. 2015;20(5):490-500.
Gómez-Outes, A., Lecumberri, R., Suárez-Gea, M. L., Terleira-Fernández, A. I., Monreal, M., & Vargas-Castrillón, E. (2015). Case Fatality Rates of Recurrent Thromboembolism and Bleeding in Patients Receiving Direct Oral Anticoagulants for the Initial and Extended Treatment of Venous Thromboembolism: A Systematic Review. Journal of Cardiovascular Pharmacology and Therapeutics, 20(5), 490-500. https://doi.org/10.1177/1074248415575154
Gómez-Outes A, et al. Case Fatality Rates of Recurrent Thromboembolism and Bleeding in Patients Receiving Direct Oral Anticoagulants for the Initial and Extended Treatment of Venous Thromboembolism: a Systematic Review. J Cardiovasc Pharmacol Ther. 2015;20(5):490-500. PubMed PMID: 25802423.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Case Fatality Rates of Recurrent Thromboembolism and Bleeding in Patients Receiving Direct Oral Anticoagulants for the Initial and Extended Treatment of Venous Thromboembolism: A Systematic Review. AU - Gómez-Outes,Antonio, AU - Lecumberri,Ramón, AU - Suárez-Gea,M Luisa, AU - Terleira-Fernández,Ana-Isabel, AU - Monreal,Manuel, AU - Vargas-Castrillón,Emilio, Y1 - 2015/03/23/ PY - 2014/10/31/received PY - 2015/01/22/accepted PY - 2015/3/25/entrez PY - 2015/3/25/pubmed PY - 2016/6/3/medline KW - anticoagulants KW - bleeding KW - case fatality rate KW - deep vein thrombosis KW - pulmonary embolism KW - recurrent event SP - 490 EP - 500 JF - Journal of cardiovascular pharmacology and therapeutics JO - J. Cardiovasc. Pharmacol. Ther. VL - 20 IS - 5 N2 - BACKGROUND: In patients with venous thromboembolism (VTE), the study of the case fatality rate (CFR) of VTE recurrences and bleeding complications may be of help to balance the risks and benefits of anticoagulant therapy. OBJECTIVE: To investigate the CFR with the direct oral anticoagulants (DOACs; dabigatran, rivaroxaban, apixaban, and edoxaban) in patients with VTE. METHODS: We conducted a systematic review and meta-analysis of randomized clinical trials testing the DOACs versus standard initial treatment of VTE (parenteral anticoagulant for ≥5 days plus vitamin K antagonists [VKAs] for ≥3 months) and DOACs versus placebo or VKA for extended treatment. Two investigators independently extracted the data. A random effects meta-analysis was conducted using StatsDirect software. RESULTS: Overall, 10 trials in 35 029 patients were included. During initial treatment, the rate of recurrent VTE per 100 patient-years (%/yr) and CFR (%) was similar in patients receiving DOACs or standard therapy (4.1%/yr vs 4.4%/yr; P = .21 and 16% vs 13%; P = .61, respectively). However, major bleeding (1.8%/yr vs 3.1%/yr; P = .003), fatal bleeding (0.1%/yr vs 0.3%/yr; P = .02), and CFR (6% vs 10%; P = .18) were lower with DOACs than with standard therapy. During extended treatment, both all-cause mortality and recurrent VTE per 100 patient-years were lower with DOACs than with placebo (0.6%/yr vs 1.1%/yr; P = .01 and 1.9%/yr vs 10.9%/yr; P < .0001, respectively), but there were no statistical differences between treatments on CFR of VTE recurrences (P = .17). No fatal bleeding events were reported during extended treatment. CONCLUSION: The use of DOACs was associated with fewer major and fatal bleedings and corresponding CFR than standard initial treatment of VTE, and fewer recurrent VTEs and mortality than placebo during extended therapy, although the CFR of recurrent VTE was not reduced. SN - 1940-4034 UR - https://www.unboundmedicine.com/medline/citation/25802423/Case_Fatality_Rates_of_Recurrent_Thromboembolism_and_Bleeding_in_Patients_Receiving_Direct_Oral_Anticoagulants_for_the_Initial_and_Extended_Treatment_of_Venous_Thromboembolism:_A_Systematic_Review_ L2 - http://journals.sagepub.com/doi/full/10.1177/1074248415575154?url_ver=Z39.88-2003&amp;rfr_id=ori:rid:crossref.org&amp;rfr_dat=cr_pub=pubmed DB - PRIME DP - Unbound Medicine ER -