Chest
Original Research: Pulmonary Vascular DiseaseDirect Oral Anticoagulants in Patients With VTE and Cancer
Section snippets
Data Sources and Searches
A protocol for this review was prospectively developed detailing the specific objectives; criteria for study selection; approach to assess study quality, outcomes, and statistical methods. We performed an unrestricted search in MEDLINE, EMBASE, and CENTRAL through December 17, 2013. The search strategy is reported in e-Table 1. No language restrictions were applied. Reference lists of retrieved articles and review articles were manually searched for other relevant studies. The term ximelagatran
Results
Overall, 915 studies were found, and 26 were selected as potentially relevant. The flow diagram for study selection is reported in Figure 1. Ten studies that reported data on patients with cancer were included in the systematic review. Interobserver agreement for study selection was good (κ = 0.87).
Baseline characteristics of the studies included in the systematic review are reported in Table 1. All trials were randomized. Reports on three phase 2 trials were selected (one on apixaban28 and two
Discussion
This study shows that the efficacy and safety profile of new anti-Xa and anti-IIa drugs for VTE treatment in patients with cancer is similar to that observed in patients without cancer. A favorable trend toward reduction of recurrent VTE was observed without concern in terms of clinically relevant bleedings.
We found a nonsignificant reduction of recurrent VTE of about 40% in favor of DOAs compared with conventional treatment with heparin followed by vitamin K antagonists. The reduction was
Conclusions
New anti-Xa and anti-IIa drugs seem to be at least as effective and safe as conventional anticoagulant treatment with vitamin K antagonists for prevention of VTE recurrence in cancer patients. Ad hoc clinical trials should be conducted to confirm our results.
Financial/nonfinancial disclosures: The authors have reported to CHEST the following conflicts of interest: Dr Agnelli reports receiving personal fees from Boehringer Ingelheim GmbH, Sanofi SA, Daiichi-Sankyo Co Ltd, Bristol-Myers Squibb,
Acknowledgments
Author contributions: M. C. V. served as principal author, had full access to all of the data in the study, and takes responsibility for the integrity of the data and the accuracy of the data analysis. M. C. V., F. G., and C. B. contributed to the study concept and design and data analysis; M. C. V., F. G., G. A., and C. B. contributed to data acquisition and interpretation; M. C. V. and F. G. contributed to drafting of the manuscript; and G. A. and C. B. contributed to revision of the
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FUNDING/SUPPORT: The authors have reported to CHEST that no financial support was received for this study. Reproduction of this article is prohibited without written permission from the American College of Chest Physicians. See online for more details.