Bleeding with Apixaban and Dalteparin in Patients with Cancer-Associated Venous Thromboembolism: Results from the Caravaggio StudyFunding This study (NCT03045406) was supported by Bristol-Myers Squibb-Pfizer Alliance. Bristol-Myers Squibb-Pfizer Alliance provided the study drugs. The corresponding author has full access to all the data in the study.
Background Direct oral anticoagulants are recommended for the treatment of cancer-associated thrombosis (CAT) as an alternative to low-molecular-weight heparin (LMWH), but an increased bleeding risk in patients with gastrointestinal cancer was reported. The Caravaggio study compared apixaban and dalteparin for the treatment of patients with CAT. Here we describe sites of bleeding, associated cancer sites, clinical presentation, and course of major bleeding in patients included in the Caravaggio study.
Methods The Caravaggio study was a multinational, randomized, open-label, noninferiority study. Bleeding events and the severity of major bleedings were adjudicated by a committee unaware of treatment allocation using predefined criteria; for the purpose of this analysis, data were analyzed in the safety population.
Results Major bleeding occurred in 22 of 576 patients on apixaban (3.8%) and in 23 of 579 patients on dalteparin (4.0%). The sites of major bleeding and their distribution according to the type of cancer were similar between the two treatment groups. Major bleeding occurred in nine patients with gastrointestinal cancer in each treatment group. The clinical presentation of major bleeding was severe or fatal in 6 patients on apixaban and in 5 patients on dalteparin, while the clinical course was severe in 5 patients on apixaban and in 7 patients on dalteparin.
Conclusion Apixaban is a safe alternative to LMWH for the treatment in patients with CAT. No excess in gastrointestinal bleeding was observed in patients who received apixaban, including those with gastrointestinal cancer.
W.A., M.C.V., C.B, and G.A. contributed to the conception of the work; A.C., M.H., R.B., and G.G. contributed to the interpretation of data for the work; W.A., M.C.V., C.B., and G.A. participated in drafting the manuscript; A.C., M.H., R.B., and G.G. critically reviewed the manuscript for important intellectual content; W.A., M.C.V., A.C., M.H., R.B., G.G., C.B., and G.A. approved the final submitted version to be published; W.A., M.C.V., A.C., M.H., R.B., G.G., C.B., and G.A. agreed to be accountable for all aspects of the work in ensuring that questions related to the accuracy or integrity of any part of the work are appropriately investigated and resolved.
Received: 12 August 2020
Accepted: 23 September 2020
17 November 2020 (online)
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