1. Clinically relevant bleeding in cancer patients treated for venous thromboembolism from the CATCH study
- Author
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P.W. Kamphuisen, A.Y.Y. Lee, G. Meyer, R. Bauersachs, M.S. Janas, M.F. Jarner, A.A. Khorana, R. Bella Santiago, S. Cerana, J.J. Zarbá, J. Andel, C.H. Barrios, A. Borba Reiriz, F. Cesario, S. de Azevedo, A.F. Ferreira Filho, F.A. Franke, S. Padilha, R. Paiva Queiroz, A. Pimenta, J. Rerin, R. Rigo, S.B. van Eyll Rocha, G. Santos Borges, G. Vacaro, V. Anastasov, T. Dragneva, G. Georgiev, P. Champion, P. Kuruvilla, C. Gonzalez, P. Ditl, J. Förster, B. Lubomir, J. Vydra, R.A. El Hassan, S. Sabri, N. Allahloubi, A. Elzawawy, S.S. Ezzat, M.S. El Kady, L. Bacchus, J. Beyer‐Westendorf, U. Kamphausen, D. Niederwieser, H. Ostermann, M. Sosada, N. Anagnostopoulos, G. Fountzilas, C. Ioannou, C. Liapis, J.F.B. Schaeffer, S. Atilli, S. Balsubramanian, S. Bondarde, S.C. Desai, C. Deshmukh, D.P. Singh, F. Gharami, L. Goyal, S. Gupta, S. Gupte, K.K. Mukherjee, S. Krishnan, K. Kumar, A. Mehta, K. Mishra, R. Naik, S. Pawar, R.V. Nagarkar, N. Warrier, B. Brenner, I. Gavish, G. Lugassy, M. Kolin, B. Enrico, M.G. Mazzucconi, G. Visani, A. Awidi, N. Novikovs, J. Miscuks, D. Abigerges, F. Farhat, P. Khoueiry, J. Makarem, O. Alvarez Ordorica, E. Anaya Santacruz, G. Calderillo Ruiz, J.H. de la Concha Ureta, W.S.R. Pantigoso, M. Philco, A.R. Pineda, E.A.V. Queszada, K. Gawrychowski, W. Witkiewicz, E. Macias, E. Teixeira, T.‐E. Ciuleanu, C.C. Ligia, D. Lungulescu, I.G. Manolescu, A. Rodica, C. Volovat, Y. Burov, I. Katelnitsky, D. Svistov, K. Ahmad, F. Algahtani, H. Al‐Zahrani, M. Qari, D. Jovanovic, N. Milanovic, B. Perin, V. Stojanovic, L. Tomasic, J. Chovanec, O. Herman, V. Kissova, F. Sasvary, S. Špánik, M. Szentivanyi, F. Barón, E. Gallardo, D. Jiménez, O. Remedios, A. Sanchez, J. Engelbrecht, N. Jonas, G. McAdam, M. Patel, B. Rapoport, B. Robertson, D. Oh, H. Kim, H.‐K. Kim, H.J. Kim, H.S. Kim, J.S. Ahn, J. Chung, J. Jang, K.U. Park, S.‐W. Shin, S.H. Kim, S‐S. Yoon, Y.‐K. Kim, C.‐F. Chiu, C.‐S. Chang, J.‐H. Liu, K.‐M. Rau, S.‐W. Chen, S. Chittima, T. Ekkapong, K. Nonglak, A. Pantep, M. Pramook, S. Thanakrit, S. Patrapim, T. Sumitra, C. Udomluck, I. Kobza, O. Nykonenko, V. Prasol, I. Vladychuk, and Cardiovascular Centre (CVC)
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Male ,medicine.medical_specialty ,anticoagulants ,Time Factors ,INTRACRANIAL HEMORRHAGE ,venous thromboembolism ,neoplasms ,BRAIN METASTASES ,Hemorrhage ,030204 cardiovascular system & hematology ,Malignancy ,Risk Assessment ,ANTICOAGULANT TREATMENT ,03 medical and health sciences ,0302 clinical medicine ,Risk Factors ,Internal medicine ,Medicine ,Humans ,Prospective Studies ,THERAPEUTIC RANGE ,Aged ,COMPLICATIONS ,tinzaparin ,business.industry ,Incidence ,Hazard ratio ,RIETE REGISTRY ,Warfarin ,Cancer ,Hematology ,Tinzaparin ,MOLECULAR-WEIGHT HEPARIN ,Middle Aged ,medicine.disease ,bleeding ,Thrombosis ,Confidence interval ,Exact test ,WARFARIN PATIENTS ,Treatment Outcome ,030220 oncology & carcinogenesis ,INTERNATIONAL NORMALIZED RATIO ,ATRIAL-FIBRILLATION ,Female ,Drug Monitoring ,business ,medicine.drug - Abstract
Essentials Cancer patients receiving anticoagulants for venous thromboembolism have an elevated bleeding risk. This secondary analysis of CATCH assessed characteristics of clinically relevant bleeding (CRB). CRB occurs in 15% of cancer patients with thrombosis using therapeutic doses of anticoagulation. After multivariate analysis, risk factors for CRB were age >75 years and intracranial malignancy. Summary Background Cancer patients with acute venous thromboembolism (VTE) receiving anticoagulant treatment have an increased bleeding risk. Objectives We performed a prespecified secondary analysis of the randomized, open-label, Phase III CATCH trial (NCT01130025) to assess the rate and sites of and the risk factors for clinically relevant bleeding (CRB). Patients/Methods Patients with active cancer and acute, symptomatic VTE received either tinzaparin 175 IU kg-1 once daily or warfarin (target International Normalized Ratio [INR] of 2.0-3.0) for 6 months. Fisher's exact test was used to screen prespecified clinical risk factors; those identified as being significantly associated with an increased risk of CRB then underwent competing risk regression analysis of time to first CRB. Results Among 900 randomized patients, 138 (15.3%) had 180 CRB events. CRB occurred in 60 patients (81 events) in the tinzaparin group and in 78 patients (99 events) in the warfarin group (hazard ratio [HR] 0.64; 95% confidence interval [CI] 0.45-0.89). Common bleeding sites were gastrointestinal (36.7%; n = 66), genitourinary (22.8%; n = 41), and nasal (10.0%; n = 18). In multivariate analysis, the risk of CRB increased with age > 75 years (HR 1.83, 95% CI 1.14-2.94) and intracranial malignancy (HR 1.97, 95% CI 1.07-3.62). In the warfarin group, 40.4% of CRB events occurred in patients with with an INR of 75 years and intracranial malignancy.
- Published
- 2018