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Clinically relevant bleeding in cancer patients treated for venous thromboembolism from the CATCH study

2018; Elsevier BV; Volume: 16; Issue: 6 Linguagem: Inglês

10.1111/jth.14007

1538-7933

Pieter W. Kamphuisen, A.Y.Y. Lee, Guy Meyer, Rupert Bauersachs, Mette S. Janas, Mikala F. Jarner, Alok A. Khorana, Rica Santiago, Susana Cerana, J. J. Zarba, Johannes Andel, C.H. Barrios, André Borba Reiriz, Fabiana Copês Cesario, S. de Azevedo, A.F. Ferreira Filho, Fábio Franke, Sérgio Lunardon Padilha, R. Paiva Queiroz, Amadeu Pimenta, Julio Rerin, R. Rigo, Sérgia Rocha, Giuliano Santos Borges, Giovana Zerwes Vacaro, V. Anastasov, T. Dragneva, Georgi P. Georgiev, P. Champion, Philip Kuruvilla, Carlos Gonzalez, P. Ditl, J. Förster, B. Lubomir, Jan Vydra, Roa Hassan, Saher S. Sabri, Nasr Allahloubi, Ahmed Elzawawy, S.S. Ezzat, Mohamed Sabry El- Kady, Leeon Bacchus, Jan Beyer‐Westendorf, Ulrich Kamphausen, D. Niederwieser, Helmut Ostermann, Markus Sosada, Nikolaos Anagnostopoulos, George Fountzilas, Christos V. Ioannou, Christos D. Liapis, J Schaeffer, S.S. Atilli, S. Balsubramanian, Shailesh Bondarde, Sunita Desai, Chetan Deshmukh, Deepak Singh, F.H. Gharami, Lipika Goyal, Sorab Gupta, S. Gupte, Kishore Mukherjee, Sundar Krishnan, Kiran Kumar KC, Ashit K. Mehta, Kundan Mishra, Rishi Naik, S. Pawar, Rajnish Nagarkar, Nisha Warrier, Benjamin Brenner, Israel Gavish, Gilles Lugassy, M Kolin, Enrico Belluco, MG Mazzucconi, Guiseppe Visani, Abdallah Awidi, Nikolajs Novikovs, J. Miscuks, D Abigerges, Fadi Farhat, Pierre Khoueiry, Jawad A. Makarem, O. Alvarez Ordorica, Elisa Santacruz, Gerardo Ruiz, J.H. de la Concha Ureta, W.S.R. Pantigoso, M. Philco, Antoni Pineda, E.A.V. Queszada, Krzysztof Gawrychowski, Wojciech Witkiewicz, Erika Gonzalez Macias, E. Teixeira, Tudor‐Eliade Ciuleanu, C.C. Ligia, Dan Lungulescu, Ileana Manolescu, Anghel Rodica, Constantin Volovăț, Yu. А. Burov, I.I. Katelnitsky, Д В Свистов, K. Ahmad, Farjah Algahtani, Hazzaa Alzahrani, Mohamad Qari, D. Jovanović, Nebojša Milanović, Branislav Perin, Vladimir Stojanović, L. Tomasic, Josef Chovanec, Oto Herman, Viera Kissova, F Sasváry, S. Špánik, M Szentiványi, Frédéric Baron, Enrique Gallardo, David Jiménez, O. Remedios, Antonio Sánchez, J. Engelbrecht, Natalie Jonas, Georgina McAdam, Mitra Patel, Bernardo L. Rapoport, Brent Robertson, Doyeun Oh, H. Kim, H.‐K. Kim, Hyun Jeong Kim, H.S. Kim, Jiyeon Ahn, Jee Eun Chung, Joanne Jang, K.U. Park, S.‐W. Shin, S.H. Kim, SS Yoon, Y.‐K. Kim, Chih-Wei Chiu, Courtney Chang, Liu H, Kun Ming Rau, S.‐W. Chen, S. Chittima, T. Ekkapong, K. Nonglak, A. Pantep, M. Pramook, S. Thanakrit, S. Patrapim, T. Sumitra, C. Udomluck, Іhor Kobza, O. Nykonenko, В. А. Прасол, I. Vladychuk,

Central Venous Catheters and Hemodialysis

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.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 < 3.0. A lower time in therapeutic range was associated with a higher risk of CRB. Conclusions CRB is a frequent complication in cancer patients with VTE during anticoagulant treatment, and is associated with age > 75 years and intracranial malignancy.