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

the CATCH Investigators

Research output: Contribution to journalArticle

10 Citations (Scopus)

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 < 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.

Original languageEnglish
Pages (from-to)1069-1077
Number of pages9
JournalJournal of Thrombosis and Haemostasis
Volume16
Issue number6
DOIs
Publication statusPublished - 2018 Jun 1

Fingerprint

Venous Thromboembolism
Hemorrhage
Neoplasms
Warfarin
International Normalized Ratio
Confidence Intervals
Anticoagulants
Multivariate Analysis
Nose
Thrombosis
Regression Analysis

Keywords

  • anticoagulants
  • bleeding
  • neoplasms
  • tinzaparin
  • venous thromboembolism

ASJC Scopus subject areas

  • Hematology

Cite this

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

In: Journal of Thrombosis and Haemostasis, Vol. 16, No. 6, 01.06.2018, p. 1069-1077.

Research output: Contribution to journalArticle

@article{0fa2507a9ddd4c7f8cc0bc0f4f23ebfc,
title = "Clinically relevant bleeding in cancer patients treated for venous thromboembolism from the CATCH study",
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 < 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.",
keywords = "anticoagulants, bleeding, neoplasms, tinzaparin, venous thromboembolism",
author = "{the CATCH Investigators} and Kamphuisen, {P. W.} and Lee, {A. Y.Y.} and G. Meyer and R. Bauersachs and Janas, {M. S.} and Jarner, {M. F.} and Khorana, {A. A.} and {Bella Santiago}, R. and S. Cerana and Zarb{\'a}, {J. J.} and J. Andel and Barrios, {C. H.} and {Borba Reiriz}, A. and F. Cesario and {de Azevedo}, S. and {Ferreira Filho}, {A. F.} and Franke, {F. A.} and S. Padilha and {Paiva Queiroz}, R. and A. Pimenta and J. Rerin and R. Rigo and {van Eyll Rocha}, {S. B.} and {Santos Borges}, G. and G. Vacaro and V. Anastasov and T. Dragneva and G. Georgiev and P. Champion and P. Kuruvilla and C. Gonzalez and P. Ditl and J. F{\"o}rster and B. Lubomir and J. Vydra and {El Hassan}, {R. A.} and S. Sabri and N. Allahloubi and A. Elzawawy and Ezzat, {S. S.} and {El Kady}, {M. S.} and L. Bacchus and J. Beyer-Westendorf and U. Kamphausen and D. Niederwieser and H. Ostermann and M. Sosada and N. Anagnostopoulos and G. Fountzilas and Shin, {Sang Won}",
year = "2018",
month = "6",
day = "1",
doi = "10.1111/jth.14007",
language = "English",
volume = "16",
pages = "1069--1077",
journal = "Journal of Thrombosis and Haemostasis",
issn = "1538-7933",
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TY - JOUR

T1 - Clinically relevant bleeding in cancer patients treated for venous thromboembolism from the CATCH study

AU - the CATCH Investigators

AU - Kamphuisen, P. W.

AU - Lee, A. Y.Y.

AU - Meyer, G.

AU - Bauersachs, R.

AU - Janas, M. S.

AU - Jarner, M. F.

AU - Khorana, A. A.

AU - Bella Santiago, R.

AU - Cerana, S.

AU - Zarbá, J. J.

AU - Andel, J.

AU - Barrios, C. H.

AU - Borba Reiriz, A.

AU - Cesario, F.

AU - de Azevedo, S.

AU - Ferreira Filho, A. F.

AU - Franke, F. A.

AU - Padilha, S.

AU - Paiva Queiroz, R.

AU - Pimenta, A.

AU - Rerin, J.

AU - Rigo, R.

AU - van Eyll Rocha, S. B.

AU - Santos Borges, G.

AU - Vacaro, G.

AU - Anastasov, V.

AU - Dragneva, T.

AU - Georgiev, G.

AU - Champion, P.

AU - Kuruvilla, P.

AU - Gonzalez, C.

AU - Ditl, P.

AU - Förster, J.

AU - Lubomir, B.

AU - Vydra, J.

AU - El Hassan, R. A.

AU - Sabri, S.

AU - Allahloubi, N.

AU - Elzawawy, A.

AU - Ezzat, S. S.

AU - El Kady, M. S.

AU - Bacchus, L.

AU - Beyer-Westendorf, J.

AU - Kamphausen, U.

AU - Niederwieser, D.

AU - Ostermann, H.

AU - Sosada, M.

AU - Anagnostopoulos, N.

AU - Fountzilas, G.

AU - Shin, Sang Won

PY - 2018/6/1

Y1 - 2018/6/1

N2 - 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 < 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.

AB - 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 < 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.

KW - anticoagulants

KW - bleeding

KW - neoplasms

KW - tinzaparin

KW - venous thromboembolism

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