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 language | English (US) |
|---|---|
| Pages (from-to) | 1069-1077 |
| Number of pages | 9 |
| Journal | Journal of Thrombosis and Haemostasis |
| Volume | 16 |
| Issue number | 6 |
| DOIs | |
| State | Published - Jun 1 2018 |
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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 journal › Article
}
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 - Naik, Rakhi Prakash
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
UR - http://www.scopus.com/inward/record.url?scp=85045715390&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=85045715390&partnerID=8YFLogxK
U2 - 10.1111/jth.14007
DO - 10.1111/jth.14007
M3 - Article
C2 - 29573330
AN - SCOPUS:85045715390
VL - 16
SP - 1069
EP - 1077
JO - Journal of Thrombosis and Haemostasis
JF - Journal of Thrombosis and Haemostasis
SN - 1538-7933
IS - 6
ER -