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Clinical Trial
. 2018 May;118(5):914-921.
doi: 10.1055/s-0038-1641150. Epub 2018 Apr 4.

Renal Impairment, Recurrent Venous Thromboembolism and Bleeding in Cancer Patients with Acute Venous Thromboembolism-Analysis of the CATCH Study

Rupert Bauersachs  1   2 , Agnes Y Y Lee  3 , Pieter W Kamphuisen  4 , Guy Meyer  5 , Mette S Janas  6 , Mikala F Jarner  6 , Alok A Khorana  7 ; CATCH Investigators
Affiliations
Clinical Trial

Renal Impairment, Recurrent Venous Thromboembolism and Bleeding in Cancer Patients with Acute Venous Thromboembolism-Analysis of the CATCH Study

Rupert Bauersachs et al. Thromb Haemost. 2018 May.

Abstract

Objective: This article assesses the impact of renal impairment (RI) on the efficacy and safety of anticoagulation in patients with cancer-associated thrombosis from the Comparison of Acute Treatments in Cancer Hemostasis (CATCH) study (NCT01130025).

Materials and methods: Renal function was assessed using the Modification of Diet in Renal Disease equation in patients with cancer-associated thrombosis who received either tinzaparin (175 IU/kg) once daily or warfarin for 6 months, in an open-label, randomized, multi-centre trial with blinded adjudication of outcomes. Associations between baseline RI (glomerular filtration rate [GFR] <60 mL/min/1.73m2) and recurrent symptomatic or incidental venous thromboembolism (VTE), clinically relevant bleeding (CRB), major bleeding and death were assessed using Fisher's exact test.

Results: Baseline-centralized GFR data were available for 864 patients (96% of study population). RI was found in 131 patients (15%; n = 69 tinzaparin). Recurrent VTE occurred in 14% of patients with and 8% of patients without RI (relative risk [RR] 1.74; 95% confidence interval [CI] 1.06, 2.85), CRB in 19% and 14%, respectively (RR 1.33; 95% CI 0.90, 1.98), major bleeding in 6.1% and 2.0%, respectively (RR 2.98; 95% CI 1.29, 6.90) and mortality rate was 40% and 34%, respectively (RR 1.20; 95% CI 0.94, 1.53). Patients with RI on tinzaparin showed no difference in recurrent VTE, CRB, major bleeding or mortality rates versus those on warfarin.

Conclusion: RI in patients with cancer-associated thrombosis on anticoagulation was associated with a statistically significant increase in recurrent VTE and major bleeding, but no significant increase in CRB or mortality. No differences were observed between long-term tinzaparin therapy and warfarin.

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Conflict of interest statement

R.B. reports personal fees from LEO Pharma during the conduct of the study and personal fees (honoraria and consultancy) from Bayer, Boehringer Ingelheim, Bristol-Myers Squibb and LEO Pharma outside the submitted work. A.Y.Y.L. reports non-financial and other support from Bristol-Myers Squibb and personal fees (consultancy) from Pfizer and LEO Pharma during the conduct of the study. P.W.K. reports personal fees from LEO Pharma during the conduct of the study and grants from Pfizer, Boehringer Ingelheim and Daichi Sankyo outside the submitted work. G.M. reports grants from Bayer, Boehringer Ingelheim and LEO Pharma and travel, accommodation or other expenses from Bayer, Pfizer and Daiichi Sankyo outside the submitted work. M.S.J. reports being an employee of LEO Pharma. M.F.J. reports personal fees from LEO Pharma during the conduct of the study and outside the submitted work. A.A.K. reports institutional grants from LEO Pharma and Amgen, personal fees (honoraria and consultancy) from LEO Pharma, Daichi Sankyo, Sanofi, AngioDynamics, Genentech, Janssen Pharmaceuticals, Boehringer Ingelheim, Halozyme and Bayer, and travel, accommodation or other expenses from AngioDynamics, Janssen Pharmaceuticals and Pfizer outside the submitted work.

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