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

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

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.

Publication types

  • Clinical Trial, Phase III
  • Comparative Study
  • Multicenter Study
  • Randomized Controlled Trial

MeSH terms

  • Adolescent
  • Adult
  • Aged
  • Aged, 80 and over
  • Drug Administration Schedule
  • Female
  • Fibrinolytic Agents / administration & dosage
  • Fibrinolytic Agents / adverse effects*
  • Glomerular Filtration Rate*
  • Hemorrhage / chemically induced*
  • Hemorrhage / mortality
  • Humans
  • Incidence
  • Kidney / physiopathology*
  • Kidney Diseases / complications*
  • Kidney Diseases / diagnosis
  • Kidney Diseases / mortality
  • Kidney Diseases / physiopathology
  • Male
  • Middle Aged
  • Neoplasms / blood
  • Neoplasms / complications*
  • Neoplasms / mortality
  • Prospective Studies
  • Recurrence
  • Risk Assessment
  • Risk Factors
  • Time Factors
  • Tinzaparin / administration & dosage
  • Tinzaparin / adverse effects*
  • Treatment Outcome
  • Venous Thromboembolism / blood
  • Venous Thromboembolism / drug therapy*
  • Venous Thromboembolism / etiology
  • Venous Thromboembolism / mortality
  • Warfarin / administration & dosage
  • Warfarin / adverse effects*
  • Young Adult

Substances

  • Fibrinolytic Agents
  • Warfarin
  • Tinzaparin

Associated data

  • ClinicalTrials.gov/NCT01130025