Characteristics of patients receiving extended treatment after incident venous thromboembolism

SummaryIn December 2014 the CATCH study was presented at the annual meeting of the American Society of Hematology. CATCH is a randomized controlled trial comparing the low molecular weight heparin tinzaparin with warfarin for 6 months extended treatment (=secondary prophylaxis) of cancer-associated venous thromboembolism (VTE). 6.9 % of patients in the tanzaparin arm experienced recurrent symptomatic and asymptomatic VTE compared with 10 % in the warfarin arm, this difference was statistically not significant. The difference became significant when only symptomatic VTEs were compared. There was no difference in the incidence of major bleeding events, but significantly fewer patients experienced clinically relevant non-major bleeding with tinzaparin than warfarin. The CATCH study is so far the largest study on extended treatment of cancer-associated VTE. It supports the guideline recommendation that low molecular weight heparins should be preferred to vitamin K antagonists for anticoagulation of cancer-associated VTE.

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Case Fatality Rates of Recurrent Thromboembolism and Bleeding in Patients Receiving Direct Oral Anticoagulants for the Initial and Extended Treatment of Venous Thromboembolism

Journal of Cardiovascular Pharmacology and Therapeutics ◽

10.1177/1074248415575154 ◽

2015 ◽

Vol 20 (5) ◽

pp. 490-500 ◽

Cited By ~ 28

Author(s):

Antonio Gómez-Outes ◽

Ramón Lecumberri ◽

M. Luisa Suárez-Gea ◽

Ana-Isabel Terleira-Fernández ◽

Manuel Monreal ◽

...

Keyword(s):

Venous Thromboembolism ◽

Oral Anticoagulants ◽

Direct Oral Anticoagulants ◽

Case Fatality ◽

Extended Treatment

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Benefits and risks of extended treatment of venous thromboembolism with rivaroxaban or with aspirin

Thrombosis Research ◽

10.1016/j.thromres.2018.06.009 ◽

2018 ◽

Vol 168 ◽

pp. 121-129 ◽

Cited By ~ 1

Author(s):

Paolo Prandoni ◽

Anthonie W.A. Lensing ◽

Martin H. Prins ◽

Martin Gebel ◽

Akos F. Pap ◽

...

Keyword(s):

Venous Thromboembolism ◽

Extended Treatment

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Extended Treatment of Venous Thromboembolism

New England Journal of Medicine ◽

10.1056/nejmc1705484 ◽

2017 ◽

Vol 376 (25) ◽

pp. 2491-2492 ◽

Cited By ~ 1

Keyword(s):

Venous Thromboembolism ◽

Extended Treatment

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Evaluation of Oral Anticoagulants for the Extended Treatment of Venous Thromboembolism Using a Mixed-Treatment Comparison, Meta-Analytic Approach

Clinical Therapeutics ◽

10.1016/j.clinthera.2014.06.033 ◽

2014 ◽

Vol 36 (10) ◽

pp. 1454-1464.e3 ◽

Cited By ~ 7

Author(s):

Brett M. Rollins ◽

Matthew A. Silva ◽

Jennifer L. Donovan ◽

Abir O. Kanaan

Keyword(s):

Venous Thromboembolism ◽

Oral Anticoagulants ◽

Analytic Approach ◽

Mixed Treatment Comparison ◽

Extended Treatment ◽

Treatment Comparison ◽

Mixed Treatment

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Influence of Thrombophilia on the Efficacy of Dabigatran Versus Warfarin for the Extended Treatment of Acute Venous Thromboembolism in RE-MEDY™

Blood ◽

10.1182/blood.v124.21.1544.1544 ◽

2014 ◽

Vol 124 (21) ◽

pp. 1544-1544 ◽

Cited By ~ 5

Author(s):

Sam Schulman ◽

Henry Eriksson ◽

Samuel Z. Goldhaber ◽

Ajay Kakkar ◽

Clive Kearon ◽

...

Keyword(s):

Pulmonary Embolism ◽

Venous Thromboembolism ◽

Treatment Efficacy ◽

Research Funding ◽

Factor V Leiden ◽

Factor V ◽

Total Study Population ◽

Extended Treatment ◽

Advisory Boards ◽

Bayer Healthcare

Abstract Background: Dabigatran etexilate (DE) was noninferior to warfarin for the prevention of recurrent venous thromboembolism (VTE), with a lower risk of bleeding, when administered as extended treatment for VTE in the RE-MEDY™ study (in which we evaluated long-term extension of treatment with dabigatran compared with warfarin). Objectives: Thrombophilia is a major risk factor for VTE recurrence. Therefore, we performed a post-hocsubgroup analysis on data from RE-MEDY™ to investigate the efficacy of DE versus warfarin in patients with and without thrombophilia (congenital or acquired) at baseline. Methods: Patients were aged ≥ 18 years and had objectively-confirmed, symptomatic, proximal deep vein thrombosis or pulmonary embolism (PE) that had been treated with an approved anticoagulant for 3–12 months, or with DE in one of two clinical trials of treatment for acute VTE (RE-COVER™ or RE-COVER™ II). Eligible patients were those at increased risk for recurrent VTE. Patients were randomly allocated to receive DE 150 mg twice daily or warfarin (international normalized ratio range 2.0–3.0) for 6–36 months. The primary efficacy outcome was recurrent, symptomatic, objectively-confirmed VTE or VTE-related death from randomization up to the end of the planned treatment period (6–36 months). No thrombophilia workup was required for enrollment in the trial. Results: Overall, 262/1430 (18.3%) patients randomized to DE and 263/1426 (18.4%) randomized to warfarin had thrombophilia identified at baseline. Factor V Leiden thrombophilia was the most common type (Table). The frequencies of VTE/VTE-related deaths, and of PE, in patients with and without thrombophilia are shown in the Table. Treatment efficacy (DE versus warfarin) was not significantly affected by the presence of thrombophilia. Table DE (n = 1430) Warfarin (n = 1426) Thrombophilia, n (%) No 433 (30.3) 407 (28.5) Yes 262 (18.3) 263 (18.4) Factor V Leiden 131 (9.2) 137 (9.6) Prothrombin mutation 35 (2.4) 28 (2.0) Antithrombin deficiency 11 (0.8) 11 (0.8) Protein C/S deficiencies 25 (1.7) 29 (2.0) Antiphospholipid antibodies and/or lupus anticoagulants 38 (2.7) 54 (3.8) Not tested 735 (51.4) 756 (53.0) VTE/VTE-related deaths, n/N (%) Pulmonary embolism, n/N (%) DE Warfarin DE Warfarin Thrombophilia No 10/433 (2.3) 3/407 (0.7) 3/433 (0.7) 1/407 (0.2) Yes 4/262 (1.5) 6/263 (2.3) 3/262 (1.1) 2/263 (0.8) Not tested 12/735 (1.6) 9/756 (1.2) 4/735 (0.5) 2/756 (0.3) Total study population: Hazard ratio (DE vs warfarin) (95% confidence interval) 1.43 (0.78, 2.61) 1.97 (0.67, 5.76) Treatment (DE vs warfarin) by thrombophilia interaction p = 0.2277 p = 0.9003 p-value from Chi-square test for overall factor effect. Full analysis set. Conclusions: The frequencies of VTE/VTE-related death, and of PE, were similar for DE and warfarin in patients with thrombophilia who were receiving extended treatment for VTE. Treatment efficacy was not affected by the presence of thrombophilia. Disclosures Schulman: Boehringer Ingelheim: Consultancy, Honoraria, Research Funding; Bayer HealthCare: Consultancy, Honoraria, Research Funding. Eriksson:Boehringer Ingelheim: Consultancy; BMS: Consultancy; Pfizer: Consultancy. Goldhaber:Boehringer Ingelheim: Consultancy; Daiichi: Consultancy, Research Funding; BMS: Consultancy, Research Funding; Janssen: Consultancy; Merck: Consultancy; Pfizer: Consultancy; Portola: Consultancy; Sanofi-Aventis: Consultancy. Kakkar:Boehringer Ingelheim: Consultancy, Honoraria, Research Funding; Pfizer: Consultancy, Honoraria, Research Funding; BMS: Consultancy, Honoraria, Research Funding; Daiichi: Consultancy, Honoraria, Research Funding; Bayer: Consultancy, Honoraria, Research Funding; Sanofi: Consultancy, Honoraria, Research Funding; Eisai: Consultancy, Honoraria, Research Funding. Kearon:Bayer Healthcare: Consultancy; Boehringer Ingelheim (Canada): Consultancy. Schellong:Boehringer Ingelheim: advisory boards Other, Consultancy, Honoraria; Bayer Healthcare: advisory boards, advisory boards Other, Consultancy, Honoraria; Daiichi Sankyo: advisory boards, advisory boards Other, Honoraria; BMS/Pfizer: Honoraria. Feuring:Boehringer Ingelheim: Employment. Friedman:Boehringer Ingelheim: Consultancy. Kreuzer:Boehringer Ingelheim: Employment.

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