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1 Dabigatran Etexilate Versus Warfarin in the Treatment of Venous ThromboembolismClinically Relevant Abstract

Oral and Poster Abstracts
Oral Session: Plenary Session
Sunday, December 6, 2009: 2:00 PM
Hall F (Ernest N. Morial Convention Center)

Sam Schulman1*, Henry Eriksson2*, Samuel Z. Goldhaber3, Ajay K Kakkar, MD, PhD4, Clive Kearon5, Patrick Mismetti6*, Sebastian M Schellong7*, David Baanstra8* and Janet Schnee9*

1Department of Medicine, McMaster University, Hamilton, ON, Canada
2Sahlgrenska University Hospital-Östra, Gothenburg, Sweden
3Brigham & Women's Hospital, Boston, MA
4Barts and the London School of Medicine, Thrombosis Research Institute, London, United Kingdom
5Henderson Hospital, McMaster University Clinic, Hamilton, ON, Canada
6Vascular pathology, Bellevue Hospital, Saint Etienne, France
7Medical Division 2, Municipal Hospital Friedrichstadt, Dresden, Germany
8Clinical Research, Boehringer Ingelheim, Alkmaar, Netherlands
9Boehringer Ingelheim, Ridgefield, CT

Background. The direct oral thrombin inhibitor, dabigatran etexilate, has a predictable anticoagulant effect and may be an alternative to warfarin in patients with acute venous thromboembolism (VTE). Methods. In a randomized, double-blind, trial of 2539 patients with acute VTE, treated with low molecular weight or unfractionated heparin for 5 to 11 days, we compared oral dabigatran etexilate, 150 mg twice daily in a fixed-dose, with warfarin dose-adjusted to an International Normalized Ratio of 2.0 and 3.0, each given for 6 months. The primary outcome was symptomatic, objectively confirmed recurrent VTE or VTE-related death up to 6 months of treatment.  Safety endpoints included bleeding events, acute coronary syndrome, liver function tests, vital signs and adverse events. Results. Of 1274 patients randomized to dabigatran etexilate, at 6 months 30 (2.4%) had recurrent VTE compared with 27 (2.2%) of 1265 patients randomized to warfarin; risk difference 0.4% [95 percent confidence interval, -0.8 to 1.5]; p<0.0001 for prespecified non-inferiority margin. During the planned study participation, through the end of the follow-up period, there were 34 vs. 32 patients who had recurrent VTE in the dabigatran etexilate vs. warfarin treated groups, respectively (hazard ratio 1.05 [95% confidence interval, 0.065 to 1.70]). Major bleeding occurred in 20 patients treated with dabigatran etexilate and 24 patients treated with warfarin (hazard ratio 0.82; 95 percent confidence interval, 0.45 to 1.48) and any bleeding occurred in 207 versus 280 patients, respectively (hazard ratio 0.71, 95 percent confidence interval, 0.59 to 0.85). Death, acute coronary syndromes, and liver function test abnormalities were infrequent and similar in the two groups. Conclusion: Fixed-dose dabigatran etexilate is as effective and safe as warfarin in the treatment of acute VTE.

Disclosures: Schulman: GSK: Honorarium for Chairman of the IDMC; Bayer HealthCare: Honorarium for Chairman of the DSMB; Boehringer-Ingelheim: Honorarium for Chairman of the Steering Committee; Sanofi-Aventis: Honorarium for Chairman of the DSMB, Research Funding. Off Label Use: Dabigatran etexilate is an oral thrombin inhibitor under investigation for anticoagulant prophylaxis or treatment in venous and arterial thrombomebolism. Kakkar: Bayer HealthCare: Consultancy, Honoraria, Research Funding, Scientific Advisory Board; Sanofi-Aventis: Consultancy, Honoraria, Research Funding, Scientific Advisory Board; Boehringer Ingelheim: Consultancy, Honoraria, Research Funding, Scientific Advisory Board; Pfizer: Consultancy, Honoraria, Research Funding, Scientific Advisory Board; Bristol–Myers Squibb: Consultancy, Honoraria, Research Funding, Scientific Advisory Board; Eisai: Consultancy, Honoraria, Research Funding, Scientific Advisory Board; Aryx therapeutics: Consultancy; GSK: Honoraria. Schellong: Bayer HealthCare: Consultancy, Honoraria, Scientific Advisory Board; Sanofi-Aventis: Consultancy, Honoraria, Scientific Advisory Board; Boehringer Ingelheim: Consultancy, Honoraria, Scientific Advisory Board; Pfizer: Scientific Advisory Board; Bristol–Myers Squibb: Consultancy, Honoraria, Scientific Advisory Board; Esai: Consultancy, Honoraria, Scientific Advisory Board; Aryx therapeutics: Consultancy; GSK: Honoraria. Baanstra: Boehringer-Ingelheim: Employment. Schnee: Boehringer-Ingelheim: Employment.

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