COMPARATIVE EFFICACY AND SAFETY ANALYSIS OF ATRIAL FIBRILLAION PATIENTS TREATED WITH DABIGATRAN IN RE-LY STUDY (CHADS 2 SCORE OF 3 OR GREATER ) VERSUS RIVAROXABAN IN ROCKET-AF

Author(s)

Rasty S1, Soliman W2, Taheri R31Roosevelt University, Buffalo Grove, IL, USA, 2Consultant, Fort lee, NJ, USA, 3West Coast University, Los Angeles, CA, USA

OBJECTIVES: In this analysis we performed comparative efficacy and safety analysis of  atrial fibrillation (AF) patients treated in RE-LY trial with ChadS2 score of 3 or greater  treated with  Dabigatran (Dab)  150mg versus AF patients treated with Rivaroxaban (Riv) in ROCKET-AF study (Avg Chads2 score=3.48). METHODS: Patient’s baseline information and primary efficacy and safety outcomes data for both cohorts were compared.  WINPEPI (2011, version 11.15) epidemiological tool was used to compare the event rates ( safety and efficacy)  per 100 patient year (100PY). RESULTS: Both groups were similar in age ( 73y), and consisted of roughly 40% females. The average SBP and DBP were 130/80 vs 130.9 /76.3 mmHg in Riv vs Dab patients. 82.5% of Riv compared to 69.8% of Dab had persistent AF. In Rocket –AF the average Chads2 score was 3.38 +/- 0.94 with 87% of patients having score of >= 3. Prior ASA intake was 36.3% in Riv vs 42.5% of Dab.  54.9% of Riv vs 55.2% of Dab had previous Stroke/TIA/Systemic embolism.  In Riv group 62.6%,92.3%, 40.4% and 16.6% had CHF, HTN, DM and MI compared to 48.3%, 91.5%,44.8% and 21.6% in the Dab patients. For the primary end point of stroke or systemic embolism 1.7 events in Riv vs 1.87 events in Dab occurred per 100PY (OR=0.91; 95%CI=0.62-1.32); for safety end point of major bleed (any) 3.6 events  in Riv vs 4.85 events in Dab occurred per 100PY (OR=0.73; 95%CI 0.57-0.93) and for Intracranial hemorrhage (ICH) 0.5 events in Riv vs 0.52 events  in Dab  occurred per 100 PY ( OR=1; 95% CI= 0.50-2.02) CONCLUSIONS: This analysis of the published data suggests similar efficacy for both agents when used in AF patients with higher risk for stroke (>=3), higher major bleeding risks with Dab and similar rates for ICH with both agents.

Conference/Value in Health Info

2012-11, ISPOR Europe 2012, Berlin, Germany

Value in Health, Vol. 15, No. 7 (November 2012)

Code

PCV2

Topic

Epidemiology & Public Health

Topic Subcategory

Safety & Pharmacoepidemiology

Disease

Cardiovascular Disorders, Respiratory-Related Disorders

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