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Assessment of a New Method of Warfarin Management vs the New Oral Anticoagulants and Conventional Warfarin Management in Atrial Fibrillation FREE TO VIEW

Henry Bussey, BScPharm; Edith Nutescu
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Genesis Clinical Research, San Antonio, TX

Chest. 2014;146(4_MeetingAbstracts):532A. doi:10.1378/chest.1985931
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SESSION TITLE: Quality & Clinical Improvement Posters I

SESSION TYPE: Original Investigation Poster

PRESENTED ON: Wednesday, October 29, 2014 at 01:30 PM - 02:30 PM

PURPOSE: To assess the impact of International Normalized Ratio (INR) self testing and online remote monitoring and management (STORM2) on clinical events and costs vs. traditional warfarin management and the new oral anticoagulants (NOACs) in atrial fibrillation (AF).

METHODS: The mean INR time in the target range (TTR) was 77.2% in 7 STORM2 trials. Thromboembolism (TE) and major bleeding (MB) rates at 30%, 45%, 55%, 65%, and 75% TTR were calculated using linear regression equations from a systematic review of 38 AF studies (approx. 34,000 patients). MB = 10.104 - 0.120x[TTR], (p = 0.004) and TE = 8.313 - 0.098x[TTR], (p = 0.03). MB and TE rates were sub-divided based on the distribution in the NOAC trials. TTR-based mortality was calculated based on a 6%/yr rate multiplied by the adjusted relative risks from a data base analysis of approximately 38,000 AF patients. Projected event rates at 75% TTR, expressed as number per 1,000 patient-years, were compared to event rates at lower TTR ranges and to rates reported in the NOAC trials. Differences in the rates of ischemic stroke, myocardial infarction, intracranial hemorrhage, major gastrointestinal bleed, and death were used to calculate cost avoidance.

RESULTS: Projected event rates with STORM2 (TTR of 75%) when compared to “conventional ” TTR of 55% to 65% were 64% to 71% lower for MB, 47% to 64% lower for TE, and 47% to 57% lower for mortality. Compared to the NOAC study results, the projected rates were 48% to 70% lower for MB, 41% to 66% lower for TE, and 40% to 53% lower for mortality. Projected cost avoidance was $10.4 million vs. a TTR of < 30%, $2.2 million vs. a TTR of 65%; and from $1.4 to $3.1 million vs the NOACs. Costs of “other” MB and TE , drug costs, and monitoring costs were not included in the estimates. The regression equation projected relative risks of stroke at various TTR values were virtually identical to those reported from the UK data base analysis.

CONCLUSIONS: STORM2 management of warfarin is projected to produce a 50% or greater reduction in major event rates with a cost avoidance of $1.4 to $10.4 million per 1,000 patients per year.

CLINICAL IMPLICATIONS: STORM2 management may transform the safety and efficacy of anticoagulation for the millions of people with AF while substantially reducing costs. These findings warrant randomized, prospective trials in AF and other indications for anticoagulation.

DISCLOSURE: Henry Bussey: Other: I am an unpaid consultant in the development of an online management system (ClotFree) which was developed and is owned by my daughter's company, Fiduciary position (of any organization, association, society, etc, other than ACCP: President and Senior Editor of ClotCare.org (a charitable 501(c)3 information service), Other: As the only , Fiduciary position (of any organization, association, society, etc, other than ACCP: Scientific Advisory Board of the North American Thrombosis Forum Edith Nutescu: Grant monies (from industry related sources): research support from Jansses Health Economics and Outcomes Research, Grant monies (from sources other than industry): research support from The Cranberry Institute, Fiduciary position (of any organization, association, society, etc, other than ACCP: Board of Regents for the American College of Clinical Pharmacy, Fiduciary position (of any organization, association, society, etc, other than ACCP: Board of Directors of the Anticoagulation Forum, Fiduciary position (of any organization, association, society, etc, other than ACCP: Medical and Scientific Advisory Board for the National Blood Clot Alliance, Consultant fee, speaker bureau, advisory committee, etc.: Consultant for Janssen Health Economics and Outcomes Research, Daichii Sankyo, and CSL Behring

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