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Abstract - Final – Jan. 6, 2011

Comparative Effectiveness of Therapies for Heart Failure (COMPARE-HF)

Topic Abstract

Background: Heart failure (HF) is one of the most important public health problems in the United States, affecting over 5 million Americans. While there have been significant advances in HF therapies, there remain significant questions regarding effectiveness in the ‘real-world.’

Objective: To estimate the effectiveness of 3 major HF therapies: aldosterone antagonists, anticoagulation, and cardiac resynchronization therapy (CRT).

Study Design: Retrospective cohort studies

Methods: To assess the effectiveness of aldosterone antagonist therapy, we will link a national HF registry with Medicare claims. The population will include approximately 5,000 linked fee-for-service patients aged 65 and older who were eligible for antagonist therapy and discharged alive to home between January 2005 and December 2008. The treatment of interest is aldosterone antagonist therapy. Patients prescribed the therapy will be compared to patients not prescribed the therapy. Outcomes include death, cardiovascular readmission, and readmission for hyperkalemia. Propensity score techniques will be used to minimize treatment selection bias. The period of follow-up for ascertainment will be 1 year following discharge.

The effectiveness of anticoagulation will be addressed in a national HF registry linked with Medicare claims. The population will include approximately 14,000 linked patients aged 65 and older with HF and atrial fibrillation who were eligible for anticoagulation and discharged alive to home between January 2005 and December 2008. Patients prescribed warfarin will be compared to patients not prescribed the therapy. Outcomes of interest include death, cardiovascular readmission, and readmission for bleeding. Propensity score techniques will be used to minimize treatment selection bias. The period of follow-up will be 3 years following discharge.

The effectiveness of CRT will be addressed in a national device registry and a national HF registry linked with Medicare claims. The study population will include approximately 130,000 linked patients aged 65 and older who were eligible for CRT therapy and discharged alive. Patients who received a CRT will be compared to patients who did not receive a device. Outcomes of interest include death and cardiovascular readmission. Disease risk score techniques will minimize treatment selection bias. The period of follow-up will be 3 years following discharge.

Expected Outputs: Three scientific reports will be generated regarding each HF therapy (aldosterone antagonists, anticoagulation, and CRT).

Expected Dates of Completion: The aldosterone antagonist project will be completed by June 2012. The anticoagulation project will be completed by August 2012, and the CRT project will be completed by July 2013.

EHC Priority Condition: Cardiovascular Disease

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