Dissemination and Adoption of Comparative Effectiveness Research Findings When Findings Challenge Current Practices. Study Design Characteristics


COMPANION was an RCT with three treatment arms, designed to evaluate the efficacy of CRT and CRT-D in patients with HF (NYHA class III or IV), cardiomyopathy (with a left ventricular ejection fraction < 35 percent), delayed ventricular conduction (QRS >120 msec), and no specific indication for an ICD or pacemaker. A total of 1,520 patients were randomized. Patients were assigned in a 1:2:2 ratio to receive optimal pharmacological therapy (OPT), OPT + CRT, or OPT + CRT-D. Follow-up duration was until the primary end point (which averaged about 16 months for those who reached an end point during the two years of the study). The primary-efficacy end point was a composite of either death from any cause or hospitalization from any cause.

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