Ventricular reverse remodeling and 6-month outcomes in patients receiving cardiac resynchronization therapy: analysis of the MIRACLE study.

OBJECTIVE: The objective of this analysis was to determine if there were differences in ventricular reverse remodeling and 6-month outcome with cardiac resynchronization therapy (CRT) among specific subgroups enrolled in the Multicenter InSync Randomized Clinical Evaluation (MIRACLE) Study.
BACKGROUND: Analysis of major subgroups receiving CRT is important in determining who may be most likely to benefit, since all patients who receive CRT do not demonstrate improvement.
METHODS: Differences in response to CRT between subgroups based on baseline echocardiographic parameters, New York Heart Association (NYHA) class, age, gender, beta blocker use, and etiology of heart failure (HF) were analyzed for the clinical end points of the study as well as 6-month HF re-hospitalization or death.
RESULTS: The benefit of CRT over control was similar in all subgroups with respect to all clinical endpoints. However, non-ischemic HF patients had greater improvements with CRT compared to ischemic HF patients in left ventricular end diastolic volume (P < 0.001) and ejection fraction (EF) (6.7% increase vs. 3.2% [P < 0.001]). Greater improvements in EF were also seen in those patients with less severe baseline mitral regurgitation (MR) (P < 0.001). Women but not men receiving CRT were more likely to be event-free from first HF hospitalization or death compared to the control group (Hazard Ratio = 0.157).
CONCLUSIONS: The benefits of CRT with respect to EF and reverse remodeling were greater in patients with non-ischemic HF and less severe MR. Women may also derive more benefit than men with respect to the occurrence of HF hospitalization or death.

RCT Entities:   Population Interventions Outcomes