Randomized Trial of Cardiac Resynchronization in Mildly Symptomatic Heart Failure Patients and in Asymptomatic Patients With Left Ventricular Dysfunction and Previous Heart Failure Symptoms
Cecilia Linde, MD, PhD*,*,
William T. Abraham, MD, FACC ,
Michael R. Gold, MD, PhD ,
Martin St. John Sutton, MD ,
Stefano Ghio, MD¶,
Claude Daubert, MD|| on behalf of the REVERSE (REsynchronization reVErses Remodeling in Systolic left vEntricular dysfunction) Study Group
* Department of Cardiology, Karolinska University Hospital, Stockholm, Sweden
Division of Cardiovascular Medicine and the Davis Heart and Lung Research Institute, Ohio State University, Columbus, Ohio
Division of Cardiology, Medical University of South Carolina, Charleston, South Carolina
University of Pennsylvania Medical Center, Philadelphia, Pennsylvania
¶ Policlinico San Matteo, Pavia, Italy
|| Département de Cardiologie, CHU, Rennes, France
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Figure 1 The HF Clinical Composite Response
The primary end point, comparing the proportion of worsened subjects at 12 months (p = 0.10). CRT-OFF = control patients; CRT-ON = patients receiving cardiac resynchronization therapy; HF = heart failure.
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Figure 2 Mean LVEDVi, and LVEF at Baseline and 12 Months in the CRT-OFF and CRT-ON Groups
Error bars represent 95% confidence intervals. Red circles = CRT-OFF (n = 163); green triangles = CRT-ON (n = 324). CRT = cardiac resynchronization therapy; LVEDVi = left ventricular end-diastolic volume index; LVEF = left ventricular ejection fraction; LVESVi = left ventricular end-systolic volume index; other abbreviations as in Figure 1.
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Figure 3 Effect of CRT on LVESVi
An analysis of the mean change in LVESVi (ml/m2) from baseline to 12 months is shown. The difference (CRT-OFF – CRT-ON) in the mean changes, along with its 95% confidence interval, is shown for each subgroup. Confidence intervals that do not include 0 indicate statistical significance (p < 0.05). The subgroups of age, systolic blood pressure, ejection fraction, end-systolic volume index, QRS width, interventricular mechanical delay, and glomerular filtration rate are divided according to the median value in the study sample. Green bars = CRT-ON; red bars = CRT-OFF. ICD = implantable cardioverter-defibrillator; IVMD = interventricular mechanical delay; NYHA = New York Heart Association; other abbreviations as in Figure 2.
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Figure 4 Effect of CRT on the HF Clinical Composite Response of Worsened in Subgroups
Analysis of the percentage worsened in the HF clinical composite response using odds ratios and 95% confidence intervals is shown. Lower odds ratios favor CRT-ON. An odds ratio of 0.5 means the odds of a patient being in worsened condition are half as high in the CRT-ON group as the CRT-OFF group. The subgroups of age, systolic blood pressure, ejection fraction, end-systolic volume index, QRS width, interventricular mechanical delay, and glomerular filtration rate are divided according to the median value in the study sample. Because of missing baseline data, not all subgroup numbers equal a total of 610. Abbreviations as in Figures 1, 2, and 3.
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Figure 5 Time to First Heart Failure Hospitalization in the First 12 Months in the CRT-OFF and CRT-ON Groups
Heart failure relatedness of hospitalizations was adjudicated by the Adverse Events Advisory Committee. The number at risk at 12 months represents the number of patients who had a randomized follow-up after 365 days and had not experienced a HF hospitalization. The number decreases at 12 months mainly because U.S. subjects finished randomized follow-up at 12 months. Abbreviations as in Figures 1 and 2.
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