JACC: Heart Failure
Clinical Research
The REDUCE FMR TrialA Randomized Sham-Controlled Study of Percutaneous Mitral Annuloplasty in Functional Mitral Regurgitation
Klaus K. Witte, Janusz Lipiecki, Tomasz Siminiak, Ian T. Meredith, Christopher J. Malkin, Steven L. Goldberg, Matthew A. Stark, Ralph Stephan von Bardeleben, Paul C. Cremer, Wael A. Jaber, David S. Celermajer, David M. Kaye and Horst Sievert
Table 2
Table 2
Primary and Secondary Outcomes According to ITT Analysis
| Endpoint | Randomized Treatment | Mean Change (95% CI) or Median (Interquartile Range) After 12 Months | Difference in Mean Change or Estimate (95% CI) | p Value |
|---|---|---|---|---|
| Primary outcome | ||||
| Mitral regurgitant volume, ml/beat | Control (n = 13) | 3.32 (−5.98, 12.62) | 10.39 (0.06, 20.71) | 0.049 |
| Treatment (n = 55) | −7.07 (−11.68, −2.46) | |||
| Secondary outcomes: LV parameters | ||||
| LVEDV, ml | Control (n = 16) | 6.54 (−5.14, 18.22) | 16.96 (1.81, 32.12) | 0.03 |
| Treatment (n = 47) | −10.42 (−18.48, −2.37) | |||
| LVESV, ml | Control (n = 16) | 6.10 (−1.42, 13.63) | 12.29 (0.32, 24.28) | 0.04 |
| Treatment (n = 47) | −6.19 (−12.78, 0.39) | |||
| LVEF, % | Control (n = 16) | −0.40 (−3.15, 2.36) | −0.59 (−4.11, 2.93) | 0.74 |
| Treatment (n = 47) | 0.19 (−1.67, 2.06) | |||
| Secondary outcomes: patient-oriented | ||||
| 6-min walk distance, m∗ | Control (n = 20) | 17.5 (−20.0, 46.5) | −14.5 (−46.0, 20.0) | 0.37 |
| Treatment (n = 65) | 32.0 (−10.0, 70.0) | |||
| KCCQ score | Control (n = 24) | 7.63 (0.22, 15.05) | −1.86 (−11.36, 7.65) | 0.70 |
| Treatment (n = 70) | 9.49 (3.26, 15.71) |
CI = confidence interval; KCCQ = Kansas City Cardiomyopathy Quality of Life Questionnaire; other abbreviations as in Table 1.
↵∗ Median measurement with interquartile range (Hodges-Lehmann location shift) and 95% CI due to non-normality of data
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