Key result
Carillon device increases clinically important 6MWT improvements by ~157% versus sham.
Why the study?
Functional outcomes over 1 year had not been compared between the Carillon device and control in patients with moderate to severe functional mitral regurgitation in a blinded sham-controlled trial.
Does the Carillon device improve functional outcomes and reduce heart failure hospitalization or death in patients with moderate to severe functional mitral regurgitation compared to a sham procedure?
RCT (n=83)
Blinded
Does the Carillon device improve functional outcomes and reduce heart failure hospitalization or death in patients with moderate to severe functional mitral regurgitation compared to a sham procedure?
The Carillon device significantly improved 6-minute walk test distance compared to a sham procedure in patients with moderate to severe functional mitral regurgitation at 1 year.
Supports Carillon for functional gains in moderate-severe FMR; extends sham-controlled RCT evidence on 6MWT.
AIMS: The objective of this study was to compare functional outcomes through 1 year in patients with core-lab verified moderate to severe (Grades 2+ to 4+) functional mitral regurgitation (FMR) treated with the Carillon device or control in the blinded sham-controlled REDUCE-FMR (Carillon Mitral Contour System for Reducing Functional Mitral Regurgitation) study. METHODS AND RESULTS: The main outcomes of this analysis were the change in 6 min walk test (6MWT) distance, incidence of heart failure hospitalization or death, change in New York Heart Association (NYHA) class, and change in Kansas City Cardiomyopathy Questionnaire (KCCQ) score through 1 year of follow-up. The minimum clinically important difference (MCID) was defined as a ≥30 m increase in 6MWT distance, an NYHA decrease in ≥1 class, and a ≥3 point increase in KCCQ score. The proportion of patients achieving the MCID in each treatment group was compared using Fisher's exact test, and the number needed to treat (NNT) with the Carillon device was calculated. Among 83 patients (62 Carillon and 21 sham), no statistically significant group differences were observed in the baseline characteristics. All outcomes at 1 year numerically favoured the Carillon group, including MCID for the 6MWT distance (59% vs. 23%, P = 0.029; NNT = 2.8), NYHA class (48% vs. 33%, P = 0.38; NNT = 6.9), KCCQ score (69% vs. 47%, P = 0.14; NNT = 4.5), and freedom from heart failure hospitalization or death (60% vs. 48%, P = 0.45; NNT = 8.3). CONCLUSIONS: REDUCE-FMR was the first blinded sham-controlled trial to report outcomes with percutaneous therapy for the treatment of FMR. Trends towards improvement in mean 6MWT distance, KCCQ score, and NYHA class were observed with the Carillon device. A substantially higher number of patients achieved MCID for all patient-centred outcomes with the Carillon device compared with the sham procedure.
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Khan et al. (2021) conducted an RCT in Functional mitral regurgitation (Grades 2+ to 4+) (n=83). Carillon device vs. Sham procedure was evaluated on Minimum clinically important difference (MCID) for 6 min walk test (6MWT) distance (≥30 m increase) (NNT 2.8, p=0.029). The Carillon device significantly increased the proportion of patients achieving a clinically important improvement in 6-minute walk test distance compared to a sham procedure (59% vs. 23%, P=0.029).
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