Patients with heart failure often have impaired physical function and reduced quality of life (QoL). Therefore, improving QoL by a minimum clinically important difference (MCID) is an important measure of the effectiveness of heart failure management.
This recently published paper is a rigorous analysis of the REDUCE FMR trial, focusing on the intended patient population based on core-lab adjudication*. It shows convincing 12-month results for the only sham-controlled randomized blinded study ever conducted in heart valve treatment.
- A substantially higher number of patients achieved MCID for all patient‐centered outcomes with the Carillon device compared with the sham procedure.
- Improvement for the 6 minute walk test (6MWT)
- Improvement in NYHA class
- Improvement in QoL, based on the KCCQ survey
- Decrease in heart failure hospitalization
- In particular, the proportion of patients who achieved MCID improvement in the 6MWT (≥30 m increase) at 1 year of follow‐up from baseline was significantly higher in the Carillon device group compared with the sham group (59% vs. 23%, respectively; P = 0.029), even though REDUCE-FMR was only powered to detect the mechanistic endpoint of mitral regurgitation reduction.
- The number needed to treat (NNT) for a ≥30 m increase in 6MWT distance with the Carillon device was 2.8, and the NNT for a ≥20 m increase in 6MWT distance was 3.6.
- Additionally, all other clinical improvements of patients receiving the device relative to control are also encouraging and support the continued utilization of the Carillon device.
The authors conclude: “The patient population in this subgroup of those enrolled in REDUCE‐FMR (EROA, 0.31 cm2; LVDD, 66 mm) resembles that of the MITRA‐FR trial and is more generalizable to patients with HF and moderate to severe FMR. However, unlike the MITRA‐FR trial, our results show a trend towards improvement in patient‐centred outcomes with the Carillion device. In fact, the low NNT for all patient‐centred outcomes suggests that the Carillon device is likely to provide benefit in a large proportion of patients with FMR, rather than just a small subset. Furthermore, unlike the COAPT and MITRA‐FR trials, the REDUCE‐FMR trial used a sham procedure in the control group, which increases the reliability of its results by minimizing placebo and nocebo effects.”
*The intended patient population analysis was conducted to assess functional outcomes of patients with heart failure with reduced ejection fraction and moderate to severe (Grades 2+ to 4+) functional mitral regurgitation (FMR) treated with the Carillon device or control. Since 29.7% of patients were enrolled with only mild core-lab adjudicated MR grade 1+, this analysis focused on the intended patient population of the REDUCE FMR Trial with inclusion criteria of MR grades 2+ to 4+.