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RESHAPE-HF2, end of the saga on MitraClip to treat functional MI in heart failure?
Key messages
- RESHAPE-HF2 is an ongoing randomized trial evaluating MitraClip in symptomatic heart failure patients with moderate to severe functional MI
- It aims to clarify the conflicting results of MITRA-FR and COAPT. But the population included is at lower risk than in COAPT with less severe MI
Introduction
Functional MI worsens the prognosis of heart failure without knowing whether it is a marker of severity of heart disease or a risk factor.
MITRA-FR studies(1) and COAPT(2) concluded conflicting results on the effectiveness of MitraClip in reducing mortality and hospitalizations for heart failure and improving functional capacity.
The positive results of COAPT were attributed to more severe MI and less advanced heart disease than in MITRA-FR. However, debate persists regarding the benefit of MitraClip in heart failure patients with functional MI.
The RESHAPE-HF2 trial aims to close the debate. Its objective is to evaluate the safety and effectiveness of MitraClip in addition to optimal medical treatment in chronic heart failure patients with clinically significant functional MI.
Methodology and results
This is a multicenter, randomized, parallel-controlled, open-label prospective trial carried out in 9 European countries (France not included) including patients between 18 and 90 years old with the following criteria:
- Symptomatic heart failure (NYHA II-IV) with LVEF between 20 and 50%
- Clinically significant functional mitral leak (moderate to severe or severe) with anatomy compatible with a MitraClip
- Hospitalization for heart failure in the preceding 12 months or BNP≥300 pg/mL or NT-proBNP ≥1000 pg/mL in the 90 days preceding inclusion
- Ambulatory and capable of performing a 6-minute walk test
- Not eligible for isolated mitral valve surgery
Eligible patients were randomized to receive either the MitraClip (latest generation, implanted percutaneously under general anesthesia) in addition to optimal medical treatment or optimal medical treatment alone (control group).
Figure 1 : Design of RESHAPE-HF2
This study had 3 main endpoints evaluated at 24 months: cardiovascular mortality and hospitalizations for heart failure, hospitalizations for heart failure, the difference in the KCCQ quality of life score (between inclusion and 12 months).
Secondary endpoints were numerous, including all-cause mortality during follow-up, NYHA class I/II at 24 months, difference in distance traveled on the 6-minute walk test between the start of the study and 12 months. , all-cause hospitalizations at 24 months, severity of MI (grade 2+ or less) at 12 months.
The statistical plan took into account the presence of the 3 main judgment criteria (Hochberg method).
A total of 506 patients were included, the last in October 2023. The average age was 70 years, only 20% were women, the average LVEF was 31% as in COAPT and MITRA-FR.
Compared to the COAPT study, the population was less comorbid, with less advanced heart disease and therefore at lower risk than in the COAPT trial. Indeed, we note in particular less history of bypass surgery, stroke, peripheral vascular disease, COPD, AF, lower BNP, better renal function, a more efficient 6-minute walk test.
Patients were also better treated than in previous studies with 96% receiving beta-blockers, 82% a mineralocorticoid inhibitor, 82% an ACE inhibitor or sacubitril/valsartan and 7% gliflozins. It seems that the MI was less severe with a regurgitant orifice surface area of 0.25 cm.2.
Conclusion
RESHAPE-HF2 aims to evaluate the benefit of MitraClip (latest generation) in functional MI in heart failure patients on the reduction of cardiovascular mortality and hospitalizations for heart failure, the reduction of hospitalizations for heart failure and improvement in quality of life at 24 months.
It aims to close the debate initiated following the results of COAPT, positive and MITRA-FR, negative on the place of MitraClip in functional MI in heart failure patients. However, the populations of RESHAPE-HF2 and COAPT are not comparable. RESHAPE-HF2 included patients with less severe MI, less advanced heart disease and therefore at lower risk.
Indeed, while the all-cause mortality at 1 year in the control group of COAPT and MITRA-FR was 23%, the interim analysis of RESHAPE-HF2 carried out in 2018 on 335 patients found a mortality at 1 year of 10- 11% (for 17% anticipated). In order to obtain sufficient power, it was necessary to increase the number and modify the statistical plan. This was done during the study by increasing from 420 to 506 patients and choosing 3 main endpoints, of which it is expected that mortality and hospitalizations for heart failure will lack power and that the results will be driven by the improvement or not in the quality of life.
The first results of this trial are expected at the congress of theESC 2024 in London.
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