Photo Credit: Ronstik
The much-anticipated RESHAPE-HF2 trial aimed to clarify the role of transcatheter edge-to-edge repair (TEER) with the MitraClip device in patients with heart failure with functional mitral regurgitation (FMR). Despite significantly reducing the risk for hospitalization and cardiovascular death while also improving health status within the first year, the trial results did not definitively settle the ongoing debate initiated by the conflicting COAPT and MITRA-FR trials.
The COAPT trial and the MITRA-FR trial were landmark studies that evaluated the use of TEER with the MitraClip device in patients with heart failure and FMR. The COAPT trial demonstrated that MitraClip, when added to optimal medical therapy (OMT), significantly reduced heart failure hospitalizations and all-cause mortality, indicating a substantial benefit for patients1. Conversely, the MITRA-FR trial did not show a significant difference in outcomes between the MitraClip plus OMT and OMT alone, leading to ongoing debates about the appropriate patient population and clinical settings for using this device2.
The conflicting results from these trials underscore the complexity of treating FMR and the necessity for further research to better define which patients benefit most from TEER. With this unresolved question as the backdrop, Stefan Anker, MD, PhD, from Charité Universitätsmedizin, in Germany presented the key findings from RESHAPE-HF2 (NCT02444338), with 3 simultaneous publications of editorials calling for an in-depth analysis of the results from this study to settle this six-year-old debate3. RESHAPE-HF2 was an investigator-initiated, prospective, randomized, parallel-controlled, multicenter trial and the results were published simultaneously in the New England Journal of Medicine4. A meta-analysis of all three trials was also simultaneously published in the Journal of the American College of Cardiology5.
Participants (n=505) were randomly assigned to either receive transcatheter mitral-valve repair alongside guideline-recommended medical therapy (device group) or medical therapy alone (control group). The primary endpoints were the rates of first or recurrent hospitalization for heart failure or cardiovascular death over 24 months, the rate of first or recurrent hospitalization for heart failure alone, and the change in health status as measured by the Kansas City Cardiomyopathy Questionnaire-Overall Summary score (KCCQ-OS) at 12 months.
At 24 months, the device group showed a significant reduction in the rate of first or recurrent hospitalization for heart failure or cardiovascular death, with 37.0 events per 100 patient-years compared with 58.9 events per 100 patient-years in the control group (rate ratio 0.64; 95% CI 0.48–0.85; P=0.002). The rate of first or recurrent hospitalization for heart failure alone was also lower in the device group (26.9 events per 100 patient-years vs 46.6 in the control group; rate ratio 0.59; 95% CI 0.42–0.82; P=0.002). However, there was no significant difference in all-cause mortality between the 2 groups.
Additionally, participants in the device group experienced a more substantial improvement in their KCCQ-OS scores, indicating better health status, with an average increase of 21.6 points compared with an 8.0-point increase in the control group (mean difference 10.9 points; 95% CI 6.8–15.0; P<0.001). Device-specific safety events were minimal, occurring in only 1.6% of patients.
The trial’s conclusions have been met with both support and scepticism, published in a series of editorials concurrent with the articles. Some experts, including COAPT’s Prof. Gregg Stone, view the results as reinforcing the superiority of MitraClip over OMT6. Conversely, MITRA-FR’s Prof. Jean-François Obadia and others question the trial’s design, including its multiple endpoints, protocol amendments, and patient selection criteria, arguing that RESHAPE-HF2 does not conclusively resolve the debate7,8.
In conclusion, while RESHAPE-HF2 contributes valuable data, it does not provide the clear guidance many had hoped for. The trial supports the use of MitraClip in specific patient populations but leaves open questions about its broader applicability, especially in terms of mortality benefits. Further studies are needed in determining the optimal use of TEER in heart failure management.
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