Key Points:
- The Mitral Transcatheter Edge-to-Edge Repair (M-TEER) procedure with the MitraClip device has shown in the previous COAPT trial to reduce heart failure hospitalizations and mortality in patients with heart failure and severe functional mitral regurgitation (FMR).
- The RESHAPE-HF2 trial demonstrated that M-TEER, when added to standard care, significantly reduces heart failure hospitalizations compared to optimal standard of care alone in patients with FMR but did not significantly reduce mortality. M-TEER also substantially improved quality of life scores in heart failure patients as compared to optimal standard of care alone.
- RESHAPE-HF2 provides further evidence of the benefits of M-TEER in patients with reduced ejection fraction and FMR.
Functional mitral regurgitation (FMR) is common in heart failure (HF) patients and is associated with poor outcomes. Surgical repair of the mitral valve involves significant operative risk with unclear benefits. The mitral transcatheter edge-to-edge repair (M-TEER) procedure via the MitraClip device, which is percutaneously implanted to reduce FMR by approximating the mitral leaflets, has shown promise in improving symptoms and left ventricular remodeling in certain studies, particularly in the COAPT trial which demonstrated benefits of M-TEER in reducing heart failure hospitalizations and mortality in patients with severe persistent FMR. However, further trials are needed to conclusively establish its safety and effectiveness, particularly in patients with moderate-severe FMR. In a breaking presentation at the 2024 ESC Congress today, Dr. Stefan Anker (Charite University Hospital, Germany) and his team presented their study: “RESHAPE-HF2: Percutaneous Repair of Moderate-to-Severe or Severe Functional Mitral Regurgitation In Patients with Symptomatic Heart Failure.”
The RESHAPE-HF trial (NCT02444338) was an international, multicenter, prospective randomized, open-label trial designed to compare M-TEER in addition to optimal standard of care therapy to optimal standard of care therapy alone among patients with 3+ or 4+ FMR with a recent HF hospitalization or elevated plasma natriuretic peptide concentration within the last 90 days. Key exclusion criteria included primary degenerative mitral regurgitation, evidence of acute coronary syndrome, stroke, or transient ischemic attack within 90 days prior to randomization, any introduction of a new heart failure drug class within 2 weeks prior to randomization, implantation/revision of any rhythm management device (such as implantable cardiac defibrillator or cardiac resynchronization therapy), or determination of mitral surgery as the preferred therapeutic option. The trial had three primary outcomes: 1) the composite rate of total HF hospitalizations and cardiovascular death during 24 months of follow-up, 2) the rate of total HF hospitalizations within 24 months, and 3) the change from baseline to 12 months in the Kansas City Cardiomyopathy Questionnaire (KCCQ) overall score.
The RESHAPE-HF2 trial enrolled a total of 505 patients over 8 years in Europe; 250 were assigned to the device group and 255 to the control group.. RESHAPE-HF2 showed a statistically significant reduction over optimal standard of care in the composite of HF hospitalizations and all-cause mortality over 2 years (37.0 per 100 patient-years vs. 58.9 per 100 patient-years; rate ratio [RR] 0.64, 95% confidence interval [CI] 0.48-0.85, p=0.002). This finding was driven by a reduction in HF hospitalizations versus the control cohort (26.9 per 100 patient-years vs 57.8 per 100 patient-years; RR: 0.59, 95% CI 0.42, 0.82, p=0.002). However, it did not achieve a statistically significant reduction in mortality (17.0% in the MitraClip cohort, 18.5% in the control cohort; hazard ratio 0.90, 95% CI 0.71-1.13, p>0.05), in contrast to the results from COAPT. The MitraClip cohort also experienced an improved KCCQ score in contrast to the control cohort (+21.6 vs. +8.0; mean difference of +10.9, 95% CI 6.8-15.0, p<0.001).
Dr. Anker concluded, “RESHAPE-HF2 now provides additional compelling evidence for using M-TEER over optimal medical therapy alone, which will help to guide medical decision making.”