MATTERHORN (mitral regurgitation)
Trial question
Is transcatheter edge-to-edge repair noninferior to mitral valve surgery in patients with HF and secondary MR?
Study design
Multi-center
Open label
RCT
Population
Characteristics of study participants
40.0% female
60.0% male
N = 208
208 patients (83 female, 125 male).
Inclusion criteria: patients with HF and secondary MR.
Key exclusion criteria: another severe valvular disease; coronary revascularization or CRT within the past 1 month; severe tricuspid regurgitation; not amenable for mitral valve surgery/percutaneous mitral valve reconstruction.
Interventions
N=104 transcatheter repair (mitral valve repair with the MitraClip™ device).
N=104 surgery (mitral valve surgery).
Primary outcome
Rate of death, hospitalization for heart failure, mitral valve reintervention, implantation of an assist device, or stroke within 1 year after the procedure
16.7%
22.5%
22.5 %
16.9 %
11.3 %
5.6 %
0.0 %
Transcatheter
repair
Surgery
Difference not exceeding
non-inferiority
margin ✓
Difference not exceeding non-inferiority margin in the rate of death, hospitalization for HF, mitral valve reintervention, implantation of an assist device, or stroke within 1 year after the procedure (16.7% vs. 22.5%; MD -6, 95% CI -17 to 6).
Secondary outcomes
Significant increase in recurrence of grade 3 or 4 MR at 1 year (8.9% vs. 1.5%; MD 7, 95% CI 0 to 14).
No significant difference in death from any cause (8.1% vs. 11.2%; HR 0.61, 95% CI 0.24 to 1.57).
Significant decrease in median in-hospital stay (4 days vs. 12 days; MD -7.88, 95% CI -10.64 to -5.11).
Safety outcomes
Significant difference in major adverse events within 30 days after the procedure (14.9% vs. 54.8%).
Conclusion
In patients with HF and secondary MR, transcatheter repair was noninferior to surgery with respect to the rate of death, hospitalization for HF, mitral valve reintervention, implantation of an assist device, or stroke within 1 year after the procedure.
Reference
Stephan Baldus, Torsten Doenst, Roman Pfister et al. Transcatheter Repair versus Mitral-Valve Surgery for Secondary Mitral Regurgitation. N Engl J Med. 2024 Nov 14;391(19):1787-1798.
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