RESHAPE-HF2
Trial question
What is the role of transcatheter mitral valve repair in addition to medical therapy in patients with HF with moderate-to-severe functional MR?
Study design
Multi-center
Open label
RCT
Population
Characteristics of study participants
20.0% female
80.0% male
N = 505
505 patients (99 female, 406 male).
Inclusion criteria: patients with HF with moderate-to-severe functional MR who received medical therapy.
Key exclusion criteria: MR primarily due to degenerative disease of mitral valve apparatus; status 1 heart transplant or prior orthotropic heart transplantation; need for any cardiovascular surgery; RRT; acute coronary syndrome, TIA, or stroke in the past 90 days.
Interventions
N=250 transcatheter repair (implantation of MitraClip™ device plus guideline-recommended medical therapy).
N=255 medical therapy alone (guideline-recommended medical therapy alone).
Primary outcome
Incidence of first or recurrent hospitalization for heart failure or CV death during 24 months
37
58.9
58.9/100 py
44.2/100 py
29.4/100 py
14.7/100 py
0.0/100 py
Transcatheter
repair
Medical therapy
alone
Significant
decrease ▼
Significant decrease in the incidence of first or recurrent hospitalization for HF or CV death during 24 months (37/100 py vs. 58.9/100 py; RR 0.64, 95% CI 0.48 to 0.85).
Secondary outcomes
Significant decrease in the incidence of first or recurrent hospitalization for HF during 24 months (26.9/100 py vs. 46.6/100 py; RR 0.59, 95% CI 0.42 to 0.82).
Significantly greater improvement in mean Kansas City Cardiomyopathy Questionnaire-Overall Summary score at 12 months (21.6 points vs. 8 points; MD 10.9, 95% CI 6.8 to 15).
Significant increase in MR grade ≤ 2 at 12 months (90.4% vs. 36.1%; OR 21.3, 95% CI 10.7 to 45.8).
Safety outcomes
No significant difference in adverse events.
Significant differences in unplanned MitraClip™ implantation (2.0% vs. 6.5%), unplanned transcatheter mitral valve repair (2% vs. 10%), death from noncardiovascular causes (4.5% vs. 9.3%).
Conclusion
In patients with HF with moderate-to-severe functional MR who received medical therapy, transcatheter repair was superior to medical therapy alone with respect to the incidence of first or recurrent hospitalization for HF or CV death during 24 months.
Reference
Stefan D Anker, Tim Friede, Ralph-Stephan von Bardeleben et al. Transcatheter Valve Repair in Heart Failure with Moderate to Severe Mitral Regurgitation. N Engl J Med. 2024 Nov 14;391(19):1799-1809.
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