COAPT
Trial question
What is the role of transcatheter mitral valve repair in patients with HF and symptomatic moderate-to-severe or severe secondary MR?
Study design
Multi-center
Open label
RCT
Population
Characteristics of study participants
36.0% female
64.0% male
N = 614
614 patients (219 female, 393 male)
Inclusion criteria: patients with HF and symptomatic moderate-to-severe or severe secondary MR despite the use of maximal doses of guideline-directed medical therapy
Key exclusion criteria: untreated clinically significant coronary artery disease requiring revascularization, CABG, PCI or TAVR within the prior 30 days, cerebrovascular accident within prior 30 days, severe symptomatic carotid stenosis, carotid surgery or stenting within prior 30 days
Interventions
N=302 transcatheter mitral valve repair (with MitraClip device within 14 days after randomization plus guideline-directed medical therapy)
N=312 control (guideline-directed medical therapy alone)
Primary outcome
All hospitalizations for heart failure within 24 months
35.8
67.9
67.9 % / p-y
50.9 % / p-y
34.0 % / p-y
17.0 % / p-y
0.0 % / p-y
Transcatheter mitral valve
repair
Control
Significant
decrease ▼
Significant decrease in all hospitalizations for HF within 24 months (35.8% / p-y vs. 67.9% / p-y; HR 0.53, 95% CI 0.4 to 0.7)
Secondary outcomes
Significant decrease in death from any cause at 2 years (29.1% vs. 46.1%; HR 0.62, 95% CI 0.46 to 0.82)
Conclusion
In patients with HF and symptomatic moderate-to-severe or severe secondary MR despite the use of maximal doses of guideline-directed medical therapy, transcatheter mitral valve repair was superior to control with respect to all hospitalizations for HF within 24 months.
Reference
Stone GW, Lindenfeld J, Abraham WT et al. Transcatheter Mitral-Valve Repair in Patients with Heart Failure. N Engl J Med. 2018 Dec 13;379(24):2307-2318.
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