Table 2. Overview of key trials and registries.
Randomized controlled trials | Registries | |||||||
---|---|---|---|---|---|---|---|---|
EVEREST-II3) | MITRA-FR6) | COAPT7) | ACCESS-EU24) | TCVT25) | TRAMI26) | STS/ACC TVT27) | ||
Number (treated patients) | 184 | 152 | 302 | 567 | 628 | 749 | 2,952 | |
Age (years) | 67.3±12.8 | 70.1±10.1 | 71.7±11.8 | 73.7±9.6 | 74.2±9.7 | 76.0 (71.0–81.0) | 82.0 (74.0–86.0) | |
Risk score | ||||||||
EuroSCORE* | - | 6.6 (3.5–11.9)† | - | 23.0±18.3‡ | 20.4±16.7‡ | 20.0 (12.0–31.0)‡ | - | |
STS score | 5.0±4.0 | - | 7.8±5.5 | - | - | 6.0 (4.0–11.0) | 6.1 (3.7–9.9)§ | |
MR etiology (%) | ||||||||
Degenerative | 73.4 | 0 | 0 | 22.9 | 28.0 | 27.8 | 85.9 | |
Functional | 26.6 | 100 | 100 | 77.1 | 72.0 | 71.3 | 8.6 | |
Acute procedural success | 77.0 | 95.8 | 95.0 | 91.0 | 95.4 | 97.0 | 91.8 | |
1-year outcomes (%) | ||||||||
Mortality | 6.1 | 24.3 | 19.1 | 17.3 | 15.3 | 20.3 | 25.8 | |
NYHA class I–II | 98.0 | - | 72.2 | 71.4 | 74.2 | 63.3 | - | |
MR ≤2+ | 79.0 | - | 94.8 | 78.9 | 94.0 | - | - |
*Shown as mean standard±deviation or median (interquartile range) as according to primary paper; †EuroSCORE II; ‡Logistic EuroSCORE; §STS score 6.1% (3.7–9.9%) and 9.2% (6.0–14.1%) for mitral valve repair and replacement, respectively.
ACC TVT = American College of Cardiology Transcatheter Valve Therapy; COAPT = Cardiovascular Outcomes Assessment of the MitraClip Percutaneous Therapy for Heart Failure Patients with Functional Mitral Regurgitation; EVEREST = Endovascular Valve Edge-to-Edge Repair Study; MITRA-FR = Percutaneous Repair with the MitraClip Device for Severe Functional/Secondary Mitral Regurgitation; MR = mitral regurgitation; NYHA = New York Heart Association; STS = Society of Thoracic Surgeons; TCVT = Transcatheter Valve Treatment Sentinel Pilot Registry; TRAMI = transcatheter mitral valve interventions.