Table 2.
Similarities and differences among COAPT, MITRA-FR, and CLASP trials with respect to study design and endpoints (Adapted with permission from [68,70]).
| COAPT | MITRA-FR | CLASP | CLASP (FMR) | |
|---|---|---|---|---|
| Patients enrolled | 614 | 304 | 124 | 85 (single arm) |
| Technical implantation success | 98% | 96% | 96% | 96% |
| Atrial fibrillation/Flutter | 57.3% | 34.5% | 53.4% | 45% |
| LVEF | 31 ± 9% | 33 ± 7% | 44 ± 14% | 37 ± 10% |
| EROA | 41 ± 15 mm2 | 31 ± 10 mm2 | 38 ± 15 mm2 | 34 ± 11 mm2 |
| LVEDV | 101 ± 34 mL/m2 | 135 ± 35 mL/m2 | 181 ± 61 mL | 199 ± 59 mL |
| Mortality at 1 y and 2 y | 19% and 29% | 23% and 34% | 9% and 20% | 12% and 28% |
| MR ≥ 3+ at discharge → 12 mo → 24 mo | 7.4% → 5% → 0.9% | 8% → 17% → not recorded | 4% * → 0% → 3% | 4% * → 0% → 5% |
FMR: functional mitral regurgitation; LVEF: left ventricle ejection fraction; EROA: effective regurgitant orifice area; LVEDV: left ventricle end-diastolic volume. * Data at 30 days.