Key differences between the COAPT and MITRA-FR trials (modified from Praz et al.78)
. | MITRA-FR . | COAPT . |
---|---|---|
Primary endpoint | All-cause death and hospitalization for HF at 12 months | All hospitalizations for HF within 24 months (including recurrent events) |
Key exclusion criteria | ||
Heart failure severity | NYHA class < II | NYHA class < II ACC/AHA stage D HF |
Left ventricular dimensions | No exclusion criteria | LVESD >70 mm |
Coronary artery disease | CABG or PCI performed within 1 month | Untreated coronary artery disease requiring revascularization |
Right ventricle | No exclusion criteria | Right-sided HF with moderate or severe right ventricular dysfunction Tricuspid valve disease requiring surgery |
Pulmonary disease | No exclusion criteria | COPD with home oxygen therapy or chronic oral steroid use PAP >70 mmHg unresponsive to vasodilator therapy |
Principal baseline characteristics | ||
Number of patients screened | 450 | 1576 |
Number of patients enrolled (ITT) | 304 | 614 |
Mean age (years) | 70 ± 10 | 72 ± 12 |
Mean LVEF (%) | 33 ± 7 | 31 ± 10 |
MR severity (EROA, cm2) | 0.31 ± 0.10 | 0.41 ± 0.15 |
<30 mm2 (%) | 52% | 13% |
30–40 mm2 (%) | 32% | 46% |
>40 mm2 | 16% | 41% |
Mean indexed LVEDV, mL/m2 | 135 ± 35 | 101 ± 34 |
Safety and efficacy endpoints in intervention arm | ||
Complicationsa (%) | 14.6 | 8.5 |
No implant (%) | 9 | 5 |
Implantation of multiple clips (%) | 54 | 62 |
Post-procedural MR grade ≤2+ (%) | 92 | 95 |
MR grade ≤2+ at 1 year (%) | 83 | 95 |
Hospitalization for HF at 1 year (%) | ||
Edge-to-edge repair + GDMT | 49 | 36 |
GDMT alone | 47 | 68 |
Thirty-day mortality (%) | ||
Edge-to-edge repair + GDMT | 3 | 2 |
GDMT alone | 3 | 1 |
One-year mortality (%) | ||
Edge-to-edge repair + GDMT | 24 | 19 |
GDMT alone | 22 | 23 |
Two-year mortality (%) | ||
Edge-to-edge repair + GDMT | 34 | 29 |
GDMT alone | 35 | 46 |
. | MITRA-FR . | COAPT . |
---|---|---|
Primary endpoint | All-cause death and hospitalization for HF at 12 months | All hospitalizations for HF within 24 months (including recurrent events) |
Key exclusion criteria | ||
Heart failure severity | NYHA class < II | NYHA class < II ACC/AHA stage D HF |
Left ventricular dimensions | No exclusion criteria | LVESD >70 mm |
Coronary artery disease | CABG or PCI performed within 1 month | Untreated coronary artery disease requiring revascularization |
Right ventricle | No exclusion criteria | Right-sided HF with moderate or severe right ventricular dysfunction Tricuspid valve disease requiring surgery |
Pulmonary disease | No exclusion criteria | COPD with home oxygen therapy or chronic oral steroid use PAP >70 mmHg unresponsive to vasodilator therapy |
Principal baseline characteristics | ||
Number of patients screened | 450 | 1576 |
Number of patients enrolled (ITT) | 304 | 614 |
Mean age (years) | 70 ± 10 | 72 ± 12 |
Mean LVEF (%) | 33 ± 7 | 31 ± 10 |
MR severity (EROA, cm2) | 0.31 ± 0.10 | 0.41 ± 0.15 |
<30 mm2 (%) | 52% | 13% |
30–40 mm2 (%) | 32% | 46% |
>40 mm2 | 16% | 41% |
Mean indexed LVEDV, mL/m2 | 135 ± 35 | 101 ± 34 |
Safety and efficacy endpoints in intervention arm | ||
Complicationsa (%) | 14.6 | 8.5 |
No implant (%) | 9 | 5 |
Implantation of multiple clips (%) | 54 | 62 |
Post-procedural MR grade ≤2+ (%) | 92 | 95 |
MR grade ≤2+ at 1 year (%) | 83 | 95 |
Hospitalization for HF at 1 year (%) | ||
Edge-to-edge repair + GDMT | 49 | 36 |
GDMT alone | 47 | 68 |
Thirty-day mortality (%) | ||
Edge-to-edge repair + GDMT | 3 | 2 |
GDMT alone | 3 | 1 |
One-year mortality (%) | ||
Edge-to-edge repair + GDMT | 24 | 19 |
GDMT alone | 22 | 23 |
Two-year mortality (%) | ||
Edge-to-edge repair + GDMT | 34 | 29 |
GDMT alone | 35 | 46 |
BNP, brain natriuretic peptide; COPD, chronic obstructive pulmonary disease; EROA, effective regurgitant orifice area; GDMT, guideline-directed medical treatment; HF, heart failure; ITT, intention to treat; LVEF, left ventricular ejection fraction; LVESD, left ventricular end-systolic diameter; MR, mitral regurgitation; NT-proBNP, N-terminal pro brain natriuretic peptide; PAP, pulmonary artery pressure.
Device implant failure, transfusion, or vascular complication requiring surgery, ASD, cardiogenic shock, cardiac embolism/stroke, tamponade, and urgent cardiac surgery.
Key differences between the COAPT and MITRA-FR trials (modified from Praz et al.78)
. | MITRA-FR . | COAPT . |
---|---|---|
Primary endpoint | All-cause death and hospitalization for HF at 12 months | All hospitalizations for HF within 24 months (including recurrent events) |
Key exclusion criteria | ||
Heart failure severity | NYHA class < II | NYHA class < II ACC/AHA stage D HF |
Left ventricular dimensions | No exclusion criteria | LVESD >70 mm |
Coronary artery disease | CABG or PCI performed within 1 month | Untreated coronary artery disease requiring revascularization |
Right ventricle | No exclusion criteria | Right-sided HF with moderate or severe right ventricular dysfunction Tricuspid valve disease requiring surgery |
Pulmonary disease | No exclusion criteria | COPD with home oxygen therapy or chronic oral steroid use PAP >70 mmHg unresponsive to vasodilator therapy |
Principal baseline characteristics | ||
Number of patients screened | 450 | 1576 |
Number of patients enrolled (ITT) | 304 | 614 |
Mean age (years) | 70 ± 10 | 72 ± 12 |
Mean LVEF (%) | 33 ± 7 | 31 ± 10 |
MR severity (EROA, cm2) | 0.31 ± 0.10 | 0.41 ± 0.15 |
<30 mm2 (%) | 52% | 13% |
30–40 mm2 (%) | 32% | 46% |
>40 mm2 | 16% | 41% |
Mean indexed LVEDV, mL/m2 | 135 ± 35 | 101 ± 34 |
Safety and efficacy endpoints in intervention arm | ||
Complicationsa (%) | 14.6 | 8.5 |
No implant (%) | 9 | 5 |
Implantation of multiple clips (%) | 54 | 62 |
Post-procedural MR grade ≤2+ (%) | 92 | 95 |
MR grade ≤2+ at 1 year (%) | 83 | 95 |
Hospitalization for HF at 1 year (%) | ||
Edge-to-edge repair + GDMT | 49 | 36 |
GDMT alone | 47 | 68 |
Thirty-day mortality (%) | ||
Edge-to-edge repair + GDMT | 3 | 2 |
GDMT alone | 3 | 1 |
One-year mortality (%) | ||
Edge-to-edge repair + GDMT | 24 | 19 |
GDMT alone | 22 | 23 |
Two-year mortality (%) | ||
Edge-to-edge repair + GDMT | 34 | 29 |
GDMT alone | 35 | 46 |
. | MITRA-FR . | COAPT . |
---|---|---|
Primary endpoint | All-cause death and hospitalization for HF at 12 months | All hospitalizations for HF within 24 months (including recurrent events) |
Key exclusion criteria | ||
Heart failure severity | NYHA class < II | NYHA class < II ACC/AHA stage D HF |
Left ventricular dimensions | No exclusion criteria | LVESD >70 mm |
Coronary artery disease | CABG or PCI performed within 1 month | Untreated coronary artery disease requiring revascularization |
Right ventricle | No exclusion criteria | Right-sided HF with moderate or severe right ventricular dysfunction Tricuspid valve disease requiring surgery |
Pulmonary disease | No exclusion criteria | COPD with home oxygen therapy or chronic oral steroid use PAP >70 mmHg unresponsive to vasodilator therapy |
Principal baseline characteristics | ||
Number of patients screened | 450 | 1576 |
Number of patients enrolled (ITT) | 304 | 614 |
Mean age (years) | 70 ± 10 | 72 ± 12 |
Mean LVEF (%) | 33 ± 7 | 31 ± 10 |
MR severity (EROA, cm2) | 0.31 ± 0.10 | 0.41 ± 0.15 |
<30 mm2 (%) | 52% | 13% |
30–40 mm2 (%) | 32% | 46% |
>40 mm2 | 16% | 41% |
Mean indexed LVEDV, mL/m2 | 135 ± 35 | 101 ± 34 |
Safety and efficacy endpoints in intervention arm | ||
Complicationsa (%) | 14.6 | 8.5 |
No implant (%) | 9 | 5 |
Implantation of multiple clips (%) | 54 | 62 |
Post-procedural MR grade ≤2+ (%) | 92 | 95 |
MR grade ≤2+ at 1 year (%) | 83 | 95 |
Hospitalization for HF at 1 year (%) | ||
Edge-to-edge repair + GDMT | 49 | 36 |
GDMT alone | 47 | 68 |
Thirty-day mortality (%) | ||
Edge-to-edge repair + GDMT | 3 | 2 |
GDMT alone | 3 | 1 |
One-year mortality (%) | ||
Edge-to-edge repair + GDMT | 24 | 19 |
GDMT alone | 22 | 23 |
Two-year mortality (%) | ||
Edge-to-edge repair + GDMT | 34 | 29 |
GDMT alone | 35 | 46 |
BNP, brain natriuretic peptide; COPD, chronic obstructive pulmonary disease; EROA, effective regurgitant orifice area; GDMT, guideline-directed medical treatment; HF, heart failure; ITT, intention to treat; LVEF, left ventricular ejection fraction; LVESD, left ventricular end-systolic diameter; MR, mitral regurgitation; NT-proBNP, N-terminal pro brain natriuretic peptide; PAP, pulmonary artery pressure.
Device implant failure, transfusion, or vascular complication requiring surgery, ASD, cardiogenic shock, cardiac embolism/stroke, tamponade, and urgent cardiac surgery.
This PDF is available to Subscribers Only
View Article Abstract & Purchase OptionsFor full access to this pdf, sign in to an existing account, or purchase an annual subscription.