Table 2

Key differences between the COAPT and MITRA-FR trials (modified from Praz et al.78)

MITRA-FRCOAPT
Primary endpointAll-cause death and hospitalization for HF at 12 monthsAll hospitalizations for HF within 24 months (including recurrent events)
Key exclusion criteria
 Heart failure severityNYHA class < II NYHA class < II
ACC/AHA stage D HF
 Left ventricular dimensionsNo exclusion criteriaLVESD >70 mm
 Coronary artery diseaseCABG or PCI performed within 1 monthUntreated coronary artery disease requiring revascularization
 Right ventricleNo exclusion criteria Right-sided HF with moderate or severe right ventricular dysfunction
Tricuspid valve disease requiring surgery
 Pulmonary diseaseNo 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 screened4501576
 Number of patients enrolled (ITT)304614
 Mean age (years)70 ± 1072 ± 12
 Mean LVEF (%)33 ± 731 ± 10
 MR severity (EROA, cm2)0.31 ± 0.100.41 ± 0.15
  <30 mm2 (%)52%13%
  30–40 mm2 (%)32%46%
  >40 mm216%41%
 Mean indexed LVEDV, mL/m2135 ± 35101 ± 34
Safety and efficacy endpoints in intervention arm
 Complicationsa (%)14.68.5
 No implant (%)95
 Implantation of multiple clips (%)5462
 Post-procedural MR grade ≤2+ (%)9295
 MR grade ≤2+ at 1 year (%)8395
Hospitalization for HF at 1 year (%)
 Edge-to-edge repair + GDMT4936
 GDMT alone4768
Thirty-day mortality (%)
 Edge-to-edge repair + GDMT32
 GDMT alone31
One-year mortality (%)
 Edge-to-edge repair + GDMT2419
 GDMT alone2223
Two-year mortality (%)
Edge-to-edge repair + GDMT3429
GDMT alone3546
MITRA-FRCOAPT
Primary endpointAll-cause death and hospitalization for HF at 12 monthsAll hospitalizations for HF within 24 months (including recurrent events)
Key exclusion criteria
 Heart failure severityNYHA class < II NYHA class < II
ACC/AHA stage D HF
 Left ventricular dimensionsNo exclusion criteriaLVESD >70 mm
 Coronary artery diseaseCABG or PCI performed within 1 monthUntreated coronary artery disease requiring revascularization
 Right ventricleNo exclusion criteria Right-sided HF with moderate or severe right ventricular dysfunction
Tricuspid valve disease requiring surgery
 Pulmonary diseaseNo 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 screened4501576
 Number of patients enrolled (ITT)304614
 Mean age (years)70 ± 1072 ± 12
 Mean LVEF (%)33 ± 731 ± 10
 MR severity (EROA, cm2)0.31 ± 0.100.41 ± 0.15
  <30 mm2 (%)52%13%
  30–40 mm2 (%)32%46%
  >40 mm216%41%
 Mean indexed LVEDV, mL/m2135 ± 35101 ± 34
Safety and efficacy endpoints in intervention arm
 Complicationsa (%)14.68.5
 No implant (%)95
 Implantation of multiple clips (%)5462
 Post-procedural MR grade ≤2+ (%)9295
 MR grade ≤2+ at 1 year (%)8395
Hospitalization for HF at 1 year (%)
 Edge-to-edge repair + GDMT4936
 GDMT alone4768
Thirty-day mortality (%)
 Edge-to-edge repair + GDMT32
 GDMT alone31
One-year mortality (%)
 Edge-to-edge repair + GDMT2419
 GDMT alone2223
Two-year mortality (%)
Edge-to-edge repair + GDMT3429
GDMT alone3546

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.

a

Device implant failure, transfusion, or vascular complication requiring surgery, ASD, cardiogenic shock, cardiac embolism/stroke, tamponade, and urgent cardiac surgery.

Table 2

Key differences between the COAPT and MITRA-FR trials (modified from Praz et al.78)

MITRA-FRCOAPT
Primary endpointAll-cause death and hospitalization for HF at 12 monthsAll hospitalizations for HF within 24 months (including recurrent events)
Key exclusion criteria
 Heart failure severityNYHA class < II NYHA class < II
ACC/AHA stage D HF
 Left ventricular dimensionsNo exclusion criteriaLVESD >70 mm
 Coronary artery diseaseCABG or PCI performed within 1 monthUntreated coronary artery disease requiring revascularization
 Right ventricleNo exclusion criteria Right-sided HF with moderate or severe right ventricular dysfunction
Tricuspid valve disease requiring surgery
 Pulmonary diseaseNo 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 screened4501576
 Number of patients enrolled (ITT)304614
 Mean age (years)70 ± 1072 ± 12
 Mean LVEF (%)33 ± 731 ± 10
 MR severity (EROA, cm2)0.31 ± 0.100.41 ± 0.15
  <30 mm2 (%)52%13%
  30–40 mm2 (%)32%46%
  >40 mm216%41%
 Mean indexed LVEDV, mL/m2135 ± 35101 ± 34
Safety and efficacy endpoints in intervention arm
 Complicationsa (%)14.68.5
 No implant (%)95
 Implantation of multiple clips (%)5462
 Post-procedural MR grade ≤2+ (%)9295
 MR grade ≤2+ at 1 year (%)8395
Hospitalization for HF at 1 year (%)
 Edge-to-edge repair + GDMT4936
 GDMT alone4768
Thirty-day mortality (%)
 Edge-to-edge repair + GDMT32
 GDMT alone31
One-year mortality (%)
 Edge-to-edge repair + GDMT2419
 GDMT alone2223
Two-year mortality (%)
Edge-to-edge repair + GDMT3429
GDMT alone3546
MITRA-FRCOAPT
Primary endpointAll-cause death and hospitalization for HF at 12 monthsAll hospitalizations for HF within 24 months (including recurrent events)
Key exclusion criteria
 Heart failure severityNYHA class < II NYHA class < II
ACC/AHA stage D HF
 Left ventricular dimensionsNo exclusion criteriaLVESD >70 mm
 Coronary artery diseaseCABG or PCI performed within 1 monthUntreated coronary artery disease requiring revascularization
 Right ventricleNo exclusion criteria Right-sided HF with moderate or severe right ventricular dysfunction
Tricuspid valve disease requiring surgery
 Pulmonary diseaseNo 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 screened4501576
 Number of patients enrolled (ITT)304614
 Mean age (years)70 ± 1072 ± 12
 Mean LVEF (%)33 ± 731 ± 10
 MR severity (EROA, cm2)0.31 ± 0.100.41 ± 0.15
  <30 mm2 (%)52%13%
  30–40 mm2 (%)32%46%
  >40 mm216%41%
 Mean indexed LVEDV, mL/m2135 ± 35101 ± 34
Safety and efficacy endpoints in intervention arm
 Complicationsa (%)14.68.5
 No implant (%)95
 Implantation of multiple clips (%)5462
 Post-procedural MR grade ≤2+ (%)9295
 MR grade ≤2+ at 1 year (%)8395
Hospitalization for HF at 1 year (%)
 Edge-to-edge repair + GDMT4936
 GDMT alone4768
Thirty-day mortality (%)
 Edge-to-edge repair + GDMT32
 GDMT alone31
One-year mortality (%)
 Edge-to-edge repair + GDMT2419
 GDMT alone2223
Two-year mortality (%)
Edge-to-edge repair + GDMT3429
GDMT alone3546

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.

a

Device implant failure, transfusion, or vascular complication requiring surgery, ASD, cardiogenic shock, cardiac embolism/stroke, tamponade, and urgent cardiac surgery.

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