Table 2. Main characteristics of the landmark analysis included and non-included populations, from the MITRA-FR trial overall population.
| Characteristics |
Landmark population (n=140) |
Non-included population (n=164) | p-value | |
|---|---|---|---|---|
| Clinical data | Age, years | 68.9±9.3 | 71.5±10.3 | 0.002 |
| Age >75 yrs, n (%) | 38 (27.1) | 72 (43.9) | 0.002 | |
| Female sex, n (%) | 34 (24.3) | 43 (26.2) | 0.79 | |
| Body mass index, kg/m² | 25.4±4.6 | 24.9±3.5 | 0.57 | |
| Systolic blood pressure, mmHg | 109.0±18.7 | 108.0±15.3 | 0.90 | |
| Heart rate, beats/min | 70.5±12.6 | 74.2±12.4 | 0.01 | |
| Medical history | Ischaemic cardiomyopathy, n (%) | 87 (62.1) | 93 (57.1) | 0.41 |
| Non-ischaemic cardiomyopathy, n (%) | 51 (36.4) | 68 (41.7) | 0.40 | |
| Previous myocardial infarction, n (%) | 61 (43.6) | 66 (40.2) | 0.56 | |
| Previous coronary revascularisation, n (%) | 64 (45.7) | 71 (43.6) | 0.72 | |
| Prior stroke, n (%) | 15 (10.7) | 13 (7.9) | 0.43 | |
| Peripheral vascular disease, n (%) | 14 (10.0) | 18 (11.0) | 0.82 | |
| History of atrial fibrillation, n (%) | 69 (49.3) | 105 (64.8) | 0.007 | |
| Renal insufficiency, n (%) | 13 (9.3) | 28 (17.1) | 0.06 | |
| Glomerular filtration rate, ml/min | 53.7±19.9 | 45.9±19.2 | 0.0003 | |
| Diabetes mellitus, n (%) | 49 (35.0) | 40 (24.4) | 0.04 | |
| Functional status/impact | NYHA Class III or IV | 83 (59.2) | 121 (73.7) | 0.001 |
| Unplanned hospitalisation for heart failure within the 12 months | 126 (90.6) | 157 (95.7) | 0.10 | |
| Median BNP* (IQR), ng/litre | 654 (309-977) | 1,016 (596-1,789) | 0.0002 | |
| Median NT-proBNP* (IQR), ng/litre | 2,251 (1,424-3,542) | 5,058 (3,002-10,052) | <0.0001 | |
| Echographic data | Left ventricular ejection fraction, % | 34.0±6.1 | 32.3±6.8 | 0.02 |
| Indexed LVEDV, ml/m² | 135.1±30.6 | 135.6±38.9 | 0.89 | |
| Indexed LVESV, ml/m² | 90.0±26.4 | 92.7±33.2 | 0.70 | |
| EROA, mm² | 29.1±10.2 | 32.4±10.9 | 0.001 | |
| Regurgitant volume, ml | 44.8±14.2 | 45.5±13.0 | 0.49 | |
| EROA/LVEDV, mm2/100 ml of LVEDV | 0.123±0.05 | 0.140±0.06 | 0.002 | |
| PASP, mmHg | 42.6±13.1 | 46.5±13.6 | 0.06 | |
| Tricuspid regurgitation >moderate, n (%) | 19 (15.0) | 33 (22.3) | 0.10 | |
| Risk scores | Median logistic EuroSCORE II (IQR) | 5.03 (3.0-10.0) | 7.09 (4.2-12.0) | 0.004 |
| Median STS score for mortality (IQR) | 2.57 (1.2-5.8) | 4.14 (2.2-7.3) | 0.001 | |
| Medical treatment | Single implantable cardioverter-defibrillator, n (%) | 76 (54.3) | 96 (58.5) | 0.48 |
| Cardiac resynchronisation therapy-defibrillator, n (%) | 79 (56.4) | 107 (65.2) | 0.12 | |
| Single cardiac resynchronisation therapy device, n (%) | 26 (18.6) | 55 (33.7) | 0.004 | |
| ACEi/ARB, n (%) | 107 (76.4) | 117 (71.3) | 0.36 | |
| Angiotensin receptor and neprilysin inhibitors, n (%) | 19 (14.6) | 12 (8.0) | 0.08 | |
| Beta blockers, n (%) | 127 (90.7) | 145 (88.4) | 0.57 | |
| Mineralocorticoid receptor antagonists, n (%) | 85 (61.2) | 81 (49.4) | 0.04 | |
| Loop diuretics, n (%) | 137 (97.9) | 163 (99.4) | 0.33 | |
| Oral anticoagulants, n (%) | 77 (55.0) | 109 (66.5) | 0.04 | |
| Plus–minus values are means±SD. *BNP was measured in 58 of the 140 patients in the landmark-studied group and in 68 of the 164 patients in the not-included group, and NT-proBNP in 68 and 79 patients, respectively. ACEi: angiotensin-converting enzyme inhibitor. ARB: angiotensin receptor blocker; EROA: effective regurgitant orifice area; GDMT: guideline-directed medical treatment; IQR: interquartile range; LVEDV: left ventricular end-diastolic volume; LVESV: left ventricular end-systolic volume; NYHA: New York Heart Association; PASP: pulmonary arterial systolic pressure; STS: Society of Thoracic Surgeons; TVMR: transcatheter mitral valve repair | ||||