Background
Methods
Study design and patient sample
Study outcomes
Statistical analysis
Results
Patient population
Diabetes (n = 3550) | No diabetes (n = 7890) | p-value | |
---|---|---|---|
Demographics
| |||
Age (years) | 80 ± 7 | 82 ± 7 | < 0.001 |
Women | 1893 (53%) | 4655 (59%) | < 0.001 |
Body mass index (kg/m2) | 28 ± 5 | 26 ± 5 | < 0.001 |
Body surface area (m2) | 1.79 ± 0.19 | 1.73 ± 0.19 | < 0.001 |
Medical history
| |||
Stroke or TIA | 410 (12%) | 770 (10%) | 0.004 |
Myocardial infarction | 615 (17%) | 933 (12%) | < 0.001 |
Previous PCI | 889 (25%) | 1514 (19%) | < 0.001 |
Previous CABG | 579 (16%) | 852 (11%) | < 0.001 |
Hypertension | 3040 (86%) | 5492 (75%) | < 0.001 |
Dyslipidaemia | 2396 (68%) | 3878 (49%) | < 0.001 |
Peripheral vascular disease | 640 (18%) | 1090 (14%) | < 0.001 |
Coronary artery disease | 1707 (48%) | 3025 (38%) | < 0.001 |
Atrial fibrillation | 945 (27%) | 2148 (27%) | 0.50 |
Renal failure | 467 (13%) | 1089 (14%) | 0.35 |
GFR (ml/min/1.73m2) | 52.4 (38.3–69.9) | 52.3 (38.9–68.9) | 0.73 |
NYHA ≥ 3 | 776 (39%) | 2000 (46%) | < 0.001 |
Risk scores
| |||
Logistic EuroSCORE (%) | 15.5 (9.5–23.6) | 15.0 (9.5–22.9) | 0.05 |
STS-PROM (%) | 7.0 (4.1–13.5) | 6.1 (3.9–12.8) | < 0.001 |
EuroSCORE II (%) | 4.7 (2.7–8.2) | 3.7 (2.2-6.0) | < 0.001 |
Medication
| |||
Statin | 480 (73%) | 932 (65%) | < 0.001 |
Aspirin | 1090 (68%) | 2593 (64%) | 0.002 |
Clopidogrel | 473 (47%) | 1089 (41%) | < 0.001 |
Oral anticoagulation | 558 (32%) | 1291 (33%) | 0.33 |
Echocardiographic characteristics
| |||
LVEF (%) | 55 ± 14 | 56 ± 14 | 0.005 |
Max gradient (mmHg) | 76 ± 22 | 81 ± 24 | < 0.001 |
Mean gradient (mmHg) | 50 ± 17 | 52 ± 17 | < 0.001 |
Aortic valve area (cm2) | 0.66 ± 0.19 | 0.67 ± 0.20 | 0.33 |
Stroke volume (mL) | 29 ± 8 | 29 ± 7 | 0.42 |
Stroke volume index (mL/m2) | 16 ± 5 | 17 ± 4 | < 0.001 |
Device Type
| |||
Balloon-expandable valve | 1918 (54%) | 4191 (53%) | 0.37 |
Third generation valve | 1101 (33%) | 2038 (28%) | < 0.001 |
Clinical outcomes in the unmatched population
Diabetes (n = 3550) | No diabetes (n = 7890) | RR (95% CI) | p Value | |
---|---|---|---|---|
Procedural
| ||||
Conversion to open heart surgery | 21 (0.7%) | 55 (0.8%) | 0.9 (0.5–1.4) | 0.54 |
Mortality < 72h | 137 (1.7%) | 51 (1.4%) | 1.2 (0.9–1.7) | 0.24 |
During hospital admission
| ||||
Mortality | 157 (4.5%) | 380 (4.9%) | 0.9 (0.8–1.1) | 0.43 |
Stroke | 60 (1.7%) | 159 (2.0%) | 0.8 (0.6–1.1) | 0.27 |
Myocardial infarction | 31 (0.9%) | 51 (0.7%) | 1.4 (0.9–2.1) | 0.18 |
Major or life-threatening bleeding | 198 (6.1%) | 480 (6.7%) | 0.9 (0.8–1.1) | 0.25 |
New onset atrial fibrillation | 76 (8.0%) | 180 (6.8%) | 1.1 (0.9–1.5) | 0.23 |
Permanent pacemaker implantation | 428 (13.3%) | 940 (13.1%) | 1.0 (0.9–1.1) | 0.74 |
Length of stay (days) | 7 (5–11) | 7 (5–11) | - | 0.96 |
At 30 Days
| ||||
Mortality | 171 (5.4%) | 439 (6.1%) | 0.9 (0.8–1.1) | 0.19 |
Stroke | 72 (2.3%) | 185 (2.6%) | 0.9 (0.7–1.2) | 0.40 |
At one year
| ||||
Mortality | 394 (17.5%) | 874 (17.4%) | 1.0 (0.9–1.1) | 0.86 |
Stroke | 114 (5.0%) | 274 (5.4%) | 0.9 (0.8–1.2) | 0.53 |
Baseline characteristics of the propensity matched population
Diabetes (n = 3281) | No diabetes (n = 3281) | p-value | SMD | |
---|---|---|---|---|
Demographics
| ||||
Age (years) | 80 ± 6 | 80 ± 8 | 0.60 | 0.013 |
Women | 1736 (54%) | 1709 (54%) | 0.50 | 0.019 |
Body mass index (kg/m2) | 28 ± 5 | 28 ± 5 | 0.95 | 0.002 |
Body surface area (m2) | 1.78 ± 0.18 | 1.78 ± 0.18 | 0.96 | 0.001 |
Medical history
| ||||
Stroke or TIA | 358 (11%) | 342 (11%) | 0.52 | 0.028 |
Myocardial infarction | 523 (16%) | 538 (17%) | 0.61 | 0.019 |
Previous PCI | 772 (24%) | 781 (25%) | 0.79 | 0.009 |
Previous CABG | 486 (15%) | 505 (16%) | 0.51 | 0.025 |
Hypertension | 2710 (85%) | 2705 (85%) | 0.86 | 0.007 |
Dyslipidaemia | 2102 (66%) | 2104 (66%) | 0.96 | 0.002 |
Peripheral vascular disease | 554 (17%) | 547 (17%) | 0.82 | 0.009 |
Coronary artery disease | 1478 (46%) | 1503 (47%) | 0.53 | 0.017 |
Atrial fibrillation | 834 (26%) | 839 (26%) | 0.89 | 0.005 |
Renal failure | 439 (14%) | 403 (13%) | 0.19 | 0.054 |
GFR (ml/min/1.73m2) | 51.4 (37.4–69.0) | 54.1 (40.6–71.4) | < 0.001 | 0.096 |
NYHA ≥ 3 | 751 (40%) | 768 (42%) | 0.14 | 0.054 |
Risk scores
| ||||
Logistic EuroSCORE (%) | 15.5 (9.5–23.0) | 14.6 (9.0-23.3) | 0.02 | 0.036 |
STS-PROM (%) | 7.0 (4.1–13.4) | 5.5 (3.3–12.0) | < 0.001 | 0.158 |
EuroSCORE II (%) | 4.6 (2.7–8.2) | 3.7 (2.2–6.4) | < 0.001 | 0.211 |
Medication
| ||||
Statin | 456 (72%) | 482 (72%) | 0.73 | 0.024 |
Aspirin | 895 (67%) | 943 (66%) | 0.69 | 0.018 |
Clopidogrel | 457 (47%) | 462 (45%) | 0.22 | 0.061 |
Oral anticoagulation | 505 (35%) | 546 (36%) | 0.39 | 0.036 |
Echocardiographic characteristics
| ||||
LVEF (%) | 55 ± 14 | 56 ± 15 | 0.65 | 0.069 |
Max gradient (mmHg) | 76 ± 22 | 77 ± 23 | 0.17 | 0.002 |
Mean gradient (mmHg) | 48 ± 16 | 48 ± 16 | 0.95 | 0.040 |
Aortic valve area (cm2) | 0.67 ± 0.19 | 0.69 ± 0.22 | < 0.001 | 0.118 |
Stroke volume (mL) | 29 ± 8 | 29 ± 7 | 0.61 | 0.052 |
Stroke volume index (mL/m2) | 16 ± 5 | 16 ± 4 | 0.42 | 0.081 |
Device Type
| ||||
Balloon-expandable valve | 1671 (53%) | 1661 (52%) | 0.80 | 0.007 |
Third generation valve | 1031 (32%) | 1011 (32%) | 0.59 | 0.016 |
Clinical outcomes in the propensity matched population
Diabetes (n = 3281) | No diabetes (n = 3281) | RR (95% CI) | p Value | |
---|---|---|---|---|
Procedural
| ||||
Conversion to open heart surgery | 21 (0.7%) | 19 (0.6%) | 1.1 (0.6–2.1) | 0.73 |
Mortality < 72h | 48 (1.5%) | 47 (1.5%) | 1.0 (0.7–1.5) | 0.92 |
During hospital admission
| ||||
Mortality | 147 (4.7%) | 134 (4.3%) | 1.1 (0.9–1.4) | 0.38 |
Stroke | 53 (1.7%) | 65 (2.1%) | 0.8 (0.6–1.2) | 0.28 |
Myocardial infarction | 24 (0.8%) | 16 (0.5%) | 1.5 (0.8–2.1) | 0.21 |
Major or life-threatening bleeding | 126 (4.4%) | 158 (5.5%) | 0.8 (0.6-1.0) | 0.05 |
New onset atrial fibrillation | 61 (7.8%) | 65 (7.1%) | 1.1 (0.8–1.6) | 0.56 |
Permanent pacemaker implantation | 400 (13.0%) | 418 (13.6%) | 1.0 (0.8–1.1) | 0.51 |
Length of stay (days) | 7 (5–11) | 7 (5–11) | - | 0.92 |
At 30 Days
| ||||
Mortality | 157 (5.6%) | 160 (5.6%) | 1.0 (0.8–1.2) | 0.96 |
Stroke | 65 (2.3%) | 75 (2.6%) | 0.9 (0.6–1.2) | 0.47 |
At one year
| ||||
Mortality | 370 (17.3%) | 349 (16.2%) | 1.1 (0.9–1.2) | 0.37 |
Stroke | 107 (4.9%) | 112 (5.2%) | 1.0 (0.7–1.2) | 0.75 |
Outcomes in diabetic patients
IDDM (n = 314) | NIDM (n = 701) | RR (95% CI) | P-value | |
---|---|---|---|---|
Procedural
| ||||
Conversion to open heart surgery | 1 (0.4%) | 3 (0.6%) | 0.8 (0.1–7.6) | 0.83 |
During hospital admission
| ||||
Mortality | 8 (2.6%) | 14 (2.0%) | 1.3 (0.5–3.1) | 0.58 |
Stroke | 10 (3.2%) | 11 (1.6%) | 2.0 (0.9–4.9) | 0.10 |
Myocardial infarction | 2 (0.8%) | 7 (1.2%) | 0.6 (0.1–3.1) | 0.57 |
Major or life-threatening bleeding | 40 (13.6%) | 86 (13.8%) | 1.0 (0.7–1.5) | 0.93 |
New onset atrial fibrillation | 9 (6.1%) | 15 (4.7%) | 1.3 (0.6–3.1) | 0.52 |
Permanent pacemaker implantation | 28 (12.3%) | 58 (10.9%) | 1.1 (0.7–1.9) | 0.58 |
30 days
| ||||
Mortality | 13 (4.4%) | 18 (2.7%) | 1.6 (0.8–3.4) | 0.17 |
Stroke | 11 (3.7%) | 12 (1.8%) | 2.1 (0.9–4.8) | 0.08 |
One year
| ||||
Mortality | 32 (15.0%) | 54 (10.5%) | 1.5 (0.9–2.4) | 0.09 |
Stroke | 14 (6.5%) | 18 (3.5%) | 1.9 (0.9–3.9) | 0.07 |