Table 4.
Crude Event Rates and PS Regression Adjusted ORs for Each of the Considered Outcomes by Valve Type for the Main Analysis That Excluded BAVs Conducted Before TAVI
| Outcome | SAPIEN Valve Patients (n=3201) | CoreValve Patients (n=2467) | ||||||
|---|---|---|---|---|---|---|---|---|
| During‐TAVI BAV (n=2336) | Direct TAVI (n=865) | PS Adjusted OR (95% CI) Without Bonferroni Correction | PS Adjusted OR (95% CI) With Bonferroni Correction | During‐TAVI BAV (n=1978) | Direct TAVI (n=489) | PS Adjusted OR (95% CI) Without Bonferroni Correction | PS Adjusted OR (95% CI) With Bonferroni Correction | |
| 30‐day mortality | 137/2336 (5.9%) | 40/865 (4.6%) | 1.13 (0.76, 1.68) | 1.13 (0.59, 2.15) | 98/1978 (5.0%) | 22/489 (4.5%) | 0.80 (0.46, 1.38) | 0.80 (0.33, 1.93) |
| MI | 17/2322 (0.73%) | 6/862 (0.70%) | 0.73 (0.27, 2.02) | 0.73 (0.14, 3.79) | 17/1968 (0.86%) | 1/482 (0.21%) | 2.17 (0.26, 18.3) | 2.17 (0.07, 68.61) |
| Stroke | 55/2325 (2.4%) | 23/860 (2.7%) | 0.63 (0.37, 1.08) | 0.63 (0.26, 1.51) | 72/1969 (3.7%) | 12/482 (2.5%) | 0.97 (0.48, 1.95) | 0.97 (0.31, 3.01) |
| Moderate/severe AR/PVL | 121/2072 (5.8%) | 32/800 (4.0%) | 1.11 (0.72, 1.71) | 1.11 (0.55, 2.23) | 306/1830 (16.7%) | 46/453 (10.2%) | 1.15 (0.79, 1.68) | 1.15 (0.63, 2.12) |
| CAO | 19/2320 (0.82%) | 7/860 (0.81%) | 0.84 (0.32, 2.19) | 0.84 (0.18, 3.97) | 14/1970 (0.71%) | 5/484 (1.0%) | 0.41 (0.13, 1.35) | 0.41 (0.06, 2.81) |
| Valve dysfunction | 50/2315 (2.2%) | 14/858 (1.6%) | 1.12 (0.58, 2.16) | 1.12 (0.39, 3.25) | 83/1964 (4.2%) | 25/483 (5.2%) | 0.58 (0.34, 0.99)a | 0.58 (0.24, 1.40) |
| PPM | 127/2324 (5.5%) | 45/858 (5.2%) | 1.18 (0.80, 1.76) | 1.18 (0.63, 2.24) | 363/1967 (18.5%) | 67/480 (14.0%) | 1.26 (0.91, 1.74) | 1.26 (0.74, 2.13) |
| Device migration | 29/2325 (1.2%) | 4/858 (0.47%) | 2.65 (0.86, 8.14) | 2.65 (0.43, 16.32) | 40/1964 (2.0%) | 18/481 (3.7%) | 0.91 (0.45, 1.83) | 0.91 (0.29, 2.83) |
| Hemofiltration/dialysis | 116/2311 (5.0%) | 44/859 (5.1%) | 0.95 (0.64, 1.42) | 0.95 (0.50, 1.82) | 62/1966 (3.2%) | 23/480 (4.8%) | 0.91 (0.50, 1.65) | 0.91 (0.35, 2.39) |
| MVC | 97/2316 (4.2%) | 31/857 (3.6%) | 0.98 (0.62, 1.54) | 0.98 (0.47, 2.04) | 77/1966 (3.9%) | 21/483 (4.3%) | 0.79 (0.44, 1.40) | 0.79 (0.31, 2.01) |
| Early safety | 573/2282 (25.1%) | 154/852 (18.1%) | 1.07 (0.86, 1.34) | 1.07 (0.75, 1.53) | 521/1957 (26.6%) | 111/473 (23.5%) | 0.85 (0.65, 1.12) | 0.85 (0.54, 1.32) |
AR indicates aortic regurgitation; BAV, balloon aortic valvuloplasty; CAO, coronary artery obstruction; MI, myocardial infarction; MVC, major vascular complication; ORs, odds ratios; PPM, pacemaker implantation; PS, propensity score; PVL, paravalvular leakage; TAVI, transcatheter aortic valve implantation.
a
Significant at the 5% level.