Table 1.
High-risk operable patients |
Inoperable patients |
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Pivotal trial |
Cont. access |
Combined* |
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TAVI | AVR | p Value | TAVI | Stand. | p Value | TAVI | Stand. | TAVI | Stand. | |
N | 348 | 351 | 179 | 179 | 41 | 49 | 220 | 228 | ||
30-day mortality | 3.4% | 6.5% | 0.07 | 5.0%† | 2.8% | 0.41 | 9.8% | 2.1% | 5.9% | 2.7% |
1-year mortality | 24.2% | 26.8% | 0.44 | 30.7% | 50.7% | <0.001 | 34.3% | 21.6% | 31.4% | 43.7% |
Sources: high-risk operable patients: Smith et al2; inoperable patients: pivotal trial: Leon et al1; Continued Access: FDA.4
The weights are based on the number of participants in the pivotal and Continued Access trials.
Uncertainty surrounding mortality is modelled with β distributions with the same mean. The α parameter of these distributions equals the number of events in the PARTNER randomised controlled trial. For example: 5% mortality on a total of 179 patients is reflected with a β distribution with the α parameter being 9 (ie, 5% of 179=9 patients) and the β parameter being 170 (ie, 179−9).
AVR, aortic valve replacement; Cont., continued; Stand., standard therapy; TAVI, transcatheter aortic valve implantation.