Table A8:
Study Results—Life-Threatening or Major/Disabling Bleeding and Acute Kidney Injury
| Author, Year N (TAVI/SAVR) | Life-Threatening or Major/Disabling Bleeding | Acute Kidney Injury | ||||
|---|---|---|---|---|---|---|
| 30 Days | 1 Year | 2 Years | 30 Days | 1 Year | 2 Years | |
| Full Cohort | ||||||
| Reardon et al, 201719 SURTAVI, mITT 1,660 (864/796) |
Percentagea TAVI: 12.2 SAVR: 9.3 95% Crl for difference: −0.1 to 5.9 |
Not reported | Not reported | Percentagea Stage 2 or 3 TAVI: 1.7 SAVR: 4.4 95% Crl for difference: 4.4 to −1.0 |
Not reported | Not reported |
| Leon et al, 201610 | KM estimateb, n (%) | KM estimateb, n (%) | KM estimateb, n (%) | KM estimateb, n (%) | KM estimateb, n (%) | KM estimateb, n (%) |
| PARTNER 2 | TAVI: 105 (10.4) | TAVI: 151 (15.2) | TAVI: 169 (17.3) | TAVI: 13 (1.3) | TAVI: 32 (3.4) | TAVI: 36 (3.8) |
| SAVR: 442 (43.4) | SAVR: 460 (45.5) | SAVR: 471 (47.0) | SAVR: 31 (3.1) | SAVR: 48 (5.0) | SAVR: 57 (6.2) | |
| 2,032 (1,011/1,021) | P < .001 | P < .001 | P < .001 | P = .006 | P = .07 | P = .02 |
| Transfemoral Cohort | ||||||
| Leon et al, 201610 | KM estimateb, n (%) | KM estimateb, n (%) | KM estimateb, n (%) | KM estimateb, n (%) | KM estimateb, n (%) | KM estimateb, n (%) |
| PARTNER 2 | TAVI: 52 (6.7) | TAVI: 84 (11.1) | TAVI: 101 (13.6) | Stage 3 | Stage 3 | Stage 3 |
| SAVR: 320 (41.4) | SAVR: 333 (43.4) | SAVR: 341 (44.7) | TAVI: 4 (0.5) | TAVI: 16 (2.2) | TAVI: 18 (2.5) | |
| 1,550 (775/775) | P < .001 | P < .001 | P < .001 | SAVR: 23 (3.0) | SAVR: 38 (5.2) | SAVR: 45 (6.4) |
| P < .001 | P = .002 | P < .001 | ||||
| Transthoracic Cohort | ||||||
| Leon et al, 201610 | KM estimateb, n (%) | KM estimateb, n (%) | KM estimateb, n (%) | KM estimateb, n (%) | KM estimateb, n (%) | KM estimateb, n (%) |
| PARTNER 2 | TAVI: 53 (22.6) | TAVI: 67 (29.1) | TAVI: 68 (29.6) | Stage 3 | Stage 3 | Stage 3 |
| SAVR: 122 (49.8) | SAVR: 127 (52.3) | SAVR: 130 (54.1) | TAVI: 9 (3.9) | TAVI: 16 (7.3) | TAVI: 18 (8.4) | |
| 482 (236/246) | P < .001 | P < .001 | P < .001 | SAVR: 8 (3.4) | SAVR: 10 (4.3) | SAVR: 12 (5.5) |
| P = .77 | P = .18 | P = .23 | ||||
Abbireviations: CrI, credible interval; KM, Kaplan-Meier; mITT, modified intention to treat; SAVR, surgical aortic valve replacement; TAVI, transcatheter aortic valve replacement.
a
Calculated by means of Bayesian analyses.
b
The percentages provided are Kaplan-Meier estimates at the specific time point and do not necessarily equal the number of patients who experienced the event divided by the total number of patients in the treatment group at the given time point.