Table 3:
Life-Threatening or Major/Disabling Bleeding
| Author, Year N (TAVI/SAVR) | Life-Threatening or Major/Disabling Bleeding, 30 Days |
|---|---|
| Full Cohort | |
| Reardon et al, 201719 | Percentageb TAVI: 12.2 |
| SURTAVI, mITTa | TAVI: 12.2 |
| 1,660 (864/796) | SAVR: 9.3 |
| 95% Crl for difference: −0.1 to 5.9 | |
| Leon et al, 201610 | KM estimate,d n (%) TAVI: 105 (10.4) |
| PARTNER 2, ITTc | TAVI: 105 (10.4) |
| 2,032 (1,011/1,021) | SAVR: 442 (43.4) |
| P < .001 | |
| Transfemoral Cohort | |
| Leon et al, 201610 | KM estimate,d n (%) TAVI: 52 (6.7) |
| PARTNER 2, ITTc | TAVI: 52 (6.7) |
| 1,550 (775/775) | SAVR: 320 (41.4) |
| P < .001 | |
| Transthoracic Cohort | |
| Leon et al, 201610 | KM estimate,d n (%) TAVI: 53 (22.6) |
| PARTNER 2, ITTc | TAVI: 53 (22.6) |
| 482 (236/246) | SAVR: 122 (49.8) |
| P < .001 | |
Abbreviations: CrI, credible interval; ITT, intention-to-treat analysis; KM, Kaplan–Meier; mITT, modified intention-to-treat analysis; SAVR, surgical aortic valve replacement; TAVI, transcatheter aortic valve replacement.
a
mITT analysis refers to patients in whom the TAVI or SAVR procedure was at least attempted.
b
Calculated by means of Bayesian analyses.
c
ITT analysis includes all patients randomized to receive either TAVI or SAVR.
d
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.