Table 3. – Summary of the results: patients at low surgical risk.
Outcomes | Participants (studies) | Quality of the evidence (GRADE) | Relative effect (95% CI) | Absolute effect |
---|---|---|---|---|
Mortality (1 year) | 2014 * † ‡ | Moderate § | OR 0.58 (0.34-0.97) | 16 less per 1000 (1 to 26) |
Stroke (1 year) | 2014 * † ‡ | Moderate § | OR 0.51 (0.28-0.94) | 15 less per 1000 (2 to 22) |
AF (1 year) | 2014 * † ‡ | High | OR 0.16 (0.12-0.2) | 295 less per 1000 (275 to 316) |
Permanent pacemaker implant (1 year) | 2014 * † ‡ | Low § // | OR 4.22 (1.27-14.02) | 141 more per 1000 (14 to 391) |
NYHA >=2 (1 year) | 1909 * † ‡ | Low § # | OR 1.31 (0.93-1.85) | 55 more per 1000 (-10 to 107) |
Life-threatening bleeding (30 days) | 2353 * † | Low § # | OR 0.17 (0.05-0.55) | 76 less per 1000 (40 to 88) |
Acute kidney failure (30 days) | 2633 * † ‡ | Low § # | OR 0.27 (0.13-0.55) | 21 less per 1000 (13 to 25) |
AF: atrial fibrillation; NYHA: New York Heart Association. * PARTNER 3. † Evolut Low Risk. ‡ NOTION. § Imprecision due to large confidence interval and/or no treatment effect. // Inconsistency, as PARTNER 3 showed no increased risk of permanent pacemaker implantation with TAVR, but Evolut Low Risk and Notion did. Unexplained heterogeneity between studies (I2 90%, p-value [p = 0.02]). ¶ Inconsistency due to the amplitude of the confidence interval. # Methodological limitations: since blinding patients and teams is impossible, measurement bias cannot be eliminated. Given that the functional assessment and bleeding severity were considered non-objective outcomes, the level of evidence was reduced.