Table 1. – Summary of the results: patients at high surgical risk.
| Outcomes | Participants (studies) | Quality of the evidence (GRADE) | Relative effect (95% CI) | Absolute effect |
|---|---|---|---|---|
| Mortality (1 year) | 1381 * † | Moderate ‡ | OR 0.9 (0.7-1.17) | 18 less per 1000 (55 less to 28 more) |
| Stroke (1 year) | 1262 * † | Low ‡ § | OR 1.06 (0.3-3.7) | 5 less per 1000 (59 less to 173 more) |
| AF (1 year) | 1446 * † | Moderate ‡ | OR 0.5 (0.29-0.86) | 106 less per 1000 (27 to 160) |
| Permanent pacemaker implant (1 year) | 1446 * † | Moderate ‡ | OR 1.78 (0.94-3.37) | 52 less per 1000 (34 less to 119 more) |
| NYHA >=2 (1 year) | 669 * | Low‡ // | OR 0.85 (0.62-1.15) | 40 less per 1000 (119 less to 34 more) |
| Life-threatening bleeding (30 days) | 747 * | Moderate // | OR 0.29 (0.2-0.42) | 215 less per 1000 (166 to 253) |
| Acute kidney failure (30 days) | 1446 * † | Very low ‡ // ¶ | OR 0.57 (0.2-1.61) | 39 less per 1000 (75 less to 50 more) |
AF: atrial fibrillation; NYHA: New York Heart Association. * US CoreValve High Risk 2014. † PARTNER 2011. ‡ Inaccuracy due to large confidence interval and/or no treatment effect. § Inconsistency, as there was a reduction in the risk of stroke in the US CoreValve High Risk study, with no statistically significant difference in the PARTNER A study. Unexplained heterogeneity between studies identified (I2 87%, p-value [p = 0.006]). // Methodological limitations, as it is not possible to exclude the measurement bias due to the impossibility of obtaining blinding patients and teams. Given that the functional assessment and bleeding severity were considered non-objective outcomes, the level of evidence was reduced. ¶ Inconsistency, as there was a reduction in the risk of acute renal failure in the US CoreValve High Risk study, with no statistically significant difference in the PARTNER A study. Unexplained heterogeneity between studies identified (I2 80%, p-value [p = 0.02]).