TABLE 2.
Summary of findings table
| Outcomes | Relative effect (95% CI) | № of participants (studies) | Certainty of the evidence (GRADE) |
|---|---|---|---|
| Mortality at longest follow‐up available | Relative risk 1.24 (1.04–1.49) | 807 (16 RCTs) |
⨁⨁◯◯ Low |
| Mortality at 30‐days | Relative risk 1.41 (1.06–1.88) | 727 (11 RCTs) |
⨁⨁◯◯ Low |
| Patients with at least one serious adverse event | Relative risk 1.42 (0.87–2.33) | 210 (4 RCTs) |
⨁◯◯◯ Very low |
| Patients with at least one adverse event | Relative Rrsk 1.09 (0.98–1.21) | 299 (6 RCTs) |
⨁◯◯◯ Very low |
| Adverse event leading to death | Relative risk 0.99 (0.19–5.06) | 76 (2 RCTs) |
⨁◯◯◯ Very low |
| Total number of serious adverse events | Rate ratio 1.18 (0.86–1.63) | 173 (3 RCTs) |
⨁◯◯◯ Very low |
| Total number of adverse events | Rate ratio 0.99 (0.86–1.15) | 524 (6 RCTs) |
⨁◯◯◯ Very low |
| Total number of non‐serious adverse events | Rate ratio 0.79 (0.62–1.01) | 173 (3 RCTs) |
⨁◯◯◯ Very low |
| Total number of device‐related adverse events | Rate ratio 2.90 (0.70–12.05) | 246 (6 RCTs) |
⨁◯◯◯ Very low |
Notes: GRADE Working Group grades of evidenceHigh certainty: we are very confident that the true effect lies close to that of the estimate of the effect.Moderate certainty: we are moderately confident in the effect estimate: the true effect is likely to be close to the estimate of the effect, but there is a possibility that it is substantially different.Low certainty: our confidence in the effect estimate is limited: the true effect may be substantially different from the estimate of the effect.Very low certainty: we have very little confidence in the effect estimate: the true effect is likely to be substantially different from the estimate of effect.