Sacubitril/valsartan compared with control for heart failure with preserved ejection fraction | |||||

Patient or population: heart failure with preserved ejection fraction Intervention: sacubitril/valsartan Comparison: control | |||||

Outcomes | No of participants (studies) follow-up | Certainty of the evidence (GRADE) | Relative effect (95% CI) | Anticipated absolute effects | |

Risk with control | Risk difference with ARNI | ||||

All-cause mortality follow-up: mean 34 months | 5174 (three RCTs) | ⨁◯◯◯ VERY LOW*†‡ | RR 0.95(0.83 to 1.09) | 140 per 1.000 | 7 fewer per 1.000(24 fewer to 13 more) |

Serious adverse events follow-up: mean 34 months | 5174 (three RCTs) | ⨁⨁◯◯ LOW*† | RR 0.99(0.94 to 1.04) | 564 per 1.000 | 6 fewer per 1.000(34 fewer to 23 more) |

Myocardial infarction follow-up: mean 34 months | 5122 (two RCTs) | ⨁⨁◯◯ LOW*‡ | RR 0.94(0.59 to 1.50) | 14 per 1.000 | 1 fewer per 1.000(6 fewer to 7 more) |

Non-serious adverse events follow-up: mean 34 months | 5122 (two RCTs) | ⨁⨁◯◯ LOW*† | RR 0.96(0.85 to 1.09) | 934 per 1.000 | 37 fewer per 1.000(140 fewer to 84 more) |

The risk in the intervention group (and its 95% CI) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI).

GRADE, Working Group grades of evidence.

High 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.

*Downgraded 1 for serious risk of bias.

†Downgraded 1 for inconsistency due to moderate heterogeneity.

‡Downgraded 1 for imprecision due to Trial Sequential Analysis showing that there was not enough information to confirm or reject a RRR of 15%. Moreover, the meta-analysis showed wide CI.

RR, risk ratio; ARNI, angiotensin receptor blocker neprilysin inhibitor; RCTs, randomised controlled trials.