Summary of findings table – heart failure with reduced ejection fraction
| Sacubitril/valsartan compared with control for heart failure with reduced ejection fraction | |||||
| Patient or population: heart failure with reduced 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 23 months | 10 794 (seven RCTs) | ⨁⨁⨁◯ MODERATE* | RR 0.86 (0.79 to 0.94) | 161 per 1.000 | 23 fewer per 1.000 (34 fewer to 10 fewer) |
| Serious adverse events follow-up: mean 23 months | 10 794 (seven RCTs) | ⨁⨁⨁◯ MODERATE* | RR 0.89 (0.86 to 0.94) | 418 per 1.000 | 46 fewer per 1.000 (59 fewer to 25 fewer) |
| Myocardial infarction follow-up: mean 25 months | 9051 (two RCTs) | ⨁◯◯◯ VERY LOW*†‡ | RR 0.98 (0.71 to 1.35) | 16 per 1.000 | 0 fewer per 1.000 (5 fewer to six more) |
| Quality of life assessed with: MLHFQ follow-up: mean 2 months | 232 (two RCTs) | ⨁◯◯◯ VERY LOW§¶ | – | MD 5.19 score lower (8.37 lower to 2.01 lower) | |
| Non-serious adverse events follow-up: mean 23 | 10 401 (nine RCTs) | ⨁⨁◯◯ LOW*† | RR 0.95 (0.84 to 1.08) | 547 per 1.000 | 27 fewer per 1.000 (88 fewer to 44 more) |
| Rehospitalisations follow-up: mean 25 months | 9476 (four RCTs) | ⨁⨁◯◯ LOW*‡ | RR 0.77 (0.69 to 0.87) | 159 per 1.000 | 37 fewer per 1.000 (49 fewer to 21 fewer) |
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 risk of bias, due to industry funding.
†Downgraded 1 for risk of 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.
§Downgraded 2 for risk of bias.
¶Downgraded 2 for risk of inconsistency due to substantial heterogeneity.
RR, risk ratio; MD, mean difference; ARNI, angiotensin receptor blocker neprilysin inhibitor; RCTs, randomised controlled trials; MLHFQ, Minnesota Living with Heart Failure Questionnaire; MD, mean difference.