Summary of findings 5. Angiotensin receptor neprilysin inhibitors (ARNIs) compared to usual care for chronic heart failure with preserved ejection fraction.
| ARNIs compared to usual care for chronic heart failure with preserved ejection fraction | ||||||
| Patient or population: patients with chronic heart failure with preserved ejection fraction Setting: secondary care Intervention: ARNI (sacubitril‐valsartan) Comparison: ARB (valsartan) | ||||||
| Outcomes | Anticipated absolute effects* (95% CI) | Relative effect (95% CI) | № of participants (studies) | Certainty of the evidence (GRADE) | Comments | |
| Risk with usual care | Risk with ARNI | |||||
| Cardiovascular mortality (RR) Median follow‐up: 35 months |
Study population | RR 0.96 (0.79 to 1.15) | 4796 (1 study) | ⊕⊕⊕⊝ MODERATE1 | ||
| 89 per 1,000 | 85 per 1,000 (70 to 102) | |||||
| Heart failure hospitalisation, first (RR) Range of follow‐up: 24 weeks to 35 months |
Study population | RR 0.89 (0.80 to 1.00) |
7362 (2 studies) |
⊕⊕⊕⊝ MODERATE1 | ||
| 142 per 1,000 | 126 per 1,000 (113 to 142) |
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| Hyperkalaemia Range of follow‐up: 36 weeks to 35 months |
Study population | RR 0.88 (0.77 to 1.01) | 5054 (2 studies) | ⊕⊕⊕⊝ MODERATE1 | ||
| 147 per 1,000 | 129 per 1,000 (113 to 148) | |||||
| All‐cause mortality (RR) Range of follow‐up: 36 weeks to 35 months |
Study population | (RR 0.97 CI 0.84 to 1.11) |
7663 (3 studies) | ⊕⊕⊕⊕ HIGH | ||
| 138 per 1,000 | 134 per 1,000 (117 to 153) | |||||
| Quality of life Range of follow‐up: 36 weeks to 35 months |
PARAMOUNT reported change from baseline for the KCCQ overall summary score for the intervention arm (n =118) as 11.25 (2.185) and the control arm (n = 116) as 11.31 (2.183) and summarised the findings as "no difference in KCCQ score between treatment groups". PARAGON‐HF reported a difference of the clinical summary score KCCQ between treatment arms as 1.0 (0.0 to 2.1). PARALLAX reported "KCCQ improved in both treatment groups, with an early benefit of S/V that was no longer significant after 24 week". |
⊕⊕⊕⊕ HIGH | ||||
| *The risk in the intervention group (and its 95% confidence interval) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI). ARB: Angiotensin receptor blocker; ARNIs: Angiotensin receptor neprilysin inhibitors; CI: Confidence interval; KCCQ: Kansas City Cardiomyopathy Questionnaire; MD: Mean difference; RCT: Randomised controlled trial; RR: Risk ratio | ||||||
| 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 | ||||||
1Downgraded by one level due to imprecision.