Heart failure & cardiomyopathiesRandomised controlled trial
Interatrial Shunt Treatment for Heart Failure: The Randomized RELIEVE-HF Trial
- Randomised controlled trial
- placebo-controlled
- stratified by left ventricular ejection fraction (LVEF)
- multicentre
Authors' conclusion
Transcatheter interatrial shunt implantation was safe but did not improve outcomes in patients with HF.
Study context
- Population
- Patients with symptomatic heart failure (HF) with any LVEF
- Participants
- 508 patients · 94 sites · 11 countries
- Comparison
- Transcatheter interatrial shunt vs placebo procedure
- Shuntn = 250
- Placebon = 258reference
- Primary endpoint
- Hierarchical composite of:
- All-cause death
- Cardiac transplantation or LV assist device implantation
- HF hospitalization
- Outpatient worsening HF events and change in KCCQ overall summary score
- As win ratio
- Follow-up
- maximum 2-year follow-up
Primary result
As reported in the abstract
2 years
Win ratio
0.86
95% CI 0.61–1.22
P = 0.20
Shunt vs Placebo
win ratio 0.86 (95% CI 0.61–1.22); P = 0.20
Further findings
Annualized rate
| Outcome | Shunt | Placebo | RR (95% CI) | P value | |
|---|---|---|---|---|---|
| Adverse CV events, reduced LVEF (≤40%) (prespecified subgroup) · prespecified hypothesis-generating analysis | 49.0% | 88.6% | 0.55 (0.42–0.73) | P < 0.0001 | |
| Adverse CV events, preserved LVEF (>40%) (prespecified subgroup) · prespecified hypothesis-generating analysis | 60.2% | 35.9% | 1.68 (1.29–2.19) | P = 0.0001 | |
| 0.512Relative risk (log scale) |
- Adverse CV events, reduced LVEF (≤40%) (prespecified subgroup): interaction P<0.0001
- Adverse CV events, preserved LVEF (>40%) (prespecified subgroup): interaction P<0.0001
Change in KCCQ overall summary score
- No between-group differences in all patients or in reduced or preserved LVEF
Safety
| Outcome | Shunt | Placebo |
|---|---|---|
| Device- or procedure-related major adverse CV or neurological events (primary safety outcome) · 30 days | ||
| upper 97.5% confidence limit | 1.5% | Not reported in the abstract |
- Device- or procedure-related major adverse CV or neurological events (primary safety outcome): vs prespecified performance goal of 11%
- Device- or procedure-related major adverse CV or neurological events (primary safety outcome): P<0.0001
Original publication
Interatrial Shunt Treatment for Heart Failure: The Randomized RELIEVE-HF Trial. Circulation. Published 23 September 2024. doi:10.1161/circulationaha.124.070870
Summarised from the published abstract; every number is checked against it