Heart failure & cardiomyopathiesSecondary analysis
2-Year Outcomes of an Atrial Shunt Device in HFpEF/HFmrEF
- Secondary analysis of the REDUCE LAP-HF II randomised trial
- sham-controlled
Authors' conclusion
At 2 years of follow-up in REDUCE LAP-HF II, there was no difference in efficacy between the atrial shunt and sham groups in the overall trial group.
Study context
- Population
- Patients with heart failure with preserved or mildly reduced EF
- Participants
- 621 patients
- Comparison
- Atrial shunt vs sham procedure
- Shuntn = 309
- Shamn = 312reference
- Primary endpoint
- Hierarchical composite of:
- CV death or nonfatal ischemic/embolic stroke
- Total HF events
- Change in health status
- Follow-up
- 2 years
Primary result
As reported in the abstract
Win ratio
1.01
95% CI 0.82–1.24
Shunt vs Sham
win ratio 1.01 (95% CI 0.82–1.24)
Further findings
| Outcome | win ratio (95% CI) | P value | |
|---|---|---|---|
| Primary endpoint in responders (subgroup, n = 313) | 1.36 (1.02–1.83) | P = 0.037 | |
| Primary endpoint in nonresponders (subgroup, n = 265) | 0.73 (0.54–0.98) | ||
| 0.512Win ratio (log scale) |
| Outcome | IRR (95% CI) | P value | |
|---|---|---|---|
| HF events in responders (subgroup) · 51% fewer HF events | 0.49 (0.25–0.95) | P = 0.034 | |
| 0.20.5125Incidence rate ratio (log scale) |
- Shunt patency at 24 months
- 98%
Safety
MACE
P = 0.018
RV volume increase ≥30%
P < 0.001
MACE
- CV mortality and nonfatal ischemic stroke not different between groups
RV volume increase ≥30%
- RV dysfunction uncommon and not different between groups
Original publication
2-Year Outcomes of an Atrial Shunt Device in HFpEF/HFmrEF. JACC Heart Fail. Published 26 June 2024. doi:10.1016/j.jchf.2024.04.011
Summarised from the published abstract; every number is checked against it