Health status similar between sacubitril/valsartan and ramipril recipients post-acute MI
Patients who receive sacubitril-valsartan after an acute myocardial infarction (MI) have a similar health status, as determined by EQ-5D visual analog scale (VAS) score, compared with those who receive ramipril, according to results of a prespecified analysis of the PARADISE-MI trial presented at HFSA 2021.
In this double-blind, active-controlled trial, patients with left ventricular ejection fraction (LVEF) ≤40 percent with ≥1 risk factor for heart failure (HF) or death*, and/or pulmonary congestion were randomized (within 0.5–7 days of an acute MI) 1:1 to receive sacubitril/valsartan (target dose: 97/103 mg BID; n=2,830) or ramipril (target dose: 5 mg BID; n=2,831). Patients with clinical instability, eGFR <30 mL/min/1.73 m2, and prior HF were excluded. The patients were followed up for a median 22 months.
Mean age of patients was 64 years and about one-fourth of patients were female. About 43 percent had diabetes, 65 percent had hypertension, and mean eGFR was 72 mL/min/1.73 m2. Mean EQ-5D visual analog scale (VAS) score at baseline was 70. Most patients were on dual antiplatelet therapy, statins, and beta-blockers at baseline.
Previously presented results suggested a non-significant reduction in the incidence of the primary outcome (cardiovascular death, hospitalization for heart failure [HHF], and outpatient HF) with sacubitril/valsartan vs ramipril (6.7 vs 7.4 per 100 patient-years; HR, 0.90, 95 percent CI, 0.78–1.04; p=0.17). [ACC.21, abstract 402-08]
In the present analysis, sacubitril/valsartan and ramipril recipients both experienced significant improvements in EQ-5D VAS scores at weeks 17 and 52. However, there was no significant difference between sacubitril/valsartan and ramipril for change in mean EQ-5D VAS scores at week 1 (69.6 in both groups; p=0.97), while there was a non-significant trend toward improved scores with sacubitril/valsartan at weeks 17 (76.6 vs 75.5; p=0.09) and 52 (77.4 vs 76.7; p=0.25). [HFSA 201, Late Breaking Clinical Trials 1 session]
After adjusting for MI type, use of percutaneous coronary intervention (PCI), region, and baseline VAS score, the treatment effect with sacubitril/valsartan was +0.9 and +0.7 compared with ramipril at weeks 17 and 52, respectively (p=0.12 and p=0.28, respectively).
Factors that influenced deterioration of VAS scores at 52 weeks included prior PCI or coronary artery bypass graft, prior stroke, pulmonary congestion, female sex, older age, and a higher BMI.
In the overall population, a significant difference in the VAS change score was noted when comparing patients with and without interval HF events over 1 year, specifically pertaining to the composite primary outcome (+3.2 vs +6.9; p=0.007) and HHF (+3.0 vs +6.8; p=0.019), but not outpatient HF (+3.6 vs +6.9; p=0.16).
There was a greater improvement in health status in patients who did not have interval HF events overall and for HHF, said study author Professor Eldrin Lewis, Chief of Cardiovascular Medicine, Stanford University School of Medicine, Stanford, California, US.
Among sacubitril/valsartan recipients, there was a significant difference in 52-week VAS score between those who did and did not experience HF events with regard to the composite outcome (+1.8 vs +7.3; p=0.007) and outpatient HF (-1.6 vs +7.3; p=0.019). Conversely, 52-week VAS score did not significantly differ with HF incidence among ramipril recipients for all outcomes. There was also no significant difference between the sacubitril/valsartan and ramipril treatment arms pertaining to the primary composite, HHF, and outpatient HF (p=0.25, 0.89, and 0.06, respectively).
The results showed that patients experienced an improvement in health status in the 1 year after an acute MI, said Lewis. In addition, patients who do not develop HF post-acute MI have greater improvements in health status compared with those who develop HF, regardless of treatment arm, he said.