Immediate coronary angiography did not significantly reduce 12-month mortality, MI, or recurrent ischemia compared to delayed angiography (HR 1.60; 95% CI 0.72-3.57; P=0.245).
RCT (n=85)
Open-label
1:1
No
Does immediate coronary angiography reduce the composite of all-cause mortality, nonfatal MI, and recurrent ischemia in patients with NSTE-ACS complicated with ADHF?
In patients with NSTE-ACS complicated by ADHF, immediate coronary angiography did not reduce the primary composite outcome compared to delayed angiography and was associated with higher cardiovascular mortality.
Hazard Ratio: 1.6 (95% CI 0.72–3.57)
Absolute Event Rate: 35.6% vs 24.2%
p-value: p=0.245
Abstract Background/Introduction Immediate coronary angiography (CAG) is currently recommended for patients with non-ST segment elevation acute coronary syndrome (NSTE-ACS) complicated with acute decompensated heart failure (ADHF) despite a lack of clinical evidence. Purpose We aimed to assess whether immediate CAG can reduce mortality and improve clinical outcomes in patients with NSTE-ACS complicated with ADHF. Methods The EARLY-HF trial was an investigator-initiated, single-center, open label, randomized clinical trial performed in single tertiary hospital in South Korea from April 2021 to October 2021. Patients with both NSTE-ACS and complicated with ADHF with pulmonary edema confirmed by chest X-ray were eligible for inclusion in the study. Patients with cardiogenic shock, ongoing refractory chest pain, or HF with an etiology other than NSTE-ACS were excluded. Patients were randomized at a 1:1 ratio to receive immediate CAG within 2h (immediate CAG group) or delayed CAG after stabilization of heart failure (HF) (delayed CAG group). The primary outcome was the composite of 12-month composite of all-cause mortality, nonfatal myocardial infarction (MI), and recurrent ischemia. Recurrent ischemia was defined by fulfillment of one of following: i) the occurrence of ischemic chest pain with changes in electrocardiogram, ii) sustained ventricular tachycardia or fibrillation, iii) acute pulmonary edema, or iv) cardiogenic shock. Results The EARLY-HF trial was prematurely terminated because of conditions related to coronavirus disease 2019 (COVID-19). A total of 85 patients were randomly divided into the immediate CAG group (n=43) or delayed CAG group (n=42). CAG was performed significantly earlier after randomization in the immediate CAG group than the delayed CAG group (mean 1.03h vs. 82.7h, respectively, P 0.001). Revascularization was performed in 67.4% and 69.1% of patients in the immediate and delayed CAG groups, respectively. The incidence of the primary outcome was 35.6% vs. 24.2% in the two groups, respectively (HR 1.60, 95% CI 0.72–3.57, P=0.245) (Figure 1). However, the 12-month cardiovascular mortality rate was higher in the immediate CAG group than the delayed CAG group (23.7% vs. 7.3%, respectively, P=0.039). Differences in other 1-month, in-hospital, and 12-month outcomes between the two groups were not statistically significant. Conclusions Immediate CAG within 2h after randomization was not beneficial compared to delayed CAG in patients with NSTE-ACS complicated by ADHF.Time to event curve for primary endpoint
Kim et al. (2025) conducted an RCT in Non-ST-segment elevation acute coronary syndrome (NSTE-ACS) complicated with acute decompensated heart failure (ADHF) (n=85). Immediate coronary angiography (within 2h) vs. Delayed coronary angiography (after stabilization of heart failure) was evaluated on 12-month composite of all-cause mortality, nonfatal myocardial infarction (MI), and recurrent ischemia (HR 1.60, 95% CI 0.72-3.57, p=0.245). Immediate coronary angiography did not significantly reduce 12-month mortality, MI, or recurrent ischemia compared to delayed angiography (HR 1.60; 95% CI 0.72-3.57; P=0.245).