The study is a prospective, multicenter, open-label trial in South Korea that aims to compare the clinical outcomes of intravascular imaging-guided percutaneous coronary intervention (PCI) and angiography-guided PCI in patients with complex coronary-artery lesions. The trial randomly assigned 1639 patients in a 2:1 ratio, with 1092 patients in the intravascular imaging group and 547 patients in the angiography group. The choice between intravascular ultrasonography and optical coherence tomography in the intravascular imaging group was at the discretion of the operators.
The primary endpoint of the study was a composite of death from cardiac causes, target-vessel-related myocardial infarction, or clinically driven target-vessel revascularization. Safety was also assessed. The median follow-up was 2.1 years.
The results of the study showed that at the end of the follow-up period, the primary endpoint occurred in 76 patients (7.7%) in the intravascular imaging group and in 60 patients (12.3%) in the angiography group. The hazard ratio was 0.64, with a 95% confidence interval of 0.45 to 0.89 and a p-value of 0.008, indicating that intravascular imaging-guided PCI led to a lower risk of the composite endpoint than angiography-guided PCI.
Regarding the individual components of the primary endpoint, death from cardiac causes occurred in 16 patients (1.7%) in the intravascular imaging group and in 17 patients (3.8%) in the angiography group. Target-vessel-related myocardial infarction occurred in 38 patients (3.7%) in the intravascular imaging group and in 30 patients (5.6%) in the angiography group. Clinically driven target-vessel revascularization occurred in 32 patients (3.4%) in the intravascular imaging group and in 25 patients (5.5%) in the angiography group.
There were no apparent differences in the incidence of procedure-related safety events between the two groups.
In conclusion, the study showed that among patients with complex coronary-artery lesions, intravascular imaging-guided PCI led to a lower risk of a composite of death from cardiac causes, target-vessel-related myocardial infarction, or clinically driven target-vessel revascularization than angiography-guided PCI. The results suggest that intravascular imaging may be a useful tool in guiding PCI in patients with complex coronary-artery lesions.
DOI: 10.1056/NEJMoa2216607
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