Intravascular Imaging- vs Angiography-Guided Complex PCI: 5-Year Outcomes From a Randomized Trial

Abstract

BACKGROUND: Data regarding long-term outcomes of intravascular imaging-guided percutaneous coronary intervention (PCI) for complex coronary artery lesions, compared with angiography-guided PCI, remain limited. OBJECTIVES: The authors sought to present long-term clinical outcomes of intravascular imaging-guided PCI compared with angiography-guided PCI in patients with complex coronary artery lesions. METHODS: Eligible patients with complex coronary artery lesions were randomly assigned 2:1 to undergo intravascular imaging-guided PCI or angiography-guided PCI in this prospective multicenter open-label superiority trial performed in South Korea. The primary endpoint was a composite of cardiac death, target vessel-related myocardial infarction, or clinically driven target vessel revascularization. RESULTS: A total of 1,639 patients underwent randomization with 1,092 assigned to imaging-guided PCI and 547 assigned to angiography-guided PCI. At a median follow-up of 5.3 years (Q1-Q3: 4.4-6.2 years), the primary endpoint occurred in 109 of 1,092 patients (10.5%) in the intravascular imaging-guided PCI group and 78 of 547 patients (14.9%) in the angiography-guided PCI group (HR: 0.68; 95% CI: 0.51-0.91; P = 0.009). Cardiac death or target vessel-related myocardial infarction occurred in 78 patients (7.6%) in the intravascular imaging-guided PCI group and in 56 patients (10.7%) in the angiography-guided PCI group, clinically driven target vessel revascularization in 45 (4.4%) and 32 (6.2%), and definite stent thrombosis in 1 (0.1%) and 4 (0.7%), respectively. There were no apparent differences in procedure-related safety events between the groups. CONCLUSIONS: In patients with complex coronary artery lesions undergoing PCI, intravascular imaging guidance reduced the risk of a composite of cardiac death, target vessel-related myocardial infarction, or clinically driven target vessel revascularization at median follow-up of 5.3 years, compared to angiography guidance. (Intravascular Imaging- Versus Angiography-Guided Percutaneous Coronary Intervention for Complex Coronary Artery Disease [RENOVATE-COMPLEX-PCI]; NCT03381872).