Intravascular Imaging-Guided Versus Angiography-Guided Complex PCI in Patients With High Bleeding Risk: A Secondary Analysis of the RENOVATE-COMPLEX PCI Trial

BACKGROUND: Although patients with high bleeding risk (HBR) often have complex coronary artery lesions, it is not known whether intravascular imaging-guided percutaneous coronary intervention (PCI) improves their prognosis. We sought to investigate the benefit of intravascular imaging-guided PCI for complex coronary artery lesions in patients with HBR. METHODS: This was a secondary analysis of the RENOVATE-COMPLEX-PCI trial (Randomized Controlled Trial of Intravascular Imaging Guidance Versus Angiography-Guidance on Clinical Outcomes After Complex Percutaneous Coronary Intervention) in which patients with complex coronary artery lesions undergoing PCI were enrolled at 20 sites in Korea from May 2018 through May 2021. Patients were randomized to receive intravascular imaging-guided PCI or angiography-guided PCI and classified according to the presence of HBR. The primary end point was target vessel failure, which was a composite of cardiac death, target vessel-related myocardial infarction, or clinically driven target vessel revascularization. RESULTS: Of 1639 trial population, 478 patients met HBR criteria. There was no significant difference in the risk of the primary end point between HBR and non-HBR patients (11.8% versus 8.2%; adjusted hazard ratio [HR], 1.05 [95% CI, 0.72–1.54]; P =0.790). However, patients with HBR were at higher risk for cardiac death or spontaneous target vessel-related myocardial infarction (adjusted HR, 2.04 [95% CI, 1.09–3.80]; P =0.025), all-cause death (adjusted HR, 3.30 [95% CI, 1.93–5.62]; P <0.001), and cardiac death (adjusted HR, 2.36 [95% CI, 1.10–5.09]; P =0.028). Intravascular imaging-guided PCI showed a lower risk of the primary end point compared with angiography-guided PCI in both HBR patients (9.7% versus 15.8%; adjusted HR, 0.57 [95% CI, 0.31–1.02]; P =0.060) and non-HBR patients (6.9% versus 10.8%; adjusted HR, 0.65 [95% CI, 0.43–0.99]; P =0.045), without significant interaction ( P for interaction=0.796). CONCLUSIONS: Patients with HBR were associated with an increased risk of adverse cardiovascular events after complex PCI compared with those without HBR. Intravascular imaging-guided PCI showed a lower risk of the target vessel failure without significant interaction between treatment strategy and the presence of HBR in patients undergoing complex PCI. REGISTRATION: URL: https://www.clinicaltrials.gov ; Unique identifier: NCT03381872.