Key result
Intravascular imaging-guided PCI fails to significantly reduce target vessel failure vs angiography in HBR patients.
Why the study?
It was unknown whether intravascular imaging-guided PCI improves prognosis in patients with high bleeding risk, who frequently present with complex coronary artery lesions.
Does intravascular imaging-guided PCI reduce target vessel failure compared to angiography-guided PCI in patients with complex coronary artery lesions and high bleeding risk?
RCT (n=1,639)
randomized
Yes
Does intravascular imaging-guided PCI reduce target vessel failure compared to angiography-guided PCI in patients with complex coronary artery lesions and high bleeding risk?
Effect estimate: adjusted HR 0.57 (95% CI 0.31-1.02)
Absolute Event Rate: 9.7% vs 15.8%
p-value: p=0.060
Intravascular imaging-guided PCI reduces the risk of target vessel failure compared to angiography-guided PCI in patients with complex coronary lesions, with consistent benefits regardless of high bleeding risk status.
Supports imaging-guided PCI in high-bleeding-risk complex cases; extends overall trial benefit without interaction by bleeding risk.
Background Although patients with high bleeding risk (HBR) often have complex coronary artery lesions, it is not known whether intravascular imaging-guided percutaneous coronary artery 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 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 presence of HBR. The primary end point was target vessel failure, which was a composite of cardiac death, target-vessel related myocardial infarction (MI), or clinically driven target vessel revascularization. Results Of 1,639 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% vs 8.2%; adjusted hazard ratio [HR], 1.05; 95% CI, 0.72-1.54; P=0.790). However, HBR patients were at higher risk for cardiac death or spontaneous target-vessel related MI (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 lower risk of primary end point compared with angiography-guided PCI in both HBR patients (9.7% vs 15.8%; adjusted HR, 0.57; 95% CI, 0.31-1.02; P=0.060) and non-HBR patients (6.9% vs 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 than those without HBR. Intravascular imaging-guided PCI showed lower risk of target vessel failure without significant interaction between treatment strategy and presence of HBR in patients undergoing complex PCI.
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Lee et al. (2025) conducted an RCT in complex coronary artery lesions with high bleeding risk (n=1,639). Intravascular imaging-guided PCI vs. Angiography-guided PCI was evaluated on target vessel failure (composite of cardiac death, target-vessel related MI, or clinically driven target vessel revascularization) (adjusted HR 0.57, 95% CI 0.31-1.02, p=0.060). Intravascular imaging-guided PCI showed a lower risk of target vessel failure compared with angiography-guided PCI in patients with high bleeding risk (9.7% vs 15.8%; adjusted HR 0.57; P=0.060).
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