Intravascular Imaging Shows Sustained Clinical Benefits at 5 Years in Complex PCI Procedures
核心洞察
Extended 5-year follow-up from the RENOVATE-COMPLEX-PCI trial confirms that intravascular imaging guidance maintains its clinical advantage over angiographic guidance for complex coronary lesions.
The study demonstrated a sustained 32% reduction in target-vessel failure and 32% reduction in cardiac death or target-vessel MI with intravascular imaging compared to angiography alone.
Benefits were most pronounced in chronic total occlusion and diffuse long lesions, with most advantages occurring within the first 2 years and no late catch-up phenomenon observed.
Extended follow-up from the RENOVATE-COMPLEX-PCI trial demonstrates that intravascular imaging continues to provide superior clinical outcomes compared to angiographic guidance alone for patients with complex coronary lesions, with benefits sustained at a median of 5.3 years after percutaneous coronary intervention (PCI).
The 5-year analysis, published in JACC, included all 1,639 patients originally randomized 2:1 to intravascular imaging or angiography guidance. The primary endpoint of target-vessel failure occurred significantly less frequently in the imaging group compared to the angiography group (10.5% vs 14.9%; HR 0.68; 95% CI 0.51-0.91), representing a sustained 32% relative risk reduction.
Durable Clinical Benefits Without Late Catch-up
The composite endpoint of cardiac death or target-vessel myocardial infarction occurred in 7.6% of the imaging group versus 10.7% of the angiography group (HR 0.68; 95% CI 0.48-0.96). Clinically driven target-lesion revascularization rates were 4.4% and 6.2%, respectively, though this difference did not reach statistical significance (HR 0.73; 95% CI 0.46-1.16).
"What this 5-year report adds is durability," said senior author Joo-Yong Hahn, MD, PhD, from Samsung Medical Center in Seoul. "The earlier benefit has been maintained over a median 5.3 years, without evidence of a late catch-up. In other words, the early procedural advantage translated into a sustained clinical benefit over time."
Landmark analyses revealed that most of the advantage for intravascular imaging occurred within the first 2 years, with no significant difference between the two groups thereafter, confirming the absence of a late catch-up phenomenon.
Greatest Impact in Specific Lesion Types
The study population included patients with various complex lesion characteristics, with around half initially presenting with stable ischemic heart disease and half with acute coronary syndromes. The most common type of complex lesion was long coronary occlusion, followed by multivessel PCI, true bifurcation, and chronic total occlusion. More than three in 10 patients had at least three of these characteristics in the target lesion.
"Notably, within the spectrum of complex coronary artery lesion subsets, the benefits of intravascular imaging-guided PCI over angiography-guided PCI were most apparent in chronic total occlusion and diffuse long lesions," the investigators noted. Patients with stable ischemic heart disease showed more prominent benefit compared to those with acute coronary syndrome, though there was no significant interaction between clinical presentation and treatment effect.
Addressing Adoption Barriers
Despite growing evidence supporting intravascular imaging, adoption remains limited in some regions, including the United States. The technology has gained endorsement in recent guidelines, with European and US guidelines providing intravascular imaging a class 1a indication for guiding PCI in chronic and acute coronary syndromes as of 2024 and 2025, respectively.
"The main barriers are still cost, reimbursement, procedural time, and operator familiarity. Usage differs widely across the world because adoption depends not only on the evidence, but also on local healthcare systems, training environments, and device availability," Hahn explained.
He recommended that in contexts where routine imaging cannot be implemented due to cost or other barriers, "it should be prioritized for cases where it is most likely to alter procedural strategy or improve stent optimization."
Mechanistic Understanding
The reduction in cardiac death aligns with results from a large meta-analysis presented at the 2023 European Society of Cardiology Congress. "Mechanistically, if imaging allows us to identify and correct underexpansion, malapposition, and edge complications at the index procedure, it reduces the substrate for later restenosis, stent failure, and thrombosis, which may ultimately translate into fewer myocardial infarctions and cardiac deaths," Hahn explained.
RENOVATE-COMPLEX-PCI stands out in the evidence base for the magnitude of improvement with intravascular imaging. "Prior studies of intravascular imaging-guided PCI have not always shown statistically significant reductions in hard endpoints, but the signal has generally been directionally consistent," Hahn noted. "In RENOVATE-COMPLEX-PCI, the benefit may have been more apparent because the trial enrolled only complex lesions where the impact of imaging is likely to be greatest, and because the longer follow-up allowed that benefit to become more evident over time."