ULTIMATE: IVUS-guided PCI superior to angiography guidance at 3 years
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In patients undergoing PCI with a drug-eluting stent, those whose procedures were guided by IVUS had less target vessel failure at 3 years than those whose procedures were guided by angiography, new data from the ULTIMATE trial showed.
As Healio previously reported, in the all-comers trial of 1,448 patients, IVUS-guided PCI was associated with lower TVF rates compared with angiography-guided PCI at 1 year. Jun-Jie Zhang, MD, PhD, associate professor, director of the cardiac catheter laboratory and vice director of cardiovascular development at Nanjing First Hospital, Nanjing Medical University, China, presented the 3-year results, which were simultaneously published in JACC: Cardiovascular Interventions, at the virtual TCT Connect.
At 3 years, among the 1,423 patients for whom data were available, TVF, defined as cardiac death, target vessel MI and clinically driven target vessel revascularization, occurred in 6.6% of the IVUS group compared with 10.7% of the angiography group (HR = 0.6; 95% CI, 0.42-0.87), Zhang said during a presentation.
In the IVUS group, patients were stratified by whether they were able to receive optimal PCI, defined as minimal lumen cross-sectional area greater than 5 mm2 in the stented segment or 90% of the distal reference lumen cross-sectional area, plaque burden less than 50% at the 5 mm proximal or distal to the stent edge and no edge dissection involving media with length greater than 3 mm.
Those with optimal PCI had a 3-year TVF rate of 4.2% compared with 9.2% for those with suboptimal PCI (HR = 0.44; 95% CI, 0.24-0.81), “which means we should not only insert an IVUS catheter into the vessel, but we should also follow the IVUS assessment and results to further optimize the stent result,” Zhang said during the presentation.
The results did not vary according to any prespecified subgroups, he said.
The mean age of patients was 66 years and 74% were men.
“IVUS guidance was associated with lower risk of 3-year TVF, particularly for patients with IVUS-defined optimal procedures compared with angiographic guidance in all comers undergoing second-generation DES implantation,” Zhang said.
Reference:
Perspective
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Amgad Mentias, MD, MSc
The major take-home message is that IVUS-guided PCI is associated with 40% relative risk reduction in the composite endpoint of cardiac death, target vessel MI or revascularization at 3 years compared to angiographic-guided PCI. This is consistent with results from prior trials and observational studies, including our study from the Medicare population which included almost 2 million patients (Mentias A, et al. JACC Cardiovasc Interv. 2020;doi:10.1016.j.jcin.2020.04.052).
The optimal utilization rate for IVUS in PCI overall is debatable. While the evidence is very strong for left main intervention and complex PCI, it is unclear if IVUS should be adopted in all PCI procedures regardless of degree of complexity. In the ULTIMATE trial, which enrolled an all-comer population, nearly 35% of patients either had left main disease, chronic total occlusion, or bifurcation lesions, and the median stent length was 66.4 mm, suggesting that the population included had a high burden of complex anatomy. In this contemporary era, PCI is increasingly being performed in very complex patients, and in some registries the prevalence of complex PCI in everyday practice is up to 50%. Future studies should aim to clarify what is the role of IVUS in non-complex PCI as well.
I think we have enough evidence to adopt IVUS guidance as the standard. Since the latest American College of Cardiology/American Heart Association PCI guidelines published in 2011, a large body of evidence has emerged to supporting the role of IVUS in improving MACE after PCI. We expect to see this reflected in the updated guidelines.
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Zhang J, et al. Late-breaking clinical science session II: Complex PCI strategies. Presented at: TCT Connect; Oct. 14-18, 2020 (virtual meeting).
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