IVUS-Guided DES Implantation in All-Comer Patients Evaluated in ULTIMATE
September 24, 2018—The Cardiovascular Research Foundation (CRF) announced that findings from the ULTIMATE trial were presented at TCT 2018, the 30th annual Transcatheter Cardiovascular Therapeutics scientific symposium, which is sponsored by CRF and held September 21–25 in San Diego, California. The study was simultaneously published online by Junjie Zhang, MD, et al in Journal of the American College of Cardiology.
According to CRF, ULTIMATE is the first study designed to determine the benefits of intravascular ultrasound (IVUS) guidance over angiography guidance during percutaneous coronary intervention (PCI) with drug-eluting stent (DES) implantation in all-comer patients. The study found that IVUS improved clinical outcomes by lowering the rate of target vessel failure (TVF) at 1 year.
As summarized in the CRF announcement, the study was composed of 1,448 all-comer patients from eight centers in China who were undergoing DES implantation from August 2014 to May 2017. Patients were randomly assigned (1:1) to either IVUS (n = 724) or angiographic guidance (n = 724). Multivessel disease was seen in 54.9% of patients. Mean lesion length was 34.5 mm, and 66.9% of lesions were classified as type B2/C. IVUS-guided procedures were longer in duration and on a per-lesion basis used slightly greater stent diameters and stent lengths.
The primary endpoint was TVF at 12 months, defined as the composite of cardiac death, target vessel myocardial infarction, and clinically driven target vessel revascularization. At 30-day follow-up, primary and secondary endpoints were comparable between the two groups.
The investigators reported that at 1 year after PCI, TVF occurred in 60 patients (4.2%), with 21 (2.9%) in the IVUS group and 39 (5.4%) in the angiography group (hazard ratio [HR], 0.530; 95% confidence interval [CI], 0.312–0.901; P = .019). In lesion-level analyses, the IVUS group had a lower rate of target lesion revascularization compared with the angiography group (0.9% vs 2.3%; P = .02). Despite the use of IVUS, 53% of patients met prespecified optimal criteria for stent implantation; in this group, TVF was 1.6%, compared with 4.4% in patients who failed to achieve all optimal IVUS criteria (HR, 0.349; 95% CI, 0.135–0.898; P = .029).
In the CRF press release, Dr. Zhang commented, “The study demonstrated that IVUS-guided stent implantation significantly improved clinical outcomes in all-comers, particularly for patients who had an IVUS-defined optimal procedure, compared to angiography guidance. While previous studies and this trial have demonstrated the overall favorable effect of IVUS guidance for patients with particular lesion subsets, this study further reports that achievement of IVUS-defined optimal PCI improves clinical outcomes for all-comers.” Dr. Zhang is Vice Director of the Cardiovascular Department at Nanjing First Hospital in Nanjing Medical University in Nanjing, China.