SAN DIEGO — Patients who underwent drug-eluting stent implantation with IVUS guidance had improved 12-month clinical outcomes compared with those who underwent implantation with angiography guidance, according to data from the ULTIMATE trial presented at TCT 2018.
PhD, MD, vice director of the cardiovascular department at Nanjing First Hospital at Nanjing Medical University in China, and colleagues analyzed data from an all-comer population of 1,448 patients with silent ischemia, MI or stable or unstable angina more than 24 hours from the onset of chest pain to hospital admission and were eligible for DES implantation. Patients were assigned either IVUS guidance (n = 724; mean age, 65 years; 74% men) or angiography guidance (n = 724; mean age, 66 years; 73% men) during PCI.
The primary endpoint was target vessel failure, defined as a composite of target vessel MI, cardiac death and clinically driven target vessel revascularization, at 12 months. Patients were followed up after hospital discharge either by visits or telephone calls at 1 month, 6 months, 12 months and annually up to 5 years.
Criteria for optimal stent deployment with IVUS guidance was defined as no edge dissection with a media length greater than 3 mm, plaque burden from 5 mm proximal or distal to the stent edge less than 50% and a minimal lumen area within the stented segment greater than 5 mm2 or 90% of minimal lumen area within distal reference segments.
TVF occurred in 2.9% of patients in the IVUS group and 5.4% in the angiography group at 12 months (HR = 0.53; 95% CI, 0.312-0.901).
In the IVUS cohort at 12 months, patients who met the optimal criteria for stent implantation had a reduced rate of target lesion failure vs. those who did not achieve all optimal criteria (1.6% vs. 4.4%; HR = 0.349; 95% CI, 0.135-0.898).
IVUS conferred a significant reduction of definite stent thrombosis and clinically driven target lesion revascularization (HR = 0.407; 95% CI, 0.188-0.88) in a lesion-level analysis, although it was not achieved in a patient-level analysis. Patients who underwent PCI had a consistently higher risk for TVR.
“In the present multicenter randomized trial, IVUS-guided DES implantation in all comers resulted in lower incidence of TVF at 12 months, compared with angiography guidance, particularly for patients who had an IVUS-defined optimal procedure,” Zhang said during the press conference. – by Darlene Dobkowski
Zhang J, et al. Late-Breaking Trials 4. Presented at: TCT Scientific Symposium; Sept. 21-25, 2018; San Diego.
Zhang J, et al. J Am Coll Cardiol. 2018;doi:10.1016/j.jacc.2018.09.013.
: Zhang reports no relevant financial disclosures.