ULTIMATE Details 3-Year Benefit of IVUS-Guided PCI vs Angiography-Guided PCI

October 16, 2020

Results from 3-year follow-up of the ULTIMATE study indicate IVUS-guided PCI was associated with lower rates of TVF and stent thrombosis.

New data related to 3-year outcomes from the ULTIMATE trial is detailing the lower risk of target vessel failure associated with use of intravascular ultrasound (IVUS)-guided drug-eluting stents (DES) compared with angiography guidance.

Results of the study, which were presented at Transcatheter Cardiovascular Therapies (TCT) Connect 2020, provide further evidence of the efficacy of IVUSD-guided DES implantation—showcasing lower rates of target vessel failure and stent thrombosis in the 1400-person trial.

“The present study demonstrated that the reduction of TVF with IVUS guidance was sustainable and became more significant throughout the 3-year clinical follow-up. Notably, we found that patients with IVUS-defined optimal PCI had better clinical outcomes than those who underwent non-optimal IVUS,” wrote investigators.

The Intravascular Ultrasound Guided Drug Eluting Stents Implantation in “All-Comers” Coronary Lesions (ULTIMATE) was designed as a prospective, investigator-initiated, randomized trial comparing IVUS-guided versus angiography-guided DES implantation in patients at 8 medical centers in China. With 1-year results from the trial suggesting a lower risk of target vessel failure, investigators sought to describe 3-year clinical outcomes between the 2 arms of the study.

Patients were deemed eligible for the trial if they had silent ischemia, stable or unstable angina, or myocardial infarction with more than 2 hours between chest pain and admission, and a de novo coronary lesion requiring DES implantation. Exclusion criteria of note included a life expectancy of less than 12 months, being intolerant to dual antiplatelet therapy, severe calcification needing rotational atherectomy, and a history of recanalization of chronic total occlusion. In total, 1448 patients were enrolled in the trial with 724 randomized to each arm.

The primary end point for the study was the risk of target vessel failure at 3 years post-index procedure—this end point included cardiac death, target-vessel myocardial infarction, and clinically driven target vessel revascularization. The safety end point of the study was definite/probable stent thrombosis.

Investigators pointed out baseline characteristics were well matched between the study arms, 30.6% of all patients had diabetes, and 78.5% presented with acute coronary syndrome. Additionally, multivessel disease was found in 54.9% of patients.

At 3 years, target vessel failure occurred in 6.6% (n=47) of patients in the IVUS-guided group and in 10.7% (n=76) of patients in the angiography-guided group (HR, 0.60; 95% CI, 0.42-0.87; P=.01). Investigators noted these were instances of target vessel failure were mainly driven be a decrease in clinically-driven target vessel revascularization, which occurred in 4.5% of the IVUS-guided group and 6.9% of the angiography-guided group (P=.05).

Additionally, results of the study indicated the definite or probable stent thrombosis rate was 0.1% in the IVUS-guided group and 1.1% in the angiography-guided group at 3 years (P=.02). Investigators pointed out the IVUS-defined optimal procedure was associated with a significant reduction in 3-year rates of target vessel failure relative to that with the suboptimal procedure.

This study, “Three-Year Outcomes of the ULTIMATE Trial Comparing Intravascular Ultrasound Versus Angiography-Guided Drug-Eluting Stent Implantation,” was presented at TCT Connect 2020 and published simultaneously in JACC: Cardiovascular Interventions.