The results of the ULTIMATE trial, presented at the TCT conference 2018, have shown that IVUS-guided PCI is superior to angiography-guided PCI in the prevention of target vessel failure in an all-comers population. The study findings have been simultaneously published in the Journal of the American College of Cardiology.
Intravascular ultrasound (IVUS)-guided drug-eluting stent (DES) implantation has previously been shown to be associated with lower major adverse cardiovascular events (MACE) when compared with angiography guidance, for patients with complex lesions. In this multicenter trial, the goal was to evaluate whether intravascular ultrasound (IVUS)-guided percutaneous coronary intervention (PCI) fared better as compared with angiography-guided PCI in an all-comers group of patients undergoing PCI.
In order to determine this, Junjie Zhang and his colleagues from China enrolled a total of 1448 all-comer patients who required DES implantation and randomly assigned them to IVUS guidance in one arm or Angiography guidance in the other. The primary outcome was target vessel failure (TVF), which was a composite of cardiac death, target vessel myocardial infarction (TV-MI), and clinically-driven target vessel revascularization (TVR). The total follow-up duration was 1 year. The procedure was defined as successful if all IVUS-defined optimal criteria were met. According to the protocol, optimal IVUS-guided PCI characteristics comprised of minimal cross-sectional area >5.0 mm2 (or 90% of distal reference lumen cross-sectional area), plaque burden at proximal and distal stent edges <50%, no edge dissection involving media with length >3 mm. This was assessed by a core laboratory on site.
[perfectpullquote align=”full” bordertop=”false” cite=”” link=”” color=”” class=”” size=””]“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.”- Dr. Junjie Zhang, M.D.[/perfectpullquote]
The primary outcome of TVF at 12 months follow-up occurred in 2.9% and 5.4% of patients in the IVUS and Angiography groups respectively. (Hazard ratio [HR] 0.530, 95% confidence interval [CI] 0.312-0.901; p=0.019). Among those who met the criteria for optimal IVUS-guided PCI, the investigators reported an enhanced benefit with lower event rates from the use of IVUS compared with angiography-guided PCI. The rates were 1.6% of patients with successful procedures, compared to 4.4% in patients who failed to achieve all optimal criteria (HR: 0.349; 95%CI: 0.135-0.898; p=0.029). All components of the composite outcome were numerically lower in the IVUS- guided PCI group, though values did not reach statistical significance.
The investigators concluded that among an all-comers population of patients undergoing PCI, IVUS-guided PCI was beneficial. IVUS-guided PCI was associated with a lower frequency of target vessel failure at 12 months compared with angiography-guided PCI. The greatest benefit, however, was in the reduction of target vessel revascularization. Multiple randomized trials now support the use of IVUS guidance in optimizing coronary stent implantation as a mechanism to reduce adverse cardiac events.
To view the interview with Dr. C. Michael Gibson, click here.