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ULTIMATE: IVUS guidance bests angiography guidance in 12-month outcomes after PCI
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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.
Jun-Jie Zhang, 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
References:
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.
Disclosure : Zhang reports no relevant financial disclosures.
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Dharam J. Kumbhani, MD, SM
ULTIMATE was a well-done multicenter trial. The investigators enrolled about 1,450 patients, and what they really wanted to test was a hypothesis that whether using IVUS routinely for PCI was helpful compared with just using angiography.
What was a little different about this trial was that they also had very clear guidelines about what constituted “successful” PCI. They had three criteria that they listed. It is fairly prescriptive in the IVUS arm that if you did not meet the three criteria, then you had to keep going until you actually achieve that. That is probably an important distinction of this trial from others.
They were able to show statistical superiority of an IVUS-guided strategy compared with angiography-based PCI for the primary endpoint of target vessel failure at 12 months. Further, all of the endpoints trended in the right direction, particularly for the need for repeat revascularization. The P value was .07.
Globally, this trial is consistent with many of the other recent trials that suggest that IVUS-guided PCI is helpful. What is different is the strict protocol that had to be followed in the IVUS group before completion of PCI, which may be a bit challenging logistically for all lesions in routine practice. Even in this trial, despite this requirement, only 60% of lesions successfully met all three criteria at the end for “optimal PCI.” Thus, I think that a practice of IVUS-guided PCI may be higher yield for certain patients and lesions.
For example, most people who practice would agree that for left main PCI, they would use IVUS almost every single time. I do that as well. For complex thrombotic or calcified lesions, IVUS-guided PCI may be helpful too. Recent studies suggest that use of IVUS/OCT for PCI in the United States is still under 10%; we are thus likely underusing this helpful technology.
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