A Multicenter, Prospective, Randomized Trial Comparing Intravascular Ultrasound-Guided Versus Angiography-Guided Implantation of Drug-Eluting Stent in All-Comers - ULTIMATE

Oct 15, 2020
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Author/Summarized by Author:
Anthony A. Bavry, MD,MPH,FACC
Summary Reviewer:
Deepak L. Bhatt, MD, MPH, MBA, FACC
Trial Sponsor:
National Natural Science Foundation of China and others.
Date Presented:
10/15/2020
Date Published:
10/15/2020
Date Updated:
10/15/2020
Original Posted Date:
09/24/2018
References

Contribution To Literature:

The ULTIMATE trial showed that IVUS-guided PCI was superior to angiography-guided PCI at preventing target vessel failure.

Description:

The goal of the trial was to evaluate intravascular ultrasound (IVUS)-guided percutaneous coronary intervention (PCI) compared with angiography-guided PCI among an all-comers group of patients undergoing PCI.

Study Design

  • Randomized
  • Parallel

Patients undergoing coronary revascularization were randomized to IVUS-guided PCI (n = 724) versus angiography-guided PCI (n = 724).

“Optimal IVUS-guided PCI” characteristics: 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.

  • Total number of enrollees: 1,448
  • Duration of follow-up: 12 months
  • Mean patient age: 65 years
  • Percentage female: 26%
  • Percentage with diabetes: 31%

Inclusion criteria:

  • All-comers group of patients undergoing PCI
  • Had silent ischemia, stable or unstable angina, or myocardial infarction (MI; including both ST-elevation and non-ST-elevation MI) >24 hours from the onset of chest pain to admission
  • Had de novo coronary lesion eligible for DES implantation

Exclusion criteria:

  • Co-morbidity with life expectancy <12 months
  • Intolerant of antithrombotic therapy
  • Significant anemia, thrombocytopenia, or leucopenia
  • History of major hemorrhage (intracranial, gastrointestinal, etc.)
  • Chronic total occlusion lesion in either left anterior descending, left circumflex, or right coronary artery not re-canalized
  • Severe calcification needing rotational atherectomy

Principal Findings:

The primary outcome, target vessel failure at 12 months (cardiac death, MI, or target vessel revascularization), occurred in 2.9% of the IVUS-guided PCI group compared with 5.4% of the angiography-guided PCI group (p = 0.019). Among those who met the criteria for optimal IVUS-guided PCI, there appeared to be enhanced benefit from the use of IVUS compared with angiography-guided PCI.

Secondary outcomes:

  • Cardiac death: 0.7% of the IVUS-guided PCI group vs. 1.4% of the angiography-guided PCI group (p = 0.19)
  • MI: 1.0% of the IVUS-guided PCI group vs. 1.5% of the angiography-guided PCI group (p = 0.34)
  • Target vessel revascularization: 1.5% of the IVUS-guided PCI group vs. 2.9% of the angiography-guided PCI group (p = 0.07)
  • Definite/probable stent thrombosis: 0.1% of the IVUS-guided PCI group vs. 0.7% of the angiography-guided PCI group (p = 0.10)

Long-term outcomes:

  • Target vessel failure (cardiac death, target vessel MI, or clinically driven target vessel revascularization) at 3 years: 6.6% of the IVUS-guided PCI group vs. 10.7% of the angiography-guided PCI group (p = 0.01)

Interpretation:

Among an all-comers group of patients undergoing PCI, IVUS-guided PCI was beneficial. IVUS-guided PCI was associated with a lower frequency of target vessel failure up to 3 years compared with angiography-guided PCI. All components of the composite outcome were numerically lower in the IVUS-guided PCI group; however, the greatest benefit seemed to be at reducing 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.


References:

Gao XF, Ge Z, Kong XQ, et al., on behalf of the ULTIMATE Investigators. Three-Year Outcomes of the ULTIMATE Trial Comparing Intravascular Ultrasound Versus Angiography-Guided Drug-Eluting Stent Implantation. JACC Cardiovasc Interv 2020;Oct 15:[Epub ahead of print].

Presented by Dr. Junjie Zhang at the Transcatheter Cardiovascular Therapeutics Virtual Meeting (TCT Connect), October 15, 2020.

Zhang J, Gao X, Kan J, et al. Intravascular Ultrasound Versus Angiography-Guided Drug-Eluting Stent Implantation: The ULTIMATE Trial. J Am Coll Cardiol 2018;72:3126-37.

Editorial Comment: di Mario C, Koskinas KC, Räber L. Clinical Benefit of IVUS Guidance for Coronary Stenting: The ULTIMATE Step Toward Definitive Evidence? J Am Coll Cardiol 2018;72:3138-41.

Presented by Dr. Junjie Zhang at the Transcatheter Cardiovascular Therapeutics meeting (TCT 2018), San Diego, CA, September 24, 2018.

Clinical Topics: Acute Coronary Syndromes, Cardiac Surgery, Invasive Cardiovascular Angiography and Intervention, Noninvasive Imaging, Prevention, Stable Ischemic Heart Disease, Aortic Surgery, Cardiac Surgery and Arrhythmias, Cardiac Surgery and SIHD, Interventions and ACS, Interventions and Imaging, Angiography, Echocardiography/Ultrasound, Nuclear Imaging, Chronic Angina

Keywords: TCT20, TCT18, Transcatheter Cardiovascular Therapeutics, Acute Coronary Syndrome, Angina, Stable, Angina, Unstable, Coronary Angiography, Chest Pain, Drug-Eluting Stents, Myocardial Infarction, Myocardial Ischemia, Myocardial Revascularization, Percutaneous Coronary Intervention, Secondary Prevention, Stents, Thrombosis, Ultrasonography


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