Intravascular Ultrasound Versus Angiography-Guided Drug-Coated Balloon Angioplasty - ULTIMATE III

Jun 20, 2024
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Author/Summarized by Author:
Anthony A. Bavry, MD,MPH,FACC
Summary Reviewer:
Kim A. Eagle, MD, MACC
Trial Sponsor:
National Natural Science Foundation of China
Date Published:
06/05/2024
Original Posted Date:
06/20/2024
References

Contribution To Literature:

The ULTIMATE III trial showed that IVUS-guided drug-coated balloon angioplasty is feasible and associated with a lower late lumen loss compared with angiography-guided drug-coated balloon angioplasty.

Description:

The goal of the trial was to evaluate intravascular ultrasound (IVUS)-guided drug-coated balloon angioplasty compared with angiography-guided drug-coated balloon angioplasty among patients with de novo coronary lesions.

Study Design

  • Randomized
  • Parallel

Patients with elevated bleeding risk and de novo coronary lesions were randomized to IVUS-guided drug-coated balloon angioplasty (n = 130) vs. angiography-guided drug-coated balloon angioplasty (n = 130).

  • Total number of enrollees: 260
  • Duration of follow-up: 6 months
  • Mean patient age: 67 years
  • Percentage female: 19%
  • Percentage with diabetes: 33%

Inclusion criteria:

  • De novo coronary lesion
  • Elevated bleeding risk
  • Reference vessel diameter 2.0-4.0 mm
  • Lesion length ≤15 mm

Exclusion criteria:

  • Target lesion length >15 mm
  • Severe calcified lesions
  • Left main disease
  • Ostial lesions
  • Multivessel disease
  • Stent implantation in the target vessel
  • Chronic total occlusion lesion not recanalized
  • Intolerant to antithrombotic therapy
  • Hemodynamic instability
  • Limited life expectancy

Principal Findings:

The primary outcome, in-segment late lumen loss at 7 months after procedure, was: -0.10 ± 0.34 mm with IVUS guidance versus 0.03 ± 0.52 mm with angiography guidance (mean difference 0.14 mm, p = 0.025).

Secondary outcomes:

  • Minimal lumen diameter: 2.06 with IVUS guidance versus 1.75 with angiography guidance (p < 0.001)
  • Target vessel failure at 6 months: 0.8% with IVUS guidance versus 3.1% with angiography guidance (p = 0.37)

Interpretation:

Among patients with de novo coronary lesions, IVUS-guided drug-coated balloon angioplasty was feasible compared with angiography-guided drug-coated balloon angioplasty. IVUS guidance was associated with a lower late lumen loss compared with angiography guidance. The vast majority of PCIs are performed with stent implantation. Further study of drug-coated balloon angioplasty as a stand-alone treatment strategy is warranted.

References:

Gao XF, Ge Z, Kong XQ, et al., on behalf of the ULTIMATE III Investigators. Intravascular Ultrasound vs Angiography-Guided Drug-Coated Balloon Angioplasty: The ULTIMATE Ⅲ Trial. JACC Cardiovasc Interv 2024;Jun 5:[Epub ahead of print].

Editorial Comment: Alfonso F, Kundu A. Intracoronary Imaging to Guide Drug-Coated Balloon Angioplasty: Ready for Primetime? JACC Cardiovasc Interv 2024;Jun 5:[Epub ahead of print].

Clinical Topics: Invasive Cardiovascular Angiography and Intervention, Noninvasive Imaging, Interventions and Imaging, Echocardiography/Ultrasound

Keywords: Angioplasty, Balloon, Ultrasonography


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