Intravascular Ultrasound vs Angiography-Guided Drug-Coated Balloon Angioplasty: The ULTIMATE Ⅲ Trial

Area of Science:

• Cardiovascular Medicine
• Interventional Cardiology
• Medical Imaging

Background:

• Drug-coated balloon (DCB) angioplasty is a viable treatment for de novo coronary lesions.
• The role of intravascular ultrasound (IVUS) guidance in DCB angioplasty for de novo lesions requires further clarification.

Purpose of the Study:

• To compare the efficacy of IVUS-guided DCB angioplasty versus angiography-guided DCB angioplasty in de novo coronary lesions.
• To assess the impact of IVUS guidance on late lumen loss and target vessel failure.

Main Methods:

• A randomized trial involving 260 high bleeding risk patients with de novo coronary lesions.
• Patients were assigned to either IVUS-guided or angiography-guided DCB angioplasty.
• Primary endpoint: in-segment late lumen loss (LLL) at 7 months; Secondary endpoint: target vessel failure at 6 months.

Main Results:

• IVUS-guided DCB angioplasty resulted in significantly lower 7-month LLL (-0.10 ± 0.34 mm) compared to angiography guidance (0.03 ± 0.52 mm; P=0.025).
• IVUS guidance led to a larger minimal lumen diameter and smaller diameter stenosis at 7 months.
• No significant difference in bailout stent implantation or target vessel failure between groups.

Conclusions:

• IVUS-guided DCB angioplasty demonstrates superior outcomes in reducing LLL for de novo coronary lesions compared to angiography guidance.
• IVUS guidance is associated with improved vessel patency post-DCB angioplasty.
• The ULTIMATE-III trial (NCT04255043) supports the use of IVUS guidance in specific DCB angioplasty procedures.