Intravascular Ultrasound vs Angiography-Guided Drug-Coated Balloon Angioplasty: The ULTIMATE Ⅲ Trial
Xiao-Fei Gao1, Zhen Ge1, Xiang-Quan Kong1
1Department of Cardiology, Nanjing First Hospital, Nanjing Medical University, Nanjing, China.
Insights
Intravascular ultrasound (IVUS)-guided drug-coated balloon (DCB) angioplasty significantly reduces late lumen loss in de novo coronary lesions compared to angiography guidance. This IVUS guidance improves outcomes for patients undergoing DCB angioplasty.
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.
Background:
Drug-coated balloon (DCB) angioplasty seems a safe and effective option for specific de novo coronary lesions. However, the beneficial effect of intravascular ultrasound (IVUS)-guided DCB angioplasty in de novo lesions remains uncertain.
Objectives:
This study aimed to assess the benefits of IVUS guidance over angiography guidance during DCB angioplasty in de novo coronary lesions.
Methods:
A total of 260 patients with high bleeding risk who had a de novo coronary lesion (reference vessel diameter 2.0-4.0 mm, and lesion length ≤15 mm) were randomly assigned to either an IVUS-guided or an angioplasty-guided DCB angioplasty group. The primary endpoint was in-segment late lumen loss (LLL) at 7 months after procedure. The secondary endpoint was target vessel failure at 6 months.
Results:
A total of 2 patients in the angiography-guided group and 7 patients in the IVUS-guided group underwent bailout stent implantation (P = 0.172). The primary endpoint of 7-month LLL was 0.03 ± 0.52 mm with angiography guidance vs -0.10 ± 0.34 mm with IVUS guidance (mean difference 0.14 mm; 95% CI: 0.02-0.26; P = 0.025). IVUS guidance was also associated with a larger 7-month minimal lumen diameter (2.06 ± 0.62 mm vs 1.75 ± 0.63 mm; P < 0.001) and a smaller diameter stenosis (28.15% ± 13.88% vs 35.83% ± 17.69%; P = 0.001) compared with angiography guidance. Five target vessel failures occurred at 6 months, with 4 (3.1%) in the angiography-guided group and 1 (0.8%) in the IVUS-guided group (P = 0.370).
Conclusions:
This study demonstrated that IVUS-guided DCB angioplasty is associated with a lower LLL in patients with a de novo coronary lesion compared with angiography guidance. (Intravascular Ultrasound Versus Angiography Guided Drug-Coated Balloon [ULTIMATE-III]; NCT04255043).
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