1. Intravascular Ultrasound vs Angiography-Guided Drug-Coated Balloon Angioplasty: The ULTIMATE Ⅲ Trial.
- Author
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Gao XF, Ge Z, Kong XQ, Chen X, Han L, Qian XS, Zuo GF, Wang ZM, Wang J, Song JX, Lin L, Pan T, Ye F, Wang Y, Zhang JJ, and Chen SL
- Subjects
- Humans, Male, Female, Middle Aged, Aged, Treatment Outcome, Time Factors, Prospective Studies, Risk Factors, China, Ultrasonography, Interventional, Coronary Angiography, Angioplasty, Balloon, Coronary instrumentation, Angioplasty, Balloon, Coronary adverse effects, Coated Materials, Biocompatible, Coronary Artery Disease therapy, Coronary Artery Disease diagnostic imaging, Predictive Value of Tests, Cardiovascular Agents administration & dosage, Cardiovascular Agents adverse effects, Cardiac Catheters
- Abstract
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)., Competing Interests: Funding Support and Author Disclosures This study was supported by the National Natural Science Foundation of China (NSFC 81970307, NSFC 82100357, NSFC 82270344, and NSFC 82200385), and was jointly supported by Jiangsu Natural Science Foundation (BK20221173), Six Talent Peaks Project of Jiangsu Province (2019-WSN-156), Jiangsu Health Committee (H2019077), and Nanjing Health Committee (JQX22007 and ZKX23030), and Social development project of Jiangsu province (BE2019615). The authors have reported that they have no relationships relevant to the contents of this paper to disclose., (Copyright © 2024 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)
- Published
- 2024
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