A randomized comparison of two paclitaxel‐coated balloons for the treatment of in‐stent restenosis: The LONGTY ISR China randomized trial ( LONGTY DCB vs. SeQuent Please DCB )
| Autor: | Guang Ji, Yong Xia, Lian-Pin Wu, Yu Cao, Jun Jiang, Jian-an Wang, Xin-Biao Qiu, Qiang Xie, Changling Li, Rui Jin, Hua Wang, Bin Li, Po Hu, Jian-Jun Jiang, Zhu-Hua Yao, Xue-Jun Jiang, Yong Sun |
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| Rok vydání: | 2021 |
| Předmět: |
Target lesion
China Time Factors Paclitaxel 030204 cardiovascular system & hematology Balloon law.invention Coronary Restenosis 03 medical and health sciences chemistry.chemical_compound 0302 clinical medicine Coated Materials Biocompatible Restenosis Randomized controlled trial law medicine Clinical endpoint Humans Radiology Nuclear Medicine and imaging Prospective Studies 030212 general & internal medicine Clinical efficacy Angioplasty Balloon Coronary business.industry Cardiovascular Agents Drug-Eluting Stents General Medicine medicine.disease Treatment Outcome chemistry In stent restenosis Cardiology and Cardiovascular Medicine business Nuclear medicine |
| Zdroj: | Catheterization and Cardiovascular Interventions. 97:988-995 |
| ISSN: | 1522-726X 1522-1946 |
| DOI: | 10.1002/ccd.29589 |
| Popis: | This study sought to compare the efficacy and clinical safety of the LONGTY drug-coated balloon (DCB) with those of SeQuent Please DCB in patients with in-stent restenosis (ISR).Although DCB technologies have evolved, little is known about the clinical efficacy of the new-generation LONGTY DCB.This was a prospective, multicenter, randomized, noninferiority trial comparing LONGTY DCB with SeQuent Please DCB in patients with ISR. The primary endpoint was target lesion late lumen loss at 9 months' follow-up.A total of 211 patients with ISR from 13 Chinese sites were included (LONGTY DCB, n = 105; SeQuent Please DCB, n = 106). Device success was achieved in all patients. At the 9 month angiographic follow-up, target lesion late lumen loss was 0.35 ± 0.42 mm with LONGTY and 0.38 ± 0.45 mm with SeQuent Please (p for noninferiority.001). The target lesion revascularization rates at 1 year were similar in both DCB groups (15.24 vs. 13.21%; p = .673). Over an extended follow-up of 2 years, the clinical endpoints, including cardiac death, myocardial infarction, and thrombus rate, were extremely low and similar in both groups.In this multicenter, head-to-head, randomized trial, the new-generation LONGTY DCB was noninferior to the SeQuent Please DCB for the primary endpoint of target lesion late lumen loss at 9 months. |
| Databáze: | OpenAIRE |
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