Non-inferiority of a paclitaxel-coated balloon versus a rapamycin-eluting metal stent for de novo non-complex small coronary vessel disease: a prospective randomized controlled trial
- 1Department of Cardiology, Fuwai Yunnan Hospital, Chinese Academy of Medical Sciences, Kunming City, China
Abstract
Introduction: While drug-coated balloons (DCB) have demonstrated efficacy for coronary small vessel disease, comparative data between DCB and drug-eluting stents (DES) in de novo coronary lesions remain limited.
Aim: This study hypothesized that a DCB-only strategy would be non-inferior to DES for angiographic outcomes in de novo small vessel coronary lesions.
Material and methods: This prospective randomized controlled trial (RCT) enrolled 228 patients with de novo (≥ 70% stenosis), non-complex coronary lesions from January 2022 to January 2024. Participants were randomized 1 : 1 to paclitaxel-coated balloon or rapamycin-eluting stent (DES). The primary endpoint was late lumen loss (LLL) at 6 and 12 months post-procedure, with a non-inferiority margin of 0.15 mm. Baseline clinical characteristics were compared between groups, with 12-month follow-up assessments including cardiac function, major adverse cardiovascular events (MACE), post-procedural angina, and bleeding events. Quantitative coronary angiography was used to evaluate minimal lumen diameter, percent stenosis, and LLL. Kaplan-Meier analysis was used to assess cumulative survival rates.
Results: Baseline clinical characteristics were similar between groups (p > 0.05). The DCB group had more Mehran Type I lesions (p < 0.05). Both groups reduced thrombogenic potential (p < 0.05). There were no significant differences in angiographic outcomes, MACE, or BARC ≥ 3 bleeding (p > 0.05). At 6 and 12 months, the 95% CI upper limits for LLL difference were below 0.15 mm (p for non-inferiority < 0.001). DCB had lower post-procedural angina frequency (p < 0.05) but similar episode duration. Survival rates did not differ significantly (p > 0.05).
Conclusions: For de novo, non-complex small coronary vessel disease, DCB monotherapy demonstrates comparable long-term efficacy to DES, meeting non-inferiority criteria.
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BibTeX
@article{xu2026noninferiority,
title = {{Non-inferiority of a paclitaxel-coated balloon versus a rapamycin-eluting metal stent for de novo non-complex small coronary vessel disease: a prospective randomized controlled trial}},
author = {XiaoYu Xu and Yi Xiang and KangHui Ge and HaoTian Shi and ZiWei Zhang and JiaLin Zheng},
journal = {Postepy w kardiologii interwencyjnej = Advances in interventional cardiology},
year = {2026},
month = sep,
doi = {10.5114/aic.2026.164688},
url = {https://europepmc.org/article/PMC/PMC13721081},
note = {CC BY-NC-SA},
}
RIS
TY - JOUR
TI - Non-inferiority of a paclitaxel-coated balloon versus a rapamycin-eluting metal stent for de novo non-complex small coronary vessel disease: a prospective randomized controlled trial
AU - XiaoYu Xu
AU - Yi Xiang
AU - KangHui Ge
AU - HaoTian Shi
AU - ZiWei Zhang
AU - JiaLin Zheng
PY - 2026
DA - 2026/09/01
JO - Postepy w kardiologii interwencyjnej = Advances in interventional cardiology
DO - 10.5114/aic.2026.164688
UR - https://europepmc.org/article/PMC/PMC13721081
AB - Introduction: While drug-coated balloons (DCB) have demonstrated efficacy for coronary small vessel disease, comparative data between DCB and drug-eluting stents (DES) in de novo coronary lesions remain limited. Aim: This study hypothesized that a DCB-only strategy would be non-inferior to DES for angiographic outcomes in de novo small vessel coronary lesions. Material and methods: This prospective randomized controlled trial (RCT) enrolled 228 patients with de novo (≥ 70% stenosis), non-complex coronary lesions from January 2022 to January 2024. Participants were randomized 1 : 1 to paclitaxel-coated balloon or rapamycin-eluting stent (DES). The primary endpoint was late lumen loss (LLL) at 6 and 12 months post-procedure, with a non-inferiority margin of 0.15 mm. Baseline clinical characteristics were compared between groups, with 12-month follow-up assessments including cardiac function, major adverse cardiovascular events (MACE), post-procedural angina, and bleeding events. Quantitative coronary angiography was used to evaluate minimal lumen diameter, percent stenosis, and LLL. Kaplan-Meier analysis was used to assess cumulative survival rates. Results: Baseline clinical characteristics were similar between groups (p > 0.05). The DCB group had more Mehran Type I lesions (p < 0.05). Both groups reduced thrombogenic potential (p < 0.05). There were no significant differences in angiographic outcomes, MACE, or BARC ≥ 3 bleeding (p > 0.05). At 6 and 12 months, the 95% CI upper limits for LLL difference were below 0.15 mm (p for non-inferiority < 0.001). DCB had lower post-procedural angina frequency (p < 0.05) but similar episode duration. Survival rates did not differ significantly (p > 0.05). Conclusions: For de novo, non-complex small coronary vessel disease, DCB monotherapy demonstrates comparable long-term efficacy to DES, meeting non-inferiority criteria.
SN - 1734-9338
SN - 1897-4295
ER -