CBS 2019
CBSMD教育中心
English

科学研究

科研文章

荐读文献

Left main coronary artery disease: importance, diagnosis, assessment, and management A sirolimus-eluting bioabsorbable polymer-coated stent (MiStent) versus an everolimus-eluting durable polymer stent (Xience) after percutaneous coronary intervention (DESSOLVE III): a randomised, single-blind, multicentre, non-inferiority, phase 3 trial Optical coherence tomography versus intravascular ultrasound to evaluate coronary artery disease and percutaneous coronary intervention Clinical Predictors for Lack of Favorable Vascular Response to Statin Therapy in Patients With Coronary Artery Disease: A Serial Optical Coherence Tomography Study Exercise unmasks distinct pathophysiologic features in heart failure with preserved ejection fraction and pulmonary vascular disease Individual Lesion-Level Meta-Analysis Comparing Various Doses of Intracoronary Bolus Injection of Adenosine With Intravenous Administration of Adenosine for Fractional Flow Reserve Assessment Optical coherence tomography predictors of target vessel myocardial infarction after provisional stenting in patients with coronary bifurcation disease Lipid-rich plaque and myocardial perfusion after successful stenting in patients with non-ST-segment elevation acute coronary syndrome: an optical coherence tomography study Fractional Flow Reserve–Guided PCI for Stable Coronary Artery Disease Retrospective Comparison of Long-Term Clinical Outcomes Between Percutaneous Coronary Intervention and Medical Therapy in Stable Coronary Artery Disease With Gray Zone Fractional Flow Reserve - COMFORTABLE Retrospective Study

Clinical Trial2025 Nov 24;18(22):2701-2710.

JOURNAL:JACC Cardiovasc Interv . Article Link

Paclitaxel-Coated Balloon for the Treatment of Small Vessel In-Stent Restenosis: A Subgroup Analysis of the AGENT IDE Randomized Trial

J Wen, S Dohad, R Shlofmitz et al. Keywords: drug-coated balloon; in-stent restenosis; small vessel; target lesion failure; target lesion revascularization; uncoated balloon.

Abstract

BACKGROUD -  Treatment of small vessel (SV) coronary artery disease is associated with higher restenosis rates. Drug-coated balloons offer a promising treatment option for stent failure by delivering an antiproliferative drug and avoiding an additional metal implant. However, evidence supporting the use of paclitaxel-coated balloons (PCBs) for in-stent restenosis (ISR) in SVs is limited.


OBJECTIVES - The aim of this study was to evaluate the efficacy and safety of PCB vs uncoated balloon angioplasty according to vessel size.


METHODS - AGENT IDE (A Clinical Trial to Assess the Agent Paclitaxel Coated PTCA Balloon Catheter for the Treatment of Subjects With In-Stent Restenosis) randomized 600 patients with ISR to treatment with PCBs or uncoated balloons (2:1). This prespecified analysis evaluated the treatment effect of PCBs in SV (reference vessel diameter [RVD] ≤2.75 mm) and large vessel (RVD >2.75 mm) ISR. The primary endpoint of 1-year target lesion failure (TLF) was a composite of target lesion revascularization, cardiac death, and target vessel-related myocardial infarction.


RESULTS -  Among 597 patients with known angiographic core laboratory-adjudicated vessel size, 56% had SVs (mean RVD 2.4 ± 0.3 mm) and 44% had large vessels (mean RVD 3.1 ± 0.3 mm). One-year TLF was 20.6% vs 22.6% in the SV vs large vessel groups, respectively (HR: 0.92; 95% CI: 0.65-1.31; P = 0.65). PCBs were associated with a 39% relative reduction in TLF compared with balloon angioplasty in patients with SVs (17.7% vs 27.4%; HR: 0.61; 95% CI: 0.37-0.99) and a 43% reduction in patients with large vessels (18.4% vs 30.5%; HR: 0.57; 95% CI: 0.34-0.96). The benefits of PCB use remained consistent, irrespective of vessel size (Pinteraction = 0.88). None of the patients treated with PCBs experienced definite or probable stent thrombosis.


CONCLUSIONS -  This prespecified subgroup analysis demonstrates that angioplasty with a PCB was associated with consistently reduced rates of 1-year TLF compared with an uncoated balloon in both SV and large vessel ISR patients. (A Clinical Trial to Assess the Agent Paclitaxel Coated PTCA Balloon Catheter for the Treatment of Subjects With In-Stent Restenosis [AGENT IDE]; NCT04647253).


Copyright © 2025 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.