CBS - The 17th Left Main & Coronary Bifurcation Summit, CBS2025

科学研究

Prediction of progression of coronary artery disease and clinical outcomes using vascular profiling of endothelial shear stress and arterial plaque characteristics: the PREDICTION Study Optical Coherence Tomography–Defined Plaque Vulnerability in Relation to Functional Stenosis Severity and Microvascular Dysfunction Treatment of Drug-Eluting Stent In-Stent Restenosis With Drug-Eluting Balloons: A Systematic Review and Meta-Analysis Orbital atherectomy for treating de novo, severely calcified coronary lesions: 3-year results of the pivotal ORBIT II trial Fractional Flow Reserve–Guided PCI as Compared with Coronary Bypass Surgery Treating Bifurcation Lesions: The Result Overcomes the Technique Percutaneous Pulmonary Angioplasty for Patients With Takayasu Arteritis and Pulmonary Hypertension Optical Coherence Tomography to Assess Proximal Side Optimization Technique in Crush Stenting Drug-Coated Balloon Versus Drug-Eluting Stent for Small Coronary Vessel Disease: PICCOLETO II Randomized Clinical Trial Percutaneous Repair or Medical Treatment for Secondary Mitral Regurgitation: Outcomes at 2 years

Sort by hits |<<... 158 159 160 161 162 163 164 ...>>|

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).

科研文章

荐读文献

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

Abstract