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

科学研究

Astro-CHARM, the First 10-year ASCVD Risk Estimator Incorporating Coronary Calcium Mortality Following Cardiovascular and Bleeding Events Occurring Beyond 1 Year After Coronary Stenting - A Secondary Analysis of the Dual Antiplatelet Therapy (DAPT) Study Prognostic impact of baseline glucose levels in acute myocardial infarction complicated by cardiogenic shock-a substudy of the IABP-SHOCK II-trial Successful Treatment of Unprotected Left Main Coronary Bifurcation Lesion Using Minimum Contrast Volume with Intravascular Ultrasound Guidance Improving the Use of Primary Prevention Implantable Cardioverter-Defibrillators Therapy With Validated Patient-Centric Risk Estimates Cutoff Value and Long-Term Prediction of Clinical Events by FFR Measured Immediately After Implantation of a Drug-Eluting Stent in Patients With Coronary Artery Disease: 1- to 3-Year Results From the DKCRUSH VII Registry Study Editor's Choice- Impact of immediate multivessel percutaneous coronary intervention versus culprit lesion intervention on 1-year outcome in patients with acute myocardial infarction complicated by cardiogenic shock: Results of the randomised IABP-SHOCK II trial Intravascular ultrasound guidance in drug-eluting stents implantation: a meta-analysis and trial sequential analysis of randomized controlled trials Benefit of switching dual antiplatelet therapy after acute coronary syndrome: the TOPIC (timing of platelet inhibition after acute coronary syndrome) randomized study Intra-aortic balloon counterpulsation in acute myocardial infarction complicated by cardiogenic shock (IABP-SHOCK II): final 12 month results of a randomised, open-label trial

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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