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

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Outcome of patients with ST-segment elevation myocardial infarction undergoing primary percutaneous coronary intervention during on- versus off-hours (a Harmonizing Outcomes with Revascularization and Stents in Acute Myocardial Infarction [HORIZONS-AMI] trial substudy) National assessment of early β-blocker therapy in patients with acute myocardial infarction in China, 2001-2011: The China Patient-centered Evaluative Assessment of Cardiac Events (PEACE)-Retrospective AMI Study Long-Term Outcomes in Women and Men Following Percutaneous Coronary Intervention Trends and Impact of Door-to-Balloon Time on Clinical Outcomes in Patients Aged <75, 75 to 84, and ≥85 Years With ST-Elevation Myocardial Infarction Impact of treatment delay on mortality in ST-segment elevation myocardial infarction (STEMI) patients presenting with and without haemodynamic instability: results from the German prospective, multicentre FITT-STEMI trial 2015 ACC/AHA/SCAI Focused Update on Primary Percutaneous Coronary Intervention for Patients With ST-Elevation Myocardial Infarction: An Update of the 2011 ACCF/AHA/SCAI Guideline for Percutaneous Coronary Intervention and the 2013 ACCF/AHA Guideline for the Management of ST-Elevation Myocardial Infa SCAI Expert Consensus Statement Update on Best Practices for Transradial Angiography and Intervention Fate of post-procedural malapposition of everolimus-eluting polymeric bioresorbable scaffold and everolimus-eluting cobalt chromium metallic stent in human coronary arteries: sequential assessment with optical coherence tomography in ABSORB Japan trial Early invasive versus non-invasive treatment in patients with non-ST-elevation acute coronary syndrome (FRISC-II): 15 year follow-up of a prospective, randomised, multicentre study Coronary Artery Plaque Characteristics Associated With Adverse Outcomes in the SCOT-HEART Study

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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