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).

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