Three-Year Clinical Follow-Up of a Novel Everolimus-Coated Balloon for Patients With In-Stent Restenosis.

Treatment of in-stent restenosis (ISR) is challenging. Drug-coated balloons (DCB) are widely used in this setting to avoid deploying another metal layer to the vessel wall. This first-in-man study sought to assess the safety and efficacy of a novel everolimus-DCB (CVT-DCB) using a new coating formulation and crystalline everolimus in patients with ISR. A total of 51 patients (mean age 69.2 years) with single ISR lesions (≤24 mm in length) were prospectively enrolled at nine sites in Europe. The primary safety endpoint, freedom from target lesion failure at 180 days, was 92.2%, with the lower bound of the 95% CI (81.1%), above the protocol-defined objective performance criterion (65% for conventional balloon angioplasty, p <0.05). The primary efficacy endpoint, in-stent late lumen loss, was 0.40 mm, lower than the protocol-defined objective performance criterion of balloon angioplasty historical control (late lumen loss 0.80 mm, p <0.001). Three-year clinical follow-up was obtained in all (100%) patients. During the first year, 4 patients required ischemia-driven target lesion revascularization. No new episodes of target vessel failure (cardiac death, myocardial infarction, or ischemia-driven target lesion revascularization) occurred beyond the first year. The target lesion failure rate at 3 years was 9.8% (95% CI 3.3%-21.4%). The clinical follow-up of this first-in-man study confirms the sustained safety and efficacy of this novel everolimus DCB in patients with ISR. (Clinical Trials Registration: NCT05731700).