Fernando Alfonso, Tamaz Shaburishvili, Bruno Farah, Ikrali Gogorishvili, Jacques Monsegu, Arvydas Baranauskas, Erwan Bressollette, George Shaburishvili, Javier Cuesta, Fernando Rivero, Raul Moreno, Manel Sabate
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引用次数: 0
Abstract
Background: Treatment of patients with in-stent restenosis (ISR) remains challenging. In this setting the use of drug-coated balloons (DCB) represents an attractive approach to avoid adding another metal layer to the coronary wall.
Aims: The Chansu Vascular Technologies (CVT)-ISR trial aimed to evaluate the safety and efficacy of a novel everolimus-DCB (CVT-DCB) using a new coating formulation and crystalline everolimus.
Methods: The CVT-ISR trial was a prospective, multicenter, open, single-arm, first-in-man (FIM) study. A total of 51 patients (mean age 69.2 years, 74.5% male) with single ISR coronary lesions (≤24 mm in length) were enrolled at nine sites in Europe.
Results: The primary safety endpoint, freedom from target lesion failure (TLF) at 180 days, was 92.2%, with the lower bound of the 95% confidence interval (81.1%), above the protocol-defined objective performance criterion (OPC) (65% for conventional balloon angioplasty, P < 0.05). At 1 year freedom from TLF was 90.2%. The primary efficacy endpoint, in-stent late lumen loss at 180 days (evaluated in a predefined subgroup of 25 patients scheduled for late angiography), was 0.40 mm (median 0.30 mm), lower than the protocol-defined OPC of the plain balloon angioplasty historical control (0.80 mm, P < 0.001).
Conclusion: This FIM study demonstrated the superior efficacy of the new everolimus CVT-DCB compared with conventional balloon angioplasty in the treatment of patients with ISR.
期刊介绍：
Coronary Artery Disease welcomes reports of original research with a clinical emphasis, including observational studies, clinical trials, translational research, novel imaging, pharmacology and interventional approaches as well as advances in laboratory research that contribute to the understanding of coronary artery disease. Each issue of Coronary Artery Disease is divided into four areas of focus: Original Research articles, Review in Depth articles by leading experts in the field, Editorials and Images in Coronary Artery Disease. The Editorials will comment on selected original research published in each issue of Coronary Artery Disease, as well as highlight controversies in coronary artery disease understanding and management.
Submitted artcles undergo a preliminary review by the editor. Some articles may be returned to authors without further consideration. Those being considered for publication will undergo further assessment and peer-review by the editors and those invited to do so from a reviewer pool.
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