A Next-Generation Bioresorbable CoronaryScaffold System: From Bench toFirst Clinical Evaluation

ABSTRACT

This study sought to perform clinical and imaging assessments of the DESolveBioresorbable Coronary Scaffold (BCS).Background BCS, which is drug eluting, may have potential advantages compared with conventionalmetallic drug-eluting stents. The DESolve system, designed to provide vessel support and neointimalsuppression, combines a poly-L-lactic acid–based scaffold with the antiproliferative myolimus.Methods The DESolve First-in-Man (A NON-RANDOMIZED, CONSECUTIVE ENROLLMENT EVALUATIONOF THE DESolve MYOLIMUS ELUTING BIORESORBABLE CORONARY STENT IN THE TREATMENT OFPATIENTS WITH DE NOVO NATIVE CORONARY ARTERY LESIONS) trial was a prospective multicenterstudy enrolling 16 patients eligible for treatment. The principal safety endpoint was a composite ofcardiac death, myocardial infarction, and clinically indicated target lesion revascularization. Theprincipal imaging endpoint was in-scaffold late lumen loss (LLL) assessed by quantitative coronaryangiography (QCA) at 6 months. Intravascular ultrasound (IVUS) and optical coherence tomography(OCT) imaging was performed at baseline and 6 months; multislice computed tomography (MSCT) wasperformed at 12 months.Results Acute procedural success was achieved in 15 of 15 patients receiving a study scaffold. At12 months, there was no scaffold thrombosis and no major adverse cardiac events directly attributableto the scaffold. At 6 months, in-scaffold LLL (by QCA) was 0.19 0.19 mm; neointimal volume (by IVUS)was 7.19 3.56%, with no evidence of scaffold recoil or late malapposition. Findings were confirmedwith OCT and showed uniform, thin neointimal coverage (0.12 0.04 mm). At 12 months, MSCTdemonstrated excellent vessel patency.