Bernard Chevalier1, Pieter C Smits2, Didier Carrié2, Julinda Mehilli2, Ad J Van Boven2, Evelyn Regar2, Fadi J Sawaya2, Daniel Chamié2, Adriaan O Kraaijeveld2, Thomas Hovasse2, Georgios J Vlachojannis2. 1. From the Ramsay Générale de Santé, Interventional Cardiology Department, Institut Cardiovasculaire Paris Sud, Massy, France (B.C., F.J.S., T.H.); Department of Cardiology, Maasstad Hospital, Rotterdam, the Netherlands (P.C.S., A.O.K., G.J.V.); Department of Cardiology, CHU Rangueil, Toulouse, France (D.C.); Department of Cardiology, Munich University Clinic, LMU Munich and Munich Heart Alliance, DZHK, Germany (J.M.); Department of Cardiology, Medisch Centrum Leeuwarden, the Netherlands (A.J.V.B.); The Thoraxcenter, Erasmus MC, Rotterdam, the Netherlands (E.R.); and Department of Invasive Cardiology, Institute Dante Pazzanese of Cardiology, Cardiovascular Research Center, Sao Paulo, Brazil (D.C.). bchevalie@aol.com. 2. From the Ramsay Générale de Santé, Interventional Cardiology Department, Institut Cardiovasculaire Paris Sud, Massy, France (B.C., F.J.S., T.H.); Department of Cardiology, Maasstad Hospital, Rotterdam, the Netherlands (P.C.S., A.O.K., G.J.V.); Department of Cardiology, CHU Rangueil, Toulouse, France (D.C.); Department of Cardiology, Munich University Clinic, LMU Munich and Munich Heart Alliance, DZHK, Germany (J.M.); Department of Cardiology, Medisch Centrum Leeuwarden, the Netherlands (A.J.V.B.); The Thoraxcenter, Erasmus MC, Rotterdam, the Netherlands (E.R.); and Department of Invasive Cardiology, Institute Dante Pazzanese of Cardiology, Cardiovascular Research Center, Sao Paulo, Brazil (D.C.).
Abstract
BACKGROUND: To assess the vessel-healing pattern of Ultimaster drug-eluting stent using optical frequency domain imaging. Our hypothesis is that biodegradable polymer-based drug-eluting technology allows complete very early strut coverage. METHODS AND RESULTS: The DISCOVERY 1TO3 study (Evaluation With OFDI of Strut Coverage of Terumo New Drug Eluting Stent With Biodegradable Polymer at 1, 2, and 3 Months) is a prospective, single-arm, multicenter study. A total of 60 patients with multivessel disease requiring staged procedure at 1 month were treated with Ultimaster. Optical frequency domain imaging was acquired at baseline, 1, 2, and 3 months. The primary end point is optical frequency domain imaging-assessed strut coverage at 3 months. Mean age of patients was 67.2±9.9 years, and 73.3% were male, and 36.7% presented with acute coronary syndrome. A total of 132 lesions were treated, with average 1.4 lesions per patient treated at baseline and 1.1 lesions treated at 1 month. Strut coverage at 3 months of single implanted stents (n=71, primary end point) was 95.2±5.2% and of combined single and overlapped stents was 95.4±4.9%. Strut coverage of combined single and overlapped stents at 1 (n=49) and 2 months (n=38) was 85.1±12.7% and 87.9±10.8%, respectively. The median neointimal hyperplasia thickness was 0.04, 0.05, and 0.06 mm, whereas mean neointimal hyperplasia obstruction was 4.5±2.4%, 5.2±3.4%, and 6.6±3.3% at 1, 2, and 3 months, respectively. CONCLUSIONS: Nearly complete strut coverage was observed in this complex population very early after implantation of Ultimaster drug-eluting stent. CLINICAL TRIAL REGISTRATION: URL: https://www.clinicaltrials.gov. Unique identifier: NCT01844843.
BACKGROUND: To assess the vessel-healing pattern of Ultimaster drug-eluting stent using optical frequency domain imaging. Our hypothesis is that biodegradable polymer-based drug-eluting technology allows complete very early strut coverage. METHODS AND RESULTS: The DISCOVERY 1TO3 study (Evaluation With OFDI of Strut Coverage of Terumo New Drug Eluting Stent With Biodegradable Polymer at 1, 2, and 3 Months) is a prospective, single-arm, multicenter study. A total of 60 patients with multivessel disease requiring staged procedure at 1 month were treated with Ultimaster. Optical frequency domain imaging was acquired at baseline, 1, 2, and 3 months. The primary end point is optical frequency domain imaging-assessed strut coverage at 3 months. Mean age of patients was 67.2±9.9 years, and 73.3% were male, and 36.7% presented with acute coronary syndrome. A total of 132 lesions were treated, with average 1.4 lesions per patient treated at baseline and 1.1 lesions treated at 1 month. Strut coverage at 3 months of single implanted stents (n=71, primary end point) was 95.2±5.2% and of combined single and overlapped stents was 95.4±4.9%. Strut coverage of combined single and overlapped stents at 1 (n=49) and 2 months (n=38) was 85.1±12.7% and 87.9±10.8%, respectively. The median neointimal hyperplasia thickness was 0.04, 0.05, and 0.06 mm, whereas mean neointimal hyperplasia obstruction was 4.5±2.4%, 5.2±3.4%, and 6.6±3.3% at 1, 2, and 3 months, respectively. CONCLUSIONS: Nearly complete strut coverage was observed in this complex population very early after implantation of Ultimaster drug-eluting stent. CLINICAL TRIAL REGISTRATION: URL: https://www.clinicaltrials.gov. Unique identifier: NCT01844843.
Authors: Joseph Robert Stevens; Ava Zamani; James Ian Atkins Osborne; Reza Zamani; Mohammad Akrami Journal: Biomed Eng Online Date: 2021-05-08 Impact factor: 2.819
Authors: Selina Vlieger; Gian B Danzi; Floris Kauer; Rohit M Oemrawsingh; Sinisa Stojkovic; Alexander J J IJsselmuiden; Helen Routledge; Peep Laanmets; Marco Roffi; Ole Fröbert; Pascual Baello; Adrian Wlodarczak; Angel Puentes; Jawed Polad; David Hildick-Smith Journal: Coron Artery Dis Date: 2021-08-01 Impact factor: 1.439