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.).
Circ Cardiovasc Interv. 2017 Dec;10(12). doi: 10.1161/CIRCINTERVENTIONS.116.004801.
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.
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.
Nearly complete strut coverage was observed in this complex population very early after implantation of Ultimaster drug-eluting stent.
URL: https://www.clinicaltrials.gov. Unique identifier: NCT01844843.
使用光频域成像评估Ultimaster 药物洗脱支架的血管愈合模式。我们的假设是，可生物降解聚合物的药物洗脱技术可实现完全的早期支架梁完全覆盖。
DISCOVERY 1TO3 研究（在 1、2 和 3 个月时使用 OFDI 评估 Terumo 新型可生物降解聚合物药物洗脱支架的支架梁覆盖率的研究）是一项前瞻性、单臂、多中心研究。共 60 名患有多支血管疾病且需要在 1 个月内行分期手术的患者接受 Ultimaster 治疗。在基线、1、2 和 3 个月时采集光频域图像。主要终点是 3 个月时的光频域成像评估的支架梁覆盖率。患者的平均年龄为 67.2±9.9 岁，73.3%为男性，36.7%为急性冠脉综合征。共治疗 132 处病变，平均每位患者在基线时治疗 1.4 处病变，在 1 个月时治疗 1.1 处病变。3 个月时，单植入支架的支架梁覆盖率（n=71，主要终点）为 95.2±5.2%，单支架和重叠支架的联合覆盖率为 95.4±4.9%。1 个月（n=49）和 2 个月（n=38）时，单支架和重叠支架联合覆盖率分别为 85.1±12.7%和 87.9±10.8%。中位新生内膜增生厚度分别为 0.04、0.05 和 0.06mm，1、2 和 3 个月时平均新生内膜增生阻塞分别为 4.5±2.4%、5.2±3.4%和 6.6±3.3%。
在接受 Ultimaster 药物洗脱支架治疗的复杂人群中，支架梁的完全覆盖可在早期观察到。
