Clinical outcome of titanium-nitride-oxide-coated cobalt-chromium stents in patients with de novo coronary lesions: 12-month results of the OPTIMAX first-in-man study

• Published in: Catheterization and cardiovascular interventions 2016-03, Vol.87 (4), p.E122-E127
• Main Authors: Karjalainen, Pasi P., Mikkelsson, Jussi, Paana, Tuomas, Nammas, Wail
• Format: Article
• Language: English
• Subjects: Aged; Chromium Alloys; Coated Materials, Biocompatible; cobalt-chromium; Coronary Angiography; Coronary Artery Disease - diagnostic imaging; Coronary Artery Disease - mortality; Coronary Artery Disease - therapy; Coronary Stenosis - diagnostic imaging; Coronary Stenosis - mortality; Coronary Stenosis - therapy; Coronary Thrombosis - etiology; Coronary Thrombosis - mortality; Female; Humans; Male; Middle Aged; Myocardial Infarction - etiology; Myocardial Infarction - mortality; Oxides; percutaneous coronary intervention; Percutaneous Coronary Intervention - adverse effects; Percutaneous Coronary Intervention - instrumentation; Percutaneous Coronary Intervention - mortality; Prospective Studies; Prosthesis Design; Risk Factors; stent thrombosis; Stents; Time Factors; Titanium; titanium-nitride-oxide; Treatment Outcome
• ISSN: 1522-1946; 1522-726X
• DOI: 10.1002/ccd.26104

Objectives We explored the 12‐month clinical outcome of the titanium‐nitride‐oxide‐coated OPTIMAX stent based on cobalt‐chromium platform. Background: The OPTIMAX stent demonstrated a satisfactory 6‐month clinical outcome in de novo coronary lesions. Methods: We enrolled 224 consecutive symptomatic patients with significant (50%) stenosis in de novo coronary lesions, who were treated with OPTIMAX stent implantation. The primary endpoint was major adverse cardiac events at 12‐month follow‐up, defined as a composite of cardiac death, non‐fatal myocardial infarction (MI), or ischemia‐driven target lesion revascularization (TLR). Stent thrombosis was adjudicated according to the definition of the Academic Research Consortium. Results: The mean age of the cohort was 67 ± 8 years (75% males). Patients presented with acute coronary syndrome in 62.1%. Radial access was used in 92%; complex (type B and C) lesions were treated in 79.9%. Both procedural and clinical success occurred in 100% of the cases. The mean follow‐up period was 366 ± 22 days. At 12‐month follow‐up, the primary endpoint occurred in 14 (6.3%) patients. Cardiac death occurred in three (1.3%) patients, non‐fatal MI in seven (3.1%) patients, and ischemia‐driven TLR in seven (3.1%) patients. No definite stent thrombosis occurred. Conclusions: In the current prospective observational study, implantation of the OPTIMAX stent demonstrated an adequate 12‐month clinical outcome, with a low rate of major adverse cardiac events, and no stent thrombosis. © 2015 Wiley Periodicals, Inc.