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

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.