The new Polish stent Chopin. Assessment of safety and efficacy in the treatment of de-novo coronary lesions using percutaneous angioplasty.

Aim: The aim of the present study was to assess the safety and efficacy of percutaneous coronary interventions (PCI) using the new Polish stent "Chopin" (Balton, Poland).

Methods: The study consisted of experimental and clinical parts. In the experimental phase, the new stent was implanted into 5 pigs and control coronary angiography as well as intracoronary ultrasonography (ICUS) were performed 30 days later. In the clinical phase, 101 patients (57% of males, mean age 55.6+/-10 years) with symptomatic coronary artery disease (CAD) with "de novo" coronary lesions (including 12% of patients with unstable angina and 19% with acute myocardial infarction [MI]) underwent stent implantation. The patients were followed for 6 months for the occurrence of cardiac events. Quantitative coronary angiography was performed at baseline and after 6 months.

Results: In total, we attempted to implant 107 stents, which resulted in the successful deployment of 106 stents to 105 coronary arteries. The mean diameter of the stents was 3.2+/-0.3 mm, and length - 15.4+/-2 mm. During a one month follow-up period no cardiac events were noted. During a 6-month follow-up no death or new MI were recorded. Repeated target vessel revascularisation due to recurrent angina and in-stent restenosis was required in 15 (15.5%) patients. Control coronary angiography was performed in 97 (96%) patients. Of 101 stents, angiographic restenosis (narrowing of dilated lesion by >50% of vessel lumen) was documented in 18.8% of cases. The mean late vessel lumen loss was 0.77+/-0.6 mm, and stenosis - 29.1+/-20%. The restenosis rate was significantly higher in patients with unstable angina rather than in those with stable angina or acute MI.

Conclusions: Implantation of the new Polish stent "Chopin" during PCI is safe and effective.