The new Polish stent Chopin. Assessment of safety and efficacy in the treatment of de-novo coronary lesions using percutaneous angioplasty.
OBJECTIVE
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.
Buszman
Paweł
P
Department of Cardiology, Silesian Medical Academy, Katowice.
Zurakowski
Aleksander
A
Kinasz
Leszek
L
Gorycki
Bogdan
B
Król
Marek
M
Lewicki
Andrzej
A
Flak
Zbigniew
Z
Milewski
Krzysztof
K
Zurek
Paweł
P
D000368:Aged; D015906:Angioplasty, Balloon, Coronary; D000818:Animals; D019917:Blood Vessel Prosthesis Implantation; D017023:Coronary Angiography; D023921:Coronary Stenosis / Q000628:therapy*; D004867:Equipment Design; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D008297:Male; D008875:Middle Aged; D011044:Poland; D015607:Stents; D013552:Swine; D016896:Treatment Outcome