Evaluation of safety and efficacy of NexGen - an ultrathin strut and hybrid cell design cobalt-chromium bare metal stent implanted in a real life patient population - the Polish NexGen Registry.
BACKGROUND
Despite the dominance of drug-eluting stents in modern interventional cardiology, there is still a niche for bare metal stents.


OBJECTIVE
The aim of the Polish NexGen registry was to evaluate the safety and efficacy of a new generation cobalt-chromium NexGen stent in a real life patient population.


METHODS
A prospective multi-center registry was conducted in five clinical sites of American Heart of Poland. Three hundred and eighty-three patients who underwent percutaneous coronary intervention (PCI) with NexGen stent implantation were included. Clinical follow-up was performed at 1, 6 and 12 months. Additionally, a group of 42 randomly selected patients underwent control angiography at 6 months (10.96% of study population). The primary endpoint was occurrence of target vessel revascularization (TVR) at 6-month follow-up. Angiographic endpoints included rates of binary restenosis and late lumen loss at 6-month follow-up based on QCA analysis. Multivessel disease was present in more than 70% of patients, and 52.4% of lesions were complex. The main indications for angiography were non-ST elevation acute coronary syndromes (54.8%) and ST elevation myocardial infarction (34.99%).


RESULTS
At 6-month follow-up 47 (12.7%) patients reached the primary endpoint of TVR. The composite of major acute cardiac event rates at 30-day and 6- and 12-month follow-up was 6.01% (n = 23), 18.5% (n = 69) and 25.21% (n = 92) respectively. Control angiography performed after 6 months showed in-stent late loss of 0.66 ±0.71 mm and a binary restenosis rate of 16.7%.


CONCLUSIONS
Our study showed that PCI with the NexGen stent is safe and effective at 6- and 12-month follow-up. Angiographic results showed a satisfactory restenosis rate and low late lumen loss.
Center for Cardiovascular Research and Development, American Heart of Poland SA, Katowice, Poland.
Krzysztof
K
Milewski
Center for Cardiovascular Research and Development, American Heart of Poland SA, Katowice, Poland.
Paweł
P
Gąsior
Center for Cardiovascular Research and Development, American Heart of Poland SA, Katowice, Poland.
Stefan
S
Samborski
Center for Cardiovascular Research and Development, American Heart of Poland SA, Katowice, Poland.
Piotr P
PP
Buszman
Center for Cardiovascular Research and Development, American Heart of Poland SA, Katowice, Poland.
Aleksandra
A
Błachut
Center for Cardiovascular Research and Development, American Heart of Poland SA, Katowice, Poland.
Adam
A
Wojtaszczyk
Center for Cardiovascular Research and Development, American Heart of Poland SA, Katowice, Poland.
Adam
A
Młodziankowski
Center for Cardiovascular Research and Development, American Heart of Poland SA, Katowice, Poland.
Artur
A
Mendyk
Center for Cardiovascular Research and Development, American Heart of Poland SA, Katowice, Poland.
Marek
M
Król
Third Division of Cardiology, Medical University of Silesia, Katowice, Poland.
Wojciech
W
Wojakowski
Center for Cardiovascular Research and Development, American Heart of Poland SA, Katowice, Poland.
Paweł E
PE
Buszman
all-comers patient population; cobalt-chromium; hybrid cell design; stent; ultrathin struts