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

Krzysztof Milewski; Paweł Gąsior; Stefan Samborski; Piotr P. Buszman; Aleksandra Błachut; Adam Wojtaszczyk; Adam Młodziankowski; Artur Mendyk; Marek Król; Wojciech Wojakowski; Paweł E. Buszman

doi:10.5114/aic.2016.61642

eISSN: 1897-4295
ISSN: 1734-9338

Advances in Interventional Cardiology/Postępy w Kardiologii Interwencyjnej

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3/2016
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abstract:

Original paper

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

Krzysztof Milewski

,

Paweł Gąsior

,

Stefan Samborski

,

Piotr P. Buszman

,

Aleksandra Błachut

,

Adam Wojtaszczyk

,

Adam Młodziankowski

,

Artur Mendyk

,

Marek Król

,

Wojciech Wojakowski

,

Paweł E. Buszman

Adv Interv Cardiol 2016; 12, 3 (45): 217–223

DOI: https://doi.org/10.5114/aic.2016.61642

Online publish date: 2016/08/19

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AMA

Milewski K, Gąsior P, Samborski S, et al. 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. Advances in Interventional Cardiology/Postępy w Kardiologii Interwencyjnej. 2016;12(3):217-223. doi:10.5114/aic.2016.61642.

APA

Milewski, K., Gąsior, P., Samborski, S., Buszman, P., Błachut, A.,  & Wojtaszczyk, A. et al. (2016). 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. Advances in Interventional Cardiology/Postępy w Kardiologii Interwencyjnej, 12(3), 217-223. https://doi.org/10.5114/aic.2016.61642

Chicago

Milewski, Krzysztof, Paweł Gąsior, Stefan Samborski, Piotr P. Buszman, Aleksandra Błachut, Adam Wojtaszczyk,  and Adam Młodziankowski et al. 2016. "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". Advances in Interventional Cardiology/Postępy w Kardiologii Interwencyjnej 12 (3): 217-223. doi:10.5114/aic.2016.61642.

Harvard

Milewski, K., Gąsior, P., Samborski, S., Buszman, P., Błachut, A., Wojtaszczyk, A., Młodziankowski, A., Mendyk, A., Król, M., Wojakowski, W.,  and Buszman, P. (2016). 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. Advances in Interventional Cardiology/Postępy w Kardiologii Interwencyjnej, 12(3), pp.217-223. https://doi.org/10.5114/aic.2016.61642

MLA

Milewski, Krzysztof et al. "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." Advances in Interventional Cardiology/Postępy w Kardiologii Interwencyjnej, vol. 12, no. 3, 2016, pp. 217-223. doi:10.5114/aic.2016.61642.

Vancouver

Milewski K, Gąsior P, Samborski S, Buszman P, Błachut A, Wojtaszczyk A et al. 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. Advances in Interventional Cardiology/Postępy w Kardiologii Interwencyjnej. 2016;12(3):217-223. doi:10.5114/aic.2016.61642.

Introduction: Despite the dominance of drug-eluting stents in modern interventional cardiology, there is still a niche for bare metal stents.

Aim: 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.

Material and 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.

keywords:

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

Krzysztof Milewski , Paweł Gąsior , Stefan Samborski , Piotr P. Buszman , Aleksandra Błachut , Adam Wojtaszczyk , Adam Młodziankowski , Artur Mendyk , Marek Król , Wojciech Wojakowski , Paweł E. Buszman

stent, cobalt-chromium, ultrathin struts, hybrid cell design, all-comers patient population

Krzysztof Milewski

,

Paweł Gąsior

,

Stefan Samborski

,

Piotr P. Buszman

,

Aleksandra Błachut

,

Adam Wojtaszczyk

,

Adam Młodziankowski

,

Artur Mendyk

,

Marek Król

,

Wojciech Wojakowski

,

Paweł E. Buszman