Carotid artery stenting with Roadsaver stent. Early and four-year results from a single-center registry

Roman Machnik; Piotr Pieniążek; Marcin Misztal; Krzysztof Plens; Marek Kazibudzki; Tomasz Tomaszewski; Andrzej Brzychczy; Robert Musiał; Mariusz Trystuła; Łukasz M. Tekieli

doi:10.5114/aic.2020.101770

eISSN: 1897-4295
ISSN: 1734-9338

Advances in Interventional Cardiology/Postępy w Kardiologii Interwencyjnej

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abstract:

Original paper

Carotid artery stenting with Roadsaver stent. Early and four-year results from a single-center registry

Roman A. Machnik

¹

,

Piotr Pieniążek

^{1, 2}

,

Marcin Misztal

¹

,

Krzysztof Plens

³

,

Marek Kazibudzki

¹

,

Tomasz Tomaszewski

⁴

,

Andrzej Brzychczy

¹

,

Robert Musiał

⁵

,

Mariusz Trystuła

¹

,

Łukasz M. Tekieli

²

Department of Vascular Surgery and Endovascular Interventions, John Paul II Hospital, Krakow, Poland
Department of Interventional Cardiology, Institute of Cardiology, Jagiellonian University, Medical College, John Paul II Hospital, Krakow, Poland
KCRI, Krakow, Poland
Department of Neurology, John Paul II Hospital, Krakow, Poland
Department of Anesthesiology and Intensive Medical Therapy, John Paul II Hospital, Krakow, Poland

Adv Interv Cardiol 2020; 16, 4 (62): 444–451

DOI: https://doi.org/10.5114/aic.2020.101770

Online publish date: 2020/12/29

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AMA

Machnik RA, Pieniążek P, Misztal M, et al. Carotid artery stenting with Roadsaver stent. Early and four-year results from a single-center registry. Advances in Interventional Cardiology/Postępy w Kardiologii Interwencyjnej. 2020;16(4):444-451. doi:10.5114/aic.2020.101770.

APA

Machnik, R. A., Pieniążek, P., Misztal, M., Plens, K., Kazibudzki, M.,  & Tomaszewski, T. et al. (2020). Carotid artery stenting with Roadsaver stent. Early and four-year results from a single-center registry. Advances in Interventional Cardiology/Postępy w Kardiologii Interwencyjnej, 16(4), 444-451. https://doi.org/10.5114/aic.2020.101770

Chicago

Machnik, Roman A, Piotr Pieniążek, Marcin Misztal, Krzysztof Plens, Marek Kazibudzki, Tomasz Tomaszewski,  and Andrzej Brzychczy et al. 2020. "Carotid artery stenting with Roadsaver stent. Early and four-year results from a single-center registry". Advances in Interventional Cardiology/Postępy w Kardiologii Interwencyjnej 16 (4): 444-451. doi:10.5114/aic.2020.101770.

Harvard

Machnik, R., Pieniążek, P., Misztal, M., Plens, K., Kazibudzki, M., Tomaszewski, T., Brzychczy, A., Musiał, R., Trystuła, M.,  and Tekieli, Ł. (2020). Carotid artery stenting with Roadsaver stent. Early and four-year results from a single-center registry. Advances in Interventional Cardiology/Postępy w Kardiologii Interwencyjnej, 16(4), pp.444-451. https://doi.org/10.5114/aic.2020.101770

MLA

Machnik, Roman et al. "Carotid artery stenting with Roadsaver stent. Early and four-year results from a single-center registry." Advances in Interventional Cardiology/Postępy w Kardiologii Interwencyjnej, vol. 16, no. 4, 2020, pp. 444-451. doi:10.5114/aic.2020.101770.

Vancouver

Machnik R, Pieniążek P, Misztal M, Plens K, Kazibudzki M, Tomaszewski T et al. Carotid artery stenting with Roadsaver stent. Early and four-year results from a single-center registry. Advances in Interventional Cardiology/Postępy w Kardiologii Interwencyjnej. 2020;16(4):444-451. doi:10.5114/aic.2020.101770.

Aim
To assess immediate and long-term safety and effectiveness of CAS using the Roadsaver double-nitinol-layer-micromesh stent.

Material and methods
Since 2014, 298 CAS procedures in 287 non-consecutive patients (203 men, mean age 70.5 ±8.6 years, 100% symptomatic/high risk lesions) have been performed using the Roadsaver stent and proximal (40%) or distal (60%) neuroprotection system. Clinical and neurological examinations as well as duplex ultrasound were completed before CAS, before discharge, at 1, 6 and 12 months, then annually.

Results
All CAS procedures were successful. Carotid stenosis was reduced from 84.9 ±9.9% to 11.0 ±9.4% (p < 000.1). In hospital, 1 ipsilateral periprocedural major (0.3%) and 3 minor (1.34%) ischemic strokes occurred, 2 (0.7%) patients died due to a cerebral hemorrhage on day 9 and 21. Three (1.0%) additional ipsilateral minor strokes within 30 consecutive days occurred. Thus, 30-day complications were observed in 9 (3.0%) patients. Two minor strokes were associated with in-stent thrombosis (0.7%). The 4-year follow-up showed 82% overall survival (95% CI: 69–91%) with no significant difference between asymptomatic (77%) and symptomatic patients (97%; p = 0.076). The stroke-free survival was 89% (95% CI: 77–95%), 84% asymptomatic vs. 98% symptomatic (p = 0.187). Seven (2.3%) patients developed > 50% in-stent restenosis.

Conclusions
Carotid artery stenting using the Roadsaver stent for symptomatic patients and high risk lesions showed to be safe and effective, with a low complication rate and acceptable in-stent restenosis risk in 4-year follow-up.

keywords:

Carotid artery stenting with Roadsaver stent. Early and four-year results from a single-center registry

Roman A. Machnik 1 , Piotr Pieniążek 1, 2 , Marcin Misztal 1 , Krzysztof Plens 3 , Marek Kazibudzki 1 , Tomasz Tomaszewski 4 , Andrzej Brzychczy 1 , Robert Musiał 5 , Mariusz Trystuła 1 , Łukasz M. Tekieli 2

carotid artery stenting, Roadsaver stent, nitinol double-layer micromesh stent

Roman A. Machnik

¹

,

Piotr Pieniążek

^{1, 2}

,

Marcin Misztal

¹

,

Krzysztof Plens

³

,

Marek Kazibudzki

¹

,

Tomasz Tomaszewski

⁴

,

Andrzej Brzychczy

¹

,

Robert Musiał

⁵

,

Mariusz Trystuła

¹

,

Łukasz M. Tekieli

²