Machnik Roman A, Pieniążek Piotr, Misztal Marcin, Plens Krzysztof, Kazibudzki Marek, Tomaszewski Tomasz, Brzychczy Andrzej, Musiał Robert, Trystuła Mariusz, Tekieli Łukasz M
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.
Postepy Kardiol Interwencyjnej. 2020 Dec;16(4):444-451. doi: 10.5114/aic.2020.101770. Epub 2020 Dec 29.
Prevention of peri- and postprocedural complications is still a challenge in carotid artery stenting (CAS).
To assess immediate and long-term safety and effectiveness of CAS using the Roadsaver double-nitinol-layer-micromesh stent.
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.
All CAS procedures were successful. Carotid stenosis was reduced from 84.9 ±9.9% to 11.0 ±9.4% ( < 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%; = 0.076). The stroke-free survival was 89% (95% CI: 77-95%), 84% asymptomatic vs. 98% symptomatic ( = 0.187). Seven (2.3%) patients developed > 50% in-stent restenosis.
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.
在颈动脉支架置入术（CAS）中，预防围手术期和术后并发症仍然是一项挑战。
评估使用Roadsaver双镍钛诺层微网支架进行CAS的即时和长期安全性及有效性。
自2014年以来，已对287例非连续患者（203例男性，平均年龄70.5±8.6岁，100%为有症状/高危病变）进行了298例CAS手术，使用了Roadsaver支架及近端（40%）或远端（60%）神经保护系统。在CAS术前、出院前、术后1个月、6个月和12个月，然后每年进行临床和神经学检查以及双功超声检查。
所有CAS手术均成功。颈动脉狭窄率从84.9±9.9%降至11.0±9.4%（P<0.001）。在住院期间，发生了1例同侧围手术期严重（0.3%）和3例轻微（1.34%）缺血性卒中，2例（0.7%）患者分别在第9天和第21天因脑出血死亡。在连续30天内又发生了3例（1.0%）同侧轻微卒中。因此，9例（3.0%）患者出现了30天并发症。2例轻微卒中与支架内血栓形成有关（0.7%）。4年随访显示总生存率为82%（95%可信区间：69-91%），无症状患者（77%）和有症状患者（97%；P=0.076）之间无显著差异。无卒中生存率为89%（95%可信区间：77-95%），无症状患者为84%，有症状患者为98%（P=0.187）。7例（2.3%）患者出现支架内再狭窄>50%。
对于有症状患者和高危病变，使用Roadsaver支架进行颈动脉支架置入术显示出安全有效，并发症发生率低，且在4年随访中支架内再狭窄风险可接受。
