A multi-center study of the MicroNET-covered stent in consecutive patients with acute carotid-related stroke: SAFEGUARD-STROKE.

IF 1.5 4区医学 Q3 CARDIAC & CARDIOVASCULAR SYSTEMS

Postepy W Kardiologii Interwencyjnej Pub Date : 2024-06-01 Epub Date: 2024-06-30 DOI:10.5114/aic.2024.140963

Lukasz Tekieli, Andrej Afanasjev, Maciej Mazgaj, Vladimir Borodetsky, Kolja Sievert, Zoltan Ruzsa, Magdalena Knapik, Audrius Širvinskas, Adam Mazurek, Karolina Dzierwa, Thomas Sanczuk, Valerija Mosenko, Malgorzata Urbanczyk-Zawadzka, Mariusz Trystula, Piotr Paluszek, Lukasz Wiewiorka, Justyna Stefaniak, Piotr Pieniazek, Inga Slautaitė, Tomasz Kwiatkowski, Artūras Mackevičius, Michael Teitcher, Horst Sievert, Iris Q Grunwald, Piotr Musialek

{"title":"A multi-center study of the MicroNET-covered stent in consecutive patients with acute carotid-related stroke: SAFEGUARD-STROKE.","authors":"Lukasz Tekieli, Andrej Afanasjev, Maciej Mazgaj, Vladimir Borodetsky, Kolja Sievert, Zoltan Ruzsa, Magdalena Knapik, Audrius Širvinskas, Adam Mazurek, Karolina Dzierwa, Thomas Sanczuk, Valerija Mosenko, Malgorzata Urbanczyk-Zawadzka, Mariusz Trystula, Piotr Paluszek, Lukasz Wiewiorka, Justyna Stefaniak, Piotr Pieniazek, Inga Slautaitė, Tomasz Kwiatkowski, Artūras Mackevičius, Michael Teitcher, Horst Sievert, Iris Q Grunwald, Piotr Musialek","doi":"10.5114/aic.2024.140963","DOIUrl":null,"url":null,"abstract":"Introduction: Acute carotid-related stroke (CRS), with its large thrombo-embolic load and large volume of affected brain tissue, poses significant management challenges. First generation (single-layer) carotid stents fail to insulate the athero-thrombotic material; thus they are often non-optimized (increasing thrombosis risk), yet their use is associated with a significant (20-30%) risk of new cerebral embolism.Aim: To evaluate, in a multi-center multi-specialty investigator-initiated study, outcomes of the MicroNET-covered (cell area ≈ 0.02-0.03 mm2) carotid stent (CGuard, InspireMD) in consecutive CRS patients eligible for emergency recanalization. Treatment, other than study device use, was according to center/operator routine.Material and methods: Seventy-five patients (age 40-89 years, 26.7% women) were enrolled in 7 interventional stroke centers.Results: The median Alberta Stroke Program Early CT Score (ASPECTS) was 9 (6-10). Study stent use was 100% (no other stent types implanted); retrograde strategy predominated (69.2%) in tandem lesions. Technical success was 100%. Post-dilatation balloon diameter was 4.0 to 8.0 mm. 89% of patients achieved final modified Thrombolysis in Cerebral Infarction (mTICI) 2b-c/3. Glycoprotein IIb/IIIa inhibitor use as intraarterial (IA) bolus + intravenous (IV) infusion was an independent predictor of symptomatic intracranial hemorrhage (OR = 13.9, 95% CI: 5.1-84.5, p < 0.001). The mortality rate was 9.4% in-hospital and 12.2% at 90 days. Ninety-day mRS0-2 was 74.3%, mRS3-5 13.5%; stent patency was 93.2%. Heparin-limited-to-flush predicted patency loss on univariate (OR = 14.3, 95% CI: 1.5-53.1, p < 0.007) but not on multivariate analysis. Small-diameter balloon/absent post-dilatation was an independent predictor of stent patency loss (OR = 15.2, 95% CI: 5.7-73.2, p < 0.001).Conclusions: This largest to-date study of the MicroNET-covered stent in consecutive CRS patients demonstrated a high acute angiographic success rate, high 90-day patency and favorable clinical outcomes despite variability in procedural strategies and pharmacotherapy (SAFEGUARD-STROKE NCT05195658).","PeriodicalId":49678,"journal":{"name":"Postepy W Kardiologii Interwencyjnej","volume":null,"pages":null},"PeriodicalIF":1.5000,"publicationDate":"2024-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11249880/pdf/","citationCount":"0","resultStr":null,"platform":"Semanticscholar","paperid":null,"PeriodicalName":"Postepy W Kardiologii Interwencyjnej","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.5114/aic.2024.140963","RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"2024/6/30 0:00:00","PubModel":"Epub","JCR":"Q3","JCRName":"CARDIAC & CARDIOVASCULAR SYSTEMS","Score":null,"Total":0}

引用次数: 0

Abstract

Introduction: Acute carotid-related stroke (CRS), with its large thrombo-embolic load and large volume of affected brain tissue, poses significant management challenges. First generation (single-layer) carotid stents fail to insulate the athero-thrombotic material; thus they are often non-optimized (increasing thrombosis risk), yet their use is associated with a significant (20-30%) risk of new cerebral embolism.

Aim: To evaluate, in a multi-center multi-specialty investigator-initiated study, outcomes of the MicroNET-covered (cell area ≈ 0.02-0.03 mm²) carotid stent (CGuard, InspireMD) in consecutive CRS patients eligible for emergency recanalization. Treatment, other than study device use, was according to center/operator routine.

Material and methods: Seventy-five patients (age 40-89 years, 26.7% women) were enrolled in 7 interventional stroke centers.

Results: The median Alberta Stroke Program Early CT Score (ASPECTS) was 9 (6-10). Study stent use was 100% (no other stent types implanted); retrograde strategy predominated (69.2%) in tandem lesions. Technical success was 100%. Post-dilatation balloon diameter was 4.0 to 8.0 mm. 89% of patients achieved final modified Thrombolysis in Cerebral Infarction (mTICI) 2b-c/3. Glycoprotein IIb/IIIa inhibitor use as intraarterial (IA) bolus + intravenous (IV) infusion was an independent predictor of symptomatic intracranial hemorrhage (OR = 13.9, 95% CI: 5.1-84.5, p < 0.001). The mortality rate was 9.4% in-hospital and 12.2% at 90 days. Ninety-day mRS0-2 was 74.3%, mRS3-5 13.5%; stent patency was 93.2%. Heparin-limited-to-flush predicted patency loss on univariate (OR = 14.3, 95% CI: 1.5-53.1, p < 0.007) but not on multivariate analysis. Small-diameter balloon/absent post-dilatation was an independent predictor of stent patency loss (OR = 15.2, 95% CI: 5.7-73.2, p < 0.001).

Conclusions: This largest to-date study of the MicroNET-covered stent in consecutive CRS patients demonstrated a high acute angiographic success rate, high 90-day patency and favorable clinical outcomes despite variability in procedural strategies and pharmacotherapy (SAFEGUARD-STROKE NCT05195658).

查看原文本刊更多论文

对急性颈动脉相关中风连续患者进行的 MicroNET 覆盖支架多中心研究：保障-中风。

导言：急性颈动脉相关中风（CRS）具有血栓栓塞负荷大、受累脑组织体积大的特点，给治疗带来了巨大挑战。第一代（单层）颈动脉支架无法隔绝粥样血栓物质，因此往往无法达到最佳效果（增加了血栓形成的风险），而使用这些支架又会带来新的脑栓塞风险（20%-30%）。目的：在一项由研究者发起的多中心多专科研究中，对符合紧急再通畅条件的连续 CRS 患者使用 MicroNET 覆盖（细胞面积≈ 0.02-0.03 mm2）颈动脉支架（CGuard，InspireMD）的效果进行评估。除研究设备的使用外，其他治疗均按照中心/操作者的常规进行：7家介入卒中中心共纳入75名患者（年龄40-89岁，26.7%为女性）：阿尔伯塔省卒中计划早期 CT 评分 (ASPECTS) 中位数为 9（6-10）。研究支架使用率为100%（未植入其他类型支架）；在串联病变中，逆行策略占主导地位（69.2%）。技术成功率为 100%。扩张后球囊直径为 4.0 至 8.0 毫米。89%的患者最终达到改良脑梗死溶栓治疗（mTICI）2b-c/3。糖蛋白IIb/IIIa抑制剂作为动脉内（IA）栓剂+静脉内（IV）输注是症状性颅内出血的独立预测因素（OR = 13.9，95% CI：5.1-84.5，p < 0.001）。院内死亡率为 9.4%，90 天死亡率为 12.2%。90天后mRS0-2为74.3%，mRS3-5为13.5%；支架通畅率为93.2%。单变量分析（OR = 14.3，95% CI：1.5-53.1，p <0.007）显示，肝素限制-冲洗可预测通畅率下降，但多变量分析显示，肝素限制-冲洗不能预测通畅率下降。小直径球囊/扩张后缺失是支架通畅损失的独立预测因素（OR = 15.2，95% CI：5.7-73.2，p < 0.001）：尽管手术策略和药物治疗存在差异，但这项迄今为止最大规模的 MicroNET 覆盖支架连续 CRS 患者研究显示了较高的急性血管造影成功率、较高的 90 天通畅率和良好的临床结果（SAFEGUARD-STROKE NCT05195658）。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

求助全文

约1分钟内获得全文求助全文

来源期刊

Postepy W Kardiologii Interwencyjnej 医学-心血管系统

CiteScore

1.60

自引率

15.40%

发文量

审稿时长

6-12 weeks

期刊介绍： Postępy w Kardiologii Interwencyjnej/Advances in Interventional Cardiology is indexed in: Index Copernicus, Ministry of Science and Higher Education Index (MNiSW). Advances in Interventional Cardiology is a quarterly aimed at specialists, mainly at cardiologists and cardiosurgeons. Official journal of the Association on Cardiovascular Interventions of the Polish Cardiac Society.