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2/2024
vol. 20
abstract:
Original paper
A multi-center study of the MicroNET-covered stent in consecutive patients with acute carotid-related stroke: SAFEGUARD-STROKE
Malgorzata Urbanczyk-Zawadzka
13
,
Piotr Pieniazek
2, 3, 14
,
Iris Q. Grunwald
19, 20
,
- St. John Paul II Hospital in Krakow Stroke Thrombectomy-Capable Cardiovascular Centre, Krakow, Poland
- Department of Cardiac and Vascular Diseases, Jagiellonian University Medical College, Krakow, Poland
- Department of Interventional Cardiology, Jagiellonian University Medical College, Krakow, Poland
- Department of Interventional Radiology, Republican Vilnius University Hospital, Vilnius, Lithuania
- Department of Diagnostic and Interventional Radiology, Stephan Cardinal Wyszynski Regional Hospital, Lublin, Poland
- Department of Interventional Radiology, Share Zedek Medical Center and Faculty of Medicine, The Hebrew University of Jerusalem, Jerusalem, Israel
- CardioVascular Center Frankfurt (CVC), Sankt Katharinen Hospital, Frankfurt, Germany
- Invasive Cardiology Division, University of Szeged, Szeged, Hungary
- Department of Radiology, Podhalanski Multispecialty Hospital, Nowy Targ, Poland
- St. John Paul II Hospital Krakow Cardiovascular Imaging Laboratory, Krakow, Poland
- Department of Neurology, Stephan Cardinal Wyszynski Regional Hospital, Lublin, Poland
- Santaros Klinikos, Vilnius University Hospital, Vilnius, Lithuania
- St. John Paul II Hospital in Krakow Department of Radiology, Krakow, Poland
- Department of Vascular Surgery and Endovascular Interventions, John Paul II Hospital, Krakow, Poland
- Department of Bioinformatics and Telemedicine, Jagiellonian University Medical College, Krakow, Poland
- Department of Neurology, Republican Vilnius University Hospital, Vilnius, Lithuania
- Department of Vascular Surgery, Republican Vilnius University Hospital, Vilnius, Lithuania
- Department of Neurology, Share Zedek Medical Center and Faculty of Medicine, The Hebrew University of Jerusalem, Jerusalem, Israel
- Division of Imaging Science and Technology, School of Medicine, University of Dundee, Dundee, Scotland, United Kingdom
- University of Dundee Chair of Neuroradiology and Ninewells Hospital Department of Radiology, Dundee, Scotland, United Kingdom
Adv Interv Cardiol 2024; 20, 2 (76): 172–193
Online publish date: 2024/06/29
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 atherothrombotic 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).
keywords:
carotid-related stroke, carotid stenosis, mechanical reperfusion, mechanical thrombectomy, stroke endovascular treatment, carotid artery stenting, cerebral protection devices, MicroNET-covered stent, CGuard, stent optimization, clinical outcomes
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