eISSN: 1897-4295
ISSN: 1734-9338
Advances in Interventional Cardiology/Postępy w Kardiologii Interwencyjnej
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SCImago Journal & Country Rank
2/2024
vol. 20
 
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abstract:
Original paper

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

Lukasz Tekieli
1, 2, 3
,
Andrej Afanasjev
4
,
Maciej Mazgaj
5
,
Vladimir Borodetsky
6
,
Kolja Sievert
7
,
Zoltan Ruzsa
8
,
Magdalena Knapik
2, 9
,
Audrius Širvinskas
4
,
Adam Mazurek
1, 2
,
Karolina Dzierwa
10
,
Thomas Sanczuk
11
,
Valerija Mosenko
12
,
Malgorzata Urbanczyk-Zawadzka
13
,
Mariusz Trystula
14
,
Piotr Paluszek
1, 14
,
Lukasz Wiewiorka
13
,
Justyna Stefaniak
15
,
Piotr Pieniazek
2, 3, 14
,
Inga Slautaitė
16
,
Tomasz Kwiatkowski
14
,
Artūras Mackevičius
17
,
Michael Teitcher
18
,
Horst Sievert
7
,
Iris Q. Grunwald
19, 20
,
Piotr Musialek
1, 2

  1. St. John Paul II Hospital in Krakow Stroke Thrombectomy-Capable Cardiovascular Centre, Krakow, Poland
  2. Department of Cardiac and Vascular Diseases, Jagiellonian University Medical College, Krakow, Poland
  3. Department of Interventional Cardiology, Jagiellonian University Medical College, Krakow, Poland
  4. Department of Interventional Radiology, Republican Vilnius University Hospital, Vilnius, Lithuania
  5. Department of Diagnostic and Interventional Radiology, Stephan Cardinal Wyszynski Regional Hospital, Lublin, Poland
  6. Department of Interventional Radiology, Share Zedek Medical Center and Faculty of Medicine, The Hebrew University of Jerusalem, Jerusalem, Israel
  7. CardioVascular Center Frankfurt (CVC), Sankt Katharinen Hospital, Frankfurt, Germany
  8. Invasive Cardiology Division, University of Szeged, Szeged, Hungary
  9. Department of Radiology, Podhalanski Multispecialty Hospital, Nowy Targ, Poland
  10. St. John Paul II Hospital Krakow Cardiovascular Imaging Laboratory, Krakow, Poland
  11. Department of Neurology, Stephan Cardinal Wyszynski Regional Hospital, Lublin, Poland
  12. Santaros Klinikos, Vilnius University Hospital, Vilnius, Lithuania
  13. St. John Paul II Hospital in Krakow Department of Radiology, Krakow, Poland
  14. Department of Vascular Surgery and Endovascular Interventions, John Paul II Hospital, Krakow, Poland
  15. Department of Bioinformatics and Telemedicine, Jagiellonian University Medical College, Krakow, Poland
  16. Department of Neurology, Republican Vilnius University Hospital, Vilnius, Lithuania
  17. Department of Vascular Surgery, Republican Vilnius University Hospital, Vilnius, Lithuania
  18. Department of Neurology, Share Zedek Medical Center and Faculty of Medicine, The Hebrew University of Jerusalem, Jerusalem, Israel
  19. Division of Imaging Science and Technology, School of Medicine, University of Dundee, Dundee, Scotland, United Kingdom
  20. 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: 2024/06/30
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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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