International Carotid Stenting Study: Protocol for a Randomised Clinical Trial Comparing Carotid Stenting with Endarterectomy in Symptomatic Carotid Artery Stenosis

2004 ◽  
Vol 18 (1) ◽  
pp. 69-74 ◽  
Author(s):  
Roland L. Featherstone ◽  
Martin M. Brown ◽  
Lucy J. Coward
2011 ◽  
Vol 258 (7) ◽  
pp. 1228-1233 ◽  
Author(s):  
Klaus Gröschel ◽  
Sonja Schnaudigel ◽  
Katrin Wasser ◽  
Sara M. Pilgram-Pastor ◽  
Ulrike Ernemann ◽  
...  

TH Open ◽  
2020 ◽  
Vol 04 (04) ◽  
pp. e393-e399
Author(s):  
Klaus Gröschel ◽  
Timo Uphaus ◽  
Ian Loftus ◽  
Holger Poppert ◽  
Hans Christoph Diener ◽  
...  

AbstractPatients with stroke or transient ischemic attacks (TIAs) and internal carotid artery stenosis harbor an increased risk of recurrent stroke especially within 2 weeks after the first event. In addition, the revascularization procedure itself (carotid endarterectomy [CEA] or carotid artery stenting [CAS]) is associated with both clinically apparent and silent brain infarctions, mainly caused by the embolic nature of the ruptured carotid plaque. The glycoprotein VI (GPVI) fusion protein Revacept is a highly specific antithrombotic drug without direct inhibition of systemic platelet function that might reduce periprocedural distal embolization from the vulnerable ruptured plaque located at the internal carotid artery. By shielding collagen at the site of vascular injury, Revacept inhibits plaque-mediated platelet adhesion and aggregation, while not directly affecting systemic hemostasis. In this phase II study, 158 patients with symptomatic carotid artery stenosis with recent TIA or stroke were randomized to receive a single dose of either Revacept (40 or 120 mg) or placebo. All patients were on standard secondary preventive therapy (statins and platelet inhibition) and underwent CEA, CAS, or best medical therapy according to current guidelines. The efficacy of Revacept was evaluated by exploratory assessment of new diffusion-weighted imaging lesions on magnetic resonance imaging after the revascularization procedure; a combination of cardiovascular events (ischemic and hemorrhagic stroke, TIA, myocardial infarction, or coronary intervention) and bleeding complications served to assess clinically critical patients' outcome and safety. This exploratory phase II randomized, double-blind clinical trial provides valuable insights on the safety, tolerability, and efficacy of Revacept in patients with symptomatic carotid artery stenosis.


Stroke ◽  
2021 ◽  
Author(s):  
Christina L. Cui ◽  
Hanaa Dakour-Aridi ◽  
Jinny J. Lu ◽  
Kevin S. Yei ◽  
Marc L. Schermerhorn ◽  
...  

Background and Purpose: Advancements in carotid revascularization have produced promising outcomes in patients with symptomatic carotid artery stenosis. However, the optimal timing of revascularization procedures after symptomatic presentation remains unclear. The purpose of this study is to compare in-hospital outcomes of transcarotid artery revascularization (TCAR), transfemoral carotid stenting (TFCAS), or carotid endarterectomy (CEA) performed within different time intervals after most recent symptoms. Methods: This is a retrospective cohort study of United States patients in the vascular quality initiative. All carotid revascularizations performed for symptomatic carotid artery stenosis between September 2016 and November 2019 were included. Procedures were categorized as urgent (0–2 days after most recent symptom), early (3–14 days), or late (15–180 days). The primary outcome of interest was in-hospital stroke and death. Secondary outcomes include in-hospital stroke, death, and transient ischemic attacks. Multivariable logistic regression was used to compare outcomes. Results: A total of 18 643 revascularizations were included: 2006 (10.8%) urgent, 7423 (39.8%) early, and 9214 (49.42%) late. Patients with TFCAS had the highest rates of stroke/death at all timing cohorts (urgent: 4.0% CEA, 6.9% TFCAS, 6.5% TCAR, P =0.018; early: 2.5% CEA, 3.8% TFCAS, 2.9% TCAR, P =0.054; late: 1.6% CEA, 2.8% TFCAS, 2.3% TCAR, P =0.003). TFCAS also had increased odds of in-hospital stroke/death compared with CEA in all 3 groups (urgent adjusted odds ratio [aOR], 1.7 [95% CI, 1.0–2.9] P =0.03; early aOR, 1.6 [95% CI, 1.1–2.4] P =0.01; and late aOR, 1.9 [95% CI, 1.2–3.0] P =0.01). TCAR and CEA had comparable odds of in-hospital stroke/death in all 3 groups (urgent aOR, 1.9 [95% CI, 0.9–4], P =0.10), (early aOR, 1.1 [95% CI, 0.7–1.7], P =0.66), (late aOR, 1.5 [95% CI, 0.9–2.3], P =0.08). Conclusions: CEA remains the safest method of revascularization within the urgent period. Among revascularization performed outside of the 48 hours, TCAR and CEA have comparable outcomes.


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