Protected carotid artery stenting (PCAS): a short medical technology assessment.
Author(s)
Bonneux, LucKeywords
WL 355 Cerebrovascular disordersWL 355 Cerebrovascular disorders
WL 355 Cerebrovascular disorders
Embolism
Embolism
Embolism
Stroke
Stroke
Stroke
Cardiovascular Surgical Procedures
Cardiovascular Surgical Procedures
Cardiovascular Surgical Procedures
Endarterectomy, Carotid
Endarterectomy, Carotid
Endarterectomy, Carotid
Carotid Stenosis
Carotid Stenosis
Carotid Stenosis
Humans
Humans
Humans
Stents
Stents
Stents
Randomized Controlled Trials
Randomized Controlled Trials
Randomized Controlled Trials
Cost-Benefit Analysis
Cost-Benefit Analysis
Cost-Benefit Analysis
Ethics, Medical
Ethics, Medical
Ethics, Medical
Medical Laboratory Science
Medical Laboratory Science
Medical Laboratory Science
Patient Selection
Patient Selection
Patient Selection
Journal Article
Journal Article
Journal Article
Belgium
Belgium
Belgium
Full record
Show full item recordAbstract
436-441After a period of experimenting with angioplasty and stenting, carotid artery stenting under embolic protection (PCAS) is becoming a viable alternative for carotid endarterectomy (CEA). A standard literature review showed that, at January 2005, there was no evidence that PCAS is more effective than CEA. The high costs of stent and protection device makes PCAS then inferior to CEA. PCAS may be the sole possible option in patients with symptomatic carotid artery stenosis unfit for surgery, where the high risk of stroke overrides uncertainty about health effects and overrides cost-effectiveness. These are a few patients per year in Belgium. Several randomised controlled trials comparing PCAS and CEA are now recruiting patients. To have answers on key questions of cost-effectiveness, it is of paramount importance that these trials recruit and publish rapidly. The KCE (Belgian HealthCare Knowledge Center/Centre Federal d'Expertise des Soins de Sante/Federaal Kenniscentrum voor de Gezondheidszorg) therefore advises cooperation with these trials. Outside these trials and compassionate use in the few symptomatic patients unfit for CEA, the use of PCAS raises serious ethical questions.
Date
2005-10-01Type
textIdentifier
oai:repository.kce.fgov.be:686http://kce.docressources.info/index.php?lvl=notice_display&id=686
686
Copyright/License
Aucun droit spécifiqueCollections
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Protected carotid artery stenting (PCAS): a short medical technology assessmentBonneux, L; ; ; JFA; CORA;; Cleemput, Irina; U0015520; ; ; ;; Ramaekers, Dirk; U0004297; ; ; ; JLA (2005)After a period of experimenting with angioplasty and stenting, carotid artery stenting under embolic protection (PCAS) is becoming a viable alternative for carotid endarterectomy (CEA). A standard literature review showed that, at January 2005, there was no evidence that PCAS is more effective than CEA. The high costs of stent and protection device makes PCAS then inferior to CEA. PCAS may be the sole possible option in patients with symptomatic carotid artery stenosis unfit for surgery, where the high risk of stroke overrides uncertainty about health effects and overrides cost-effectiveness. These are a few patients per year in Belgium. Several randomised controlled trials comparing PCAS and CEA are now recruiting patients. To have answers on key questions of cost-effectiveness, it is of paramount importance that these trials recruit and publish rapidly. The KCE (Belgian HealthCare Knowledge Center/Centre Fédéral d'Expertise des Soins de Santé/Federaal Kenniscentrum voor de Gezondheidszorg) therefore advises cooperation with these trials. Outside these trials and compassionate use in the few symptomatic patients unfit for CEA, the use of PCAS raises serious ethical questions.
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The appropriate use of carotid endarterectomyBarnett, Henry J.M. (Canadian Medical Association, 2002)"FOR THE FIRST 30 YEARS AFTER CAROTID ENDARTERECTOMY WAS FIRST DEVELOPED, anecdotal evidence was used to identify patients with internal carotid artery disease for whom this procedure would be appropriate. More recently, the appropriateness of carotid endarterectomy for symptomatic patients and asymptomatic subjects has emerged from 7 randomized trials. Risk of stroke and benefit from the procedure are greatest for symptomatic patients with at least 70% stenosis of the internal carotid artery. Within this group, carotid endarterectomy is most beneficial for the following patients: otherwise healthy elderly patients, those with hemispheric transient ischemic attack, those with tandem extracranial and intracranial lesions and those without evidence of collateral vessels. Risk of perioperative stroke and death is higher in the following groups, although they still benefit: patients with widespread leukoaraiosis, those with occlusion of the contralateral internal carotid artery and those with intraluminal thrombus. Patients with 50% to 69% stenosis experience lesser benefit, and some other groups may even be harmed by carotid endarterectomy, including women and patients with transient monocular blindness only. The procedure is indicated for patients presenting with lacunar stroke and for those with a nearly occluded internal carotid artery, but the benefit is muted. Patients with less than 50% stenosis do not benefit. In the largest randomized trial of asymptomatic subjects, the perioperative risk of stroke and death was very low (1.5%), but the results indicated that a prohibitively high number of subjects (83) must be treated to prevent one stroke in 2 years. The subsequent literature reported higher perioperative risks (2.8% to 5.6%). In asymptomatic individuals nearly half of the strokes that occur may be due to heart and small-vessel disease. These limitations counter any potential benefit. Another trial is in progress and may identify subgroups of asymptomatic subjects who would benefit. Meanwhile, most individuals without symptoms fare better with medical care."