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Lancet Neurol. 2019 Apr;18(4):348-356. doi: 10.1016/S1474-4422(19)30028-6. Epub 2019 Feb 6.

Long-term outcomes of stenting and endarterectomy for symptomatic carotid stenosis: a preplanned pooled analysis of individual patient data.

Author information

1
Department of Neurology, Mayo Clinic, Jacksonville, FL, USA.
2
Department of Neurology, Hôpital Sainte-Anne, Université Paris-Descartes, DHU Neurovasc Sorbonne Paris Cité, INSERM U894, Paris, France.
3
Department of Biostatistics, UAB School of Public Health, University of Alabama at Birmingham, Birmingham, AL, USA.
4
Department of Medical Statistics, London School of Hygiene & Tropical Medicine, London, UK.
5
Department of Neurology and Neurosurgery, UMC Utrecht Brain Center, University Medical Center Utrecht, Utrecht University, Utrecht, Netherlands; Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht, Utrecht University, Utrecht, Netherlands.
6
Vascular Institute of Paris East, Hôspital Paul D Egine, Champigny-sur-Marne, France.
7
Department of Vascular Surgery, University Medical Center Utrecht, Utrecht University, Utrecht, Netherlands.
8
Medical Research Council Population Health Research Unit, Clinical Trial Service Unit and Epidemiological Studies Unit, Nuffield Department of Population Health, University of Oxford, Oxford, UK.
9
Department for Vascular and Endovascular Surgery-Vascular Center, Klinikum rechts der Isar, Technical University Munich, Munich, Germany.
10
Department of Vascular Surgery, Medical University of Innsbruck, Innsbruck, Austria.
11
Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht, Utrecht University, Utrecht, Netherlands.
12
Department of Radiology, University Medical Center Utrecht, Utrecht University, Utrecht, Netherlands.
13
Clinic for Radiology and Neuroradiology, University Hospital Schleswig-Holstein, Campus Kiel, Kiel, Germany.
14
Department of Neurology, Medical University of South Carolina, Charleston, SC, USA.
15
Department of Neurology, University of Heidelberg Medical School, Heidelberg, Germany.
16
Stroke Research Centre, Department of Brain Repair and Rehabilitation, UCL Queen Square Institute of Neurology, University College London, London, UK. Electronic address: martin.brown@ucl.ac.uk.
17
Stroke Research Centre, Department of Brain Repair and Rehabilitation, UCL Queen Square Institute of Neurology, University College London, London, UK; Department of Neurology and Stroke Center, Department of Clinical Research, University Hospital, University of Basel, Basel, Switzerland.

Abstract

BACKGROUND:

The risk of periprocedural stroke or death is higher after carotid artery stenting (CAS) than carotid endarterectomy (CEA) for the treatment of symptomatic carotid stenosis. However, long-term outcomes have not been sufficiently assessed. We sought to combine individual patient-level data from the four major randomised controlled trials of CAS versus CEA for the treatment of symptomatic carotid stenosis to assess long-term outcomes.

METHODS:

We did a pooled analysis of individual patient-level data, acquired from the four largest randomised controlled trials assessing the relative efficacy of CAS and CEA for treatment of symptomatic carotid stenosis (Endarterectomy versus Angioplasty in Patients with Symptomatic Severe Carotid Stenosis trial, Stent-Protected Percutaneous Angioplasty of the Carotid Artery versus Endarterectomy trial, International Carotid Stenting Study, and Carotid Revascularization Endarterectomy versus Stenting Trial). The risk of ipsilateral stroke was assessed between 121 days and 1, 3, 5, 7, 9, and 10 years after randomisation. The primary outcome was the composite risk of stroke or death within 120 days after randomisation (periprocedural risk) or subsequent ipsilateral stroke up to 10 years after randomisation (postprocedural risk). Analyses were intention-to-treat, with the risk of events calculated using Kaplan-Meier methods and Cox proportional hazards analysis with adjustment for trial.

FINDINGS:

In the four trials included, 4775 patients were randomly assigned, of whom a total of 4754 (99·6%) patients were followed up for a maximum of 12·4 years. 21 (0·4%) patients immediately withdrew consent after randomisation and were excluded. Median length of follow-up across the studies ranged from 2·0 to 6·9 years. 129 periprocedural and 55 postprocedural outcome events occurred in patients allocated CEA, and 206 and 57 for those allocated CAS. After the periprocedural period, the annual rates of ipsilateral stroke per person-year were similar for the two treatments: 0·60% (95% CI 0·46-0·79) for CEA and 0·64% (0·49-0·83) for CAS. Nonetheless, the periprocedural and postprocedural risks combined favoured CEA, with treatment differences at 1, 3, 5, 7, and 9 years all ranging between 2·8% (1·1-4·4) and 4·1% (2·0-6·3).

INTERPRETATION:

Outcomes in the postprocedural period after CAS and CEA were similar, suggesting robust clinical durability for both treatments. Although long-term outcomes (periprocedural and postprocedural risks combined) continue to favour CEA, the similarity of the postprocedural rates suggest that improvements in the periprocedural safety of CAS could provide similar outcomes of the two procedures in the future.

FUNDING:

None.

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