Barbara Rantner1, Barbara Kollerits1, Gary S Roubin1, Peter A Ringleb1, Olaf Jansen1, George Howard1, Jeroen Hendrikse1, Alison Halliday1, John Gregson1, Hans-Henning Eckstein1, David Calvet1, Richard Bulbulia1, Leo H Bonati1, Jean-Pierre Becquemin1, Ale Algra1, Martin M Brown1, Jean-Louis Mas1, Thomas G Brott1, Gustav Fraedrich2. 1. From the Department of Vascular Surgery (B.R., G.F.) and Division of Genetic Epidemiology, Department of Medical Genetics, Molecular and Clinical Pharmacology (B.K.), Medical University of Innsbruck, Austria; Cardiovascular Associates of the Southeast, Birmingham, AL (G.S.R.); Department of Neurology, University of Heidelberg Medical School, Germany (P.A.R.); Clinic for Radiology and Neuroradiology, UKSH Campus Kiel, Germany (O.J.); Department of Biostatistics, UAB School of Public Health, Birmingham, AL (G.H.); Department of Radiology (J.H.), Department of Neurology and Neurosurgery, Brain Centre Rudolf Magnus (A.A.), and Julius Centre for Health Sciences and Primary Care (A.A.), University Medical Centre Utrecht, the Netherlands; Nuffield Department of Surgical Sciences, John Radcliffe Hospital, Oxford, United Kingdom (A.H.); Department of Medical Statistics, London School of Hygiene and Tropical Medicine, United Kingdom (J.G.); Department of Vascular and Endovascular Surgery/Vascular Centre, Klinikum rechts der Isar der Technischen Universität München, Munich, Germany (H.-H.E.); Department of Neurology, Hôpital Sainte-Anne, Université Paris-Descartes, DHU Neurovasc Sorbonne Paris Cité, INSERM U894, France (D.C.); Clinical Trial Service Unit and Epidemiological Studies Unit, Nuffield Department of Population Health, Oxford University, United Kingdom (R.B.); Department of Neurology and Stroke Centre, University Hospital Basel, Switzerland (L.H.B.); Department of Brain Repair and Rehabilitation, UCL Institute of Neurology, University College London, United Kingdom (L.H.B., M.M.B.); University of Paris, XII, Vascular Surgery, Hôpital Henri Mondor, Créteil, France (J.-P.B.); Department of Neurology, Hôpital Sainte-Anne, Université Paris-Descartes, DHU Neurovasc Sorbonne Paris Cité, INSERM U894, France (J.-L.M.); and Department of Neurology, Mayo Clinic, Jacksonville, FL (T.G.B.). 2. From the Department of Vascular Surgery (B.R., G.F.) and Division of Genetic Epidemiology, Department of Medical Genetics, Molecular and Clinical Pharmacology (B.K.), Medical University of Innsbruck, Austria; Cardiovascular Associates of the Southeast, Birmingham, AL (G.S.R.); Department of Neurology, University of Heidelberg Medical School, Germany (P.A.R.); Clinic for Radiology and Neuroradiology, UKSH Campus Kiel, Germany (O.J.); Department of Biostatistics, UAB School of Public Health, Birmingham, AL (G.H.); Department of Radiology (J.H.), Department of Neurology and Neurosurgery, Brain Centre Rudolf Magnus (A.A.), and Julius Centre for Health Sciences and Primary Care (A.A.), University Medical Centre Utrecht, the Netherlands; Nuffield Department of Surgical Sciences, John Radcliffe Hospital, Oxford, United Kingdom (A.H.); Department of Medical Statistics, London School of Hygiene and Tropical Medicine, United Kingdom (J.G.); Department of Vascular and Endovascular Surgery/Vascular Centre, Klinikum rechts der Isar der Technischen Universität München, Munich, Germany (H.-H.E.); Department of Neurology, Hôpital Sainte-Anne, Université Paris-Descartes, DHU Neurovasc Sorbonne Paris Cité, INSERM U894, France (D.C.); Clinical Trial Service Unit and Epidemiological Studies Unit, Nuffield Department of Population Health, Oxford University, United Kingdom (R.B.); Department of Neurology and Stroke Centre, University Hospital Basel, Switzerland (L.H.B.); Department of Brain Repair and Rehabilitation, UCL Institute of Neurology, University College London, United Kingdom (L.H.B., M.M.B.); University of Paris, XII, Vascular Surgery, Hôpital Henri Mondor, Créteil, France (J.-P.B.); Department of Neurology, Hôpital Sainte-Anne, Université Paris-Descartes, DHU Neurovasc Sorbonne Paris Cité, INSERM U894, France (J.-L.M.); and Department of Neurology, Mayo Clinic, Jacksonville, FL (T.G.B.). gustav.fraedrich@i-med.ac.at.
Abstract
BACKGROUND AND PURPOSE: Patients undergoing carotid endarterectomy (CEA) for symptomatic stenosis of the internal carotid artery benefit from early intervention. Heterogeneous data are available on the influence of timing of carotid artery stenting (CAS) on procedural risk. METHODS: We investigated the association between timing of treatment (0-7 days and >7 days after the qualifying neurological event) and the 30-day risk of stroke or death after CAS or CEA in a pooled analysis of individual patient data from 4 randomized trials by the Carotid Stenosis Trialists' Collaboration. Analyses were done per protocol. To obtain combined estimates, logistic mixed models were applied. RESULTS: Among a total of 4138 patients, a minority received their allocated treatment within 7 days after symptom onset (14% CAS versus 11% CEA). Among patients treated within 1 week of symptoms, those treated by CAS had a higher risk of stroke or death compared with those treated with CEA: 8.3% versus 1.3%, risk ratio, 6.7; 95% confidence interval, 2.1 to 21.9 (adjusted for age at treatment, sex, and type of qualifying event). For interventions after 1 week, CAS was also more hazardous than CEA: 7.1% versus 3.6%, adjusted risk ratio, 2.0; 95% confidence interval, 1.5 to 2.7 (P value for interaction with time interval 0.06). CONCLUSIONS: In randomized trials comparing stenting with CEA for symptomatic carotid artery stenosis, CAS was associated with a substantially higher periprocedural risk during the first 7 days after the onset of symptoms. Early surgery is safer than stenting for preventing future stroke. CLINICAL TRIAL REGISTRATION: URL: http://www.clinicaltrials.gov. Unique identifier: NCT00190398; URL: http://www.controlled-trials.com. Unique identifier: ISRCTN57874028; Unique identifier: ISRCTN25337470; URL: http://www.clinicaltrials.gov. Unique identifier: NCT00004732.
BACKGROUND AND PURPOSE: Patients undergoing carotid endarterectomy (CEA) for symptomatic stenosis of the internal carotid artery benefit from early intervention. Heterogeneous data are available on the influence of timing of carotid artery stenting (CAS) on procedural risk. METHODS: We investigated the association between timing of treatment (0-7 days and >7 days after the qualifying neurological event) and the 30-day risk of stroke or death after CAS or CEA in a pooled analysis of individual patient data from 4 randomized trials by the Carotid Stenosis Trialists' Collaboration. Analyses were done per protocol. To obtain combined estimates, logistic mixed models were applied. RESULTS: Among a total of 4138 patients, a minority received their allocated treatment within 7 days after symptom onset (14% CAS versus 11% CEA). Among patients treated within 1 week of symptoms, those treated by CAS had a higher risk of stroke or death compared with those treated with CEA: 8.3% versus 1.3%, risk ratio, 6.7; 95% confidence interval, 2.1 to 21.9 (adjusted for age at treatment, sex, and type of qualifying event). For interventions after 1 week, CAS was also more hazardous than CEA: 7.1% versus 3.6%, adjusted risk ratio, 2.0; 95% confidence interval, 1.5 to 2.7 (P value for interaction with time interval 0.06). CONCLUSIONS: In randomized trials comparing stenting with CEA for symptomatic carotid artery stenosis, CAS was associated with a substantially higher periprocedural risk during the first 7 days after the onset of symptoms. Early surgery is safer than stenting for preventing future stroke. CLINICAL TRIAL REGISTRATION: URL: http://www.clinicaltrials.gov. Unique identifier: NCT00190398; URL: http://www.controlled-trials.com. Unique identifier: ISRCTN57874028; Unique identifier: ISRCTN25337470; URL: http://www.clinicaltrials.gov. Unique identifier: NCT00004732.
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