Timing of procedural stroke and death in asymptomatic patients undergoing carotid endarterectomy: individual patient analysis from four RCTs.


Journal

The British journal of surgery
ISSN: 1365-2168
Titre abrégé: Br J Surg
Pays: England
ID NLM: 0372553

Informations de publication

Date de publication:
05 2020
Historique:
received: 26 07 2019
revised: 11 09 2019
accepted: 31 10 2019
pubmed: 13 3 2020
medline: 29 12 2020
entrez: 13 3 2020
Statut: ppublish

Résumé

The effectiveness of carotid endarterectomy (CEA) for stroke prevention depends on low procedural risks. The aim of this study was to assess the frequency and timing of procedural complications after CEA, which may clarify underlying mechanisms and help inform safe discharge policies. Individual-patient data were obtained from four large carotid intervention trials (VACS, ACAS, ACST-1 and GALA; 1983-2007). Patients undergoing CEA for asymptomatic carotid artery stenosis directly after randomization were used for the present analysis. Timing of procedural death and stroke was divided into intraoperative day 0, postoperative day 0, days 1-3 and days 4-30. Some 3694 patients were included in the analysis. A total of 103 patients (2·8 per cent) had serious procedural complications (18 fatal strokes, 68 non-fatal strokes, 11 fatal myocardial infarctions and 6 deaths from other causes) [Correction added on 20 April, after first online publication: the percentage value has been corrected to 2·8]. Of the 86 strokes, 67 (78 per cent) were ipsilateral, 17 (20 per cent) were contralateral and two (2 per cent) were vertebrobasilar. Forty-five strokes (52 per cent) were ischaemic, nine (10 per cent) haemorrhagic, and stroke subtype was not determined in 32 patients (37 per cent). Half of the strokes happened on the day of CEA. Of all serious complications recorded, 44 (42·7 per cent) occurred on day 0 (20 intraoperative, 17 postoperative, 7 with unclear timing), 23 (22·3 per cent) on days 1-3 and 36 (35·0 per cent) on days 4-30. At least half of the procedural strokes in this study were ischaemic and ipsilateral to the treated artery. Half of all procedural complications occurred on the day of surgery, but one-third after day 3 when many patients had been discharged. La efectividad de la endarterectomía carotídea (carotid endarterectomy, CEA) en la prevención de un accidente cerebrovascular depende de que este procedimiento tenga pocos riesgos. El objetivo de este estudio fue evaluar la frecuencia y el momento de aparición de las complicaciones tras una CEA, lo que podría clarificar los mecanismos subyacentes y ayudar a establecer una política de altas hospitalarias segura. MÉTODOS: Se utilizaron los datos de los pacientes incluidos en cuatro grandes ensayos de intervención carotídea (VACS, ACAS, ACST-1 y GALA; 1983-2007). Para el presente análisis se utilizaron los datos de pacientes sometidos a CEA por estenosis de la arteria carótida asintomática recogidos inmediatamente tras la aleatorización. Se consideraron diferentes intervalos entre el procedimiento, la muerte o el accidente cerebrovascular: intraoperatorio día 0, postoperatorio día 0, postoperatorio días 1-3 y postoperatorio días 4-30. En el análisis se incluyeron 3.694 pacientes. Se detectaron complicaciones graves relacionadas con el procedimiento en 103 (2,8%) pacientes (18 accidentes cerebrovasculares fatales, 68 accidentes cerebrovasculares no fatales, 11 infartos de miocardio fatales y 6 muertes por otras causas). De los 86 accidentes cerebrovasculares, 67 (78%) fueron ipsilaterales, 17 (20%) contralaterales y dos (2%) vertebrobasilares. Los accidentes cerebrovasculares fueron isquémicos en 45 (52%) casos, hemorrágicos en 9 (10%) y no se pudo determinar el subtipo de ictus en 32 (37%). La mitad de los accidentes cerebrovasculares ocurrieron el día de la CEA. De todas las complicaciones graves registradas, 44 (43%) ocurrieron en el día 0 (20 intraoperatorias, 17 postoperatorias y 7 en períodos poco definidos), 23 (22%) entre los días 1-3 y 36 (35%) entre los días 4-30. CONCLUSIÓN: En este estudio, al menos la mitad de los accidentes cerebrovasculares relacionados con la CEA fueron isquémicos e ipsilaterales respecto a la arteria tratada. La mitad de todas las complicaciones de la CEA ocurrieron el día de la cirugía, pero un tercio de los casos se presentaron después del día 3, cuando muchos pacientes ya habían sido dados de alta.

Sections du résumé

BACKGROUND
The effectiveness of carotid endarterectomy (CEA) for stroke prevention depends on low procedural risks. The aim of this study was to assess the frequency and timing of procedural complications after CEA, which may clarify underlying mechanisms and help inform safe discharge policies.
METHODS
Individual-patient data were obtained from four large carotid intervention trials (VACS, ACAS, ACST-1 and GALA; 1983-2007). Patients undergoing CEA for asymptomatic carotid artery stenosis directly after randomization were used for the present analysis. Timing of procedural death and stroke was divided into intraoperative day 0, postoperative day 0, days 1-3 and days 4-30.
RESULTS
Some 3694 patients were included in the analysis. A total of 103 patients (2·8 per cent) had serious procedural complications (18 fatal strokes, 68 non-fatal strokes, 11 fatal myocardial infarctions and 6 deaths from other causes) [Correction added on 20 April, after first online publication: the percentage value has been corrected to 2·8]. Of the 86 strokes, 67 (78 per cent) were ipsilateral, 17 (20 per cent) were contralateral and two (2 per cent) were vertebrobasilar. Forty-five strokes (52 per cent) were ischaemic, nine (10 per cent) haemorrhagic, and stroke subtype was not determined in 32 patients (37 per cent). Half of the strokes happened on the day of CEA. Of all serious complications recorded, 44 (42·7 per cent) occurred on day 0 (20 intraoperative, 17 postoperative, 7 with unclear timing), 23 (22·3 per cent) on days 1-3 and 36 (35·0 per cent) on days 4-30.
CONCLUSION
At least half of the procedural strokes in this study were ischaemic and ipsilateral to the treated artery. Half of all procedural complications occurred on the day of surgery, but one-third after day 3 when many patients had been discharged.
ANTECEDENTES
La efectividad de la endarterectomía carotídea (carotid endarterectomy, CEA) en la prevención de un accidente cerebrovascular depende de que este procedimiento tenga pocos riesgos. El objetivo de este estudio fue evaluar la frecuencia y el momento de aparición de las complicaciones tras una CEA, lo que podría clarificar los mecanismos subyacentes y ayudar a establecer una política de altas hospitalarias segura. MÉTODOS: Se utilizaron los datos de los pacientes incluidos en cuatro grandes ensayos de intervención carotídea (VACS, ACAS, ACST-1 y GALA; 1983-2007). Para el presente análisis se utilizaron los datos de pacientes sometidos a CEA por estenosis de la arteria carótida asintomática recogidos inmediatamente tras la aleatorización. Se consideraron diferentes intervalos entre el procedimiento, la muerte o el accidente cerebrovascular: intraoperatorio día 0, postoperatorio día 0, postoperatorio días 1-3 y postoperatorio días 4-30.
RESULTADOS
En el análisis se incluyeron 3.694 pacientes. Se detectaron complicaciones graves relacionadas con el procedimiento en 103 (2,8%) pacientes (18 accidentes cerebrovasculares fatales, 68 accidentes cerebrovasculares no fatales, 11 infartos de miocardio fatales y 6 muertes por otras causas). De los 86 accidentes cerebrovasculares, 67 (78%) fueron ipsilaterales, 17 (20%) contralaterales y dos (2%) vertebrobasilares. Los accidentes cerebrovasculares fueron isquémicos en 45 (52%) casos, hemorrágicos en 9 (10%) y no se pudo determinar el subtipo de ictus en 32 (37%). La mitad de los accidentes cerebrovasculares ocurrieron el día de la CEA. De todas las complicaciones graves registradas, 44 (43%) ocurrieron en el día 0 (20 intraoperatorias, 17 postoperatorias y 7 en períodos poco definidos), 23 (22%) entre los días 1-3 y 36 (35%) entre los días 4-30. CONCLUSIÓN: En este estudio, al menos la mitad de los accidentes cerebrovasculares relacionados con la CEA fueron isquémicos e ipsilaterales respecto a la arteria tratada. La mitad de todas las complicaciones de la CEA ocurrieron el día de la cirugía, pero un tercio de los casos se presentaron después del día 3, cuando muchos pacientes ya habían sido dados de alta.

Autres résumés

Type: Publisher (spa)
La efectividad de la endarterectomía carotídea (carotid endarterectomy, CEA) en la prevención de un accidente cerebrovascular depende de que este procedimiento tenga pocos riesgos. El objetivo de este estudio fue evaluar la frecuencia y el momento de aparición de las complicaciones tras una CEA, lo que podría clarificar los mecanismos subyacentes y ayudar a establecer una política de altas hospitalarias segura. MÉTODOS: Se utilizaron los datos de los pacientes incluidos en cuatro grandes ensayos de intervención carotídea (VACS, ACAS, ACST-1 y GALA; 1983-2007). Para el presente análisis se utilizaron los datos de pacientes sometidos a CEA por estenosis de la arteria carótida asintomática recogidos inmediatamente tras la aleatorización. Se consideraron diferentes intervalos entre el procedimiento, la muerte o el accidente cerebrovascular: intraoperatorio día 0, postoperatorio día 0, postoperatorio días 1-3 y postoperatorio días 4-30.

Identifiants

pubmed: 32162310
doi: 10.1002/bjs.11441
doi:

Types de publication

Journal Article Meta-Analysis Research Support, Non-U.S. Gov't

Langues

eng

Sous-ensembles de citation

IM

Pagination

662-668

Informations de copyright

© 2020 BJS Society Ltd Published by John Wiley & Sons Ltd.

Références

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Executive Committee for the Asymptomatic Carotid Atherosclerosis Study. Endarterectomy for asymptomatic carotid artery stenosis. JAMA 1995; 273: 1421-1428.
Halliday A, Harrison M, Hayter E, Kong X, Mansfield A, Marro J et al.; Asymptomatic Carotid Surgery Trial (ACST) Collaborative Group. 10-year stroke prevention after successful carotid endarterectomy for asymptomatic stenosis (ACST-1): a multicentre randomised trial. Lancet 2010; 376: 1074-1084.
Halliday A, Mansfield A, Marro J, Peto C, Peto R, Potter J et al.; MRC Asymptomatic Carotid Surgery Trial (ACST) Collaborative Group. Prevention of disabling and fatal strokes by successful carotid endarterectomy in patients without recent neurological symptoms: randomised controlled trial. Lancet 2004; 363: 1491-1502.
Volkers EJ, Algra A, Kappelle LJ, Jansen O, Howard G, Hendrikse J et al.; Carotid Stenosis Trialists' Collaboration. Prediction models for clinical outcome after a carotid revascularization procedure. Stroke 2018; 49: 1880-1885.
de Borst GJ, Moll FL, van de Pavoordt HD, Mauser HW, Kelder JC, Ackerstaf RG. Stroke from carotid endarterectomy: when and how to reduce perioperative stroke rate? Eur J Vasc Endovasc Surg 2001; 21: 484-489.
Gala Trial Collaborative Group, Lewis SC, Warlow CP, Bodenham AR, Colam B, Rothwell PM, Torgerson D et al. General anaesthesia versus local anaesthesia for carotid surgery (GALA): a multicentre, randomised controlled trial. Lancet 2008; 372: 2132-2142.
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Gough MJ, Bodenham A, Horrocks M, Colam B, Lewis SC, Rothwell PM et al. GALA: an international multicentre randomised trial comparing general anaesthesia versus local anaesthesia for carotid surgery. Trials 2008; 9: 28.
Huibers A, de Borst GJ, Thomas DJ, Moll FL, Bulbulia R, Halliday A; ACST-1 Collaborative Group. The mechanism of procedural stroke following carotid endarterectomy within the asymptomatic carotid surgery trial 1. Cerebrovasc Dis 2016; 42: 178-185.
Müller MD, von Felten S, Algra A, Becquemin JP, Brown M, Bulbulia R et al.; Carotid Stenosis Trialists' Collaboration. Immediate and delayed procedural stroke or death in stenting versus endarterectomy for symptomatic carotid stenosis. Stroke 2018; 49: 2715-2722.
Huibers A, Calvet D, Kennedy F, Czuriga-Kovács KR, Featherstone RL, Moll FL et al. Mechanism of procedural stroke following carotid endarterectomy or carotid artery stenting within the International Carotid Stenting Study (ICSS) randomised trial. Eur J Vasc Endovasc Surg 2015; 50: 281-288.
Riles TS, Imparato AM, Jacobowitz GR, Lamparello PJ, Giangola G, Adelman MA et al. The cause of perioperative stroke after carotid endarterectomy. J Vasc Surg 1994; 19: 206-14.
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Auteurs

M H F Poorthuis (MHF)

Clinical Trial Service Unit and Epidemiological Studies Unit, University of Oxford, Oxford, UK.
Medical Research Council Population Health Research Unit, Nuffield Department of Population Health, University of Oxford, Oxford, UK.
Department of Vascular Surgery, University Medical Centre, Utrecht, the Netherlands.

R Bulbulia (R)

Clinical Trial Service Unit and Epidemiological Studies Unit, University of Oxford, Oxford, UK.
Medical Research Council Population Health Research Unit, Nuffield Department of Population Health, University of Oxford, Oxford, UK.

D R Morris (DR)

Clinical Trial Service Unit and Epidemiological Studies Unit, University of Oxford, Oxford, UK.
Medical Research Council Population Health Research Unit, Nuffield Department of Population Health, University of Oxford, Oxford, UK.

H Pan (H)

Clinical Trial Service Unit and Epidemiological Studies Unit, University of Oxford, Oxford, UK.
Medical Research Council Population Health Research Unit, Nuffield Department of Population Health, University of Oxford, Oxford, UK.

P M Rothwell (PM)

Centre for Prevention of Stroke and Dementia, Nuffield Department of Clinical Neurosciences, University of Oxford, Oxford, UK.

A Algra (A)

Department of Neurology and Neurosurgery, UMC Utrecht Brain Centre, Utrecht, the Netherlands.
Julius Centre for Health Sciences and Primary Care, Utrecht University, Utrecht, the Netherlands.

J-P Becquemin (JP)

Vascular Institute of Paris East, Hôpital Paul D Egine, Champigny-sur-Marne, France.

L H Bonati (LH)

Stroke Research Centre, Department of Brain Repair and Rehabilitation, Institute of Neurology, University College London, London, UK.
Department of Neurology and Stroke Centre, Department of Clinical Research, University Hospital, University of Basle, Basle, Switzerland.

T G Brott (TG)

Department of Neurology, Mayo Clinic, Jacksonville, Florida, USA.

M M Brown (MM)

Stroke Research Centre, Department of Brain Repair and Rehabilitation, Institute of Neurology, University College London, London, UK.

D Calvet (D)

Department of Neurology, Hôpital Sainte-Anne, Université Paris-Descartes, Département Hospitalo-Universitaire Neurovasc Sorbonne Paris Cité, Institut National de la Santé et de la Recherche Médicale U894, Paris, France.

H-H Eckstein (HH)

Department for Vascular and Endovascular Surgery - Vascular Centre, Klinikum rechts der Isar, Technical University Munich, Munich, Germany.

G Fraedrich (G)

Department of Vascular Surgery, Medical University of Innsbruck, Innsbruck, Austria.

J Gregson (J)

Department of Medical Statistics, London School of Hygiene and Tropical Medicine, London, UK.

J P Greving (JP)

Julius Centre for Health Sciences and Primary Care, Utrecht University, Utrecht, the Netherlands.

J Hendrikse (J)

Department of Radiology, University Medical Centre Utrecht, Utrecht University, Utrecht, the Netherlands.

G Howard (G)

Department of Biostatistics, UAB School of Public Health, University of Alabama at Birmingham, Birmingham, Alabama, USA.

O Jansen (O)

Clinic for Radiology and Neuroradiology, University Hospital Schleswig-Holstein, Campus Kiel, Kiel, Germany.

J-L Mas (JL)

Department of Neurology, Hôpital Sainte-Anne, Université Paris-Descartes, Département Hospitalo-Universitaire Neurovasc Sorbonne Paris Cité, Institut National de la Santé et de la Recherche Médicale U894, Paris, France.

S C Lewis (SC)

Edinburgh Clinical Trials Unit, Usher Institute of Population Health Sciences and Informatics, University of Edinburgh, Edinburgh, UK.

G J de Borst (GJ)

Department of Vascular Surgery, University Medical Centre, Utrecht, the Netherlands.

A Halliday (A)

Nuffield Department of Surgical Sciences, John Radcliffe Hospital, University of Oxford, Oxford, UK.

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