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

M H F Poorthuis; R Bulbulia; D R Morris; H Pan; P M Rothwell; A Algra; J-P Becquemin; L H Bonati; T G Brott; M M Brown; D Calvet; H-H Eckstein; G Fraedrich; J Gregson; J P Greving; J Hendrikse; G Howard; O Jansen; J-L Mas; S C Lewis; G J de Borst; A Halliday; Carotid Stenosis Trialists' Collaboration

doi:10.1002/bjs.11441

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

Br J Surg. 2020 May;107(6):662-668. doi: 10.1002/bjs.11441. Epub 2020 Mar 12.

Authors

M H F Poorthuis^{1

2

3}, R Bulbulia^{1

2}, D R Morris^{1

2}, H Pan^{1

2}, P M Rothwell⁴, A Algra^{5

6}, J-P Becquemin⁷, L H Bonati^{8

9}, T G Brott¹⁰, M M Brown⁸, D Calvet¹¹, H-H Eckstein¹², G Fraedrich¹³, J Gregson¹⁴, J P Greving⁶, J Hendrikse¹⁵, G Howard¹⁶, O Jansen¹⁷, J-L Mas¹¹, S C Lewis¹⁸, G J de Borst³, A Halliday¹⁹; Carotid Stenosis Trialists' Collaboration

Affiliations

¹ Clinical Trial Service Unit and Epidemiological Studies Unit, University of Oxford, Oxford, UK.
² Medical Research Council Population Health Research Unit, Nuffield Department of Population Health, University of Oxford, Oxford, UK.
³ Department of Vascular Surgery, University Medical Centre, Utrecht, the Netherlands.
⁴ Centre for Prevention of Stroke and Dementia, Nuffield Department of Clinical Neurosciences, University of Oxford, Oxford, UK.
⁵ Department of Neurology and Neurosurgery, UMC Utrecht Brain Centre, Utrecht, the Netherlands.
⁶ Julius Centre for Health Sciences and Primary Care, Utrecht University, Utrecht, the Netherlands.
⁷ Vascular Institute of Paris East, Hôpital Paul D Egine, Champigny-sur-Marne, France.
⁸ Stroke Research Centre, Department of Brain Repair and Rehabilitation, Institute of Neurology, University College London, London, UK.
⁹ Department of Neurology and Stroke Centre, Department of Clinical Research, University Hospital, University of Basle, Basle, Switzerland.
¹⁰ Department of Neurology, Mayo Clinic, Jacksonville, Florida, USA.
¹¹ 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.
¹² Department for Vascular and Endovascular Surgery - Vascular Centre, Klinikum rechts der Isar, Technical University Munich, Munich, Germany.
¹³ Department of Vascular Surgery, Medical University of Innsbruck, Innsbruck, Austria.
¹⁴ Department of Medical Statistics, London School of Hygiene and Tropical Medicine, London, UK.
¹⁵ Department of Radiology, University Medical Centre Utrecht, Utrecht University, Utrecht, the Netherlands.
¹⁶ Department of Biostatistics, UAB School of Public Health, University of Alabama at Birmingham, Birmingham, Alabama, USA.
¹⁷ Clinic for Radiology and Neuroradiology, University Hospital Schleswig-Holstein, Campus Kiel, Kiel, Germany.
¹⁸ Edinburgh Clinical Trials Unit, Usher Institute of Population Health Sciences and Informatics, University of Edinburgh, Edinburgh, UK.
¹⁹ Nuffield Department of Surgical Sciences, John Radcliffe Hospital, University of Oxford, Oxford, UK.

PMID: 32162310
DOI: 10.1002/bjs.11441

Abstract
in English, Spanish

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.

Publication types

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

MeSH terms

Adult
Aged
Aged, 80 and over
Asymptomatic Diseases
Carotid Stenosis / complications
Carotid Stenosis / surgery*
Endarterectomy, Carotid / adverse effects*
Endarterectomy, Carotid / mortality*
Female
Humans
Male
Middle Aged
Postoperative Complications* / diagnosis
Postoperative Complications* / epidemiology
Randomized Controlled Trials as Topic
Stroke / epidemiology
Stroke / etiology*
Stroke / prevention & control
Time Factors
Treatment Outcome

Abstract in English, Spanish

Publication types

MeSH terms

Abstract
in English, Spanish