Immediate and Delayed Procedural Stroke or Death in Stenting Versus Endarterectomy for Symptomatic Carotid Stenosis

Mandy D Müller; Stefanie von Felten; Ale Algra; Jean-Pierre Becquemin; Martin Brown; Richard Bulbulia; David Calvet; Hans-Henning Eckstein; Gustav Fraedrich; Alison Halliday; Jeroen Hendrikse; John Gregson; George Howard; Olav Jansen; Jean-Louis Mas; Thomas G Brott; Peter A Ringleb; Leo H Bonati; Carotid Stenosis Trialists’ Collaboration

doi:10.1161/STROKEAHA.118.020684

Immediate and Delayed Procedural Stroke or Death in Stenting Versus Endarterectomy for Symptomatic Carotid Stenosis

Stroke. 2018 Nov;49(11):2715-2722. doi: 10.1161/STROKEAHA.118.020684.

Authors

Mandy D Müller¹, Stefanie von Felten², Ale Algra³, Jean-Pierre Becquemin⁴, Martin Brown⁵, Richard Bulbulia⁶, David Calvet⁷, Hans-Henning Eckstein⁸, Gustav Fraedrich⁹, Alison Halliday¹⁰, Jeroen Hendrikse¹¹, John Gregson¹², George Howard¹³, Olav Jansen¹⁴, Jean-Louis Mas⁷, Thomas G Brott¹⁵, Peter A Ringleb¹⁶, Leo H Bonati^{1

5}; Carotid Stenosis Trialists’ Collaboration

Affiliations

¹ From the Department of Neurology and Stroke Center (M.D.M., L.H.B.), University Hospital Basel, University of Basel, Switzerland.
² Department of Clinical Research, Clinical Trial Unit (S.v.F.), University Hospital Basel, University of Basel, Switzerland.
³ Department of Neurology and Neurosurgery, Brain Center Rudolf Magnus and Julius Center for Health Sciences and Primary Care (A.A.), University Medical Center Utrecht, the Netherlands.
⁴ Vascular Institute Paris East, Hôpital privé Paul D'Egine, Ramsay Group, France (J.-P.B.).
⁵ Department of Brain Repair and Rehabilitation, UCL Institute of Neurology, University College London, United Kingdom (M.B., L.H.B.).
⁶ MRC Population Health Research Unit, Clinical Trial Service Unit and Epidemiological Studies Unit, Nuffield Department of Population Health, Oxford University, United Kingdom (R.B.).
⁷ Department of Neurology, Hôpital Sainte-Anne, Université Paris-Descartes, DHU Neurovasc Sorbonne Paris Cité, INSERM U894, France (D.C., J.-L.M.).
⁸ Department of Vascular and Endovascular Surgery, Klinikum rechts der Isar, Technical University of Munich, Germany (H.-H.E.).
⁹ Department of Vascular Surgery, Medical University of Innsbruck, Austria (G.F.).
¹⁰ Nuffield Department of Surgical Sciences, John Radcliffe Hospital, Oxford, United Kingdom (A.H.).
¹¹ Department of Radiology (J.H.), University Medical Center Utrecht, the Netherlands.
¹² Department of Medical Statistics, London School of Hygiene and Tropical Medicine, United Kingdom (J.G.).
¹³ Department of Biostatistics, UAB School of Public Health, Birmingham, AL (G.H.).
¹⁴ Clinic for Radiology and Neuroradiology, UKSH Campus Kiel, Germany (O.J.).
¹⁵ Department of Neurology, Mayo Clinic, Jacksonville, FL (T.G.B.).
¹⁶ Department of Neurology, University of Heidelberg Medical School, Germany (P.A.R.).

Abstract

Background and Purpose- Stenting for symptomatic carotid stenosis (carotid artery stenting [CAS]) carries a higher risk of procedural stroke or death than carotid endarterectomy (CEA). It is unclear whether this extra risk is present both on the day of procedure and within 1 to 30 days thereafter and whether clinical risk factors differ between these periods. Methods- We analyzed the risk of stroke or death occurring on the day of procedure (immediate procedural events) and within 1 to 30 days thereafter (delayed procedural events) in 4597 individual patients with symptomatic carotid stenosis who underwent CAS (n=2326) or CEA (n=2271) in 4 randomized trials. Results- Compared with CEA, patients treated with CAS were at greater risk for immediate procedural events (110 versus 42; 4.7% versus 1.9%; odds ratio, 2.6; 95% CI, 1.9-3.8) but not for delayed procedural events (59 versus 46; 2.5% versus 2.0%; odds ratio, 1.3; 95% CI, 0.9-1.9; interaction P=0.006). In patients treated with CAS, age increased the risk for both immediate and delayed events while qualifying event severity only increased the risk of delayed events. In patients treated with CEA, we found no risk factors for immediate events while a higher level of disability at baseline and known history of hypertension were associated with delayed procedural events. Conclusions- The increased procedural stroke or death risk associated with CAS compared with CEA was caused by an excess of events occurring on the day of procedure. This finding demonstrates the need to enhance the procedural safety of CAS by technical improvements of the procedure and increased operator skill. Higher age increased the risk for both immediate and delayed procedural events in CAS, mechanisms of which remain to be elucidated. Clinical Trial Registration- URL: https://clinicaltrials.gov . Unique identifier: NCT00190398. URL: http://www.isrctn.com . Unique identifier: ISRCTN57874028. URL: http://www.isrctn.com . Unique identifier: ISRCTN25337470. URL: https://clinicaltrials.gov . Unique identifier: NCT00004732.

Keywords: carotid stenosis; endarterectomy; risk; stents; stroke.

Publication types

Comparative Study
Research Support, Non-U.S. Gov't

MeSH terms

Age Factors
Aged
Carotid Stenosis / therapy*
Endarterectomy, Carotid*
Female
Humans
Male
Middle Aged
Mortality
Odds Ratio
Postoperative Complications / epidemiology*
Risk Factors
Stents*
Stroke / epidemiology*
Time Factors
Treatment Outcome

Associated data

ClinicalTrials.gov/NCT00190398
ClinicalTrials.gov/NCT00004732
ISRCTN/ISRCTN57874028
ISRCTN/ISRCTN25337470

Abstract

Publication types

MeSH terms

Associated data

Grants and funding