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

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.).

PMID: 30355202
PMCID: PMC6209445
DOI: 10.1161/STROKEAHA.118.020684

Comparative Study

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

Mandy D Müller et al. Stroke. 2018 Nov.

. 2018 Nov;49(11):2715-2722.

doi: 10.1161/STROKEAHA.118.020684.

Authors

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.).

PMID: 30355202
PMCID: PMC6209445
DOI: 10.1161/STROKEAHA.118.020684

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.

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Conflict of interest statement

Disclosures

LHB has received an unrestricted research grant from AstraZeneca, as well as consultancy and advisory board fees from Amgen, Bayer, Bristol-Myers Squibb, and Claret Medical. PR has received lecture fees and advisory board fees from Bayer, Boehringer Ingelheim, Bristol-Myers Squibb, Covidien, and Pfizer. OJ received speaker fees from Medtronic, Stryker and Philips. All other authors declare no competing interests.

Figures

**Figure 1 –. flow chart.**
Study flow chart depicting all patients in the source trials included in this meta-analysis as well as events that precluded them from analysis.

**Figure 2 –. Kaplan-Meier curve.**
Kaplan-Meier curve of the cumulative incidence of periprocedural stroke or death within 30 days after treatment in the stenting and endarterectomy group seperately. Number of events: 169 events in the CAS group, 88 events in the CEA group. The cumulative incidence of stroke or death was 7.3% in the CAS group and 3.9% in the CEA group.

**Figure 3 –. Effects of baseline variables on the risk of stroke or death in patients treated with carotid artery stenting.**
Forest plot showing the odds ratios for the effects of the three baseline variables “patient age”, any “history of smoking”, and “qualifying event severity” on the incidence of stroke or death on the day of treatment (day 0), between day 1 and 30, or within 30 days in patients treated with stenting. ORs were estimated by three separate GLMMs (one for the day of treatment, one for day 1–30, and one for the full procedural period), each containing age, any history of smoking, and QE severity (stroke > TIA > ocular ischemia). CI=Confidence Interval; OR=Odds Ratio; QE=Qualifying event; GLMM=general linear mixed model.

**Figure 4 –. Effects of baseline variables on the risk of stroke or death in patients treated with carotid endarterectomy.**
Forest plot showing the odds ratios for the effects of the baseline variable “mRS at baseline”, and “history of hypertension” on the incidence of stroke or death on the day of treatment (day 0), between day 1 and 30, or within 30 days in patients treated with endarterectomy. ORs were estimated by three separate GLMMs (one for the day of treatment, one for day 1–30, and one for the full procedural period). OR=Odds ratio; CI=confidence interval; GLMM=general linear mixed model; mRS=modified Rankin Scale

See this image and copyright information in PMC

References

1. Carotid Stenting Trialists Collaboration, Bonati LH, Dobson J, Algra A, Branchereau A, Chatellier G, et al. Short-term outcome after stenting versus endarterectomy for symptomatic carotid stenosis: A preplanned meta-analysis of individual patient data. Lancet. 2010;376:1062–1073 - PubMed
1. Howard G, Roubin GS, Jansen O, Hendrikse J, Halliday A, Fraedrich G, et al. Association between age and risk of stroke or death from carotid endarterectomy and carotid stenting: A meta-analysis of pooled patient data from four randomised trials. Lancet. 2016;387:1305–1311 - PubMed
1. Bonati LH, Dobson J, Featherstone RL, Ederle J, Van Der Worp HB, De Borst GJ, et al. Long-term outcomes after stenting versus endarterectomy for treatment of symptomatic carotid stenosis: The international carotid stenting study (icss) randomised trial. Lancet. 2015;385:529–538 - PMC - PubMed
1. Mas JL, Arquizan C, Calvet D, Viguier A, Albucher JF, Piquet P, et al. Long-term follow-up study of endarterectomy versus angioplasty in patients with symptomatic severe carotid stenosis trial. Stroke. 2014;45:2750–2756 - PubMed
1. Brott TG, Howard G, Roubin GS, Meschia JF, Mackey A, Brooks W, et al. Long-term results of stenting versus endarterectomy for carotid-artery stenosis. The New England journal of medicine. 2016;374:1021–1031 - PMC - PubMed

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

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

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Conflict of interest statement

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