Meta-Analysis

. 2019 Aug;12(8):e007870.

doi: 10.1161/CIRCINTERVENTIONS.119.007870. Epub 2019 Aug 5.

Secular Trends in Procedural Stroke or Death Risks of Stenting Versus Endarterectomy for Symptomatic Carotid Stenosis

Mandy D Müller¹, Stefanie von Felten², Ale Algra³, Jean-Pierre Becquemin⁴, Richard Bulbulia^{5

6}, David Calvet⁷, Hans-Henning Eckstein⁸, Gustav Fraedrich⁹, Alison Halliday¹⁰, Jeroen Hendrikse¹¹, George Howard¹², John Gregson¹³, Olav Jansen¹⁴, Martin M Brown¹⁵, Jean-Louis Mas⁷, Thomas G Brott¹⁶, Peter A Ringleb¹⁷, Leo H Bonati^{1

15}

Affiliations

¹ Department of Neurology and Stroke Center (M.D.M. and 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, Utrecht University, the Netherlands.
⁴ Vascular Institute Paris East, Hôpital privé Paul D'Egine, Ramsay Group, Champigny sur Marne, France (J.-P.B.).
⁵ Clinical Trial Service Unit and Epidemiological Studies Unit (R.B.), Nuffield Department of Population Health, University of Oxford, United Kingdom.
⁶ Medical Research Council Population Health Research Unit (R.B.), Nuffield Department of Population Health, University of Oxford, United Kingdom.
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, Utrecht University, the Netherlands.
¹² Department of Biostatistics, UAB School of Public Health, Birmingham, AL (G.H.).
¹³ Department of Medical Statistics, London School of Hygiene and Tropical Medicine, United Kingdom (J.G.).
¹⁴ Clinic for Radiology and Neuroradiology, Universitätsklinikum Schleswig-Holstein Campus Kiel, Germany (O.J.).
¹⁵ Department of Brain Repair and Rehabilitation, Stroke Research Centre, UCL Queen Square Institute of Neurology, University College London, United Kingdom (M.M.B., L.H.B.).
¹⁶ Department of Neurology, Mayo Clinic, Jacksonville, FL (T.G.B.).
¹⁷ Department of Neurology, University of Heidelberg Medical School, Germany (P.A.R.).

PMID: 31378071
PMCID: PMC6823842
DOI: 10.1161/CIRCINTERVENTIONS.119.007870

Meta-Analysis

Secular Trends in Procedural Stroke or Death Risks of Stenting Versus Endarterectomy for Symptomatic Carotid Stenosis

Mandy D Müller et al. Circ Cardiovasc Interv. 2019 Aug.

. 2019 Aug;12(8):e007870.

doi: 10.1161/CIRCINTERVENTIONS.119.007870. Epub 2019 Aug 5.

Authors

Affiliations

¹ Department of Neurology and Stroke Center (M.D.M. and 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, Utrecht University, the Netherlands.
⁴ Vascular Institute Paris East, Hôpital privé Paul D'Egine, Ramsay Group, Champigny sur Marne, France (J.-P.B.).
⁵ Clinical Trial Service Unit and Epidemiological Studies Unit (R.B.), Nuffield Department of Population Health, University of Oxford, United Kingdom.
⁶ Medical Research Council Population Health Research Unit (R.B.), Nuffield Department of Population Health, University of Oxford, United Kingdom.
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, Utrecht University, the Netherlands.
¹² Department of Biostatistics, UAB School of Public Health, Birmingham, AL (G.H.).
¹³ Department of Medical Statistics, London School of Hygiene and Tropical Medicine, United Kingdom (J.G.).
¹⁴ Clinic for Radiology and Neuroradiology, Universitätsklinikum Schleswig-Holstein Campus Kiel, Germany (O.J.).
¹⁵ Department of Brain Repair and Rehabilitation, Stroke Research Centre, UCL Queen Square Institute of Neurology, University College London, United Kingdom (M.M.B., L.H.B.).
¹⁶ Department of Neurology, Mayo Clinic, Jacksonville, FL (T.G.B.).
¹⁷ Department of Neurology, University of Heidelberg Medical School, Germany (P.A.R.).

PMID: 31378071
PMCID: PMC6823842
DOI: 10.1161/CIRCINTERVENTIONS.119.007870

Abstract

Background: Over the past decades, stroke risk associated with carotid disease has decreased, reflecting improvements in medical therapy and a more rigorous control of vascular risk factors. It is less clear whether the procedural risk of carotid revascularization has declined over time.

Methods: We analyzed temporal changes in procedural risks among 4597 patients with symptomatic carotid stenosis treated with carotid artery stenting (n=2326) or carotid endarterectomy (n=2271) in 4 randomized trials between 2000 and 2008, using generalized linear mixed-effects models with a random intercept for each source trial. Models were additionally adjusted for age and other baseline characteristics predicting treatment risk. The primary outcome event was any procedural stroke or death, occurring during or within 30 days after revascularization.

Results: The procedural stroke or death risk decreased significantly over time in all patients (unadjusted odds ratio per year, 0.91; 95% CI, 0.85-0.97; P=0.006). This effect was driven by a decrease in the carotid endarterectomy group (unadjusted odds ratio per year, 0.82; 95% CI, 0.73-0.92; P=0.003), whereas no significant decrease was found after carotid artery stenting (unadjusted odds ratio, 0.96; 95% CI, 0.88-1.04; P=0.33). Carotid endarterectomy patients had a lower procedural stroke or death risk compared with carotid artery stenting patients, and the difference significantly increased over time (interaction P=0.031). After adjustment for baseline characteristics, the results remained essentially the same.

Conclusions: The risk of stroke or death associated with carotid endarterectomy for symptomatic carotid stenosis decreased over an 8-year period, independent of clinical predictors of procedural risk. No corresponding reduction in procedural risk was seen in patients treated with stenting.

Clinical trial registration: URL: https://www.clinicaltrials.gov; http://www.isrctn.com. Unique identifier: NCT00190398 (EVA-3S), NCT00004732 (CREST), ISRCTN57874028 (SPACE), and ISRCTN25337470 (ICSS).

Keywords: carotid stenosis; endarterectomy; humans; risk factors; stents.

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Conflict of interest statement

Disclosures

All other authors declare no competing interests.

Figures

**Figure 1.. Study flow chart**
Study flow chart depicting all patients in enrolled in the source trials included in meta-analysis as well as events precluding patients from analysis.

**Figure 2.. Decline in risk of stroke or death over time – unadjusted model**
Modelled risks of stroke or death occurring within 30 days after treatment over time by treatment group in the unadjusted generalized linear mixed-effects model. Open and closed circles represent fitted values from the model. Error bars represent Bayesian 95% credible intervals. The interaction between type of treatment and year of treatment was statistically significant (interaction p=0.031). CEA – carotid endarterectomy; CAS – carotid artery stenting.

**Figure 3.. Decline in risk of stroke or death over time – adjusted model**
Modelled risks of stroke or death (fitted values) occurring within 30 days after treatment over time by treatment group in the adjusted generalized linear mixed-effects model. The fitted values are shown for a “model patient” with median age and modified Rankin Scale (mRS) score at baseline, history of hypertension and severe carotid stenosis, but no history of diabetes mellitus. Open and closed circles represent fitted values from the model. Error bars represent Bayesian 95% credible intervals. The interaction between type of treatment and year of treatment was statistically significant (interaction p=0.038). CEA – carotid endarterectomy; CAS – carotid artery stenting.

See this image and copyright information in PMC

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Secular Trends in Procedural Stroke or Death Risks of Stenting Versus Endarterectomy for Symptomatic Carotid Stenosis

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Secular Trends in Procedural Stroke or Death Risks of Stenting Versus Endarterectomy for Symptomatic Carotid Stenosis

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