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Plea of the defence—critical comments on the interpretation of EVA3S, SPACE and ICSS

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Abstract

Three randomised controlled trials (RCTs) comparing outcomes after carotid artery stenting (CAS) with carotid endarterectomy (CEA) have recently been published. Recent systematic reviews have recommended that CAS is no longer justified for patients suitable for CEA. Indeed, in many centres, pooled data of RCTs show higher peri-operative risk of performing CAS vs. CEA with comparable long-term efficacy. Due to limitations in SPACE, EVA3S and ICSS study design and conduct, the inferiority of CAS to CEA as a method remains inconclusive. The goal of this review is not to discredit these trials but to develop a more differentiated and critical interpretation of the data and to create more discussion. It will discuss the necessity of RCTs for Interventional Neuroradiology in general and particular problems in study design (non-inferiority design and interpretation of results, clinical equipoise, study endpoints), practical study conduct difficulties (operator and centre experience, antiaggregation, timing of treatment) and the interpretation of the results (relation of internal and external validity, procedural complexity, the 68-year surprise, longer-term outcome). A premature rejection of CAS based on the data from these studies could harm future patients who would have had benefited from this procedure. For the time being, there is no reason why centres with good and independently controlled track records should stop performing CAS. Designing a single cooperative European trial that incorporates the lessons learned would be major step forward.

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Conflict of interest statement

AC has been a Proctor for Boston Scientific; he has no current affiliations. JF has previously received Speaker’s fees from Boston Scientific, ev3 and Cordis Neurovascular; he has no current affiliations. CG has previously received speaker’s fees from Boston Scientific, ev3 and Codman; he has no current affiliations. OJ has previously received speaker’s fees from Boston Scientific; he has no current affiliations.

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Authors and Affiliations

  1. Department of Neuroradiology, University Medical Centre Hamburg-Eppendorf, Martinistrasse 52, 20246, Hamburg, Germany

    Jens Fiehler

  2. Department of Neuroradiology, Oslo University Hospital, Rikshospitalet, 0027, Oslo 1, Norway

    Søren Jacob Bakke

  3. St George’s University of London and St George’s NHS Healthcare Trust, London, SW17 0QT, UK

    Andrew Clifton

  4. Service de Neuroradiologie, Université Paris VII, Lariboisière Hospital, 2 rue Ambroise Paré, 75010, Paris, France

    Emmanuel Houdart

  5. Department of Neuroradiology, UKSH Campus Kiel, Arnold-Heller-Strasse 3, 24105, Kiel, Germany

    Olav Jansen

  6. Department of Neuroradiology, NeuroCenter, Hirslanden Clinic, Witellikerstrasse 40, 8032, Zurich, Switzerland

    Daniel Rüfenacht

  7. Department of Neuroradiology, Karolinska University Hospital, 17176, Stockholm, Sweden

    Michael Söderman

  8. Service de Neuroradiologie, Hôpital Purpan, Place du Dr Baylac, 31059, Toulouse, France

    Christophe Cognard

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  1. Jens Fiehler
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Correspondence to Jens Fiehler.

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Fiehler, J., Bakke, S.J., Clifton, A. et al. Plea of the defence—critical comments on the interpretation of EVA3S, SPACE and ICSS. Neuroradiology 52, 601–610 (2010). https://doi.org/10.1007/s00234-010-0707-4

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  • DOI: https://doi.org/10.1007/s00234-010-0707-4

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