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Neuroradiology

, Volume 50, Issue 12, pp 1049–1053 | Cite as

Differences in complication rates among the centres in the SPACE study

  • Jens FiehlerEmail author
  • Olav Jansen
  • Jürgen Berger
  • Hans-Henning Eckstein
  • Peter A. Ringleb
  • Robert Stingele
Interventional Neuroradiology

Abstract

Introduction

Despite the high grade of standardisation of study protocols, there is still room for variability among the centres in specific treatment aspects. We evaluated the treatment risk in stent-protected angioplasty of the carotid versus endarterectomy (SPACE) associated with the specific patient enrolment rates of the centres.

Materials and methods

The analysed endpoints were ipsilateral stroke or death [primary outcome event (pOE)] and any stroke or death [secondary outcome event (sOE)] until 30 days after treatment. A binary logistic regression analysis with random effects was performed separately for each treatment arm. The centres were secondarily categorised in three classes: I) ≥25 patients enrolled, II) ten to 24 patients and III) <10 patients and a hierarchic log linear model was fitted to test the three-way interaction of treatment, number of patients per class and outcome.

Results

The random effects logistic regression analysis in the carotid artery stenting (CAS) arm proved a significant increase in pOE with decreasing number of patients enrolled (−0.0190 ± 0.0085, p = 0.025, deviance 35.7 with 32 df), whereas no such effect was found in the carotid endartectomy (CEA) arm (−0.010 ± 0.008, p = 0.24, deviance 39.78 with 32 df). In the log linear model, there was a significant interaction between treatment, number of patients per centre and sOE (p = 0.023). The odds ratios for sOE in the enrolment classes (CAS vs. CEA) were 0.98 (95% CI 0.50–1.94, p = 0.95) for class I, 1.13 (95% CI 0.47–2.77, p = 0.77) for class II and 11.56 (95% CI 1.40–253.45, p = 0.01) for class III centres.

Conclusion

Despite rigorous standardisation and quality requirements for operator qualification, there seemed to be a decrease in complication rate with increasing patient enrolment numbers in the CAS arm while this signal could not be detected in the CEA arm of SPACE.

Keywords

Carotid stenosis Carotid stenting Carotid endarterectomy Postoperative complications Learning curve 

Notes

Acknowledgements

We thank the patients who agreed to participate in SPACE. Funding was provided from the Federal Ministry of Education and Research (BMBF: 01GI9918), German Research Foundation (DFG: HA 1394/4-2 and HA 1397/4-3), German Society of Neurology, German Society of Neuroradiology, German Radiological Society, Boston Scientific, Guidant, and Sanofi-Aventis.

Conflict of interest statement

We declare that we have no conflict of interest.

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Copyright information

© Springer-Verlag 2008

Authors and Affiliations

  • Jens Fiehler
    • 1
    Email author
  • Olav Jansen
    • 2
  • Jürgen Berger
    • 3
  • Hans-Henning Eckstein
    • 4
  • Peter A. Ringleb
    • 5
  • Robert Stingele
    • 6
  1. 1.Department of NeuroradiologyUniversity Medical Center Hamburg-EppendorfHamburgGermany
  2. 2.Department of NeuroradiologyUniversity Hospital Schleswig-HolsteinKielGermany
  3. 3.Department of Medical Biometry and EpidemiologyUniversity Medical CenterHamburgGermany
  4. 4.Department of Vascular Surgery, Rechts der Isar Medical Center MunichTechnical University of MunichMunichGermany
  5. 5.Department of NeurologyUniversity of HeidelbergHeidelbergGermany
  6. 6.Department of NeurologyUniversity Hospital Schleswig-HolsteinKielGermany

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