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Differences in complication rates among the centres in the SPACE study.

Jens Fiehler1, Olav Jansen, Jürgen Berger

  • 1Department of Neuroradiology, University Medical Center Hamburg-Eppendorf, Hamburg, Germany. fiehler@uke.de

Neuroradiology
|September 24, 2008
PubMed
Summary

Higher patient volumes in carotid artery stenting (CAS) correlate with fewer complications, unlike carotid endarterectomy (CEA). The SPACE trial found increased risks in lower-volume CAS centers, highlighting the importance of experience in carotid revascularization outcomes.

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Area of Science:

  • Vascular Surgery
  • Interventional Cardiology
  • Health Services Research

Background:

  • Standardized protocols exist for carotid revascularization, yet center-specific variations in treatment execution persist.
  • The SPACE trial investigated the comparative risks of carotid artery stenting (CAS) versus endarterectomy (CEA) concerning patient enrollment rates at participating centers.

Purpose of the Study:

  • To evaluate the impact of patient enrollment volume on treatment risk for CAS and CEA.
  • To analyze the relationship between the number of procedures performed at a center and patient outcomes.

Main Methods:

  • Analysis of ipsilateral stroke or death (primary) and any stroke or death (secondary) within 30 days post-treatment.
  • Random effects logistic regression was applied separately for CAS and CEA arms.

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  • Centers were categorized by patient enrollment: Class I (≥25), Class II (10-24), Class III (<10). A hierarchical log-linear model tested treatment, enrollment class, and outcome interactions.

    • Main Results:

    • In the CAS arm, a statistically significant increase in primary outcome events was observed with decreasing patient enrollment (p=0.025).
    • No such effect was found in the CEA arm (p=0.24).
    • A significant three-way interaction between treatment, patient enrollment class, and secondary outcome events was detected (p=0.023). Centers with <10 CAS patients had substantially higher odds of secondary outcome events compared to CEA (OR=11.56, p=0.01).

    Conclusions:

    • Increasing patient enrollment numbers in CAS were associated with a reduced complication rate, a trend not observed in CEA.
    • Despite rigorous standardization and operator qualification, center experience, indicated by patient volume, appears to influence CAS outcomes.
    • These findings suggest that patient volume may be a critical factor in the safety and efficacy of CAS procedures.