During late breaking trials session at EuroPCR 2003, Klaus Mathias, Director of Radiology in Dortmund, Germany, presented an update from the European Carotid High Risk Study (CHRS).
This is a non-randomised single-arm study, using the carotid Wallstent monorail system with cerebral protection. The study includes 14 active study sites, which have enrolled 161 patients, and follow-up is to be at 30 days, 6 months and 12 months.
The primary endpoint of the study, said Mathias, is stroke morbidity and mortality at 30 days and the secondary endpoint ipsilateral stroke and death at 12 months.
According to Mathias, technical success rate was 99% (163/165) and at 30 days death/stroke/MI was 7.6%. Mathias said, “When these results are compared with other high-risk trials like ARCHeR or SAPPHIRE we are in the same range.” At six months, in the CHRS study, in the 142 patients followed-up there was a death/stroke/MI of 12%, with seven major and four minor strokes.
From the results so far Mathias said that he believes: “Carotid stenting appears to be a viable option for treating high-risk patients.” One-year results are due to be presented at EuroPCR 2004.
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