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Coated Stents Remain Safe Two Years After Implantation: Presented at ESC(CARD)2004

By Ed Susman

MUNICH, GERMANY -- September 1, 2004 -- When compared to conventional bare stents, the coated sirolimus-eluting stents maintain their effectiveness in keeping blood vessels patent up to 2 years after implantation, researchers said Wednesday.

"Our study shows that there is no indication that the superiority of the sirolimus-eluting stent over the bare metal stent is in any way impaired at 2 years of clinical follow-up," said Joachim Schofer, MD, Professor of Internal Medicine, Center for Cardiology and Vascular Intervention, Hamburg, Germany, who presented the findings here September 1st at the European Society of Cardiology 2004 Congress.

In presenting the results of the Cordis-sponsored European Sirolimus-Eluting Stent in De Novo Native Coronary Lesions (E-SIRIUS) trial, Dr. Schofer said that among the 177 patients who were randomised to receive the bare metal stent there was a 29.9% incidence of major adverse coronary events while in the 175 patients who received the drug-eluting stent there was a 10.3% rate of events. He said that difference was statistically significant to the P =.001 level.

After 2 years, 26.6% of patients who received the bare stent required target lesion revascularisation compared with 5.1% of patients who had sirolimus-eluting stents implanted. He said that difference also was statistically significant to the P =.001 level.

"We saw no indication of a late 'catch up' phenomenon sometimes experienced in patients receiving brachytherapy," Dr. Schofer said in a press briefing.

"The long-term results seen in the E-SIRIUS study are very reassuring," said Peter Kearney, MD, Consultant Cardiologist, University Hospital, Cork, Ireland.

Dr. Schofer said there were 45 major adverse coronary events in the group of patients who received the bare metal stents, including 4 deaths. There were 8 events in the sirolimus-eluting stents, including 2 deaths. There were no significant differences between the groups in mortality or myocardial infarction rates.

He noted that the difference between the groups continues to diverge. After 2 years, 89.7% of patients were free of coronary events in the drug-eluting group, compared to 70% of those who received the bare metal stents.


[Abstract title: "Hot Line and Clinical Trial Update II: E-SIRIUS: 2-year Clinical Follow-Up in Patients With de Novo Lesions Treated With Sirolimus-Eluting Stents." Abstract 3595]

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