Drug-Eluting Stents: Safe, Effective in Acute MI? : Studies compare patient outcomes with sirolimus-and paclitaxel-eluting models vs. bare-metal stents.

Treatment with a sirolimus-eluting stent appeared safe, with a 3.4% rate of stent thrombosis throughout all 12 months of follow-up, and a 0.3% rate of stent thrombosis after the first 30 days following treatment. In the bare-metal stent group, the overall rate of stent thrombosis was 3.6%, which included a 0.6% rate after 30 days. In the trial protocol, patients were directed to take aspirin and clopidogrel daily for at least 6 months after stent placement, Dr. Spaulding said at the meeting.

The study of the paclitaxel-eluting stent (Taxus) was done at two hospitals in the Netherlands. The PASSION (Randomized Comparison of Paclitaxel-Eluting Stent Versus Conventional Stent in ST-Segment Elevation Myocardial Infarction) study did not have any industry support.

During 2003–2004, researchers enrolled patients with symptoms of acute MI who had a culprit lesion in a native coronary artery. The primary end point was the combined rate of cardiac death, recurrent MI, or need for target lesion revascularization during the first year of follow-up.

In the 309 patients receiving a paclitaxel-eluting stent, the incidence of the end point was 8.7%, compared with 12.6% in the 310 patients receiving a bare-metal stent. Although this was a 32% risk reduction associated with the paclitaxel-eluting stent, the difference was not statistically significant, reported Dr. Maurits T. Dirksen, a cardiologist at Onze Lieve Vrouwe Gasthuis Hospital, Amsterdam.

'The data … are very mixed. Some study results suggest safety. Others suggest possible harm.' DR. STONE