Sirolimus-Eluting Stents Edge Past Paclitaxel Stents

The third set of study results presented at the meeting came from a single-center study with a total of 250 patients, all of whom had diabetes. Like the larger Swiss trial, this study had no commercial funding; the paclitaxel-eluting stent versus sirolimus-eluting stent for the prevention of restenosis in diabetic patients with coronary artery disease study, named ISAR-DIABETES, was sponsored solely by the German Heart Center in Munich.

This study had fewer exclusion criteria than the REALITY study. Exclusions were limited to patients with acute MI, left-main disease, in-stent restenosis, or an allergy to one of the study drugs.

The study's primary end point was the rate of in-segment, late lumen loss at 6-8 months after stenting, as measured by angiography. Follow-up angiography was done in 82% of patients. The average amount of late loss was 0.43 mm in patients who received sirolimus-eluting stents and 0.67 mm among those who got paclitaxel-eluting stents, a difference that was statistically significant, reported Adnan Kastrati, M.D., a professor of cardiology at the German Heart Center.

Patients who received sirolimus-eluting stents also had significantly less angiographic restenosis compared with those who got paclitaxel-eluting stents, 6.9% compared with 16.5%, respectively. But the results failed to show statistically significant differences in clinical end points. The rate of clinical restenosis was 6.4% in the patients who got sirolimus-eluting stents and 12.0% in those who received paclitaxel-eluting stents, a statistically nonsignificant difference. And the rates of death and MI at 9 months after stenting were similar in the two treatment groups.

Although the results from this third study showed differences only for angiographic end points but not for clinical end points, Dr. Kastrati said that he was convinced by the outcome. “The results will push us to select sirolimus-eluting stents for patients with diabetes,” he said.

Last August, Dr. Kastrati reported the results from a fourth study that compared the two stent types, in 200 patients with in-stent restenosis. In that study, patients who received sirolimus-eluting stents had significantly less clinical restenosis than did patients who received paclitaxel-eluting stents.