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, called ISAR-DIABETES, had no commercial funding and 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. The average amount of late loss was 0.43 mm in patients who received sirolimus stents and 0.67 mm in those who got paclitaxel stents, a difference that was statistically significant, reported Adnan Kastrati, M.D., professor of cardiology at the German Heart Center.
Patients who received sirolimus stents also had significantly less angiographic restenosis than did those who got paclitaxel stents, 6.9% vs. 16.5%, respectively. But there were no statistically significant differences in clinical end points, including clinical restenosis and the rates of death and MI at 9 months after stenting.
Although the results from this third study showed differences only for angiographic 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.
In January, results were reported from a fourth study by Dr. Kastrati and associates 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 compared with the patients who received paclitaxel-eluting stents (JAMA 2005;293:165-71).