Sirolimus-eluting stents significantly improve post-angioplasty outcomes for patients with diabetes compared with standard bare metal stents, according to an article in the October 4 issue of Circulation.

“All indicators of renarrowing were dramatically reduced in the arteries of the diabetic patients treated with the sirolimus-eluting stent,” said Manel Sabate, MD, PhD, lead author of the study and consultant in cardiology at San Carlos University Hospital in Madrid, Spain.

In the first randomized trial of its type, 160 patients were randomized evenly between bare metal and drug-eluting stents. Stents were implanted between February and November 2003.

Sabate said “Overall, the outcomes of diabetic patients after angioplasty are poorer than those of nondiabetics. Conventional stent implantation still exhibits a high incidence of major cardiac events in the diabetic population, especially in those requiring insulin. With the use of conventional stents, the expected renarrowing rate may vary from 30 percent to 60 percent in diabetic patients versus 15 percent to 30 percent in nondiabetic patients.”

The primary purpose was to determine the degree of restenosis at nine months after stent implantation. Additional outcome points are one and two years after implantation.

Although the trial was not blinded, angiographic follow-up was blinded. Analysts at the University of Florida’s Health Science Center in Jacksonville compared angiograms taken directly after stent implantation with films taken at nine months.

At nine months, key differences included the following: Degree of restenosis was 0.06 mm with sirolimus-eluting stents compared with 0.47 mm for standard stents. Only 10 percent of the drug-eluting stent group experienced adverse cardiac events such as cardiac death, myocardial infarction, and revascularization compared with 36.3 percent of the bare stent group. Finally, only 6.3 percent of the drug-eluting stent group required a repeat revascularization procedure compared with 31.3 percent of the base stent group.

One patient from each group had a cardiac death between 30 and 270 days (the nine-month outcome point).