Drug-Eluting Stents Prove Successful in Small Coronary Vessel Revascularization

Sirolimus-eluting stents are proving to be successful in the revascularization of very small coronary arteries, where bare metal stents and bypass grafting have not, Italian researchers reported here during a late-breaking clinical trials session on the opening day of the American College of Cardiology’s Annual Scientific Session 2004.

SES-SMART, a randomized comparison of a “Sirolimus-Eluting and an uncoated Stent in the prevention of restensosis in SMall coronary ARTeries,” shows that the drug-eluting stents were markedly superior to bare stents, announced Dr. Diego Ardissino of the University of Parma, Italy,

Patients with acute coronary syndrome, de novo coronary lesions of 2.75 mm or less in diameter, lesion severity of 50% to 90% and length fully covered by a 33 mm stent were eligible for enrollment. Of the total 257 patients enrolled, 129 were randomized to receive sirolimus-eluting stents and 128 to bare stents. The primary endpoint was 8-month angiographic binary restenosis.

Dr. Ardissino reported that the restenosis rate with bare stents was 53.1% compared with 9.8% in the sirolimus group. “That’s a 90% relative risk reduction…a big divergence in restenosis rate,” he noted. Late lumen loss was 69% with bare stents and 16% with drug-eluting stents. Loss index was 68% in the bare stent group and 11% in the sirlomus group. The rate of major adverse cardiac events at 8 months was 31.3% with bare stents and 9.3% with sirolimus stents.

The relative risk reduction with sirolimus-eluting stents was independent of gender, age, the presence of diabetes, unstable angina or stent diameter.

“Bypass grafting of small arteries is considered to be suboptimal. Bare metal stents have proved to be very effective in larger vessels, but in small arteries, they are not as effective,” he said.

“Finally, today we have a means to revascularize small coronary arteries,” Dr. Ardissino declared.