Sirolimus-eluting stent halts intimal hyperplasia: in-stent restenosis rate reduced by 91%. ('Rare' Magnitude of Benefit).

WASHINGTON -- Sirolimus-eluting stents virtually eliminated in-stent intimal hyperplasia across all treatment groups in a clinical trial involving more than 50 U.S. medical centers, according to investigators at a meeting sponsored by the Cardiovascular Research Foundation.

Participants at the international conference hailed the findings of the SIRIUS (Sirolimus-Eluting Stent) trial as "groundbreaking" and certain to change the course of heart disease management.

"It is rare in medicine that you see this magnitude of a treatment effect, and this constancy of a treatment effect, across all types of patients and all types of lesions," said Dr. Martin B. Leon, a principal investigator of the trial and president of the Cardiovascular Research Foundation at Lenox Hill Hospital in New York.

Less than a month after the data were reported, the stent used in the trial became the first drug-eluting device recommended for approval by a Food and Drug Administration advisory panel. (See box on p. 2.)

Definitive results of the trial have been awaited ever since promising preliminary results on the first few dozen patients were reported at the annual American Heart Association meeting last spring, he noted. The final findings reported here by Dr. Leon and coinvestigator Dr. Jeffrey Moses reflect 9-month follow-up on the entire study cohort of more than 1,000 subjects.

A total of 553 subjects received sirolimus-eluting stents, and 525 received uncoated stents. Subjects with short lesions and those with obstruction of major vessels were excluded for this reason, said Dr. Moses, chief of interventional cardiology at Lenox Hill Hospital.

More than 25% of the SIRIUS subjects had diabetes, nearly 75% had hyperlipidemia, and more than 40% had multivessel disease. The average lesion length was 14.4 mm, and an average of 1.4 stents per patient were placed.