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More Positive News About Sirolimus-Eluting Stents from the U.S.

Patients with complex coronary lesions benefited from these stents.

Drug-eluting stents seem to have almost unlimited promise. Small studies have suggested that sirolimus-eluting stents virtually eliminate restenosis. U.S. researchers at 53 centers tested this promise by randomizing patients with complex coronary lesions to sirolimus-eluting stents or standard (control) stents. The study was sponsored by a stent manufacturer.

Each patient had a single, newly diagnosed target lesion (length, 15 mm to 30 mm) in a native coronary artery (mean diameter, 2.80 mm). Among the exclusion criteria were presence of an ostial lesion or of a vessel with thrombus or severe calcification, leaving 1058 patients in the final cohort (mean age, 62; 71% male; 26% with diabetes; 42% with multivessel disease).

At 8 months, mean in-stent minimum luminal diameter was significantly larger in the sirolimus group (2.50 mm) than in the control group (1.69 mm), and significantly fewer sirolimus (3%) than control (35%) patients had binary in-stent restenosis (>50% of the luminal diameter). The in-segment restenosis difference was slightly smaller (9% vs. 36%, respectively), due to a smaller reduction in late luminal loss in the in-segment zone than the in-stent zone for the sirolimus group.

Nine-month incidence of the primary composite endpoint (death from cardiac causes, MI, or target-lesion revascularization [TLR]) was significantly lower in the sirolimus group (7%) than in the control group (19%), mostly due to the difference in TLR (4% vs. 17%). Stent-thrombosis rates were similar in the 2 groups. Findings were similar across relevant subgroups, including diabetes patients.

Comment: The good news continues for sirolimus-eluting stents. This large study shows that these stents are essentially meeting the early expectations for them (although complete elimination of restenosis, documented by some earlier reports, was not achieved). A crucial lingering challenge is how the health care system will absorb the cost of this effective technology. Note: On October 29, 2003, the FDA issued a public health notification regarding subacute thromboses and possible hypersensitivity reactions among some recipients of the sirolimus-eluting stent used in this study. The FDA has not yet determined whether the event rates are different from those experienced with bare-metal stents.

— Harlan M. Krumholz, MD, SM

Published in Journal Watch Cardiology November 14, 2003

Citation(s):

Moses JW et al. for the SIRIUS Investigators. Sirolimus-eluting stents versus standard stents in patients with stenosis in a native coronary artery. N Engl J Med 2003 Oct 2; 349:1315-23.

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• Medline abstract (Free)

Marks AR. Sirolimus for the prevention of in-stent restenosis in a coronary artery. N Engl J Med 2003 Oct 2; 349:1307-9.

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• Medline abstract (Free)