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MORE POSITIVE NEWS ABOUT SIROLIMUS-ELUTING 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 and a related study from Europe (E-SIRIUS; Journal Watch Cardiology Nov 14 2003) show 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: Recently, an FDA public health notification highlighted the potential risk for subacute stent thrombosis and hypersensitivity reactions with the stent used in this study yet cautioned that the thrombosis risk appears not to differ from that with bare-metal stents. We await further updates.

— Harlan M. Krumholz, MD, SM

Published in Journal Watch Cardiology January 2, 2004

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.

• Original article (Subscription may be required)
• Medline abstract (Free)