on May 3, 2004
Circulation. 2004
Published online before print May 3, 2004, doi: 10.1161/01.CIR.0000129767.45513.71
Published online before print May 3, 2004, doi: 10.1161/01.CIR.0000129767.45513.71
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© American Heart Association, Inc.
Clinical Investigation and Reports |
Impact of Sirolimus-Eluting Stents on Outcome in Diabetic Patients
A SIRIUS (SIRolImUS-coated Bx Velocity balloon-expandable stent in the treatment of patients with de novo coronary artery lesions) Substudy
From The Lenox Hill Heart and Vascular Institute and Cardiovascular Research Foundation, New York, NY (I.D.M., M.B.L., J.W.M.); Brigham and Women’s Hospital, Boston, Mass (D.S.B., J.J.P., R.E.K.); William Beaumont Hospital, Royal Oak, Mich (W.W.O.); Scripps Memorial Hospital, La Jolla, Calif (M.B.); JFK Memorial Hospital, Palm Beach County. Fla (J.M.); Sanger Clinic, Charlotte, NC (C.A.S.); and Cordis (Johnson & Johnson), Warren, NJ (E.K., P.W.).
Correspondence to Issam Moussa, MD, Lenox Hill Heart and Vascular Institute, 130 East 77th St, 9th Floor, New York, NY 10021. E-mail imoussa{at}lenoxhill.net
Received February 18, 2004; revision received March 23, 2004; accepted March 23, 2004.
Background— Randomized clinical trials have shown that a sirolimus-eluting stent significantly reduces restenosis after percutaneous coronary revascularization. Diabetic patients are known to have a higher risk of restenosis compared with nondiabetic patients. The purpose of this analysis was to determine the impact of sirolimus-eluting stents on outcomes of diabetic compared with nondiabetic patients.
Methods and Results— The SIRIUS (SIRolImUS-coated Bx Velocity balloon-expandable stent in the treatment of patients with de novo coronary artery lesions) trial is a randomized, double-blind study that compared sirolimus-eluting and bare metal stent implantation in 1058 patients with de novo native coronary artery lesions. Diabetes mellitus was present in 279 (26%) patients (diabetes mellitus group, 131 patients received sirolimus-eluting stents and 148 patients received bare metal stents) and was absent in 778 patients (no–diabetes mellitus group, 402 patients received sirolimus-eluting stents and 376 patients received bare metal stents). At 270 days, target lesion revascularization was reduced in diabetic patients from 22.3% with bare metal stents to 6.9% with sirolimus-eluting stents (P<0.001) and in nondiabetic patients from 14.1% to 2.99% (P<0.001), respectively. Major adverse cardiac events were reduced in diabetic patients from 25% with bare metal stents to 9.2% with sirolimus-eluting stents (P<0.001) and from 16.5% to 6.5% (P<0.001) in nondiabetic patients, respectively.
Conclusions— Implantation of sirolimus-eluting stents compared with bare metal stents in de novo coronary lesions reduces major adverse cardiac events in patients with and without diabetes mellitus. However, among patients receiving sirolimus-eluting stents, there remains a trend toward a higher frequency of repeat intervention in diabetic patients compared with nondiabetic patients, particularly in the insulin-requiring patients.
Key Words: stents • diabetes mellitus • restenosis
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