Circulation. 2004;109:2273-2278
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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(Circulation. 2004;109:2273-2278.)
© 2004 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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|
|
|
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|
|
|
|
 |
|
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|
|
|
|
 |
|
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|
|
|
|
 |
|
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|
|
|
|
|
|
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|
|
|
|
 |
|
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|
|
|
|
|
|
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|
|
|
|
|
|
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|
|
|
|
|
|
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|
|
|
|
|
|
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|
|
|
|
|
|
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|
|
|
|
|
|
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|
|
|
|
|
|
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|
|
|
|
|
|
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|
|
|
|
 |
|
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|
|
|
|
|
|
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|
|
|
|
|
|
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|
|
|
|
 |
|
 V K Bhatia and C Di Mario Darwin and the survival of the fittest in modern interventional cardiology Heart, August 1, 2006; 92(8): 1017 - 1018. [Abstract] [Full Text] [PDF]
|
|
|
|
 |
|
 V. I. Patel, S. Daniel, C. R. Longo, G. V. Shrikhande, S. T. Scali, E. Czismadia, C. M. Groft, T. Shukri, C. Motley-Dore, H. E. Ramsey, et al. A20, a modulator of smooth muscle cell proliferation and apoptosis, prevents and induces regression of neointimal hyperplasia FASEB J, July 1, 2006; 20(9): 1418 - 1430. [Abstract] [Full Text] [PDF]
|
|
|
|
|
|
P. Jimenez-Quevedo, M. Sabate, D. J. Angiolillo, M. A. Costa, F. Alfonso, J. A. Gomez-Hospital, R. Hernandez-Antolin, C. Banuelos, J. Goicolea, F. Fernandez-Aviles, et al. Vascular Effects of Sirolimus-Eluting Versus Bare-Metal Stents in Diabetic Patients: Three-Dimensional Ultrasound Results of the Diabetes and Sirolimus-Eluting Stent (DIABETES) Trial J. Am. Coll. Cardiol., June 6, 2006; 47(11): 2172 - 2179. [Abstract] [Full Text] [PDF]
|
|
|
|
|
|
A. Kastrati, A. Dibra, J. Mehilli, S. Mayer, S. Pinieck, J. Pache, J. Dirschinger, and A. Schomig Predictive Factors of Restenosis After Coronary Implantation of Sirolimus- or Paclitaxel-Eluting Stents Circulation, May 16, 2006; 113(19): 2293 - 2300. [Abstract] [Full Text] [PDF]
|
|
|
|
|
|
W. Kim, M. H. Jeong, K. H. Kim, I. S. Sohn, Y. J. Hong, H. W. Park, J. H. Kim, Y. K. Ahn, J. G. Cho, J. C. Park, et al. The Clinical Results of a Platelet Glycoprotein IIb/IIIa Receptor Blocker (Abciximab: ReoPro)-Coated Stent in Acute Myocardial Infarction J. Am. Coll. Cardiol., March 7, 2006; 47(5): 933 - 938. [Abstract] [Full Text] [PDF]
|
|
|
|
|
|
R. Seabra-Gomes Percutaneous coronary interventions with drug eluting stents for diabetic patients. Heart, March 1, 2006; 92(3): 410 - 419. [Full Text] [PDF]
|
|
|
|
 |
|
 M. E. Williams Coronary Revascularization in Diabetic Chronic Kidney Disease/End-Stage Renal Disease: A Nephrologist's Perspective Clin. J. Am. Soc. Nephrol., March 1, 2006; 1(2): 209 - 220. [Full Text] [PDF]
|
|
|
|
 |
|
 J. A. Alarcon, J. M. Arribas, V. Ruiz, L. Czupryniak, M. Pawlowski, J. Loba, R. F. Bonvini, V. Verin, R. Waksman, R. M. Wolfram, et al. Drug-eluting coronary stents. N. Engl. J. Med., December 1, 2005; 353(22): 2404 - 2408. [Full Text] [PDF]
|
|
|
|
|
|
M. Sabate, P. Jimenez-Quevedo, D. J. Angiolillo, J. A. Gomez-Hospital, F. Alfonso, R. Hernandez-Antolin, J. Goicolea, C. Banuelos, J. Escaned, R. Moreno, et al. Randomized Comparison of Sirolimus-Eluting Stent Versus Standard Stent for Percutaneous Coronary Revascularization in Diabetic Patients: The Diabetes and Sirolimus-Eluting Stent (DIABETES) Trial Circulation, October 4, 2005; 112(14): 2175 - 2183. [Abstract] [Full Text] [PDF]
|
|
|
|
|
|
S. B. King III, G. Dangas, J. W. Moses, S. B. King III, G. Dangas, and J. W. Moses Surgery Is Preferred for the Diabetic With Multivessel Disease Circulation, September 6, 2005; 112(10): 1500 - 1515. [Full Text] [PDF]
|
|
|
|
|
|
A. Dibra, A. Kastrati, J. Mehilli, J. Pache, H. Schuhlen, N. von Beckerath, K. Ulm, R. Wessely, J. Dirschinger, A. Schomig, et al. Paclitaxel-Eluting or Sirolimus-Eluting Stents to Prevent Restenosis in Diabetic Patients N. Engl. J. Med., August 18, 2005; 353(7): 663 - 670. [Abstract] [Full Text] [PDF]
|
|
|
|
 |
|
 J. Molnar, S. Yu, N. Mzhavia, C. Pau, I. Chereshnev, and H. M. Dansky Diabetes Induces Endothelial Dysfunction but Does Not Increase Neointimal Formation in High-Fat Diet Fed C57BL/6J Mice Circ. Res., June 10, 2005; 96(11): 1178 - 1184. [Abstract] [Full Text] [PDF]
|
|
|
|
|
|
D. J. Kereiakes, R. E. Kuntz, L. Mauri, and M. W. Krucoff Surrogates, substudies, and real clinical end points in trials of drug-eluting stents J. Am. Coll. Cardiol., April 19, 2005; 45(8): 1206 - 1212. [Full Text] [PDF]
|
|
|
|
|
|
W. W. O'Neill, S. R. Dixon, and C. L. Grines The year in interventional cardiology J. Am. Coll. Cardiol., April 5, 2005; 45(7): 1117 - 1134. [Full Text] [PDF]
|
|
|
|
|
|
Authors/Task Force Members, S. Silber, P. Albertsson, F. F. Aviles, P. G. Camici, A. Colombo, C. Hamm, E. Jorgensen, J. Marco, J.-E. Nordrehaug, et al. Guidelines for Percutaneous Coronary Interventions: The Task Force for Percutaneous Coronary Interventions of the European Society of Cardiology Eur. Heart J., April 2, 2005; 26(8): 804 - 847. [Full Text] [PDF]
|
|
|
|
|
|
R. Wessely, J. Hausleiter, C. Michaelis, B. Jaschke, M. Vogeser, S. Milz, B. Behnisch, T. Schratzenstaller, M. Renke-Gluszko, M. Stover, et al. Inhibition of Neointima Formation by a Novel Drug-Eluting Stent System That Allows for Dose-Adjustable, Multiple, and On-Site Stent Coating Arterioscler Thromb Vasc Biol, April 1, 2005; 25(4): 748 - 753. [Abstract] [Full Text] [PDF]
|
|
|
|
|
|
J. D. Flaherty and C. J. Davidson Diabetes and Coronary Revascularization JAMA, March 23, 2005; 293(12): 1501 - 1508. [Abstract] [Full Text] [PDF]
|
|
|
|
|
|
A. V. Finn, I. F. Palacios, A. Kastrati, and H. K. Gold Drug-eluting stents for diabetes mellitus: A rush to judgment? J. Am. Coll. Cardiol., February 15, 2005; 45(4): 479 - 483. [Abstract] [Full Text] [PDF]
|
|
|
|
 |
|
 Y.-m. Yang and I. Moussa Percutaneous coronary intervention and drug-eluting stents Can. Med. Assoc. J., February 1, 2005; 172(3): 323 - 325. [Full Text] [PDF]
|
|
|
|
 |
|
 J Butany and M J Collins Analysis of prosthetic cardiac devices: a guide for the practising pathologist J. Clin. Pathol., February 1, 2005; 58(2): 113 - 124. [Abstract] [Full Text] [PDF]
|
|
|
|
|
|
L. Mauri, E. J. Orav, A. J. O'Malley, J. W. Moses, M. B. Leon, D. R. Holmes Jr, P. S. Teirstein, J. Schofer, G. Breithardt, D. E. Cutlip, et al. Relationship of Late Loss in Lumen Diameter to Coronary Restenosis in Sirolimus-Eluting Stents Circulation, January 25, 2005; 111(3): 321 - 327. [Abstract] [Full Text] [PDF]
|
|
|
|
|
|
A. J. Scheen, F. Warzee, and V. M.G. Legrand Drug-eluting stents: meta-analysis in diabetic patients Eur. Heart J., December 1, 2004; 25(23): 2167 - 2168. [Full Text] [PDF]
|
|
|
|
|
|
A. Bagust, A. Bakhai, R. Dickson, Y. Dundar, R. A Hill, and T. Walley Exploring groups at high risk of restenosis Eur. Heart J., December 1, 2004; 25(23): 2168 - 2169. [Full Text] [PDF]
|
|
|
|
 |
|
 Other articles noted Evid. Based Med., September 1, 2004; 9(5): e5 - e5. [Full Text] [PDF]
|
|