Long-term clinical benefit of sirolimus-eluting stent implantation in diabetic patients with de novo coronary stenoses: Long-term results of the DIABETES trial

European Heart Journal

Volumn 28, Issue 16, 2007, Pages 1946-1952

  Jiménez Quevedo, Pilar ^a   Sabaté, Manel ^a   Angiolillo, Dominick J ^a   Alfonso, Fernando ^a   Hernández Antolín, Rosana ^a   SanMartín, Marcelo ^b   Gómez Hospital, Joan Antoni ^c   Bañuelos, Camino ^a   Escaned, Javier ^a   Moreno, Raúl ^a   Fernández, Cristina ^a   Fernández Avilés, Francisco ^d   Macaya, Carlos ^a  

^a HOSPITAL CLÍNICO SAN CARLOS   (Spain)

^b Do Meixoeiro University Hospital   (Spain)

^c 'Princeps d'Espanya' Univ Hospital   (Spain)

^d HOSPITAL CLÍNICO UNIVERSITARIO DE VALLADOLID   (Spain)

Author keywords

Diabetes mellitus; Restenosis; Sirolimus eluting stent; Stent thrombosis; Target lesion revascularization; Trial

Indexed keywords

ACETYLSALICYLIC ACID; CLOPIDOGREL; RAPAMYCIN;

AGED; ANGIOCARDIOGRAPHY; ARTICLE; CLINICAL TRIAL; COMPARATIVE STUDY; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; CORONARY ARTERY ATHEROSCLEROSIS; CORONARY ARTERY OBSTRUCTION; DIABETES MELLITUS; DIABETIC PATIENT; DISEASE COURSE; DRUG EFFICACY; DRUG ELUTING STENT; DRUG WITHDRAWAL; FEMALE; FOLLOW UP; GASTROINTESTINAL HEMORRHAGE; HUMAN; LONG TERM CARE; MAJOR CLINICAL STUDY; MALE; METAL STENT; MULTICENTER STUDY; PRIORITY JOURNAL; PROSPECTIVE STUDY; RANDOMIZATION; RANDOMIZED CONTROLLED TRIAL; REVASCULARIZATION; SAFETY; STENT; STENT THROMBOSIS; THERAPY EFFECT; THROMBOSIS; VITREOUS HEMORRHAGE;

AGED; ASPIRIN; BLOOD VESSEL PROSTHESIS; CORONARY RESTENOSIS; CORONARY STENOSIS; DEATH, SUDDEN, CARDIAC; DIABETIC ANGIOPATHIES; DRUG-ELUTING STENTS; FEMALE; FOLLOW-UP STUDIES; HUMANS; IMMUNOSUPPRESSIVE AGENTS; MALE; MYOCARDIAL INFARCTION; MYOCARDIAL REVASCULARIZATION; PLATELET AGGREGATION INHIBITORS; PROSPECTIVE STUDIES; PROSTHESIS FAILURE; REOPERATION; SIROLIMUS; TICLOPIDINE; TREATMENT OUTCOME;

EID: 35348902083     PISSN: 0195668X     EISSN: 15229645     Source Type: Journal    
DOI: 10.1093/eurheartj/ehm197     Document Type: Article

References (30)

1. Van Belle E, Abolmaali K, Bauters C, McFadden EP, Lablanche JM, Bertrand ME. Restenosis, late vessel occlusion and left ventricular function six months after balloon angioplasty in diabetic patients. J Am Coll Cardiol 1999;34:476-485.
2. Elezi S, Kastrati A, Pache J, Wehinger A, Hadamitzky M, Dirschinger J, Neumann FJ, Schomig A. Diabetes Mellitus and the clinical and angiographic outcome after coronary stent placement. J Am Coll Cardiol 1998;32:1866-1873.
3. Van Belle E, Perie M, Braune D, Chmait A, Meurice T, Abolmaali K, McFadden EP, Bauters C, Lablanche JM, Bertrand ME. Effects of coronary stenting on vessel patency and long-term clinical outcome after percutaneous coronary revascularization in diabetic patients. J Am Coll Cardiol 2002;40:410-417.
4. Rozenman Y, Sapoznikov D, Mosseri M, Gilon D, Lotan C, Nassar H, Weiss AT, Hasin Y, Gotsman MS. Long-term angiographic follow-up of coronary balloon angioplasty in patients with diabetes mellitus a clue to the explanation of the results of the BARI study. J Am Coll Cardiol 1997;30:1420-1425.
5. Morice MC, Serruys PW, Sousa JE, Fajadet J, Ban Hayashi E, Perin M, Colombo A, Schuler G, Barragan P, Guagliumi G, Molnar F, Falotico R, RAVEL Study Group. Randomized Study with the Sirolimus-Coated Bx Velocity Balloon-Expandable Stent in the Treatment of Patients with de Novo Native Coronary Artery Lesions. A randomized comparison of a sirolimus-eluting stent with a standard stent for coronary revascularization. N Engl J Med 2002;346:1773-1780.
6. Moses JW, Leon MB, Popma JJ, Fitzgerald PJ, Holmes DR, O'Shaughnessy C, Caputo RP, Kereiakes DJ, Williams DO, Teirstein PS, Jaeger JL, Kuntz RE, SIRIUS Investigators. Sirolimus-eluting stents versus standard stents in patients with stenosis in a native coronary artery. N Engl J Med 2003;349:1315- 1323.
7. Colombo A, Drzewiecki J, Banning A, Grube E, Hauptmann K, Silber S, Dudek D, Fort S, Schiele F, Zmudka K, Guagliumi G, Russell ME, TAXUS II Study Group. Randomized study to assess the effectiveness of slow- and moderate-release polymer-based paclitaxel-eluting stents for coronary artery lesions. Circulation 2003;108:788-794.
8. Stone GW, Ellis SG, Cox DA, Hermiller J, O'Shaughnessy C, Mann JT, Turco M, Caputo R, Bergin P, Greenberg J, Popma JJ, Russell ME, TAXUS-IV Investigators. A polymer-based, paclitaxel-eluting stent in patients with coronary artery disease. N Engl J Med 2004;350:221-231.
9. Moussa I, Leon MB, Baim DS, O'Neill WW, Popma JJ, Buchbinder M, Midwall J, Simonton CA, Keim E, Wang P, Kuntz RE, Moses JW. 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. Circulation 2004;109:2273-2278.
10. Kip KE, Faxon DP, Detre KM, Yeh W, Kelsey SF, Currier JW. Coronary angioplasty in diabetic patients. The National Heart, Lung, and Blood Institute Percutaneous Transluminal Coronary Angioplasty Registry. Circulation 1996;94:1818-1825.
11. Abizaid A, Costa MA, Blanchard D, Albertal M, Eltchaninoff H, Guagliumi G, Geert-Jan L, Abizaid AS, Sousa AG, Wuelfert E, Wietze L, Sousa JE, Serruys PW, Morice MC; Ravel Investigators. Sirolimus-eluting stents inhibit neointimal hyperplasia in diabetic patients. Insights from the RAVEL Trial. Eur Heart J 2004;25:107-112.
12. Creager MA, Lüscher TF, Cosentino F, Beckman JA. Diabetes and vascular disease: pathophysiology, clinical consequences, and medical therapy: Part I. Circulation 2003;108:1527-1532.
13. Sabaté M, Jiménez-Quevedo P, Angiolillo DJ, Gómez-Hospital JA, Alfonso F, Hernández-Antolín R, Goicolea J, Bañuelos C, Escaned J, Moreno R, Fernández C, Fernández-Avilés F, Macaya C. A randomized comparison of sirolimus-eluting stent versus standard stent for percutaneous coronary revascularization in diabetic patients: the DIABETES trial. Circulation 2005;112:2175-2183.
14. Alberti KGMM, Zimmet PZ, for the WHO Consultation. Definition, diagnosis and classification of diabetes mellitus and its complications. Part 1: diagnosis and classification of diabetes mellitus. Provisional report of a WHO consultation. Diabet Med 1998;15:539-553.
15. Jimenez-Quevedo P, Sabate M, Angiolillo DJ, Costa MA, Alfonso F, Gomez-Hospital JA, Hernandez-Antolin R, Banuelos C, Goicolea J, Fernandez-Aviles F, Bass T, Escaned J, Moreno R, Fernandez C, Macaya C, DIABETES Investigators. 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 2006;47:2172-2179.
16. Holmes DR Jr, Leon MB, Moses JW, Popma JJ, Cutlip D, Fitzgerald PJ, Brown C, Fischell T, Wong SC, Midei M, Snead D, Kuntz RE. Analysis of 1-year clinical outcomes in the SIRIUS trial: a randomized trial of a sirolimus-eluting stent versus a standard stent in patients at high risk for coronary restenosis. Circulation 2004;109:634-640.
17. Fajadet J, Morice MC, Bode C, Barragan P, Serruys PW, Wijns W, Constantini CR, Guermonprez JL, Eltchaninoff H, Blanchard D, Bartorelli A, Laarman GJ, Perin M, Sousa JE, Schuler G, Molnar F, Guagliumi G, Colombo A, Ban Hayashi E, Wulfert E. Maintenance of long-term clinical benefit with sirolimus-eluting coronary stents: three-year results of the RAVEL trial. Circulation 2005;111:1040-1044.
18. Yerkey MW, Kernis SJ, Franklin BA, Sandberg KR, McCullough PA. Renal dysfunction and acceleration of coronary disease. Heart 2004;8:961-966.
19. Lemos PA, Arampatzis CA, Hoye A, Daemen J, Ong AT, Saia F, van der Giessen WJ, McFadden EP, Sianos G, Smits PC, de Feyter P, Hofma SH, van Domburg RT, Serruys PW. Impact of baseline renal function on mortality after percutaneous coronary intervention with sirolimus-eluting stents or bare metal stents. Am J Cardiol 2005;95:167-172.
20. Sadeghi HM, Stone GW, Grines CL, Mehran R, Dixon SR, Lansky AJ, Fahy M, Cox DA, Garcia E, Tcheng JE, Griffin JJ, Stuckey TD, Turco M, Carroll JD. Impact of renal insufficiency in patients undergoing primary angioplasty for acute myocardial infarction. Circulation 2003;108:2769-2775.
21. Molitch ME, DeFronzo RA, Franz MJ, Keane WF, Mogensen CE, Parving HH, American Diabetes Association. Diabetic nephropathy. Diabetes Care 2003;26(Suppl. 1):S94-S98.
22. Briguori C, Condorelli G, Airoldi F, Manganelli F, Violante A, Focaccio A, Ricciardelli B, Colombo A. Impact of microvascular complications on outcome after coronary stent implantations in patients with diabetes. J Am Coll Cardiol 2005;45:464-466.
23. The BARI investigators. Influence of diabetes on 5-year mortality and morbidity in a randomized trial comparing CABG and PTCA in patients with multivessel disease: The Bypass Angioplasty Revascularization Investigation (BARI). Circulation 1997;96:1761-1769.
24. Abizaid A, Costa MA, Centemero M, Abizaid AS, Legrand VM, Limet RV, Schuler G, Mohr FW, Lindeboom W, Sousa AG, Sousa JE, van Hout B, Hugenholtz PG, Unger F, Serruys PW, Arterial Revascularization Therapy Study Group. Clinical and economic impact of diabetes mellitus on percutaneous and surgical treatment of multivessel coronary disease patients: insights from the Arterial Revascularization Therapy Study (ARTS) trial. Circulation 2001;104:533-538.
25. Loutfi M, Mulvihill NT, Boccalatte M, Farah B, Fajadet J, Marco J. Impact of restenosis and disease progression on clinical outcome after multivessel stenting in diabetic patients. Catheter Cardiovasc Interv 2003;58:451-454.
26. Virmani R, Guagliumi G, Farb A, Musumeci G, Grieco N, Motta T, Mihalcsik L, Tespili M, Valsecchi O, Kolodgie FD. Localized hypersensitivity and late coronary thrombosis secondary to a sirolimus-eluting stent: should we be cautious? Circulation 2004;109:701-705.
27. Muir DF, Stevens A, Napier-Hemy RO, Fath-Ordoubadi F, Curzen N. Recurrent stent thrombosis associated with lupus anticoagulant due to renal cell carcinoma. Int J Cardiovasc Intervent 2003;5:44-46.
28. Marcucci C, Chassot PG, Gardaz JP, Magnusson L, Ris HB, Delabays A, Spahn DR. Fatal myocardial infarction after lung resection in a patient with prophylactic preoperative coronary stenting. Br J Anaesth 2004;92:743-747.
29. Niccoli G, Siviglia M, De Vita M, Altamura L, Fusco B, Leone AM, Ferrante G, Rebuzzi AG, Crea F. A case of fatal stent thrombosis after Carbostent implantation: is clopidogrel alone antiplatelet therapy a safe alternative to aspirin alone antiplatelet therapy? Int J Cardiol 2007;114:279- 281.
30. Grines CL, Bonow RO, Casey DE Jr, Gardner TJ, Lockhart PB, Moliterno DJ, O'Gara P, Whitlow P; American Heart Association; American College of Cardiology; Society for Cardiovascular Angiography Interventions; American College of Surgeons; American Dental Association; American College of Physicians. Prevention of premature discontinuation of dual antiplatelet therapy in patients with coronary artery stents: a science advisory from the American Heart Association, American College of Cardiology, Society for Cardiovascular Angiography and Interventions, American College of Surgeons, and American Dental Association, with representation from the American College of Physicians. Circulation 2007;115:813-818.