Neointimal hyperplasia after sirolimus-eluting and paclitaxel-eluting stent implantation in diabetic patients: The Randomized Diabetes and Drug-Eluting Stent (DiabeDES) Intravascular Ultrasound Trial

European Heart Journal

Volumn 29, Issue 22, 2008, Pages 2733-2741

  Jensen, Lisette Okkels ^a   Maeng, Michael ^b   Thayssen, Per ^a   Christiansen, Evald Hoej ^b   Hansen, Knud Noerregaard ^a   Galloe, Anders ^c   Kelbaek, Henning ^d   Lassen, Jens Flensted ^b   Thuesen, Leif ^b  

^a ODENSE UNIVERSITY HOSPITAL   (Denmark)

^b AARHUS UNIVERSITY HOSPITAL   (Denmark)

^c UNIVERSITY OF COPENHAGEN   (Denmark)

^d Rigshospitalet   (Denmark)

Author keywords

Diabetes mellitus; Drug eluting stent; Intravascular ultrasound; Neointimal hyperplasia

Indexed keywords

PACLITAXEL; RAPAMYCIN;

ADULT; AGED; ARTERY INTIMA PROLIFERATION; ARTICLE; CLINICAL TRIAL; COMPARATIVE STUDY; CONTROLLED CLINICAL TRIAL; CORONARY STENT; DISEASE SEVERITY; DRUG ELUTING STENT; FEMALE; HUMAN; IN-STENT RESTENOSIS; INTRAVASCULAR ULTRASOUND; MAJOR CLINICAL STUDY; MALE; NON INSULIN DEPENDENT DIABETES MELLITUS; PRIORITY JOURNAL; TREATMENT OUTCOME;

ANGIOPLASTY, TRANSLUMINAL, PERCUTANEOUS CORONARY; CORONARY RESTENOSIS; CORONARY VESSELS; DIABETIC ANGIOPATHIES; DRUG-ELUTING STENTS; FEMALE; HUMANS; HYPERPLASIA; IMMUNOSUPPRESSIVE AGENTS; MALE; MIDDLE AGED; PACLITAXEL; SIROLIMUS; TREATMENT OUTCOME; TUNICA INTIMA;

EID: 56449091111     PISSN: 0195668X     EISSN: 15229645     Source Type: Journal    
DOI: 10.1093/eurheartj/ehn434     Document Type: Article

References (36)

1. Abizaid A, Kornowski R, Mintz GS, Hong MK, Abizaid AS, Mehran R, Pichard AD, Kent KM, Satler LF, Wu H, Popma JJ, Leon MB. The influence of diabetes mellitus on acute and late clinical outcomes following coronary stent implantation. J Am Coll Cardiol 1998;32:584-589.
2. Flaherty JD, Davidson CJ. Diabetes and coronary revascularization. JAMA 2005;293:1501-1508.
3. Kornowski R, Mintz GS, Kent KM, Pichard AD, Satler LF, Bucher TA, Hong MK, Popma JJ, Leon MB. Increased restenosis in diabetes mellitus after coronary interventions is due to exaggerated intimal hyperplasia. A serial intravascular ultrasound study. Circulation 1997;95:1366-1369.
4. Luscher TF, Creager MA, Beckman JA, Cosentino F. Diabetes and vascular disease: pathophysiology, clinical consequences, and medical therapy: Part II. Circulation 2003;108:1655-1661.
5. Larsen JR, Tsunoda T, Tuzcu EM, Schoenhagen P, Brekke M, Arnesen H, Hanssen KF, Nissen SE, Dahl-Jorgensen K. Intracoronary ultrasound examinations reveal significantly more advanced coronary atherosclerosis in people with type 1 diabetes than in age- and sex-matched non-diabetic controls. Diab Vasc Dis Res 2007;4:62-65.
6. West NE, Ruygrok PN, Disco CM, Webster MW, Lindeboom WK, O'Neill WW, Mercado NF, Serruys PW. Clinical and angiographic predictors of restenosis after stent deployment in diabetic patients. Circulation 2004;109:867- 873.
7. Jensen LO, Thayssen P, Mintz GS, Maeng M, Junker A, Galloe A, Christiansen EH, Hoffmann SK, Pedersen KE, Hansen HS, Hansen KN. Intravascular ultrasound assessment of remodelling and reference segment plaque burden in type-2 diabetic patients. Eur Heart J 2007;28:1759-1764.
8. 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. Sirolimus-eluting stents versus standard stents in patients with stenosis in a native coronary artery. N Engl J Med 2003;349:1315-1323.
9. 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. A polymer-based, paclitaxel-eluting stent in patients with coronary artery disease. N Engl J Med 2004;350:221-231.
10. 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.
11. Hermiller JB, Raizner A, Cannon L, Gurbel PA, Kutcher MA, Wong SC, Russell ME, Ellis SG, Mehran R, Stone GW. Outcomes with the polymer-based paclitaxel-eluting TAXUS stent in patients with diabetes mellitus: the TAXUS-IV trial. J Am Coll Cardiol 2005;45:1172-1179.
12. Sabate M, Jimenez-Quevedo P, Angiolillo DJ, Gomez-Hospital JA, Alfonso F, Hernandez-Antolin R, Goicolea J, Banuelos C, Escaned J, Moreno R, Fernandez C, Fernandez-Aviles F, Macaya C. 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 2005;112:2175-2183.
13. Jensen LO, Maeng M, Kaltoft A, Thayssen P, Hansen HH, Bottcher M, Lassen JF, Krussel LR, Rasmussen K, Hansen KN, Pedersen L, Johnsen SP, Soerensen HT, Thuesen L. Stent thrombosis, myocardial infarction, and death after drug-eluting and bare-metal stent coronary interventions. J Am Coll Cardiol 2007;50:463-470.
14. 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. Sirolimus-eluting stents inhibit neointimal hyperplasia in diabetic patients. Insights from the RAVEL Trial. Eur Heart J 2004;25:107-112.
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. 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. Weissman NJ, Koglin J, Cox DA, Hermiller J, O'Shaughnessy C, Mann JT, Turco M, Caputo R, Bergin P, Greenberg J, Kutcher M, Wong SC, Strickland W, Mooney M, Russell ME, Ellis SG, Stone GW. Polymer-based paclitaxel-eluting stents reduce in-stent neointimal tissue proliferation: a serial volumetric intravascular ultrasound analysis from the TAXUS-IV trial. J Am Coll Cardiol 2005;45:1201-1205.
17. Serruys PW, Degertekin M, Tanabe K, Abizaid A, Sousa JE, Colombo A, Guagliumi G, Wijns W, Lindeboom WK, Ligthart J, de Feyter PJ, Morice MC. Intravascular ultrasound findings in the multicenter, randomized, double-blind RAVEL (RAndomized study with the sirolimus-eluting VElocity balloon-expandable stent in the treatment of patients with de novo native coronary artery Lesions) trial. Circulation 2002;106:798-803.
18. Tanabe K, Serruys PW, Degertekin M, Guagliumi G, Grube E, Chan C, Munzel T, Belardi J, Ruzyllo W, Bilodeau L, Kelbaek H, Ormiston J, Dawkins K, Roy L, Strauss BH, Disco C, Koglin J, Russell ME, Colombo A. Chronic arterial responses to polymer-controlled paclitaxel-eluting stents: comparison with bare metal stents by serial intravascular ultrasound analyses: data from the randomized TAXUS-II trial. Circulation 2004;109:196-200.
19. Maeng M, Jensen LO, Kaltoft A, Hansen HH, Bottcher M, Lassen JF, Thayssen P, Krusell LR, Rasmussen K, Pedersen L, Sørensen HT, Johnsen SP, Thuesen L. Stent thrombosis, myocardial infarction, and mortality following drug-eluting and bare-metal stent coronary interventions in Danish patients with diabetes mellitus. Am J Cardiol 2008;102:165-172.
20. Stettler C, Allemann S, Egger M, Windecker S, Meier B, Diem P. Efficacy of drug eluting stents in patients with and without diabetes mellitus: indirect comparison of controlled trials. Heart 2006;92:650-657.
21. Dibra A, Kastrati A, Mehilli J, Pache J, Schuhlen H, von BN, Ulm K, Wessely R, Dirschinger J, Schomig A. Paclitaxel-eluting or sirolimus-eluting stents to prevent restenosis in diabetic patients. N Engl J Med 2005;353:663-670.
22. Galloe AM, Thuesen L, Kelbaek H, Thayssen P, Rasmussen K, Hansen PR, Bligaard N, Saunamaki K, Junker A, Aaroe J, Abildgaard U, Ravkilde J, Engstrom T, Jensen JS, Andersen HR, Botker HE, Galatius S, Kristensen SD, Madsen JK, Krusell LR, Abildstrom SZ, Stephansen GB, Lassen JF. Comparison of paclitaxel- and sirolimus-eluting stents in everyday clinical practice: the SORT OUT II randomized trial. JAMA 2008;299:409-416.
23. Jensen LO, Thayssen P, Pedersen KE, Stender S, Haghfelt T. Low variation and high reproducibility in plaque volume with intravascular ultrasound. Int J Cardiol 2004;97:463-469.
24. Jensen LO, Thayssen P. Accuracy of electrocardiographic-gated versus nongated volumetric intravascular ultrasound measurements of coronary arterial narrowing. Am J Cardiol 2007;99:279-283.
25. Mintz GS, Nissen SE, Anderson WD, Bailey SR, Erbel R, Fitzgerald PJ, Pinto FJ, Rosenfield K, Siegel RJ, Tuzcu EM, Yock PG. American College of Cardiology Clinical Expert Consensus Document on Standards for Acquisition, Measurement and Reporting of Intravascular Ultrasound Studies (IVUS). A report of the American College of Cardiology Task Force on Clinical Expert Consensus Documents. J Am Coll Cardiol 2001;37:1478-1492.
26. Cutlip DE, Windecker S, Mehran R, Boam A, Cohen DJ, van Es GA, Steg PG, Morel MA, Mauri L, Vranckx P, McFadden E, Lansky A, Hamon M, Krucoff MW, Serruys PW. Clinical end points in coronary stent trials: a case for standardized definitions. Circulation 2007;115:2344-2351.
27. Popma JJ, Leon MB, Moses JW, Holmes DR Jr, Cox N, Fitzpatrick M, Douglas J, Lambert C, Mooney M, Yakubov S, Kuntz RE. Quantitative assessment of angiographic restenosis after sirolimus-eluting stent implantation in native coronary arteries. Circulation 2004;110:3773-3780.
28. Escolar E, Mintz GS, Popma J, Michalek A, Kim SW, Mandinov L, Koglin J, Stone G, Ellis SG, Grube E, Dawkins KD, Weissman NJ. Meta-analysis of angiographic versus intravascular ultrasound parameters of drug-eluting stent efficacy (from TAXUS IV, V, and VI). Am J Cardiol 2007;100:621- 626.
29. Mintz GS, Hong MK, Raizner AE, Lee CW, Kim JJ, Escolar E, Fearnot NE, Park SW, Park SJ, Weissman NJ. Intravascular ultrasound assessment of neointima distribution and the length of stent that was free of intravascular ultrasound-detectable intimal hyperplasia in paclitaxel-eluting stents. Am J Cardiol 2005;95:107-109.
30. Grube E, Silber S, Hauptmann KE, Buellesfeld L, Mueller R, Lim V, Gerckens U, Russell ME. Two-year-plus follow-up of a paclitaxel-eluting stent in de novo coronary narrowings (TAXUS I). Am J Cardiol 2005;96:79- 82.
31. Serruys PW, Degertekin M, Tanabe K, Russell ME, Guagliumi G, Webb J, Hamburger J, Rutsch W, Kaiser C, Whitbourn R, Camenzind E, Meredith I, Reeves F, Nienaber C, Benit E, Disco C, Koglin J, Colombo A. Vascular responses at proximal and distal edges of paclitaxel-eluting stents: serial intravascular ultrasound analysis from the TAXUS II trial. Circulation 2004;109:627-633.
32. Sousa JE, Costa MA, Abizaid A, Feres F, Seixas AC, Tanajura LF, Mattos LA, Falotico R, Jaeger J, Popma JJ, Serruys PW, Sousa AG. Four-year angiographic and intravascular ultrasound follow-up of patients treated with sirolimus-eluting stents. Circulation 2005;111:2326-2329.
33. Aoki J, Colombo A, Dudek D, Banning AP, Drzewiecki J, Zmudka K, Schiele F, Russell ME, Koglin J, Serruys PW. Peristent remodeling and neointimal suppression 2 years after polymer-based, paclitaxel-eluting stent implantation: insights from serial intravascular ultrasound analysis in the TAXUS II study. Circulation 2005;112:3876-3883.
34. Lemos PA, Saia F, Ligthart JM, Arampatzis CA, Sianos G, Tanabe K, Hoye A, Degertekin M, Daemen J, McFadden E, Hofma S, Smits PC, de Feyter P, van der Giessen WJ, van Domburg RT, Serruys PW. Coronary restenosis after sirolimus-eluting stent implantation: morphological description and mechanistic analysis from a consecutive series of cases. Circulation 2003;108:257-260.
35. Corbett SJ, Cosgrave J, Melzi G, Babic R, Biondi-Zoccai GG, Godino C, Morici N, Airoldi F, Michev I, Montorfano M, Sangiorgi GM, Bonizzoni E, Colombo A. Patterns of restenosis after drug-eluting stent implantation: insights from a contemporary and comparative analysis of sirolimus- and paclitaxel-eluting stents. Eur Heart J 2006;27:2330-2337.
36. Billinger M, Beutler J, Taghetchian KR, Remondino A, Wenaweser P, Cook S, Togni M, Seiler C, Stettler C, Eberli FR, Luscher TF, Wandel S, Juni P, Meier B, Windecker S. Two-year clinical outcome after implantation of sirolimus-eluting and paclitaxel-eluting stents in diabetic patients. Eur Heart J 2008;29:718-725.