Randomized trial of three rapamycin-eluting stents with different coating strategies for the reduction of coronary restenosis

European Heart Journal

Volumn 29, Issue 16, 2008, Pages 1975-1982

  Mehilli, Julinda ^a   Byrne, Robert A ^a   Wieczorek, Anna ^a   Iijima, Raisuke ^a   Schulz, Stefanie ^a   Bruskina, Olga ^a   Pache, Jürgen ^a   Wessely, Rainer ^a   Schömig, Albert ^a   Kastrati, Adnan ^a  

^a TECHNICAL UNIVERSITY OF MUNICH   (Germany)

Author keywords

Biodegradable; Coronary restenosis; Drug eluting stents; Polymer; Rapamycin

Indexed keywords

POLYMER; RAPAMYCIN;

ADULT; ANGIOCARDIOGRAPHY; ARTICLE; BIODEGRADABILITY; BIOSAFETY; CLINICAL FEATURE; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; CORONARY ARTERY OBSTRUCTION; DRUG ELUTING STENT; FEMALE; HUMAN; IN-STENT RESTENOSIS; MAJOR CLINICAL STUDY; MALE; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL; RESTENOSIS; THERAPY EFFECT; TREATMENT OUTCOME; TREATMENT RESPONSE;

AGED; COATED MATERIALS, BIOCOMPATIBLE; CORONARY RESTENOSIS; CORONARY STENOSIS; DRUG-ELUTING STENTS; FEMALE; HUMANS; MALE; POLYMERS; PROSPECTIVE STUDIES; SIROLIMUS; STENTS; TREATMENT OUTCOME; TUBULIN MODULATORS;

EID: 49749103102     PISSN: 0195668X     EISSN: 15229645     Source Type: Journal    
DOI: 10.1093/eurheartj/ehn253     Document Type: Article

References (40)

1. Sousa JE, Serruys PW, Costa MA. New frontiers in cardiology: drug-eluting stents: Part I. Circulation 2003;107:2274-2279.
2. Daemen J, Serruys PW. Drug-eluting stent update 2007: Part I. A survey of current and future generation drug-eluting stents: meaningful advances or more of the same? Circulation 2007;116:316-328.
3. 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. A randomized comparison of a sirolimus-eluting stent with a standard stent for coronary revascularization. N Engl J Med 2002;346:1773-1780.
4. Babapulle MN, Joseph L, Belisle P, Brophy JM, Eisenberg MJ. A hierarchical Bayesian meta-analysis of randomised clinical trials of drug-eluting stents. Lancet 2004;364:583-591.
5. Kastrati A, Dibra A, Eberle S, Mehilli J, Suarez de Lezo J, Goy JJ, Ulm K, Schömig A. Sirolimus-eluting stents vs paclitaxel-eluting stents in patients with coronary artery disease: meta-analysis of randomized trials. JAMA 2005;294:819-825.
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. Sirolimus-eluting stents versus standard stents in patients with stenosis in a native coronary artery. N Engl J Med 2003;349:1315-1323.
7. Lemos PA, Serruys PW, van Domburg RT, Saia F, Arampatzis CA, Hoye A, Degertekin M, Tanabe K, Daemen J, Liu TK, McFadden E, Sianos G, Hofma SH, Smits PC, van der Giessen WJ, de Feyter PJ. Unrestricted utilization of sirolimus-eluting stents compared with conventional bare stent implantation in the 'real world': the Rapamycin-Eluting Stent Evaluated At Rotterdam Cardiology Hospital (RESEARCH) registry. Circulation 2004;109:190-195.
8. Windecker S, Remondino A, Eberli FR, Juni P, Raber L, Wenaweser P, Togni M, Billinger M, Tuller D, Seiler C, Roffi M, Corti R, Sutsch G, Maier W, Luscher T, Hess OM, Egger M, Meier B. Sirolimus-eluting and paclitaxel-eluting stents for coronary revascularization. N Engl J Med 2005;353:653-662.
9. Roiron C, Sanchez P, Bouzamondo A, Lechat P, Montalescot G. Drug eluting stents: an updated meta-analysis of randomised controlled trials. Heart 2006;92:641-649.
10. McFadden EP, Stabile E, Regar E, Cheneau E, Ong AT, Kinnaird T, Suddath WO, Weissman NJ, Torguson R, Kent KM, Pichard AD, Satler LF, Waksman R, Serruys PW. Late thrombosis in drug-eluting coronary stents after discontinuation of antiplatelet therapy. Lancet 2004;364:1519-1521.
11. Iakovou I, Schmidt T, Bonizzoni E, Ge L, Sangiorgi GM, Stankovic G, Airoldi F, Chieffo A, Montorfano M, Carlino M, Michev I, Corvaja N, Briguori C, Gerckens U, Grube E, Colombo A. Incidence, predictors, and outcome of thrombosis after successful implantation of drug-eluting stents. JAMA 2005;293:2126-2130.
12. Daemen J, Wenaweser P, Tsuchida K, Abrecht L, Vaina S, Morger C, Kukreja N, Juni P, Sianos G, Hellige G, van Domburg RT, Hess OM, Boersma E, Meier B, Windecker S, Serruys PW. Early and late coronary stent thrombosis of sirolimus-eluting and paclitaxel-eluting stents in routine clinical practice: data from a large two-institutional cohort study. Lancet 2007;369:667-678.
13. Lee CH, Lim J, Low A, Tan HC, Lim YT. Late angiographic stent thrombosis of polymer based paclitaxel eluting stent. Heart 2006;92:551-553.
14. Wessely R, Kastrati A, Schömig A. Late restenosis in patients receiving a polymer-coated sirolimus-eluting stent. Ann Intern Med 2005;143:392-394.
15. van der Giessen WJ, Lincoff AM, Schwartz RS, van Beusekom HM, Serruys PW, Holmes DR Jr, Ellis SG, Topol EJ. Marked inflammatory sequelae to implantation of biodegradable and nonbiodegradable-polymers in porcine coronary arteries. Circulation 1996;94:1690-1697.
16. Sousa JE, Costa MA, Abizaid A, Abizaid AS, Feres F, Pinto IM, Seixas AC, Staico R, Mattos LA, Sousa AG, Falotico R, Jaeger J, Popma JJ, Serruys PW. Lack of neointimal proliferation after implantation of sirolimus-coated stents in human coronary arteries: a quantitative coronary angiography and three-dimensional intravascular ultrasound study. Circulation 2001;103:192-195.
17. Guagliumi G, Farb A, Musumeci G, Valsecchi O, Tespili M, Motta T, Virmani R. Images in cardiovascular medicine. Sirolimus-eluting stent implanted in human coronary artery for 16 months: pathological findings. Circulation 2003;107:1340-1341.
18. 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.
19. Nebeker JR, Virmani R, Bennett CL, Hoffman JM, Samore MH, Alvarez J, Davidson CJ, McKoy JM, Raisch DW, Whisenant BK, Yarnold PR, Belknap SM, West DP, Gage JE, Morse RE, Gligoric G, Davidson L, Feldman MD. Hypersensitivity cases associated with drug-eluting coronary stents: a review of available cases from the Research on Adverse Drug Events and Reports (RADAR) project. J Am Coll Cardiol 2006;47:175-181.
20. Virmani R, Liistro F, Stankovic G, Di Mario C, Montorfano M, Farb A, Kolodgie FD, Colombo A. Mechanism of late in-stent restenosis after implantation of a paclitaxel derivate-eluting polymer stent system in humans. Circulation 2002;106:2649-2651.
21. Joner M, Finn AV, Farb A, Mont EK, Kolodgie FD, Ladich E, Kutys R, Skorija K, Gold HK, Virmani R. Pathology of drug-eluting stents in humans: delayed healing and late thrombotic risk. J Am Coll Cardiol 2006;48:193-202.
22. Grube E, Sonoda S, Ikeno F, Honda Y, Kar S, Chan C, Gerckens U, Lansky AJ, Fitzgerald PJ. Six- and twelve-month results from first human experience using everolimus-eluting stents with bioabsorbable polymer. Circulation 2004;109:2168-2171.
23. Wessely R, Kastrati A, Mehilli J, Dibra A, Pache J, Schömig A. Randomized trial of rapamycin- and paclitaxel-eluting stents with identical biodegradable-polymeric coating and design. Eur Heart J 2007;28:2720-2725.
24. Wessely R, Hausleiter J, Michaelis C, Jaschke B, Vogeser M, Milz S, Behnisch B, Schratzenstaller T, Renke-Gluszko M, Stover M, Wintermantel E, Kastrati A, Schömig A. 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 2005;25:748-753.
25. Hausleiter J, Kastrati A, Wessely R, Dibra A, Mehilli J, Schratzenstaller T, Graf I, Renke-Gluszko M, Behnisch B, Dirschinger J, Wintermantel E, Schömig A. Prevention of restenosis by a novel drug-eluting stent system with a dose-adjustable, polymer-free, on-site stent coating. Eur Heart J 2005;26:1475-1481.
26. Mehilli J, Kastrati A, Wessely R, Dibra A, Hausleiter J, Jaschke B, Dirschinger J, Schömig A. Randomized trial of a nonpolymer-based rapamycin-eluting stent versus a polymer-based paclitaxel-eluting stent for the reduction of late lumen loss. Circulation 2006;113:273-279.
27. Dibra A, Kastrati A, Mehilli J, Pache J, von Oepen R, Dirschinger J, Schömig A. Influence of stent surface topography on the outcomes of patients undergoing coronary stenting: a randomized double-blind controlled trial. Catheter Cardiovasc Interv 2005;65:374-380.
28. Ellis SG, Vandormael MG, Cowley MJ, DiSciascio G, Deligonul U, Topol EJ, Bulle TM. Coronary morphologic and clinical determinants of procedural outcome with angioplasty for multivessel coronary disease. Implications for patient selection. Multivessel Angioplasty Prognosis Study Group. Circulation 1990;82:1193-1202.
29. Mehran R, Dangas G, Abizaid AS, Mintz GS, Lansky AJ, Satler LF, Pichard AD, Kent KM, Stone GW, Leon MB. Angiographic patterns of in-stent restenosis: classification and implications for long-term outcome. Circulation 1999;100:1872-1878.
30. 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.
31. Dibra A, Kastrati A, Mehilli J, Pache J, Schuhlen H, von Beckerath N, Ulm K, Wessely R, Dirschinger J, Schömig A. Paclitaxel-eluting or sirolimus-eluting stents to prevent restenosis in diabetic patients. N Engl J Med 2005;353:663-670.
32. O'Brien R, Muller K. Applied Analysis of Variance in Behavioural Science. New York, NY: Marcel Dekker; 1993.
33. Chow S, Liu J. Design and Analysis of Bioavailability and Bioequivalence Studies. New York, NY: Marcel Dekker; 1992.
34. Levin AD, Vukmirovic N, Hwang CW, Edelman ER. Specific binding to intracellular proteins determines arterial transport properties for rapamycin and paclitaxel. Proc Natl Acad Sci USA 2004;101:9463-9467.
35. Finn AV, Kolodgie FD, Harnek J, Guerrero LJ, Acampado E, Tefera K, Skorija K, Weber DK, Gold HK, Virmani R. Differential response of delayed healing and persistent inflammation at sites of overlapping sirolimus- or paclitaxel-eluting stents. Circulation 2005;112:270-278.
36. Wessely R, Schömig A, Kastrati A. Sirolimus and paclitaxel on polymer-based drug-eluting stents: similar but different. J Am Coll Cardiol 2006;47:708-714.
37. Wessely R, Blaich B, Belaiba RS, Merl S, Gorlach A, Kastrati A, Schömig A. Comparative characterization of cellular and molecular anti-restenotic profiles of paclitaxel and sirolimus. Implications for local drug delivery. Thromb Haemost 2007;97:1003-1012.
38. Schömig A, Dibra A, Windecker S, Mehilli J, Suarez de Lezo J, Kaiser C, Park SJ, Goy JJ, Lee JH, Di Lorenzo E, Wu J, Juni P, Pfisterer ME, Meier B, Kastrati A. A meta-analysis of 16 randomized trials of sirolimus-eluting stents versus paclitaxel-eluting stents in patients with coronary artery disease. J Am Coll Cardiol 2007;50:1373-1380.
39. Stettler C, Wandel S, Allemann S, Kastrati A, Morice MC, Schömig A, Pfisterer ME, Stone GW, Leon MB, de Lezo JS, Goy JJ, Park SJ, Sabate M, Suttorp MJ, Kelbaek H, Spaulding C, Menichelli M, Vermeersch P, Dirksen MT, Cervinka P, Petronio AS, Nordmann AJ, Diem P, Meier B, Zwahlen M, Reichenbach S, Trelle S, Windecker S, Juni P. Outcomes associated with drug-eluting and bare-metal stents: a collaborative network meta-analysis. Lancet 2007;370:937-948.
40. Commandeur S, van Beusekom HM, van der Giessen WJ. Polymers, drug release, and drug-eluting stents. J Interv Cardiol 2006;19:500- 506.