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The purpose of this study is to evaluate the efficacy of 3 different rapamycin-eluting-stent platforms to reduce coronary artery reblockage after stent implantation
Coronary artery reblockage remains still a drawback of percutaneous coronary interventions even in the era of drug-eluting stents (DES). DESs working principle consists of the delivery of controlled amounts of antiproliferative agents at the local level, which results in the suppression of neointimal proliferation, the main cause of lumen re-narrowing after stent implantation. At present, several DES platforms have been developed and evaluated for clinical use. They differ between them with regard to the stent type, anti-proliferative drug, presence of polymers employed for drug storage and modification of drug-release kinetics as well as type of polymer used for this purpose. Although their mid-term efficacy has been well-established, there is an ongoing debate on the potential of an increased incidence of late stent thrombosis, particularly after discontinuation of thienopyridine therapy, as well as of delayed onset of restenosis or catch-up phenomenon with DESs. Based on animal and human pathological data, investigators have linked the above-mentioned concerns to the presence of polymers in DESs, which have a proinflammatory and prothrombinogenic potential, and sometimes may induce a hypersensitivity reaction. This trial will compare the anti-restenotic efficacy of the permanent polymer (PP), biodegradable polymer (BP) and polymer-free (PF) rapamycin-eluting stents in patients with coronary artery disease. Cypher stent (PP) is a stainless steel stent coated with sirolimus with use of permanent polymers while the ISAR stent is a rough surface stainless steel stent which allows not only polymeric coating (for example biodegradable polymer, BP ISAR stent) but also coating without the need of polymer (PF ISAR stent) in the cath lab.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A | Active Comparator | Drug eluting stent using biodegradable polymer BP stent |
|
| B | Active Comparator | polymer-free drug eluting stent PF stent |
|
| C | Active Comparator | permanent polymer using stents PP stent |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| rapamycin-eluting Stent with permanent polymer | Device | due to randomization, rapamycin-eluting stent with permanent polymer will be implanted |
|
| Measure | Description | Time Frame |
|---|---|---|
| in-stent late luminal loss | at 6 to 8-month follow-up angiogram |
| Measure | Description | Time Frame |
|---|---|---|
| In-segment binary angiographic restenosis | at 6 to 8-month follow-up angiogram | |
| Need of target lesion revascularization | at 9-month follow-up | |
| Combined incidence of death or myocardial infarction |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Albert Schoemig, MD | Deutsches Herzzentrum Muenchen | Study Chair |
| Adnan Kastrati, MD | Deutsches Herzzentrum Muenchen | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Deutsches Herzzentrum Muenchen | Munich | 80636 | Germany | |||
| 1. Medizinische Klinik, Klinikum rechts der Isar |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 12732594 | Background | Sousa JE, Serruys PW, Costa MA. New frontiers in cardiology: drug-eluting stents: Part I. Circulation. 2003 May 6;107(17):2274-9. doi: 10.1161/01.CIR.0000069330.41022.90. No abstract available. | |
| 15313358 | Background | 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 Aug 14-20;364(9434):583-91. doi: 10.1016/S0140-6736(04)16850-5. |
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| rapamycin-eluting stent with biodegradable polymer | Device | due to randomization, rapamycin-eluting stent with biodegradable polymer will be implanted |
|
| polymer-free, rapamycin-eluting stent | Device | due to randomization, polymer-free.rapamycin-eluting stent will be implanted |
|
| at 9-month follow-up |
| Incidence of stent thrombosis. | at 9-month follow-up |
| München |
| 81675 |
| Germany |
| 16106007 | Background | Kastrati A, Dibra A, Eberle S, Mehilli J, Suarez de Lezo J, Goy JJ, Ulm K, Schomig A. Sirolimus-eluting stents vs paclitaxel-eluting stents in patients with coronary artery disease: meta-analysis of randomized trials. JAMA. 2005 Aug 17;294(7):819-25. doi: 10.1001/jama.294.7.819. |
| 15870416 | Background | 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 May 4;293(17):2126-30. doi: 10.1001/jama.293.17.2126. |
| 15500897 | Background | 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 Oct 23-29;364(9444):1519-21. doi: 10.1016/S0140-6736(04)17275-9. |
| 16106033 | Background | Wessely R, Kastrati A, Schomig A. Late restenosis in patients receiving a polymer-coated sirolimus-eluting stent. Ann Intern Med. 2005 Sep 6;143(5):392-4. doi: 10.7326/0003-4819-143-5-200509060-00119. Epub 2005 Aug 16. No abstract available. |
| 14744976 | Background | 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 Feb 17;109(6):701-5. doi: 10.1161/01.CIR.0000116202.41966.D4. Epub 2004 Jan 26. |
| 15123533 | Background | 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 May 11;109(18):2168-71. doi: 10.1161/01.CIR.0000128850.84227.FD. Epub 2004 May 3. |
| 15975990 | Background | Hausleiter J, Kastrati A, Wessely R, Dibra A, Mehilli J, Schratzenstaller T, Graf I, Renke-Gluszko M, Behnisch B, Dirschinger J, Wintermantel E, Schomig A; investigators of the individualizable durg-eluting Stent System to Abrogate Restenosis Project. Prevention of restenosis by a novel drug-eluting stent system with a dose-adjustable, polymer-free, on-site stent coating. Eur Heart J. 2005 Aug;26(15):1475-81. doi: 10.1093/eurheartj/ehi405. Epub 2005 Jun 23. |
| 16391155 | Background | Mehilli J, Kastrati A, Wessely R, Dibra A, Hausleiter J, Jaschke B, Dirschinger J, Schomig A; Intracoronary Stenting and Angiographic Restenosis--Test Equivalence Between 2 Drug-Eluting Stents (ISAR-TEST) Trial Investigators. 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 Jan 17;113(2):273-9. doi: 10.1161/CIRCULATIONAHA.105.575977. Epub 2006 Jan 3. |
| 15681298 | Background | 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, Schomig 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 Apr;25(4):748-53. doi: 10.1161/01.ATV.0000157579.52566.ee. Epub 2005 Jan 27. |
| 16105990 | Background | Dibra A, Kastrati A, Mehilli J, Pache J, Schuhlen H, von Beckerath N, Ulm K, Wessely R, Dirschinger J, Schomig A; ISAR-DIABETES Study Investigators. Paclitaxel-eluting or sirolimus-eluting stents to prevent restenosis in diabetic patients. N Engl J Med. 2005 Aug 18;353(7):663-70. doi: 10.1056/NEJMoa044372. Epub 2005 Aug 16. |
| 14523139 | Background | 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 Oct 2;349(14):1315-23. doi: 10.1056/NEJMoa035071. |
| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| ID | Term |
|---|---|
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular Diseases |
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