MAHOROBA, first-in-man study: 6-month results of a biodegradable polymer sustained release tacrolimus-eluting stent in de novo coronary stenoses

European Heart Journal

Volumn 30, Issue 12, 2009, Pages 1477-1485

  Onuma, Yoshinobu ^a   Serruys, Patrick ^a   Den Heijer, Peter ^b   Joesoef, Kaiyum Sheik ^c   Duckers, Henricus ^a   Regar, Evelyn ^a   Kukreja, Neville ^a   Tanimoto, Shuzou ^a   Garcia Garcia, Hector M ^d   Van Beusekom, Heleen ^a   Van Der Giessen, Willem ^a   Nishide, Takuji ^e  

^a ERASMUS MEDICAL CENTER   (Netherlands)

^b AMPHIA HOSPITAL   (Netherlands)

^c Medisch Centrum Rijnmond Zuid   (Netherlands)

^d CARDIALYSIS   (Netherlands)

^e KANEKA CORPORATION   (Japan)

Author keywords

Coronary artery disease; Drug eluting stent; First in man study; Tacrolimus eluting stent

Indexed keywords

POLYMER; TACROLIMUS;

ADULT; AGED; ARTERY INTIMA PROLIFERATION; ARTICLE; BIODEGRADABLE IMPLANT; CLINICAL ARTICLE; CLINICAL TRIAL; CORONARY ARTERY OBSTRUCTION; CORONARY STENT; DRUG ELUTING STENT; FEMALE; FOLLOW UP; HEART INFARCTION; HUMAN; INTRAVASCULAR ULTRASOUND; MALE; OUTCOME ASSESSMENT; PRIORITY JOURNAL; TREATMENT FAILURE;

ABSORBABLE IMPLANTS; AGED; ANGIOPLASTY, TRANSLUMINAL, PERCUTANEOUS CORONARY; CORONARY ANGIOGRAPHY; CORONARY STENOSIS; DRUG-ELUTING STENTS; FEASIBILITY STUDIES; FEMALE; HUMANS; HYPERPLASIA; IMMUNOSUPPRESSIVE AGENTS; MALE; MIDDLE AGED; PROSPECTIVE STUDIES; TACROLIMUS; THROMBOSIS; TIME FACTORS; TREATMENT OUTCOME; TUNICA INTIMA; ULTRASONOGRAPHY, INTERVENTIONAL;

EID: 67651089942     PISSN: 0195668X     EISSN: 15229645     Source Type: Journal    
DOI: 10.1093/eurheartj/ehp127     Document Type: Article

References (36)

1. Serruys PW, Kutryk MJ, Ong AT. Coronary-artery stents. N Engl J Med 2006; 354:483-495.
2. 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.
3. Farb A, Burke AP, Kolodgie FD, Virmani R. Pathological mechanisms of fatal late coronary stent thrombosis in humans. Circulation 2003; 108:1701-1706.
4. Finn AV, Joner M, Nakazawa G, Kolodgie F, Newell J, John MC, Gold HK, Virmani R. Pathological correlates of late drug-eluting stent thrombosis: strut coverage as a marker of endothelialization. Circulation 2007; 115:2435-2441.
5. 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.
6. Togni M, Windecker S, Cocchia R, Wenaweser P, Cook S, Billinger M, Meier B, Hess OM. Sirolimus-eluting stents associated with paradoxic coronary vasoconstriction. J Am Coll Cardiol 2005; 46:231-236.
7. Hofma SH, van der Giessen WJ, van Dalen BM, Lemos PA, McFadden EP, Sianos G, Ligthart JM, van Essen D, de Feyter PJ, Serruys PW. Indication of longterm endothelial dysfunction after sirolimus-eluting stent implantation. Eur Heart J 2006; 27:166-170.
8. Ho S, Clipstone N, Timmermann L, Northrop J, Graef I, Fiorentino D, Nourse J, Crabtree GR. The mechanism of action of cyclosporin A and FK506. Clin Immunol Immunopathol 1996; 80:S40-S45.
9. Parry TJ, Brosius R, Thyagarajan R, Carter D, Argentieri D, Falotico R, Siekierka J. Drug-eluting stents: sirolimus and paclitaxel differentially affect cultured cells and injured arteries. Eur J Pharmacol 2005; 524:19-29.
10. Mohacsi PJ, Tuller D, Hulliger B, Wijngaard PL. Different inhibitory effects of immunosuppressive drugs on human and rat aortic smooth muscle and endothelial cell proliferation stimulated by platelet-derived growth factor or endothelial cell growth factor. J Heart Lung Transplant 1997; 16:484-492.
11. Matter CM, Rozenberg I, Jaschko A, Greutert H, Kurz DJ, Wnendt S, Kuttler B, Joch H, Grunenfelder J, Zund G, Tanner FC, Luscher TF. Effects of tacrolimus or sirolimus on proliferation of vascular smooth muscle and endothelial cells. J Cardiovasc Pharmacol 2006; 48:286-292.
12. Steffel J, Latini RA, Akhmedov A, Zimmermann D, Zimmerling P, Luscher TF, Tanner FC. Rapamycin, but not FK-506, increases endothelial tissue factor expression: implications for drug-eluting stent design. Circulation 2005; 112:2002-2011.
13. Stahli BE, Camici GG, Steffel J, Akhmedov A, Shojaati K, Graber M, Luscher TF, Tanner FC. Paclitaxel enhances thrombin-induced endothelial tissue factor expression via c-Jun terminal NH2 kinase activation. Circ Res 2006; 99:149-155.
14. van Beusekom H, Sorop O, Weymaere M, Duncker D, van der Giessen W. The neointimal response to stents eluting tacrolimus from a degradable coating depends on the balance between polymer degradation and drug release. Eurointervention 2008; 4:139-147.
15. Tanimoto S, Serruys PW, Thuesen L, Dudek D, de Bruyne B, Chevalier B, Ormiston JA. Comparison of in vivo acute stent recoil between the bioabsorbable everolimus-eluting coronary stent and the everolimus-eluting cobalt chromium coronary stent: insights from the ABSORB and SPIRIT trials. Catheter Cardiovasc Interv 2007; 70:515-523.
16. Tanimoto S, van der Giessen WJ, van Beusekom HM, Sorop O, Kukreja N, Fukaya K, Nishide T, Nakano R, Maeda H, Serruys PW. MAHOROBATM: tacrolimus eluting coronary stent. Eurointervention 2007; 3:149-153.
17. Serruys P, De Jaegere P, Bertrand M, Kober G, Marquis JF, Piessens J, Uebis R, Valeix B, Wiegand V. Morphologic change in coronary artery stenosis with the Medtronic Wiktor stent: initial results from the core laboratory for quantitative angiography. Cathet Cardiovasc Diagn 1991; 24:237-245.
18. de Jaegere P, Serruys PW, van Es GA, Bertrand M, Wiegand V, Marquis JF, Vrolicx M, Piessens J, Valeix B, Kober G, Rutsch W, Uebis R. Recoil following Wiktor stent implantation for restenotic lesions of coronary arteries. Cathet Cardiovasc Diagn 1994; 32:147-156.
19. de Jaegere P, Serruys PW, Bertrand M, Wiegand V, Marquis JF, Vrolicx M, Piessens J, Valeix B, Kober G, Bonnier H, Rutsch W, Uebis R. Angiographic predictors of recurrence of restenosis after Wiktor stent implantation in native coronary arteries. Am J Cardiol 1993; 72:165-170.
20. Hamers R, Bruining N, Knook M, Sabate M, Roelandt JRTC. A novel approach to quantitative analysis of intravascular ultrasound images. Comput Cardiol 2001; 28:589-592.
21. De Winter SA, Hamers R, Degertekin M, Tanabe K, Lemos PA, Serruys PW, Roelandt JR, Bruining N. Retrospective image-based gating of intracoronary ultrasound images for improved quantitative analysis: the intelligate method. Catheter Cardiovasc Interv 2004; 61:84-94.
22. Ryan TJ, Antman EM, Brooks NH, Califf RM, Hillis LD, Hiratzka LF, Rapaport E, Riegel B, Russell RO, Smith EE 3rd, Weaver WD, Gibbons RJ, Alpert JS, Eagle KA, Gardner TJ, Garson A Jr, Gregoratos G, Ryan TJ, Smith SC Jr. 1999 update: ACC/AHA guidelines for the management of patients with acute myocardial infarction. A report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines (Committee on Management of Acute Myocardial Infarction). J Am Coll Cardiol 1999; 34:890-911.
23. 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.
24. Sousa JE, Costa MA, Abizaid AC, Rensing BJ, Abizaid AS, Tanajura LF, Kozuma K, Van Langenhove G, Sousa AG, Falotico R, Jaeger J, Popma JJ, Serruys PW. Sustained suppression of neointimal proliferation by sirolimus-eluting stents:one-year angiographic and intravascular ultrasound follow-up. Circulation 2001; 104:2007-2011.
25. Rensing BJ, Vos J, Smits PC, Foley DP, van den Brand MJ, van der Giessen WJ, de Feijter PJ, Serruys PW. Coronary restenosis elimination with a sirolimus eluting stent: first European human experience with 6-month angiographic and intravascular ultrasonic follow-up. Eur Heart J 2001; 22:2125-2130.
26. Tanabe K, Serruys PW, Degertekin M, Grube E, Guagliumi G, Urbaszek W, Bonnier J, Lablanche JM, Siminiak T, Nordrehaug J, Figulla H, Drzewiecki J, Banning A, Hauptmann K, Dudek D, Bruining N, Hamers R, Hoye A, Ligthart JM, Disco C, Koglin J, Russell ME, Colombo A. Incomplete stent apposition after implantation of paclitaxel-eluting stents or bare metal stents:insights from the randomized TAXUS II trial. Circulation 2005; 111:900-905.
27. Wieneke H, Dirsch O, Sawitowski T, Gu YL, Brauer H, Dahmen U, Fischer A, Wnendt S, Erbel R. Synergistic effects of a novel nanoporous stent coating and tacrolimus on intima proliferation in rabbits. Catheter Cardiovasc Interv 2003; 60:399-407.
28. Kollum M, Farb A, Schreiber R, Terfera K, Arab A, Geist A, Haberstroh J, Wnendt S, Virmani R, Hehrlein C. Particle debris from a nanoporous stent coating obscures potential antiproliferative effects of tacrolimus-eluting stents in a porcine model of restenosis. Catheter Cardiovasc Interv 2005; 64:85-90.
29. Bartorelli A. Tacrolimus drug-eluting stents. In: The Sorin JANUS FIM Results (JUPITER I) and New Clinical Trial Insights. Washington: TCT; 2004.
30. Morice M-C, Bestehorn H-P, Carrié D, Macaya C, Aengevaeren W, Wijns W, Dubois C, de Winter R, Verheye S, Hoffmann S, Pachinger O, Mario CD. Direct stenting of de novo coronary stenoses with tacrolimus-eluting versus carbon-coated carbostents. The randomized JUPITER II trial. Eurointervention 2006; 2:45-52.
31. Dawkins KD. Randomized, multi-center evaluation of the pimecrolimus-eluting and the dual pimecrolimus/paclitaxel-eluting coronary stent system in patients with de novo lesions of the native coronary arteries: GENESIS trial 6 month results. SCAI/ACCi2 2008, Chicago, 2008.
32. Zhang J, Rodila R, Watson P, Ji Q, El-Shourbagy TA. Determination of sirolimus in rabbit arteries using liquid chromatography separation and tandem mass spectrometric detection. Biomed Chromatogr 2007; 21:1036-1044.
33. Garcia-Garcia HM, Gonzalo N, Kukreja N, Alfonso F. Greyscale intravascular ultrasound and IVUS-radiofrequency tissue characterisation to improve understanding of the mechanisms of coronary stent thrombosis in drug-eluting stents. Eurointervention 2008; 4:C33-C38.
34. Serruys PW, Sianos G, Abizaid A, Aoki J, den Heijer P, Bonnier H, Smits P, McClean D, Verheye S, Belardi J, Condado J, Pieper M, Gambone L, Bressers M, Symons J, Sousa E, Litvack F. The effect of variable dose and release kinetics on neointimal hyperplasia using a novel paclitaxel-eluting stent platform: the Paclitaxel In-Stent Controlled Elution Study (PISCES). J Am Coll Cardiol 2005; 46:253-260.
35. 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.
36. Degertekin M, Lemos PA, Lee CH, Tanabe K, Sousa JE, Abizaid A, Regar E, Sianos G, van der Giessen WJ, de Feyter PJ, Wuelfert E, Popma JJ, Serruys PW. Intravascular ultrasound evaluation after sirolimus eluting stent implantation for de novo and in-stent restenosis lesions. Eur Heart J 2004; 25:32-38.