First report of a novel abluminal groove filled biodegradable polymer rapamycin-eluting stent in de novo coronary artery disease: Results of the first in man FIREHAWK trial

Chinese Medical Journal

Volumn 125, Issue 6, 2012, Pages 970-976

  Qian, Jie ^a   Xu, Bo ^a   Lansky, Alexandra J ^b   Yang, Yue Jin ^a   Qiao, Shu Bin ^a   Wu, Yong Jian ^a   Chen, Jue ^a   Hu, Feng Huan ^a   Yang, Wei Xian ^a   Mintz, Gary S ^c   Leon, Martin B ^c,d   Gao, Run Lin ^a  

^a FUWAI HOSPITAL   (China)

^b YALE UNIVERSITY SCHOOL OF MEDICINE   (United States)

^c CARDIOVASCULAR RESEARCH FOUNDATION   (United States)

^d Department of Medicine   (United States)

Author keywords

Coronary artery disease; First in man study; Optical coherence tomography; Rapamycin eluting stent

Indexed keywords

ACETYLSALICYLIC ACID; CHROMIUM; CLOPIDOGREL; COBALT; POLYLACTIC ACID; RAPAMYCIN;

ADULT; ANGIOCARDIOGRAPHY; ARTICLE; BIODEGRADABLE IMPLANT; BRAIN HEMORRHAGE; CLINICAL ARTICLE; CLINICAL TRIAL; CORONARY ARTERY DISEASE; DEATH; DEVICE SAFETY; DRUG ELUTING STENT; FEASIBILITY STUDY; FEMALE; FOLLOW UP; HUMAN; LOADING DRUG DOSE; MALE; NEOINTIMA; OPTICAL COHERENCE TOMOGRAPHY; REVASCULARIZATION; STENOSIS;

AGED; ANGIOPLASTY, BALLOON, CORONARY; CORONARY ANGIOGRAPHY; CORONARY ARTERY DISEASE; DRUG-ELUTING STENTS; FEMALE; FOLLOW-UP STUDIES; HUMANS; MALE; MIDDLE AGED; POLYMERS; SIROLIMUS; TOMOGRAPHY, OPTICAL COHERENCE;

EID: 84862256444     PISSN: 03666999     EISSN: None     Source Type: Journal    
DOI: 10.3760/cma.j.issn.0366-6999.2012.06.003     Document Type: Article

References (24)

1. Moses JW, Leon MB, Popma JJ, Fitzgerald PJ, Holmes DR, O'Shaughnessy C, et al. Rapamycin-eluting stents versus standard stents in patients with stenosis in a native coronary artery. N Engl J Med 2003; 349: 1315-1323.
2. Colombo A, Drzewiecki J, Banning A, Grube E, Hauptmann K, Silber S, et al. 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.
3. Iakovou I, Schmidt T, Bonizzoni E, Ge L, Sangiorgi GM, Stankovic G, et al. Incidence, predictors, and outcome of thrombosis after successful implantation of drug-eluting stents. JAMA 2005; 293: 2126-2130.
4. Daemen J, Wenaweser P, Tsuchida K, Abrecht L, Vaina S, Morger C, et al. Early and late coronary stent thrombosis of rapamycin-eluting and paclitaxel-eluting stents in routine clinical practice: data from a large two-institutional cohort study. Lancet 2007; 369: 667-678.
5. Joner M, Finn AV, Farb A, Mont EK, Kolodgie FD, Ladich E, et al. Pathology of drug-eluting stents in humans: delayed healing and late thrombotic risk. J Am Coll Cardiol 2006; 48: 193-202.
6. Farb A, Burke AP, Kolodgie FD, Virmani R. Pathological mechanisms of fatal late coronary stent thrombosis in humans. Circulation 2003; 108: 1701-1706.
7. Finn AV, Joner M, Nakazawa G, Kolodgie F, Newell J, John MC, et al. Pathological correlates of late drug-eluting stent thrombosis: strut coverage as a marker of endothelialization. Circulation 2007; 115: 2435-2441.
8. Virmani R, Guagliumi G, Farb A, Musumeci G, Grieco N, Motta T, et al. Localized hypersensitivity and late coronary thrombosis secondary to a rapamycin-eluting stent: should we be cautious? Circulation 2004; 109: 701-705.
9. Dani S, Kukreja N, Parikh P, Joshi H, Prajapati J, Jain S, et al. Biodegradable-polymer-based, rapamycin-eluting Supralimus stent: 6-month angiographic and 30-month clinical follow-up results from the series I prospective study. EuroIntervention 2008; 4: 59-63.
10. Kaluza GL, Kiesz S, Gil R. Novel paclitaxel-eluting, biodegradable polymer coated stent in the treatment of de novo coronary lesions: a prospective multicenter registry. Catheter Cardiovasc Intervent 2008; 71: 51-57.
11. TM paclitaxel-eluting stent. Proceedings of EuroPCR, May 25, 2010, Paris, France.
12. Morice MC, Serruys PW, Sousa JE, Fajadet J, Ban Hayashi E, Perin M, et al. A randomized comparison of a rapamycin-eluting stent with a standard stent for coronary revascularization. N Engl J Med 2002; 346: 1773-1780.
13. Schofer J, Schlüter M, Gershlick AH, Wijns W, Garcia E, Schampaert E, et al. Rapamycin-eluting stents for treatment of patients with long atherosclerotic lesions in small coronary arteries: double-blind, randomised controlled trial (E-SIRIUS). Lancet 2003; 362: 1093-1099.
14. Stone GW, Ellis SG, Cox DA, Hermiller J, O'Shaughnessy C, Mann JT, et al. A polymer-based, paclitaxel-eluting stent in patients with coronary artery disease. N Engl J Med 2004; 350: 221-231.
15. Grube E, Silber S, Hauptmann KE, Mueller R, Buellesfeld L, Gerckens U, et al. TAXUS I: Six- and twelve-month results from a randomized, double-blind trial on a slow-release paclitaxel-eluting stent for de novo coronary lesions. Circulation 2003; 107: 38-42.
16. Fajadet J, Wijns W, Laarman GJ, Kuck KH, Ormiston J, Münzel T, et al. Randomized, double-blind, multicenter study of the Endeavor zotarolimus-eluting phosphorylcholine-encapsulated stent for treatment of native coronary artery lesions: clinical and angiographic results of the ENDEAVOR II trial. Circulation 2006; 114: 798-806.
17. Zhang Q, Xu B, Yang YJ, Zhang RY, Li JP, Qiao SB, et al. Sirolimus-eluting cobalt alloyed stents in treating patients with coronary artery disease: six-month angiographic and one-year clinical follow-up result. A prospective, historically controlled, multi-center clinical study. Chin Med J 2007; 120: 533-538.
18. Matsumoto D, Shite J, Shinke T, Otake H, Tanino Y, Ogasawara D, et al. Neointimal coverage of sirolimus-eluting stents at 6-month follow-up: evaluated by optical coherence tomography. Eur Heart J 2007; 28: 961-967.
19. Miyoshi N, Shite J, Shinke T, Otake H, Tanino Y, Ogasawara D, et al. Comparison of paclitaxel-eluting stents with rapamycin-eluting stents implanted in a single coronary artery in one procedure by optical coherence tomography: 6-month follow-up. Circ J 2010; 74: 903-908.
20. Chen BX, Ma FY, Luo W, Ruan JH, Xie WL, Zhao XZ, et al. Neointimal coverage of bare-metal and rapamycin-eluting stents evaluated with optical coherence tomography. Heart 2008; 94: 566-570.
21. Finn AV, Joner M, Nakazawa G, Kolodgie F, Newell J, John MC, et al. Pathological correlates of late drug-eluting stent thrombosis: strut coverage as a marker of endothelialization. Circulation 2007; 115: 2435-2441.
22. Windecker S, Serruys PW, Wandel S, Buszman P, Trznadel S, Linke A, et al. Biolimus-eluting stent with biodegradable polymer versus rapamycineluting stent with durable polymer for coronary revascularization (LEADERS): a randomized non-inferiority trial. Lancet 2008; 372: 1163-1173.
23. Byrne RA, Kastrati A, Kufner S, Massberg S, Birkmeier KA, Laugwitz KL, et al. Randomized, non-inferiority trial of three limus agent-eluting stents with different polymer coatings: the Intracoronary Stenting and Angiographic Results: Test Efficacy of 3 Limus-Eluting Stents (ISAR-TEST-4) Trial. Eur Heart J 2009; 20: 2441-2449.
24. Stone GW, Rizvi A, Newman W, Mastali K, Wang JC, Caputo R, et al, SPIRIT IV investigators. Everolimus-eluting versus paclitaxeleluting stents in coronary artery disease. N Engl J Med 2010; 362: 1663-1674.