Novel paclitaxel-eluting, biodegradable polymer coated stent in the treatment of de novo coronary lesions: A prospective multicenter registry

Catheterization and Cardiovascular Interventions

Volumn 71, Issue 1, 2008, Pages 51-57

  Buszman, Paweł ^a,b   Trznadel, Stanisław ^b   Milewski, Krzysztof ^a,b   Rzeźniczak, Janusz ^c   Przewłocki, Tadeusz ^d   Kośmider, Maciej ^e   Wójcik, Jaroslaw ^f   Janczak, Jacek ^g   Zurakowski, Aleksander ^a   Kondys, Marek ^b   Król, Marek ^b   Kinasz, Leszek ^b   Jaklik, Andrzej ^a   Rzeszutko, Łukasz ^d   Kałuza, Grzegorz L ^h   Kiesz, Stephan ⁱ   Gil, Robert ^g  

^a MEDICAL UNIVERSITY OF SILESIA   (Poland)

^b American Heart of Poland ^*  (Poland)

^c J Strusia Hospital   (Poland)

^d JAGIELLONIAN UNIVERSITY MEDICAL COLLEGE   (Poland)

^e MEDICAL UNIVERSITY OF LODZ   (Poland)

^f MEDICAL UNIVERSITY OF LUBLIN   (Poland)

^g Military Hospital Warszawa   (Poland)

^h HOUSTON METHODIST RESEARCH INSTITUTE   (United States)

ⁱ San Antonio Endovascular and Heart Institute   (United States)

Author keywords

Percutaneous coronary intervention; Quantitative coronary angiography; Restenosis; Thrombosis

Indexed keywords

PACLITAXEL;

ADULT; AGED; ARTERY LESION; ARTERY THROMBOSIS; ARTICLE; CLINICAL TRIAL; CORONARY ARTERY DISEASE; DRUG ELUTING STENT; FEMALE; FOLLOW UP; HEART INFARCTION; HUMAN; IN-STENT RESTENOSIS; MAJOR CLINICAL STUDY; MALE; MULTICENTER STUDY; PROSPECTIVE STUDY; SAFETY; TREATMENT OUTCOME;

AGED; COATED MATERIALS, BIOCOMPATIBLE; COMORBIDITY; CORONARY ANGIOGRAPHY; CORONARY DISEASE; CORONARY RESTENOSIS; CORONARY STENOSIS; DRUG-ELUTING STENTS; FEMALE; HUMANS; MALE; MIDDLE AGED; PACLITAXEL; PROSPECTIVE STUDIES; REGISTRIES;

EID: 38549103648     PISSN: 15221946     EISSN: 1522726X     Source Type: Journal    
DOI: 10.1002/ccd.21392     Document Type: Article

References (24)

1. Stone GW, Moses J, Ellis SG, Schofer J, Dawkins KD, Morice MC, Colombo A, Schampaert E, Grube E, Kirtane AJ, Cutlip DE, Fahy M, Pocock SJ, Mehran R, Leon MB. Safety and efficacy of sirolimus- and paclitaxel-eluting coronary stents. N Engl J Med 2007;356:998-1008.
2. 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.
3. Colombo A, Drzewiecki J, Banning A, Grube E, Hauptmann K, Silber S, Dudek D, Fort S, Schiele F, Zmudka K, Guagliumi G, Russell ME. 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.
4. Holmes DR, Leon MB, Moses JW, Popma JJ, Cutlip D, Fitzgerald PJ, Brown C, Fischell T, Wong SC, Midei M, Snead D, Kuntz RE. Analysis of 1-year clinical outcomes in the SIRIUS trial: A randomized trial of a sirolimus-eluting stent versus a standard stent in patients at high risk for coronary restenosis. Circulation 2004;109:634-640.
5. Stone GW, Ellis SG, Cox D Hermiller, O'shaughnessy C, Tift Mann J, Turco M, Caputo RP, Bergin P, Greenberg J, Popma JJ, Russell ME. One-year clinical results with the slow-release, polymer-based, paclitaxel-eluting TAXUS stent. Circulation 2004;109:1942-1947.
6. 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.
7. Suzuki T, Kopia G, Hayashi S, Bailey LR, Llanos G, Wilensky R, Klugherz BD, Papandreou G, Narayan P, Leon MB, Yeung AC, Tio F, Tsao PS, Falotico R, Carter AJ. Stent-based delivery of sirolimus reduces neointimal formation in a porcine coronary model. Circulation 2001;104:1188-1193.
8. Drachman DE, Edelman ER, Seifert P, Groothuis AR, Bornstein DA, Kamath KR, Palasis M, Yang D, Nott SH, Rogers C. Neointimal thickening after stent delivery of paclitaxel: Change in composition and arrest of growth over six months. J Am Coll Cardiol 2000;36:2325-2332.
9. 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.
10. Ong AT, McFadden EP, Regar E, de Jaegere PP, van Domburg RT, Serruys PW. Late angiographic stent thrombosis (LAST) events with drug-eluting stents. J Am Coll Cardiol 2005;45: 2088-2092.
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. 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.
13. Pfisterer M, Brunner-La Rocca HP, Buser PT, Rickenbacher P, Hunziker P, Mueller C, Jeger R, Bader F, Osswald S, Kaiser C. Late clinical events after clopidogrel discontinuation may limit the benefit of drug-eluting stents: An observational study of drug-eluting versus bare-metal stents. J Am Coll Cardiol 2006;48: 2584-2591.
14. Buszman P, Zurakowski A, Kinasz L, Gorycki B, Krol M, Lewicki A, Flak Z, Milewski K, Zurek P. The new Polish stent chopin. Assessment of safety and efficacy in the treatment of de-novo coronary lesions using percutaneous angioplasty. Kardiol Pol 2005;62:451-459; discussion 460-461.
15. Milewski K, Buszman P, Zurakowski A, Pajak J, Stojko J, AbuSamra M. Biodegradable Polymer coated, paclitaxel eluting stents in the porcine coronary arteries (TCT abstract). Am J Cardiol Suppl 2005.
16. Carter AJ, Aggarwal M, Kopia GA, Tio F, Tsao PS, Kolata R, Yeung AC, Llanos G, Dooley J, Falotico R. Long-term effects of polymer-based, slow-release, sirolimus-eluting stents in a porcine coronary model. Cardiovasc Res 2004;63:617-624.
17. Farb A, Heller PF, Shroff S, Cheng L, Kolodgie FD, Carter AJ, Scott DS, Froehlich J, Virmani R. Pathological analysis of local delivery of paclitaxel via a polymer-coated stent. Circulation 2001;104:473-479.
18. Scheller B, Grandt A, Wnendt S, Lorenz G, Bohm M, Nickenig G. Comparative study of tacrolimus and paclitaxel stent coating in the porcine coronary model. Z Kardiol 2005;94:445-452.
19. Aoki J, Abizaid AC, Serruys PW, Ong AT, Boersma E, Sousa JE, Bruining N. Evaluation of four-year coronary artery response after sirolimus-eluting stent implantation using serial quantitative intravascular ultrasound and computer-assisted grayscale value analysis for plaque composition in event-free patients. J Am Coll Cardiol 2005;46:1670-1676.
20. Daemen J, Ong AT, Stefanini GG, Tsuchida K, Spindler H, Sianos G, de Jaegere PP, van Domburg RT, Serruys PW. Three-year clinical follow-up of the unrestricted use of sirolimus-eluting stents as part of the Rapamycin-Eluting Stent Evaluated at Rotterdam Cardiology Hospital (RESEARCH) registry. Am J Cardiol 2006;98:895-901.
21. Fajadet J, Morice MC, Bode C, Barragan P, Serruys PW, Wijns W, Constantini CR, Guermonprez JL, Eltchaninoff H, Blanchard D, Bartorelli A, Laarman GJ, Perin M, Sousa JE, Schuler G, Molnar F, Guagliumi G, Colombo A, Ban Hayashi E, Wulfert E. Maintenance of long-term clinical benefit with sirolimus-eluting coronary stents: Three-year results of the RAVEL trial. Circulation 2005;111:1040-1044.
22. 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.
23. Stone GW, Ellis SG, Cannon L, Mann JT, Greenberg JD, Spriggs D, O'shaughnessy CD, DeMaio S, Hall P, Popma JJ, Koglin J, Russell ME. Comparison of a polymer-based paclitaxel-eluting stent with a bare metal stent in patients with complex coronary artery disease: A randomized controlled trial. JAMA 2005;294:1215-1223.
24. Vranckx P, Serruys PW, Gambhir S, Sousa E, Abizaid A, Lemos P, Ribeiro E, Dani SI, Dalal JJ, Mehan V, Dhar A, Dutta AL, Reddy KN, Chand R, Ray A, Symons J. Biodegradable-polymer-based, paclitaxel-eluting Infinnium stent: 9-Month clinical and angiographic follow-up results form the SIMPLE II prospective multi-centre registry study. Eurointervention 2006;2: 310-317.