Coronary Artery Disease

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

  1. Paweł Buszman1,2,*,
  2. Stanisław Trznadel2,
  3. Krzysztof Milewski1,2,
  4. Janusz Rzeźniczak3,
  5. Tadeusz Przewłocki4,
  6. Maciej Kośmider5,
  7. Jaroslaw Wójcik6,
  8. Jacek Janczak7,
  9. Aleksander Żurakowski1,
  10. Marek Kondys2,
  11. Marek Król2,
  12. Leszek Kinasz2,
  13. Andrzej Jaklik1,
  14. Łukasz Rzeszutko4,
  15. Grzegorz L. Kałuża8,
  16. Stephan Kiesz9,
  17. Robert Gil10

Article first published online: 20 DEC 2007

DOI: 10.1002/ccd.21392

Issue

Catheterization and Cardiovascular Interventions

Catheterization and Cardiovascular Interventions

Volume 71, Issue 1, pages 51–57, 1 January 2008

Additional Information

How to Cite

Buszman, P., Trznadel, S., Milewski, K., Rzeźniczak, J., Przewłocki, T., Kośmider, M., Wójcik, J., Janczak, J., Żurakowski, A., Kondys, M., Król, M., Kinasz, L., Jaklik, A., Rzeszutko, Ł., Kałuża, G. L., Kiesz, S. and Gil, R. (2008), Novel paclitaxel-eluting, biodegradable polymer coated stent in the treatment of de novo coronary lesions: A prospective multicenter registry. Cathet. Cardiovasc. Intervent., 71: 51–57. doi: 10.1002/ccd.21392

Author Information

  1. 1

    Coronary Care Unit, Silesian Medical University, Katowice, Poland

  2. 2

    American Heart of Poland, Ustroń, Poland

  3. 3

    Invasive Cardiology Department, J. Strusia Hospital, Poznań, Poland

  4. 4

    Institute of Cardiology, Jagiellonian University Medical College, Kraków, Poland

  5. 5

    Cardiological and Cardiosurgical Department, Medical University, Łódź, Poland

  6. 6

    Clinic of Cardiology, Medical Academy, Lublin, Poland

  7. 7

    Haemodynamic Department, Central Clinical Military Hospital, Warsaw, Poland

  8. 8

    The Methodist Hospital Research Institute, Houston, Texas

  9. 9

    Endovascular and Heart Institute, San Antonio, Texas

  10. 10

    Invasive Cardiology Clinic, Military Hospital, Warsaw, Poland

*Upper Silesian Medical Center, Coronary Care Unit, ul. Ziolowa 47, 40-635 Katowice, Poland

  1. †

    This study was supported by BALTON, Warszawa, Poland by offering free product to the sites and financial support of the data collection and management, as well of the independent angiographic core lab analysis.

Publication History

  1. Issue published online: 20 DEC 2007
  2. Article first published online: 20 DEC 2007
  3. Manuscript Accepted: 5 SEP 2007
  4. Manuscript Received: 10 JUN 2007

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REFERENCES

  • 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.
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