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

被引:33
作者
Buszman, Pawel [1 ,2 ]
Trznadel, Stanislaw [2 ]
Milewski, Krzysztof [1 ,2 ]
Rzezniczak, Janusz [3 ]
Przewlocki, Tadeusz [4 ]
Kosmider, Maciej [5 ]
Wojcik, Jaroslaw [6 ]
Janczak, Jacek [7 ]
Zurakowski, Aleksander [1 ]
Kondys, Marek [2 ]
Krol, Marek [2 ]
Kinasz, Leszek [2 ]
Jaklik, Andrzej [1 ]
Rzeszutko, Lukasz [4 ]
Kaluza, Grzegorz L. [8 ]
Kiesz, Stephan [9 ]
Gil, Robert [10 ]
机构
[1] Upper Silesian Med Ctr, Coronary Care Unit, Ziolowa 47, PL-40635 Katowice, Poland
[2] Amer Heart Poland, Ustron, Poland
[3] J Strusia Hosp, Invas Cardiol Dept, Poznan, Poland
[4] Jagiellonian Univ, Coll Med, Inst Cardiol, Krakow, Poland
[5] Med Univ Lodz, Cardiol & Cardiosurg Dept, Lodz, Poland
[6] Med Acad, Clin Cardiol, Lublin, Poland
[7] Cent Clin Mil Hosp, Haemodynam Dept, Warsaw, Poland
[8] Methodist Hosp, Res Inst, Houston, TX USA
[9] Endovasc & Heart Inst, San Antonio, TX USA
[10] Mil Hosp, Invas Cardiol Clin, Warsaw, Poland
关键词
percutaneous coronary intervention; restenosis; thrombosis; quantitative coronary angiography;
D O I
10.1002/ccd.21392
中图分类号
R5 [内科学];
学科分类号
1002 ; 100201 ;
摘要
Objectives: The purpose of the present study was to evaluate the efficacy and safety of a biodegradable polymer coated, paclitaxel eluting stent (Luc-Chopin(2)) based on 9-months angiographic and 12-months clinical follow-up results. Background: First-generation drug-eluting stents utilize nonbioabsorbable polymeric coatings, whose persistent presence in the arterial wall may negatively affect long-term outcomes. Bioabsorbable coatings with a degradation period matched to that of the drug elution may be a better alternative, clinically and economically. Methods: We conducted a prospective, multicenter first-in-man registry of a novel, locally developed, bioabsorbable-coated, paclitaxel-eluting coronary stent in 116 patients with single-lesion de novo coronary disease. Results: Major adverse cardiac events occurred in 7.8% patients within 12 months. There were no late thrombotic events, death, stroke, or surgical revascularization in that period. There were two myocardial infarctions, one related to recent subacute stent thrombosis and another associated with restenosis. By 12 months, target vessel revascularization was performed in 7.8%; 2.9% were ischemia-driven and the rest were mandated at 9 months in accordance with a control angiography protocol. Core-lab assessed binary in-stent restenosis (>= 50% DS) was noted in 11.9% patients and mean late loss was 0.46 +/- 0.47 mm. Conclusions: This first-in-man experience obtained in a multicenter registry of real-world de novo lesions (almost half of lesions were class B2 or C by AHA classification) showed a favorable safety profile and acceptable efficacy through 12 months. Randomized comparison with a benchmark nonbioabsorbable polymer coated paclitaxel eluting stent should be undertaken to validate this initial positive experience. (c) 2008 Wiley-Liss, Inc.
引用
收藏
页码:51 / 57
页数:7
相关论文
共 25 条
[1]   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].
Aoki, J ;
Abizaid, AC ;
Serruys, PW ;
Ong, ATL ;
Boersma, E ;
Sousa, JE ;
Bruining, N .
JOURNAL OF THE AMERICAN COLLEGE OF CARDIOLOGY, 2005, 46 (09) :1670-1676
[2]  
BUSZMAN P, 2005, KARDIOL POL, V62, P460
[3]  
Buszman Pawel, 2005, Kardiol Pol, V62, P451
[4]   Long-term effects of polymer-based, slow-release, sirolimus-eluting stents in a porcine coronary model [J].
Carter, AJ ;
Aggarwal, M ;
Kopia, GA ;
Tio, F ;
Tsao, PS ;
Kolata, R ;
Yeung, AC ;
Llanos, G ;
Dooley, L ;
Falotico, R .
CARDIOVASCULAR RESEARCH, 2004, 63 (04) :617-624
[5]   Randomized study to assess the effectiveness of slow- and moderate-release polymer-based paclitaxel-eluting stents for coronary artery lesions [J].
Colombo, A ;
Drzewiecki, J ;
Banning, A ;
Grube, E ;
Hauptmann, K ;
Silber, S ;
Dudek, D ;
Fort, S ;
Schiele, F ;
Zmudka, K ;
Guagliumi, G ;
Russell, ME .
CIRCULATION, 2003, 108 (07) :788-794
[6]   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 [J].
Daemen, Joost ;
Ong, Andrew T. L. ;
Stefanini, Giulio G. ;
Tsuchida, Keiichi ;
Spindler, Helle ;
Sianos, Georgios ;
de Jaegere, Peter P. T. ;
van Domburg, Ron T. ;
Serruys, Patrick W. .
AMERICAN JOURNAL OF CARDIOLOGY, 2006, 98 (07) :895-901
[7]   Neointimal thickening after stent delivery of paclitaxel: Change in composition and arrest of growth over six months [J].
Drachman, DE ;
Edelman, ER ;
Seifert, P ;
Groothuis, AR ;
Bornstein, DA ;
Kamath, KR ;
Palasis, M ;
Yang, DC ;
Nott, SH ;
Rogers, C .
JOURNAL OF THE AMERICAN COLLEGE OF CARDIOLOGY, 2000, 36 (07) :2325-2332
[8]   Maintenance of long-term clinical benefit with sirolimus-eluting coronary stents -: Three-year results of the RAVEL trial [J].
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, MA ;
Sousa, JE ;
Schuler, G ;
Molnar, F ;
Guagliumi, G ;
Colombo, A ;
Hayashi, EB ;
Wülfert, E .
CIRCULATION, 2005, 111 (08) :1040-1044
[9]   Pathological analysis of local delivery of paclitaxel via a polymer-coated stent [J].
Farb, A ;
Heller, PF ;
Shroff, S ;
Cheng, L ;
Kolodgie, FD ;
Carter, AJ ;
Scott, DS ;
Froehlich, J ;
Virmani, R .
CIRCULATION, 2001, 104 (04) :473-479
[10]   Differential response of delayed healing and persistent inflammation at sites of overlapping sirolimus- or paclitaxel-eluting stents [J].
Finn, AV ;
Kolodgie, FD ;
Harnek, J ;
Guerrero, LJ ;
Acampado, E ;
Tefera, K ;
Skorija, K ;
Weber, DK ;
Gold, HK ;
Virmani, R .
CIRCULATION, 2005, 112 (02) :270-278