And Paclitaxel-Eluting Stent
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Long term follow-up after drug-eluting stent implantation and early experience with endothelial progenitor cell capture stent De resultaten van drug-eluting stent implantatie op lange termijn en vroegtijdige ervaringen met de endotheliale progenitor cell gecoate stent Jiro Aoki Cover illustrations: Front Cover: Photo of IJsselmeer from Afsluitdijk Back Cover: Cover page of “Kaitai-shinsyo” Kaitai-shinsho is the first medical book in Japan. The events leading up to the publication of the work are described in detail in a later work by Gempaku, his Rangaku Kotohajime, where he states that in March 1771. Gempaku, Ryotaku and others observed the dis- section of the body of a criminal executed at Honegahara in the Senju district of Edo. Comparing their findings with the Anatomische Tabellen, a Dutch translation of a work on anatomy by the German Johann Adam Kulmus, they were astonished at its exactitude, and undertook to do a Japanese translation, which they achieved after three and a half years of indescribable labor. This translation was published under the title Kaitai-shinsho. The Kaitai-shinsho not only contributed greatly to the advancement of medicine in Ja- pan, it also stimulated a wider interest in Rangaku or Dutch studies, and in this sense too it is a landmark work of classic translation. Long term follow-up after drug-eluting stent implantation and early experience with endothelial progenitor cell capture stent De resultaten van drug-eluting stent implantatie op lange termijn en vroegtijdige ervaringen met de endotheliale progenitor cell gecoate stent Thesis to obtain the degree of Doctor from the Erasmus University Rotterdam by command of the Rector Magnificus Prof.dr. S.W.J. Lamberts and in accordance with the decision of the Doctorate Board The public defence shall be held on Wednesday, June 14, 2006 at 15:45 hrs by Jiro Aoki born in Tokyo, Japan Doctoral Committee Promotors Prof.dr. P.W. Serruys Prof.dr. W.J. van der Giessen Other members Prof.dr. P.J. de Feyter Prof.dr. A.F.W. van der Steen Dr. Eric Boersma For Asato Table of Contents Long term follow-up after drug-eluting stent implantation and early experience with EPC capture stent Chapter 1 Introduction and Over view of the thesis 11 Part 1 Long term tissue growth inside and outside drug eluting stent in humans 17 Chapter 2 Evaluation of Four-year Coronary Artery Response After Sirolimus-Eluting Stent Implan- tation by Using Serial Quantitative IVUS and Computer Assisted Grey-Scale Value Analysis for Plaque Composition Aoki J, Abizaid A, Serruys PW, Ong AT, Boersma E, Sousa E, Bruining N. J Am Coll Cardiol. 2005;46:1670-1676 21 Chapter 3 Peri-stent remodeling and neointimal suppression two-years after polymer based pacli- taxel eluting stents implantation- insight from serial IVUS analysis in the TAXUS II study Aoki J, Colombo A, Dudek D, Banning A, Drzewiecki J, Zmudka K, Shiele F, Russell ME, Koglin J, Serruys PW. Circulation. 2005;112:3876-3883 29 Chapter 4 One-year clinical effect of various doses and pharmacokinetic releases of paclitaxel elut- ed from an erodable polymer – Insights from the Paclitaxel In-Stent Controlled Elution Study (PISCES) Aoki J, Ong AT, Abizaid A, den Heijer P, Bonnier H, McClean D, Verheye S, Belardi G, Con- dado J, Pieper M, Sousa E, Bressers M, Symons J, Litvack F, Sianos G, Serruys PW Eurointervention. 2005;2:165-172 39 Chapter 5 Serial Assessment of Tissue Growth Inside and Outside the Stent after Implantation of Drug-Eluting Stent in Clinical Trials. -Does delayed neointimal growth exist? Aoki J, Abizaid A, Ong AT, Tsuchida K, Serruys PW Eurointervention. 2005;3:253-255 59 Part 2 Efficacy of drug eluting stent for high risk patients 55 Chapter 6 "Full Metal Jacket" (stented length ≥ 64 mm) Using Drug-Eluting Stents for De Novo Coronary Artery Lesions Aoki J, Ong AT, Rodriguez-Granillo GA, Mc Fadden E, van Mieghem CA, Valgimigli M, Tsuchida K, Sianos G, Regar E, de Jaegere P, van der Giessen W, de Feyter P, van Domburg R, Serruys PW. A Heart J. 2005;150:994-999 57 Chapter 7 The Efficacy of Sirolimus-Eluting Stents versus Bare Metal Stents for Diabetic Patients Un- dergoing Elective Percutaneous Coronary Intervention Aoki J, Ong AT, Rodriguez-Granillo GA, van Mieghem CA, Daemen J, Sonnenschein K, Mc Fadden E, Sianos G, van der Giessen W, de Feyter P, van Domburg R, Serruys PW. J Invasive Cardiol. 2005;17:344-348 65 Chapter 8 Outcomes of Unrestricted Utilization of Paclitaxel versus Sirolimus-Eluting Stents in 293 Unselected Consecutive Diabetic Patients Ong AT, Aoki J, Hoye A, van Mieghem CA, Rodriguez Granillo GA, Valgimigli M, Tsuchida K, Sonnenschein K, Regar E, van der Giessen WJ, de Jaegere PP, Sianos G, McFadden EP, de Feyter PJ, van Domburg RT, Serruys PW. Am J Cardiol. 2005;96:358-362 73 Chapter 9 Sirolimus-eluting stent implantation for chronic total occlusion of the left main coronary artery Aoki J, Hoye A, Saferov A, Alekyan B, Serruys P. J Interv Cardiol. 2005;18:65-69 81 Chapter 10 Short-and long-term clinical outcome after drug-eluting stent implantation for the percutaneous treatment of left main coronary artery disease: insight from the rapamycin- eluting and taxus stent evaluated at Rotterdam cardiology hospital registries Valgimigli M, van Mieghem CA, Ong AT, Aoki J, Rodriguez Granillo GA, McFadden EP, Kappetein AP, de Feyter PJ, Smith PC, Regar E, van der Giessen WJ, Sianos G, de Jaegere PP, van Domburg RT, Serruys PW. Circulation. 2005;111:1383-1189 89 Chapter 11 Sirolimus- versus Paclitaxel-Eluting stent implantation for the percutaneous treatment of left main coronary artery disease. A combined RESEARCH and TSEARCH Long-term Analysis Valgimigli M, Malagutti P, Aoki J, Garcia-Garcia HM, Rodriguez Granillo GA, van Mieghem C, Loghart JML, Ong ATL, Sianos G, Regar E, van Domburg R, de Feyter P, de Jaegere P, Serruys PW. J Am Coll Cardiol. 2006;47:507-514 99 Chapter 12 Significant reduction in restenosis after the use of sirolimus-eluting stents in the treat- ment of chronic total occlusions Hoye A, Tanabe K, Lemos PA, Aoki J, Saia F, Arampatzis C, Degertekin M, Hofma SH, Sianos G, McFadden E, van der Giessen WJ, Smits PC, de Feyter PJ, van Domburg RT, Serruys PW. J Am Coll Cardiol. 2004;43:1954-1958 109 Chapter 13 Drug-Eluting Stent Implantation for Chronic Total Occlusions: Comparison between the Sirolimus- and Paclitaxel-Eluting Stent Hoye A, Ong AT, Aoki J, van Mieghem CA, Rodriguez Granillo GA, Valgimigli M, Sianos G, McFadden EP, van der Giessen WJ, de Feyter PJ, van Domburg RT, Serruys PW. Eurointervention. 2005;2:193-197 117 Chapter 14 Restenosis rates following bifurcation stenting with sirolimus-eluting stents for de novo narrowings Tanabe K, Hoye A, Lemos PA, Aoki J, Arampatzis CA, Saia F, Lee CH, Degertekin M, Hofma SH, Sianos G, McFadden E, Smits PC, van der Giessen WJ, de Feyter P, van Domburg RT, Serruys PW. Am J Cardiol. 2004;94:115-118 125 Chapter 15 Treatment of De novo bifurcation lesions; Comparison of Sirolimus- and Paclitaxel-elut- ing stents Hoye A, van Mieghem C, Ong ATL, Aoki J,Rodriguez Granillo GA, Valgimigli M, Tsuchida K, Sianos G, McFadden EP, van der Giessen WJ, de Feyter P, van Domburg R, Serruys PW. Eurointervention. 2005;1:24-30 131 Part 3 Endothelial progenitor cell – alternative to drug-eluting stents 141 Chapter 16 Thirty-day incidence and six-month clinical outcome of thrombotic stent occlusion after bare-metal, sirolimus, or paclitaxel stent implantation Ong AT, Hoye A, Aoki J, van Mieghem CA, Rodriguez Granillo GA,Sonnenschein K, Regar E, McFadden EP, Sianos G, van der Giessen WJ, de Jaegere PP, de Feyter P, van Domburg RT, Serruys PW. J Am Coll Cardiol. 2005;45(6):947-953 143 Chapter 17 How to Accelerate the Re-endothelialization of Stents Ong AT, Aoki J, Kutryk, MJ, Serruys PW. Arch Mal Coeur Vaiss 2005; 98:123-126 153 Chapter 18 Endothelial Progenitor Cell Capture By Stents Coated With Antibody Against CD34-The HEALING-FIM (Healthy Endothelial Accelerated Lining Inhibits Neointimal Growth-First In Man) Registry. Aoki J, Serruys PW, van Beusekom H, Ong AT, McFadden E, Sianos G, van der Giessen, Regar E, de Feyter P, Davis R, Rowland S, Kutryk M. J Am Coll Cardiol. 2005;45:1574-1579 155 Part 4 Future direction to the interventional cardiology 167 Chapter 19 Emergent strategies in the interventional cardiology. Aoki J, Rodriguez-Granillo GA, Serruys PW. Revista Espanola de Cardiologia. 2005;58:962-973 169 Summary and Conclusions 183 Samenvatting en Conclusies 189 Acknowledgements 195 Curriculum Vitae 203 List of Publications 207 Color figures 221 Chapter 1 Introduction and Overview of the Thesis Introduction INTRODUCTION AND OVERVIEW OF THE THESIS Intracoronary stent replacement is being used increasingly for the treatment of athero- sclerotic coronary artery disease and has gained widespread acceptance. Although stent implantation itself has been shown to reduce restenosis compared to balloon angioplas- ty, in-stent restenosis still occurs in 10-40% of patients.1,2 In-stent restenosis has long been considered the main limitation hampering the long-term efficacy of coronary stent- ing. Restenosis after stent occurs secondary to the accumulation of smooth muscle cells and extracellular matrix which consists of proteoglycans, hyaluronan and collagen.3,4 To overcome this major limitation, drug-eluting stents were developed. Drug-elut- ing stents consist of a drug (immunosuppressive, antiproliferative, or anti-inflammatory drug), a polymer, and a stent platform. Several drugs with durable or erodable polymers were tested in clinical trials and showed that drug-eluting stents significantly inhibit neo- intimal growth compared with bare metal stents.5-7 Currently, drug-eluting stents have been widely distributed all over the world and become main-stream of percutaneous coronary intervention.