Cover Page i SIROLIMUSELUTING STENTS FROM RESEARCH TO CLINICAL PRACTICE Page ii Other Taylor & Francis Titles byPatrick W Serruys Handbook of Coronary Stents (1997, 1998, 2000, 2002) Frontiers in Interventional Cardiology (1997) Handbook of Vascular Brachytherapy (1998, 2000) Coronary Stenting: Current Perspectives, a Companion to the Handbook of Coronary Stents (1999) Coronary Lesions: A Pragmatic Approach (2001) High Risk Cardiac Revascularization (2002) Handbook of the Vulnerable Plaque (2004) Handbook of Cardiac Cell Transplantation (2004) Handbook of Drug Eluting Stents (2005) Page iii SIROLIMUS ELUTING STENTS FROM RESEARCH TO CLINICAL PRACTICE Edited by Patrick W Serruys MD PhD FACC FESC Professor and Head Department of Interventional Cardiology Thoraxcenter Erasmus University Rotterdam The Netherlands and Pedro A Lemos MD PhD Interventional Cardiologist Interventional Cardiology Service Heart Institute (InCor) University of São Paulo Medical School São Paulo Brazil Foreword by Martin B Leon MD Chairman, Cardiovascular Research Foundation Columbia University School of Medicine New York NY USA LONDON AND NEW YORK A MARTIN DUNITZ BOOK Page iv © 2005 Taylor & Francis, an imprint of the Taylor & Francis Group First published in the United Kingdom in 2004 by Taylor & Francis, an imprint of the Taylor & Francis Group, 2 Park Square, Milton Park, Abingdon, Oxon, OX14 4RN Tel.: +44 (0)1235 828600 Fax.: +44 (0)1235 829000 Email: [email protected] Website: http://www.dunitz.co.uk This edition published in the Taylor & Francis eLibrary, 2005. 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Library of Congress CataloginginPublication Data Data available on application ISBN 0203306872 Master ebook ISBN ISBN (OEB Format) ISBN 1 84184 492 6 (Print Edition) Distributed in North and South America by Taylor & Francis 2000 NW Corporate Blvd Boca Raton, FL 33431, USA Within Continental USA Tel.: 800 272 7737; Fax.: 800 374 3401 Outside Continental USA Tel.: 561 994 0555; Fax.: 561 361 6018 Email: [email protected] Distributed in the rest of the world by Thomson Publishing Services Cheriton House North Way Andover, Hampshire SP10 5BE, UK Tel.: +44 (0)1264 332424 Email: [email protected] Composition by Scribe Design, Ashford, Kent, UK Page v To all the international fellows who have worked in the Thoraxcenter in the past (1976–2004) and I thank them for having made me wiser…. PWS To my wife, Francine PAL Page vi CONTENTS Contributors ix Foreword xii I SirolimusEluting Stents in the Clinical Practice: Concepts, and General Overview 1 SirolimusEluting Stents as an AntiRestenosis Device: Basic Concepts and Summary of Pivotal Studies 3 Patrick W Serruys, Pedro A Lemos 2 SirolimusEluting Stents in The ‘Real World’: The RESEARCH Registry Rationale and Study Design 15 Pedro A Lemos, Patrick W Serruys, Ron T van Domburg 3 Unrestricted Utilization of SirolimusEluting Stents for De Novo Coronary Lesions 23 Pedro A Lemos, Patrick W Serruys, Ron T van Domburg II SirolimusEluting Stents for Patients at High Clinical Risk 4 Early Safety of SirolimusEluting Stents for Patients with Acute Coronary Syndromes 35 Pedro A Lemos, Chihang Lee, Patrick W Serruys 5 SirolimusEluting Stents for Patients with Acute Myocardial Infarction 41 Francesco Saia, Pedro A Lemos, Patrick W Serruys 6 SirolimusEluting Stents for Patients with Impaired Renal Function 49 Pedro A Lemos, Ron T van Domburg, Patrick W Serruys 7 Sirolimuseluting Stents for Patients with Prior Coronary Bypass Graft Surgery 53 Angela Hoye, Patrick W Serruys 8 SirolimusEluting Stents for Left Main Coronary Artery Disease 59 Chourmouzios A Arampatzis, Patrick W Serruys 9 SirolimusEluting Stents for Patients with Multivessel Coronary Disease 67 Chourmouzios A Arampatzis, Pedro A Lemos Page vii 10 SirolimusEluting Stents for Elderlies 73 Maniyal Vijayakumar, Pedro A Lemos, Patrick W Serruys III SirolimusEluting Stents for Patients at Special Anatomic Groups 11 SirolimusEluting Stents for Chronic Total Occlusions 79 Angela Hoye, Kengo Tanabe, Patrick W Serruys 12 SirolimusEluting Stents for Very Small Coronary Vessels 87 Pedro A Lemos, Patrick W Serruys 13 SirolimusEluting Stents for Very Long Lesions 93 Muzaffer Degertekin, Chourmouzios A Arampatzis, Pedro A Lemos 14 SirolimusEluting Stents for Bifurcation Lesions 99 Kengo Tanabe, Angela Hoye, Patrick W Serruys 15 SirolimusEluting Stents for Coronary Narrowings <50% in Diameter 107 Angela Hoye, Pedro A Lemos, Patrick W Serruys 16 SirolimusEluting Stents for InStent Restenosis 113 Francesco Saia, Patrick W Serruys 17 PostDilatation of Undersized SirolimusEluting Stents 125 Francesco Saia, Pedro A Lemos IV Complications after SirolimusEluting Stents 18 Thrombotic Stent Occlusion After SirolimusEluting Stent Implantation 135 Evelyn Regar, Pedro A Lemos, Patrick W Serruys 19 Morphology and Mechanisms of Restenosis After SirolimusEluting Stents 141 Pedro A Lemos, Francesco Saia 20 Predictors of Restenosis after SirolimusEluting Stent Implantation in Complex Patients 147 Pedro A Lemos, Dick Goedhart, Patrick W Serruys 21 Late Luminal Loss Response Pattern after SirolimusEluting Stent Implantation or Conventional Stenting 153 Pedro A Lemos, Ron T Van Domburg, Patrick W Serruys 22 Treatment of PostSirolimusEluting Stent Restenosis 157 Pedro A Lemos, Carlos AG van Mieghem, Patrick W Serruys Page viii V Costs of SirolimusEluting Stents 23 CostEffectiveness of SirolimusEluting Stents 165 Patrick W Serruys, Ben van Hout, Pedro A Lemos References 169 Index 189 Page ix CONTRIBUTORS Jiro Aoki MD Research fellow Catheterization Laboratory Erasmus University Rotterdam Erasmus Medical Center Thoraxcenter Rotterdam, The Netherlands Chourmouzios A Arampatzis MD, PhD Interventional Cardiologist Euromedica Clinic Thessaloniki, Greece Marcel JBM van den Brand MD, PhD Interventional Cardiologist Catheterization Laboratory Erasmus University Rotterdam Erasmus Medical Center Thoraxcenter Rotterdam, The Netherlands Paul Cummins RN Research coordinator Catheterization Laboratory Erasmus University Rotterdam Erasmus Medical Center Thoraxcenter Rotterdam, The Netherlands Joost Daemen Medical student Erasmus University Rotterdam Erasmus Medical Center Rotterdam, Netherlands Muzaffer Degertekin MD, PhD Associate Professor of Cardiology Department of Interventional Cardiology Kosuyolu Heart & Research Hospital Istanbul, Turkey Ron T van Domburg PhD Clinical Epidemiologist Clinical Epidemiology Group Erasmus University Rotterdam Erasmus Medical Center Thoraxcenter Rotterdam, The Netherlands Marco van Duuren Medical student Erasmus University Rotterdam Erasmus Medical Center Rotterdam, Netherlands GerritAnne van Es PhD Director of Research & Development Cardialysis B.V. Rotterdam, The Netherlands Pim de J Feyter MD, PhD Professor, NonInvasive Diagnosis of Ischemic Heart Diseases Interventional Cardiologist Erasmus University Rotterdam Erasmus Medical Center Thoraxcenter Rotterdam, The Netherlands Willem J van der Giessen MD, PhD Interventional Cardiologist Catheterization Laboratory Erasmus University Rotterdam Erasmus Medical Center Thoraxcenter Rotterdam, The Netherlands Dick Goedhart Statistician Cardialysis B.V. Rotterdam, The Netherlands