C O N T E M P O R A R Y C A R D I O L O G Y Primary Angioplasty in Acute Myocardial Infarction Edited by James E. Tcheng, MD HUMANA PRESS P A A M I RIMARY NGIOPLASTY IN CUTE YOCARDIAL NFARCTION C C ONTEMPORARY ARDIOLOGY CHRISTOPHER P. CANNON, MD SERIES EDITOR Primary Angioplasty in Acute Myocardial Infarction, edited by James E. Tcheng,MD, 2002 Cardiogenic Shock: Diagnosis and Treatment, edited by David Hasdai, MD, Peter B. Berger, MD, Alexander Battler, MD, and David R. Holmes, Jr., MD, 2002 Management of Cardiac Arrhythmias, edited by Leonard I. Ganz, MD, 2002 Diabetes and Cardiovascular Disease, edited by Michael T. Johnstone and Aristidis Veves,MD,DSC, 2001 Blood Pressure Monitoring in Cardiovascular Medicine and Therapeutics, edited by William B. White, MD, 2001 Vascular Disease and Injury: Preclinical Research, edited by Daniel I. Simon, MD, and Campbell Rogers, MD 2001 Preventive Cardiology: Strategies for the Prevention and Treatment of Coronary Artery Disease, edited by JoAnne Micale Foody, MD, 2001 Nitric Oxide and the Cardiovascular System,edited by Joseph Loscalzo, MD, PhD and Joseph A. Vita, MD, 2000 Annotated Atlas of Electrocardiography: A Guide to Confident Interpretation,byThomas M. Blake, MD, 1999 Platelet Glycoprotein IIb/IIIa Inhibitors in Cardiovascular Disease, edited by A. Michael Lincoff, MD, and Eric J. Topol, MD, 1999 Minimally Invasive Cardiac Surgery, edited by Mehmet C. Oz, MD and Daniel J. Goldstein, MD, 1999 Management of Acute Coronary Syndromes,edited by Christopher P. Cannon, MD, 1999 P A RIMARY NGIOPLASTY A M IN CUTE YOCARDIAL I NFARCTION Edited by J E. T , AMES CHENG MD Duke Clinical Research Institute and Division of Cardiology Duke University Health System, Durham, NC H P UMANA RESS T , N J OTOWA EW ERSEY © 2002 Humana Press Inc. 999 Riverview Drive, Suite 208 Totowa, New Jersey 07512 www.humanapress.com For additional copies, pricing for bulk purchases, and/or information about other Humana titles, contact Humana at the above address or at any of the following numbers: Tel.: 973-256-1699; Fax: 973-256-8341, E-mail: [email protected]; or visit our Website: http://humanapress.com All rights reserved. No part of this book may be reproduced, stored in a retrieval system, or transmitted in any form or by any means, electronic, mechanical, photocopying, microfilming, recording, or otherwise without written per- mission from the Publisher. All articles, comments, opinions, conclusions, or recommendations are those of the author(s), and do not neces- sarily reflect the views of the publisher. Due diligence has been taken by the publishers, editors, and authors of this book to assure the accuracy of the information published and to describe generally accepted practices. The contributors herein have carefully checked to ensure that the drug selections and dosages set forth in this text are accurate and in accord with the standards accepted at the time of publication. Notwithstanding, as new research, changes in government regulations, and knowledge from clinical experience relating to drug therapy and drug reactions constantly occurs, the reader is advised to check the product information provided by the manufacturer of each drug for any change in dosages or for additional warnings and contraindications. This is of utmost importance when the recommended drug herein is a new or infrequently used drug. It is the responsibility of the treating physician to determine dosages and treatment strategies for individual patients. Further it is the responsibility of the health care provider to ascertain the Food and Drug Administration status of each drug or device used in their clinical practice. The publisher, editors, and authors are not responsible for errors or omissions or for any consequences from the application of the information presented in this book and make no warranty, express or implied, with respect to the contents in this publication. Cover illustration: Left chamber—Mitral and Aortic with Blood Cells. LifeART image copyright 2002 by Lippincott Williams & Wilkins. All rights reserved. Cover design by Patricia F. Cleary. This publication is printed on acid-free paper. ∞ ANSI Z39.48-1984 (American National Standards Institute) Permanence of Paper for Printed Library Materials. Photocopy Authorization Policy: Authorization to photocopy items for internal or personal use, or the internal or personal use of specific clients, is granted by Humana Press Inc., provided that the base fee of US $10.00 per copy, plus US $00.25 per page, is paid directly to the Copyright Clearance Center at 222 Rosewood Drive, Danvers, MA 01923. For those organizations that have been granted a photocopy license from the CCC, a separate system of payment has been arranged and is acceptable to Humana Press Inc. The fee code for users of the Transactional Reporting Service is: [0-89603-904-8/02 $10.00 + $00.25]. Printed in the United States of America. 10 9 8 7 6 5 4 3 2 1 Library of Congress Cataloging-in-Publication Data P REFACE Over the past 50 years, care of the patient sustaining an acute myocardial infarction has undergone a stunning evolution. In the early days, there was little to offer the patient with an acute infarction except for weeks of absolute bedrest, and substantial morbidity and high rates of mortality were the norm. Just 15 years ago, thrombolytic therapies were being introduced as a pharmacologic approach to treat the acute event more aggressively and, fortunately, more successfully. About the same time, a few brave pioneers asked the question, why not perform emergency angioplasty as a primary reperfusion strategy? These individuals, despite being thought of as heretical by mainstream cardiology, nonetheless persevered, proving the benefit of “state of the art” balloon angioplasty com- pared to “state of the art” thrombolytic therapy in a series of landmark trials published in the New England Journal of Medicine in 1993. Since then, there has been no turning back, and today the technique has evolved to incorporate a multifaceted approach including the best of angioplasty technologies coupled with a rich and growing armamentarium of adjunctive medications, all designed to optimize both short- and long-term outcomes. It is a pleasure to bring together in this volume the best available data about direct percutaneous coronary intervention (PCI) as primary treatment of acute myocardial infarction. The first three chapters provide critical background infor- mation about the lexicon and requirements personnel and institutions must un- derstand and fulfill to have a safe and successful program. The next two chapters tell the early history of direct PCI, including a review of the inauspicious begin- nings in plain old balloon angioplasty and how these beginnings led to current stent PCI strategies; a second chapter discusses the use of emergency PCI as a bailout procedure for failed thrombolysis. Chapters 6–9 survey the contempo- rary strategies that define direct PCI today, including the growing movement to institute direct PCI programs in hospitals that do not have full-time surgical backup; adjunctive therapies aimed at reducing reperfusion injury and maintain- ing TIMI grade 3 flow; the potent platelet inhibitors known as glycoprotein (GP) IIb/IIIa receptor inhibitors and their role in PCI; and the randomized clinical trial evaluations of stent implantation and GP IIb/IIIa inhibitors singularly and in combination. The final chapter fills in the economic justification for a medical procedure that could arguably be recommended to as many as half a million patients in the United States per year. I am grateful to my colleagues, the authors of the chapters in this book, for their willingness to share their knowledge, their research, and their insights. In an age when any time spent away from research and practice is precious, it is a tribute to their dedication to the highest quality clinical care that they were v vi Preface willing to spend so much time putting their thoughts down so that we could all benefit from them. I would also like to extend special notes of thanks to Joyce Sizemore and Penny Hodgson for their managerial and editorial contributions. Most importantly, I dedicate this book to my forever sweetheart, Mary Ann Powers, without whose patience, understanding, and love this project could not have been accomplished. James E. Tcheng, MD C ONTENTS Preface..................................................................................................v Contributors ........................................................................................ix 1 Rationale and Lexicon of Primary Angioplasty.........................1 Warren J. Cantor 2 Operator and Site Requirements for Primary Angioplasty........9 J. Conor O’Shea 3 Primary Coronary Intervention for Acute Myocardial Infarction:Technical Approaches....................................19 David A. Cox 4 Primary Angioplasty (POBA) vs Thrombolysis: The Early 1990s Experience ............................................37 Bruce R. Brodie 5 Rescue Percutaneous Coronary Intervention for Failed Thrombolysis....................................................................53 Debabrata Mukherjee and Stephen G. Ellis 6 Primary Angioplasty in Community Hospitals without On-Site Cardiac Surgery.....................................65 Thomas P. Wharton, Jr. and Nancy Sinclair McNamara 7 Drug Strategies for Angioplasty in Acute Myocardial Infarction...........................................................................93 Edward Kim and Alan W. Heldman 8 Platelet Glycoprotein IIb/IIIa Receptor Blockade in Primary Angioplasty.......................................................117 Abdulhay Albirini and Sorin J. Brener 9 Integrating Coronary Stents and Glycoprotein IIb/IIIa Inhibitors into a Mechanical Reperfusion Strategy: The CADILLAC and ADMIRAL Trials.............................139 Gregg W. Stone, David E. Kandzari, and Cindy L. Grines 10 Health Economics of Primary Percutaneous Transluminal Coronary Angioplasty ....................................................169 Russell J. Ivanhoe Index........................................................................................177 vii C ONTRIBUTORS ABDULHAY ALBIRINI,MD,Department of Cardiology, The Cleveland Clinic Foundation, Cleveland, OH SORIN J. BRENER,MD,Department of Cardiology, The Cleveland Clinic Foundation, Cleveland, OH BRUCE R. BRODIE,MD,LeBauer Cardiovascular Research Foundation and Moses Cone Heart & Vascular Center, Greensboro, NC WARREN J. CANTOR,MD,Division of Cardiology, St Michael’s Hospital, Toronto, Ontario, Canada DAVID A. COX,MD,Mid Carolina Cardiology, Charlotte, NC STEPHEN G. ELLIS, MD, Department of Cardiology, The Cleveland Clinic Foundation, Cleveland, OH CINDY L. GRINES,MD,University of Michigan Medical Center, Ann Arbor, MI ALAN W. HELDMAN, MD, Johns Hopkins University School of Medicine, Baltimore, MD RUSSELL J. IVANHOE,MD,Winter Park, FL DAVID E. KANDZARI,MD,Duke Clinical Research Institute, Durham, NC EDWARD KIM,MD,Johns Hopkins University School of Medicine, Baltimore, MD NANCY SINCLAIR MCNAMARA,RN,BSN,Division of Cardiology, Exeter Hospital, Exeter, NH DEBABRATA MUKHERJEE,MD,Division of Cardiology, University of Michigan Health System, Ann Arbor, MI J. CONOR O’SHEA,MD,Cardiology Division, Duke University Medical Center and Duke Clinical Research Institute, Durham, NC GREGG W. STONE,MD,Cardiovascular Research Foundation, New York, NY JAMES E. TCHENG,MD,Duke Clinical Research Institute, and Division of Cardiology, Duke University Health System, Durham, NC THOMAS P. WHARTON, JR., MD, Division of Cardiology, Exeter Hospital, Exeter, NH, and Division of Cardiology, Portsmouth Regional Hospital, Portsmouth, NH ix