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Classic Papers in Coronary Angioplasty

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Clive Handler and Michael Cleman (Eds)

Classic Papers in Coronary

Angioplasty

With 18 Figures

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Clive Handler, MD, FACC, FESC Consultant Cardiologist and Physician The National Pulmonary Hypertension Unit The Royal Free Hospital

London, UK and

Consultant Cardiologist Highgate Hospital London, UK

Michael Cleman, MD, FACC Professor of Medicine Director

Cardiac Catheterization Laboratory and Angioplasty Services

Yale University School of Medicine/Yale-New Haven Hospital

New Haven, Connecticut, USA

British Library Cataloguing in Publication Data

A catalogue record for this book is available from the British Library Library of Congress Control Number: 2006922470

ISBN-10: 1-84628-400-7 e-ISBN: 1-84628-454-6 Printed on acid-free paper ISBN-13: 978-1-84628-400-7

© Springer-Verlag London Limited 2006

Apart from any fair dealing for the purposes of research or private study, or criticism or review, as permitted under the Copyright, Designs and Patents Act 1988, this publication may only be reproduced, stored or transmitted, in any form or by any means, with the prior permission in writing of the publishers, or in the case of reprographic reproduction in accordance with the terms of licences issued by the Copyright Licensing Agency. Enquiries concerning reproduction outside those terms should be sent to the publishers.

The use of registered names, trademarks, etc. in this publication does not imply, even in the absence of a specific statement, that such names are exempt from the relevant laws and regulations and therefore free for general use.

Product liability: The publisher can give no guarantee for information about drug dosage and application thereof contained in this book. In every individual case the respective user must check its accuracy by consulting other pharmaceutical literature.

Whilst we have made considerable efforts to contact all holders of copyright material contained in this book, we may have failed to locate some of them. Should holders wish to contact the Publisher, we will be happy to come to some arrangement with them.

Printed in the United States of America (EB) 9 8 7 6 5 4 3 2 1

Springer Science+Business Media springer.com

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Contents

Editors vi

Contributors vi

Acknowledgements viii

Preface ix

Foreword xi

Chapter 1 Vascular biology of atherosclerosis 1

Peter F. Bodary, Daniel T. Eitzman

Chapter 2 Quantification of coronary atherosclerosis for cardiovascular

risk assessment: the hole in the doughnut? 21

Paul Schoenhagen, Steven E. Nissen

Chapter 3 Primary angioplasty (PPCI) in ST-elevation myocardial

infarction 39

Iqbal Saeed Malik, Rodney Foale

Chapter 4 Coronary angioplasty for acute coronary syndromes 65 Steven Pfau

Chapter 5 High-risk coronary intervention: a selective literature review

of high-risk subsets 89

Jeffrey J. Popma, Hung Ly

Chapter 6 Stenting in coronary angioplasty 115

Jeptha P. Curtis, John F. Setaro

Chapter 7 Ancillary techniques in interventional cardiology 141 John M. Lasala, George Chrysant, Adrian Messerli

Chapter 8 Anti-thrombotic management in interventional cardiology 163 James Tcheng, Steve Kindsvater

Chapter 9 Coronary artery bypass grafts in the era of percutaneous

coronary angioplasty 191

Thanos Athanasiou, Brian Glenville

Chapter 10 Epilogue 217

Gerry Coghlan

Frequently cited papers in coronary angioplasty 229

Index 231

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Editors

Clive Handler MD, FACC, FESC

Consultant Cardiologist and Physician, The National Pulmonary Hypertension Unit, The Royal Free Hospital, London, UK

and Consultant Cardiologist, Highgate Hospital, London, UK

Michael Cleman MD, FACC

Professor of Medicine, Director, Cardiac Catheterization Laboratory and Angioplasty Services, Yale University School of Medicine/Yale-New Haven Hospital, New Haven, Connecticut, USA

Contributors

Thanos Athanasiou MD, PhD, FETCS

Consultant Cardiothoracic Surgeon, St. Mary’s Hospital, London, UK

Peter F. Bodary PhD

Research Investigator of Internal Medicine/Cardiology, University of Michigan, Ann Arbor, Michigan, USA

George Steven Chrysant MD

Director, Advanced Cardiac Imaging, Integris Heart Hospital, Oklahoma City, Oklahoma, USA

Gerry Coghlan MD, FRCP

Consultant Cardiologist, The Royal Free Hospital, London, UK

Jeptha P. Curtis MD

Instructor of Medicine, Section of Cardiovascular Medicine, Yale University School of Medicine, New Haven, Connecticut, USA

Daniel T. Eitzman MD, FACC

Associate Professor of Internal Medicine/Cardiology, University of Michigan, Ann Arbor, Michigan, USA

Rodney Foale MBBS, FRCP, FACC, FESC, FCSANZ

Consultant Cardiologist and Clinical Director of Surgery, Cardiovascular Science and Critical Care, Waller Department of Cardiology, St. Mary’s Hospital, London, UK

Brian Glenville BSc(Hons), MS

Professor and Head of Department of Cardiothoracic Surgery, Hadassah University Hospital, Jerusalem, Israel

Steven Michael Kindsvater MD

Keesler Medical Center, Keesler AFB, Mississippi, USA

John M. Lasala MD, PhD

Associate Professor of Cardiology, Washington University School of Medicine, St Louis, Missouri, USA

Hung Ly MD

Interventional Cardiology Fellow, Cardiology Division, Brigham and Women’s Hospital, Boston, Massachusetts, USA

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Iqbal Saeed Malik MA, MRCP, PhD

Consultant Interventional Cardiologist, Waller Department of Cardiology, St. Mary’s Hospital, London, UK

Adrian W. Messerli MD

Cardiology Associates of Kentucky, Lexington, Kentucky, USA

Steven E. Nissen MD, FACC

Medical Director, Cleveland Clinic Cardiovascular Research Coordinating Center, The Cleveland Clinic Foundation, Cleveland, Ohio, USA

Steven Pfau MD

Associate Professor of Medicine, Yale University School of Medicine, Cardiology Section, New Haven, Connecticut, USA

Jeffrey J. Popma MD

Director, Interventional Cardiology, Brigham and Women’s Hospital, Associate Professor of Medicine, Harvard Medical School, Boston, Massachusetts, USA

Paul Schoenhagen MD, FAHA

Cardiovascular Imaging, Departments of Radiology and Cardiovascular Medicine, The Cleveland Clinic Foundation, Cleveland, Ohio, USA

John F. Setaro MD

Associate Professor of Medicine, Section of Cardiovascular Medicine, Yale University School of Medicine, New Haven, Connecticut, USA

James E. Tcheng MD, FACC, FBCAI, FESC

Associate Professor of Medicine; Associate Professor of Community & Family Medicine, Duke Clinical Research Institute, Duke University Medical Center Durham, North Carolina, USA

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Acknowledgements

Both Clive Handler and Michael Cleman would like to thank Professor Lawrence Cohen for writ- ing the foreword to this book and for arranging the transatlantic link between London and New Haven, which was essential for this project, and for his encouragement and wise counsel.

Clive Handler would like to acknowledge the support of his wife, Caroline, and their three children, Charlotte, Sophie and Julius, during the production of this book. The idea for this book came from his colleague from school, Dr Neil Soni, who co-edited the first book in this series, Classic Papers in Critical Care. He is also grateful to his colleague from the Royal Free Hospital, Dr Gerry Coghlan, who not only contributed the final chapter but also proof read the book.

Michael Cleman would like to acknowledge his wife Marilyn, and his children, Jake and Katie for their patience and support in this project. The support and expertise of his interventional colleagues at Yale has been invaluable in collating the material.

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Preface

Percutaneous coronary intervention (PCI) is one of the most commonly performed cardiac pro- cedures. Physicians, all healthcare professionals and healthcare managers, as well as patients and their families, the world over, are aware that it is a very useful and powerful tool to help improve the lives of patients with coronary heart disease. But how did we get here?

Cardiologists of our generation were in training when PCI was in its infancy. There was no evidence base to guide us and we witnessed and practiced with comparatively primitive equip- ment. We all had to learn from our own successes and failures as well as from the experiences of colleagues. The residents and trainees of today may not fully appreciate the anxieties of inter- ventionists during procedures during those early years. Inherent problems included imaging and evaluating the significance of a coronary artery lesion; lack of data on what constituted high risk lesions and patients which made case selection difficult (this, in turn added uncertainty when discussing and quantifying the procedural risks to patients); arterial access problems and bleeding (particularly during the anticoagulation era); primitive and traumatic hardware compli- cating target lesion access; the sinking feeling of dealing with abrupt vessel closure, dissection and haemodynamic collapse before the availability of stents; and the disappointment felt by patients and interventionists with a comparatively high incidence of restenosis. Subacute thrombosis was an infrequent but worrying and unpredictable complication. On-site backup coronary artery surgery was generally considered mandatory and this had a knock-on effect on the work and finances of hospitals and providers.

Memories of those early days when our expectations of the procedure, performed mainly for accessible, proximal, comparatively simple lesions in patients with single vessel disease, were that plain old balloon angioplasty would keep our patients away from the surgeons for a little while longer, and that it could be used as a salvage procedure for “inoperable” patients, have faded and have been replaced with a different, more confident, evidence-based practice. The frontiers have been pushed back; PCI incorporating drug-eluting stents and modern antiplatelet treatments is a routine, low-risk, day-case procedure performed in patients of all ages and co-morbidity, with high patient and clinician expectations for both acute and chronic coronary artery disease, without the necessity of on-site surgery.

PCI has changed the way we approach clinical problems. Physicians managing patients with known or suspected coronary heart disease, whether in their office, in the emergency room or in the coronary care unit, understand that prompt diagnosis and treatment are now available.

We continually search for improvements and refinements in equipment and pharmacological therapies. We collaborate with our basic science colleagues to find answers to molecular and cellular biological obstacles. Our imaging and vascular colleagues are key members of the multidisciplinary approach to develop and expand the use of the technique and enhance the quality of service we provide our patients.

These rapid developments in the management of coronary heart disease, which will eventu- ally affect nearly all of us, have been possible only through the vision, persistence, intellectual curiosity, skill and discipline of our predecessors. Interventionists today have been handed the baton and continue the quest.

The aim of this book is not intended to be a birthday party for PCI, although its publication coin- cides with the 25th anniversary of Grüntzig’s paper. We wanted to pause, take breath and try to produce a small, useful and enjoyable book that would remind all those involved in PCI, of some of the major contributions to the literature. Looking back often helps in seeing what may lie ahead.

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We have invited some of the world’s leading interventionists to help us and they have done a fine job. They were given a difficult task. We asked them to provide us with their personal choice of the papers that have most influenced their practice and understanding of PCI in a number of its components.

As busy clinicians, we are not often (if ever) forced to identify the papers that have been the most influential in shaping our practice. It may be considered a somewhat artificial approach, but reading an expert’s personal, restricted choice of papers that he would take on a desert island (without internet or library access), is of interest. Dr Mitchell Fink MD, in his preface to

“Classic Papers in Critical Care”, excused the personal choices of the contributors by likening them to the views of a San Francisco restaurant critic. We have also included citation indices for each paper so that our readers have the additional views of the wider PCI community.

You may have your own personal choices and may disagree with the choice of our contrib- utors. We would beg your tolerance with this, an inherent weakness of this book. But it is also a strength, because the very nature and enjoyment of this series is that leading world experts allow readers to peep at their academic proclivities and personal perspectives of papers they think are scientifically and clinically useful. We feel that it provides a useful reference for others and has educational and historical value.

Our friend and teacher, the eminent Professor Lawrence Cohen, confessed in his foreword, that he “got it wrong” at his first attempt to 25 years ago. Even he could not have anticipated how things were to turn out. This collection of “Classic Papers in Coronary Angioplasty”, 25 years down the road, is an opportunity to look behind us as we enter an early lap of a long dis- tance race. Together with our contributors, we hope that you will enjoy this coned-in snapshot of PCI in 2005. We have no doubt that the next quarter of a century will bring us more surprises and improved care for our patients.

Clive Handler MD, FACC, FESC Michael Cleman MD, FACC Preface

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Foreword

I am particularly pleased to get a second chance. I refer to the fact that at the time of my first chance, I got it all wrong. The year was 1979 and Dr Andreas Grüntzig had recently published an article in The New England Journal of Medicine entitled Nonoperative Dilation of Coronary Artery Stenosis: Percutaneous Transluminal Coronary Angioplasty. I took the opportunity to write a Letter to the Editor in which I stated:

“A method for relief of coronary obstructions that did not involve operations would obvi- ously have a major impact on medical, surgical, economic and psychologic aspects of this disease...”

“Although this report is of great interest, it would be wise for cardiologists to maintain a healthy skepticism... This operation is clearly not the answer for most patients with obstructive coronary lesions. It is appropriate for only a fraction of patients with coronary artery disease – perhaps between 3 and 10 per cent. It may be successful in some patients with intrinsic coronary lesions and even in some who have previously undergone bypass grafting with subsequent occlusion of the graft.”

I further went on to say:

“Even when the obstructive lesion can be reached by the catheter, in how many patients will the dilatation be successful and free from complications such as intimal dissection?

Further, if a lesion can be dilated, will the obstruction remain open for an extended period or will it return in days, weeks or months?”

Perhaps you can understand my relief at being given a second chance to visit the topic of coro- nary angioplasty. This excellent book explores the growth in our knowledge gleaned over a quarter of a century. It explores the field from perspectives ranging from that of the vascular biol- ogist to that of the surgeon who must thoughtfully reassess the diminishing role of coronary artery bypass surgery now that a non-operative approach is not only possible but in many instances preferable. It would not be a stretch to say that coronary angioplasty is to cardiology as the Rosetta Stone was to Egyptian hieroglyphics, allowing the language to be translated.

The opening chapter on “Vascular Biology of Atherosclerosis” begins with the seminal work of Ross which was the first to identify the vascular smooth muscle cell as playing a critical role in the development of the atherosclerotic plaque. In collaboration with L. Harker, Ross went on to point to the role of hyperlipidemia in causing endothelial injury. The chapter by Schoenhagen and Nissen chronicles our ability to quantify the extent of coronary plaquing and also estimate the composition of coronary plaques. Proudfit’s paper of 40 years ago reports on the correla- tion between clinical findings and selective cine coronary arteriography in 1000 patients. For the first time, a patient’s clinical symptoms could be evaluated alongside a picture of the coronary arterial tree. This chapter also contains the 1990 article by Nissen et al. describing the develop- ment of intravascular ultrasound (IVUS), a technique that is able not only to quantify the extent of plaque but also its morphology.

As experience with coronary angioplasty grew in patients with stable angina, it is not sur- prising that clinicians would extend this technique to the patient who is in the midst of a myocar- dial infarction. This approach is compared to the previous gold standard, thrombolytic therapy.

It is now generally agreed that although both procedures have their respective roles, primary

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percutaneous coronary intervention (PPCI) is the preferable method if the patient can be brought to the catheterization laboratory in a timely manner.

Coronary angioplasty has spawned a wealth of research directed at prevention of thrombo- sis. The work on platelet glycoprotein IIb/IIIa receptor inhibition was stimulated by the need to prevent thrombosis at the site of angioplasty. It is unlikely that this field of research would have been advanced as far as it is today had it not been for the needs brought about by angioplasty.

Once balloon angioplasty became an established therapeutic procedure, the addition of coronary stenting was a natural sequence. It was hoped that stenting would help prevent restenosis, a complication that plagued up to 20 per cent of patients undergoing balloon angio- plasty. Starting slowly 15 years ago, coronary stents are now placed in 80 per cent of patients undergoing balloon angioplasty. The latest improvement is the development of drug-eluting stents to further prevent smooth muscle proliferation leading to restenosis.

Chapter 9 of this important book is a reflective commentary on the respective roles of angio- plasty and coronary artery bypass surgery. From its slow beginnings in 1980 where there were about 1000 angioplasties performed, there are currently 900,000 angioplasties performed annually. Most of these angioplasties are performed in patients who could not have been con- sidered candidates when the procedure was first introduced over 25 years ago. It has already become the primary treatment of patients with coronary artery disease.

Finally, I want to commend the two editors Drs Clive Handler and Michael Cleman. I first met Dr Handler when I was a Visiting Professor at the Brompton Hospital in 1985. He was a mem- ber of the Junior Cardiac Club. We became colleagues and friends, a relationship that has been a mutual pleasure for the past 20 years. Dr Cleman is my respected colleague at Yale. I have watched him grow from the time he came to Yale as a Cardiology Fellow 25 years ago, to his becoming a Professor and Head of our Interventional Cardiology Team.

As I indicated in the beginning of this piece, I am grateful to both of them for the opportunity of having a second chance to visit coronary angioplasty. This time I believe I got it right.

Professor Lawrence S. Cohen The Ebenezer K. Hunt Professor of Medicine Yale University School of Medicine New Haven, CT USA Fellow, British Cardiac Society Foreword

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