Coronary Stenting: A Companion to Topol's Textbook of Interventional Cardiology

238 Pages·2013·33.855 MB·English

by  Matthew J. Price

C S
ORONARY TENTING
A Companion to Topol’s Textbook
of Interventional Cardiology

C
ORONARY
S
TENTING
A Companion to Topol’s Textbook
of Interventional Cardiology
MATTHEW J. PRICE, MD
Director, Cardiac Catheterization Laboratory
Scripps Green Hospital;
Division of Cardiovascular Diseases
Scripps Clinic;
Assistant Professor
Scripps Translational Science Institute
La Jolla, California
1600 John F. Kennedy Blvd.
Ste 1800
Philadelphia, PA 19103-2899
CORONARY STENTING: A COMPANION TO TOPOL’S TEXTBOOK ISBN: 978-1-4557-0764-5
OF INTERVENTIONAL CARDIOLOGY
Copyright © 2014 by Saunders, an imprint of Elsevier Inc.
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Library of Congress Cataloging-in-Publication Data
Coronary stenting : a companion to Topol’s Textbook of interventional cardiology / [edited by]
Matthew J. Price.—1st ed.
p. ; cm.
Includes index.
Companion to: Textbook of interventional cardiology / edited by Eric J. Topol, Paul S. Teirstein. 6th ed.
c2012.
ISBN 978-1-4557-0764-5 (hardcover)
I. Price, Matthew J., 1969- II. Topol, Eric J., 1954- Textbook of interventional cardiology.
[DNLM: 1. Coronary Artery Disease. 2. Stents. 3. Cardiac Surgical Procedures. 4. Coronary
Restenosis. 5. Drug-Eluting Stents. WG 300]
RD598
617.4′12059–dc23
2013003641
Executive Content Strategist: Dolores Meloni
Senior Content Development Specialist: Joan Ryan
Publishing Services Manager: Pat Joiner
Project Manager: Nisha Selvaraj
Design Direction: Ellen Zanolle
Printed in China
Last digit is the print number: 9 8 7 6 5 4 3 2 1
To my wife, Martha, for her patience, support, and love; and to my children, Alexander and Gabriella.
CONTRIBUTORS
Christina Adams, MD Juan F. Granada, MD, FACC
Chief Fellow, Cardiovascular Division Executive Director and Chief Scientific Officer
Scripps Clinic/Scripps Green Hospital Skirball Center for Cardiovascular Research
La Jolla, California The Cardiovascular Research Foundation;
Assistant Professor
Dominick J. Angiolillo, MD, PhD, FACC, FESC, FSCAI Columbia University Medical Center
Director, Cardiovascular Research New York, New York
Associate Professor of Medicine
University of Florida College of Medicine–Jacksonville J. Aaron Grantham, MD
Jacksonville, Florida Associate Professor of Medicine
University of Missouri—Kansas City
Gill Louise Buchanan, MBChB Saint Luke’s Mid America Heart Institute
Invasive Cardiology Unit Kansas City, Missouri
San Raffaele Scientific Institute
Milan, Italy Karthik Gujja, MD, MPH
Interventional Cardiology
Alaide Chieffo, MD Division of Cardiovascular Diseases
Invasive Cardiology Unit Beth Israel Medical Center
San Raffaele Scientific Institute New York, New York
Milan, Italy
Greg L. Kaluza, MD, PhD, FACC
Marco A. Costa MD, PhD Director of Research
Harrington Heart and Vascular Institute Skirball Center for Cardiovascular Research
University Hospitals of Cleveland The Cardiovascular Research Foundation
Case Western Reserve University New York, New York
Cleveland, Ohio
Ajay J. Kirtane, MD, SM
Ricardo A. Costa, MD Chief Academic Officer
Chief Center for Interventional Vascular Therapy;
Clinical Research Director, Interventional Cardiology Fellowship Program
Department of Invasive Cardiology Columbia University Medical Center/New York-Presbyterian
Institute Dante Pazzanese of Cardiology; Hospital
Director New York, New York
Angiographic Core Laboratory
Cardiovascular Research Center Frank D. Kolodgie, PhD
São Paulo, Brazil Associate Director
CVPath Institute, Inc.
David Daniels, MD Gaithersburg, Maryland
Palo Alto Medical Foundation
Woodside, California Lawrence D. Lazar, MD
Clinical Instructor of Medicine
Andrejs Ērglis, MD Division of Cardiology
Professor School of Medicine
University of Latvia; University of California, Los Angeles
Chief Los Angeles, California
Latvian Centre of Cardiology
Pauls Stradins Clinical University Hospital Michael S. Lee, MD
Riga, Latvia Assistant Clinical Professor of Medicine
Division of Cardiology
William F. Fearon, MD School of Medicine
Associate Professor University of California, Los Angeles
Director, Interventional Cardiology Los Angeles, California
Division of Cardiovascular Medicine
Stanford University Medical Center William L. Lombardi, MD, FACC, FSCAI
Stanford, California Medical Director
Cardiac Catheterization Laboratories
Aloke V. Finn, MD PeaceHealth St. Joseph Medical Center
Assistant Professor Bellingham, Washington
Division of Cardiology
Emory University School of Medicine
Atlanta, Georgia
vii
viii Contributors
Roxana Mehran, MD Armando Tellez, MD
Professor of Medicine Assistant Director, Pathology
Department of Cardiology Skirball Center for Cardiovascular Research
Mount Sinai School of Medicine The Cardiovascular Research Foundation
Mount Sinai Medical Center New York, New York
New York, New York
Marco Valgimigli, MD, PhD, FESC
William J. Mosley II, MD Director, Catheterization Laboratory
Division of Cardiovascular Diseases University Hospital of Ferrara
Scripps Clinic Ferrara, Italy
La Jolla, California
Renu Virmani, MD
Masataka Nakano, MD President and Medical Director
CVPath Institute, Inc. CVPath Institute, Inc.
Gaithersburg, Maryland Gaithersburg, Maryland
Amar Narula, MD Georgios J. Vlachojannis, MD, PhD
Division of Cardiology Interventional Cardiovascular Research
New York University Medical Center Mount Sinai Medical Center
New York, New York New York, New York
Yoshinobu Onuma, MD Mark W. I. Webster, MBChB
Thoraxcenter Auckland City Hospital
Erasmus Medical Center Auckland, New Zealand
Rotterdam, The Netherlands
Neil J. Wimmer, MD
John A. Ormiston, MBChB Division of Cardiovascular Medicine
Mercy Angiography, Mercy Hospital Brigham and Women’s Hospital
Auckland City Hospital Harvard Medical School
Auckland, New Zealand Boston, Massachusetts
Fumiyuki Otsuka, MD, PhD Hirosada Yamamoto, MD
CVPath Institute, Inc. Harrington Heart and Vascular Institute
Gaithersburg, Maryland University Hospitals of Cleveland
Case Western Reserve University
Matthew J. Price, MD Cleveland, Ohio
Director, Cardiac Catheterization Laboratory
Scripps Green Hospital; Robert W. Yeh, MD, MBA
Division of Cardiovascular Diseases Medical Director of Clinical Trial Design
Scripps Clinic; Harvard Clinical Research Institute;
Assistant Professor Assistant Professor
Scripps Translational Science Institute Cardiology Division, Department of Medicine
La Jolla, California Massachusetts General Hospital
Harvard Medical School
Richard A. Schatz, MD Boston, Massachusetts
Director of Research, Cardiovascular Interventions
Scripps Clinic Jennifer Yu, MD
La Jolla, California Interventional Cardiology Fellow
Mount Sinai Medical Center
Patrick W. Serruys, MD, PhD New York, New York
Thoraxcenter
Erasmus Medical Center
Rotterdam, The Netherlands
Gregg W. Stone, MD
Professor of Medicine
Columbia University;
Director of Cardiovascular Research and Education
Center for Interventional Vascular Therapy
Columbia University Medical Center/New York-Presbyterian
Hospital;
Co-Director of Medical Research and Education
The Cardiovascular Research Foundation
New York, New York
PREFACE
The procedure first performed by Andreas Gruntzig on September 16, applied in the research setting and in clinical practice in particular. I
1977—dilating a coronary stenosis with a semicompliant balloon on have divided the text into four sections. The prologue discusses the
a catheter—was revolutionary. Yet the coronary stent, in combination development and history of stents. The second section, “Basic Prin-
with advances in adjunctive pharmacology, overcame the substantial ciples,” focuses on the fundamentals of stent design, the ways in which
limitations of coronary angioplasty (e.g., acute vessel closure and poor stent safety is validated in preclinical models, the design and biology
long-term patency) and is responsible for successfully transforming the of bioresorbable scaffolds, and the methods used to assess safety and
management of patients with obstructive coronary artery disease. This clinical efficacy. The third, “Clinical Use,” examines the adjunctive
paradigm shift in patient care from surgical to percutan eous coronary devices and pharmacologic measures that can optimize clinical out-
revascularization was consolidated further by the development of the comes during and after stent implantation and discusses the clinical
drug-eluting stent, which substantially reduced neointimal prolifera- differences between bare metal and drug-eluting stents that may guide
tion and the need for repeat revascularization that were observed with operator decision-making. The last section, “Specific Lesion Subsets,”
bare metal stents. To the neophyte interventional cardiology fellow, provides a detailed focus on the role, techniques, and outcomes of
the acute efficacy of the coronary stent to treat a severe dissection stenting in particular types of coronary anatomies and patient popula-
caused by balloon angioplasty appears self-evident, an observation tions, incorporating the most recent randomized clinical trials that
that reminds me of an aphorism that William Ganz once shared with can inform patient management.
me while I was in training, as he leaned into my ear and spoke softly, Coronary Stenting will be especially useful for interventional and
as if sharing a secret: “You don’t need fancy statistics to tell you when invasive cardiologists in training or in practice. It will also serve as a
something really works.” valuable resource for medical trainees with an interest in cardiology
However, the introduction and rapid adoption of the stent into and for the ever-growing number of providers of patient care before,
clinical practice raised a host of scientific and clinical questions that during, and after percutaneous coronary intervention, including phy-
led to the establishment and maturation of a new field of research and sician assistants, nurse practitioners, and cardiac catheterization labo-
clinical inquiry. Appropriate preclinical models were developed to ratory staff.
assess stent safety; the investigation of the vascular response to injury I am indebted to my colleagues who have contributed their time
and the biology of platelet activation and aggregation unraveled the and expertise to this volume, to Joan Ryan at Elsevier, and to Eric
mechanisms of neointimal proliferation and stent thrombosis; a work- Topol, the editor of the seminal Textbook of Interventional Cardiology,
able framework to measure angiographic efficacy outcomes was devel- to which this text serves as a companion. I have been lucky to have
oped (e.g., quantitative coronary angiography and the endpoints of Paul Teirstein as a mentor and colleague and can only hope to emulate
acute gain and late luminal loss); and the design of randomized clini- his ability to push the boundaries of our field with such energy and
cal trials was standardized to definitively assess safety and the angio- wit. I am especially grateful to the many patients whom I have treated
graphic and clinical efficacy of different stent types. The development in the cardiac catheterization laboratory; if the care of a single such
of drug-eluting stents added further layers of complexity in device patient is improved through this text, then the efforts of this endeavor
development, required the expansion of preclinical models, and after will have proved worthwhile.
the observation of the phenomenon of late stent thrombosis, neces-
sitated studies with longer-term clinical follow-up to better assess Matthew J. Price, MD
safety. The coronary stent has therefore become one of the most La Jolla, California
intensively studied devices in medical history and certainly deserves January, 2013
a textbook that is specifically dedicated to it.
The goal of Coronary Stenting is to provide the reader with a broad
and deep understanding of the field of coronary stenting that can be
ix
CHAPTER 1
Development of Coronary Stents:
A Historical Perspective
RICHARD A. SCHATZ | CHRISTINA ADAMS
KEY POINTS in the hospital. Furosemide and aminophylline were added if the
patient developed congestive heart failure as determined by physical
• Angioplasty was a very important milestone in cardiology; however, examination. It was not unusual for a patient to be hospitalized for 4
results were limited by abrupt closure and restenosis.
to 6 weeks during this observation period. Nitroglycerin was strictly
• Many investigators recognized these limitations in the 1960s and forbidden for fear of hypotension and worsening ischemia from a
1970s and attempted to overcome them with self-expanding metal “steal” phenomenon. There was much consternation and anxiety
coils in experimental animal models. during this period for both the patient and the physician because
• Palmaz, inspired by Grüntzig, conceived of the first balloon expandable options were very limited.
stainless steel stent in the late 1970s.
• The first stents were rigid slotted tubes, 30 mm in length and 3 mm in
Angioplasty: The Beginnings
diameter.
• In 1985, Palmaz teamed up with Schatz and placed the first stents in In September 1977, a daring young physician in Zurich, Switzerland,
dog coronaries. These were smaller but still rigid. performed the first angioplasty on a conscious patient with a tight
• As the U.S. trials began in the late 1980s, several competing lesion of the left anterior descending (LAD) artery. Andreas Grüntzig
devices appeared, including a self-expanding spring and a balloon had been quietly working on a concept that he had conceived while
expandable coil. studying under one of the great mentors of radiology, Charles Dotter.
Grüntzig had watched Dotter’s procedure of dilating peripheral arte-
• The Palmaz-Schatz stent underwent several changes to make it more
flexible and more deliverable and was released outside the United rial stenoses with progressively larger, tapered tubes. From these obser-
States in 1988. vations, he had the idea of adding a balloon to the catheter tip and
a central lumen inside the catheter to fill the balloon with contrast
• After many years of trials, the Gianturco-Roubin stent was approved in
material. On expansion of the balloon at the target site, the plaque
the United States, followed by the Palmaz-Schatz stent in 1994.
would give way (like “crushed snow”) and, it was hoped, remain open.
• By 1998, two more stents were approved, the Multilink and the
Grüntzig struggled to get support from many sources to build a work-
Advanced Vascular Engineering Microstent, followed by the Crown
able prototype and to test it in animal models. He eventually was able
stent, a modification of the Palmaz-Schatz stent, and later the GFX
to build a catheter suitable for human use and after much difficulty
stent.
received permission to try the first case in a human. The case was a
• Since the introduction of stents, millions of patients have been treated
success, and the 37-year-old patient walked out of the hospital angina
with coronary stents, virtually eliminating abrupt closure and reducing
free without bypass surgery. The world would never be the same.1
restenosis compared with angioplasty.
Word of Grüntzig’s work spread quickly. Physicians from all over
• Despite their limitations, stents are the cornerstone of interventional the world traveled to Zurich to see live case demonstrations of this
therapy for the treatment of coronary artery disease worldwide.
new procedure, which was coined “coronary angioplasty.” Although
many were mesmerized by the possibilities of such a paradigm-shifting
approach to obstructive coronary artery disease (CAD), others were
skeptical and dismissed it as a passing fancy. Eventually, after meeting
No discipline in the history of medicine has seen the explosion of resistance at home, Grüntzig moved to the United States in 1980 and
growth and innovation that has occurred in interventional cardiology. built the first laboratory for teaching his new procedure at Emory
This explosion was due to a combination of a driving need for better University. This soon became the epicenter for this new discipline of
results for the treatment of a deadly and prevalent disease and the “interventional” cardiology. Hundreds of physicians made the pilgrim-
unique personality of individuals attracted to the specialty of cardiol- age to Emory to watch, learn, and then return home to start angio-
ogy. In the early 1970s, the treatment of coronary disease was fairly plasty programs at their respective institutions. Grüntzig was
pedestrian, with a few drugs (nitroglycerin and propranolol), a few meticulous at collecting data and painfully honest regarding his new
diagnostic tests, no randomized trials, and little understanding of the procedure, and he encouraged registries, randomized trials, and the
more acute phases of myocardial infarction. Diagnostic angiography sharing of information to understand the limitations of what he was
was a relatively new procedure with crude equipment by today’s stan- proposing. To say the participants in his courses were in awe of his
dards and strict rules about when a patient could be offered angiog- performance and results would be an understatement, myself included.
raphy. Bypass surgery was reserved strictly for patients who had severe The tension in the room was palpable as Grüntzig would cannulate
angina despite maximal medical therapy. Even angiography was the coronaries, pass crude balloons with fixed wire tips down the
strongly discouraged unless the patient had refractory symptoms and vessels, and then expand the balloons. ST segment elevation and
a strongly positive stress test. Noninvasive testing as we now know it ventricular arrhythmias were common and routinely prompted pan-
did not exist. Echocardiography and nuclear medicine did not become icked shouts from the crowd to deflate the balloon; when the balloon
widely available as adjuncts to the basic treadmill until the late 1970s. would deflate, an audible gasp of relief could be heard from the crowd,
The treatment for myocardial infarction was even more alarming followed by applause and sometimes standing ovations as the final
by today’s standards. Patients were admitted to the intensive care unit angiogram showed a widely patent vessel and brisk flow down the
and given only oxygen and morphine and observed for weeks at a time artery. Not all cases went smoothly, and abrupt closure, dissection,
3