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

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

Matthew J. Price

(2013)

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Book Details

Abstract

Make optimal use of the latest coronary stenting techniques and adjunctive devices with well-rounded guidance from Coronary Stenting, a companion volume to Dr. Topol’s Textbook of Interventional Cardiology. This comprehensive, up-to-date interventional cardiology book keeps you abreast of the latest trial data on efficacy and safety as well as cutting-edge clinical applications in coronary stenting.

  • Achieve optimal outcomes and minimize complications with expert guidance from the foremost teachers and writers in the field of interventional cardiology.
  • Implement the latest knowledge on cutting-edge topics such as drug-eluting stent design; appropriate interpretation of randomized clinical trials and comparative effectiveness studies of coronary stents; the use of fractional flow reserve, intravascular ultrasound and optical coherence tomography to optimize lesion selection and stent implantation; anterograde and retrograde approaches to chronic total occlusions; and percutaneous revascularization of diabetics and patients with left main or multivessel disease.
  • Quickly and easily find the coronary stenting information you need thanks to highly templated chapters and high-quality full-color illustrations that incorporate the latest clinical trial data into recommendations for proper patient and device selection.

Table of Contents

Section Title Page Action Price
Front cover cover
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Coronary Stenting: A Companion to Topol's Textbook of Interventional Cardiology i
Copyright page iv
Dedication v
Contributors vii
Preface ix
Table of Contents xi
One Prologue 1
1 Development of Coronary Stents: 3
Key Points 3
Angioplasty: The Beginnings 3
Genesis of the Metal Graft 4
First Human Case 5
Stent Thrombosis 6
Solving Embolization 7
Randomized Clinical Trials 7
Other Slotted Tube Stents 9
Limitations of the Bare Metal Stent 9
First “Drug-Coated” Stent 9
Modern Drug-Eluting Stents 10
Conclusion 10
References 10
Two Basic Principles 11
2 Fundamentals of Drug-Eluting Stent Design 13
Key Points 13
Scaffold Design Parameters 13
Scaffold Characteristics 13
Flexibility and Trackability 13
Conformability 15
Radial Strength 15
Longitudinal Strength 15
Recoil 16
Radiopacity 16
Impact of Strut Thickness 16
Stent Alloys 16
Cellular Architecture: Open and Closed Cell Designs 17
Antiproliferative Agents 17
Paclitaxel 17
Rapamycin and Its Analogues 17
Sirolimus 17
Everolimus 19
Zotarolimus 19
Biolimus A9 19
Polymers 19
Nonerodable Polymers in Clinical Use 20
Poly(styrene-b-isobutylene-b-styrene) 20
Poly(ethylene-co-vinyl acetate) and Poly(n-butyl methacrylate) Blend 21
Vinylidene Fluoride and Hexafluoropropylene Copolymer 21
Phosphorylcholine Polymer 22
BioLinx 22
Drug-Eluting Stents 23
Cypher 23
Taxus Express and Taxus Liberté 24
Promus Element 24
Taxus Element (ION) 25
Xience Series 26
Endeavor 27
Resolute Integrity 27
Conclusions 27
References 28
3 Preclinical Evaluation of Coronary Stents 30
Key Points 30
Historical Background 30
Animal Models Used for Stent Validation Testing 30
Normal Swine Models 30
Atherosclerotic Animal Models and Stent Efficacy 31
Evaluation of Bare Metal Stents 31
Arterial Overstretch and Porcine Model of Stent Restenosis 31
Inflammation after Bare Metal Stent Implantation 32
Temporal Response after Bare Metal Stent Implantation 32
Methodologies for Preclinical Testing of Bare Metal Stents 32
Evaluation of Drug-Eluting Stents 34
Key Concepts of Drug-Eluting Stent Validation 34
Polymers 35
Drug-Release Kinetics 36
Preclinical Assessment of Combined Drug-Eluting Stent Platform (Polymer, Drug, and Stent) 36
Preclinical Assessment of Sirolimus-Eluting and Paclitaxel-Eluting Stents 37
Newer Generation Drug-Eluting Stents 38
Bioresorbable Scaffolds and Bioabsorbable Stents 39
Initial Bench Testing 39
Preclinical Animal Testing 39
Endovascular Imaging Versus Histomorphometry 40
Measures of Efficacy for Bioresorbable Scaffolds 40
Specific Bioresorbable Technologies 40
ABSORB Bioresorbable Vascular Scaffold 41
Bioresorbable Magnesium Alloy Stent 41
ReZolve Sirolimus-Eluting Bioresorbable Coronary Scaffold 41
Conclusion 41
References 42
4 Design, Analysis, and Interpretation of Comparative Effectiveness Studies and Randomized Clinical Trials of Coronary Stents 44
Key Points 44
Introduction 44
Fundamentals of Clinical Trials Evaluating Coronary Stents 44
What is the Question? 44
Minimizing Variation 45
Stratified Randomization 45
Randomization and Comparators 45
Blinding 45
Equipoise 45
Selection of Comparators 45
Endpoints 46
Angiographic Endpoints 46
Clinical Endpoints 46
Monitoring Trial Progress and Performing Interim Analyses 46
Patient Populations 46
Analysis of Randomized Clinical Trial Data 47
Principle of Intention to Treat 48
Per-Protocol Analyses 48
Subgroup Analyses 48
Limitations and Disadvantages of Randomized Clinical Trials 48
Case Study: The TAXUS Paclitaxel-Eluting Stent Randomized Clinical Trial Program 48
More Recent Trends in Randomized Clinical Trials of Drug-Eluting Stents 49
All Comers Trials 49
Single-Arm Trials with Historical Controls 51
Equivalence and Noninferiority Trials 52
Example of a Noninferiority Trial of Coronary Stents: PLATINUM Trial 52
Control Arms in Noninferiority Studies 52
Noninferiority Margin 52
Intention to Treat and Per-Protocol Analyses in Noninferiority Trials 52
Observational Studies to Determine Comparative Effectiveness 52
Analytical Strategies for Nonrandomized Comparative Effectiveness Studies 53
Cohort Studies 53
Case-Control Studies 53
Analytical Control for Confounding 53
Stratified Analyses 53
Regression Analyses 53
Propensity Scores 54
Instrumental Variable Analyses 54
Case Study of Methods to Control for Confounding: is There a Mortality Benefit with Drug-Eluting Stents Compared with Bare Metal Stents? 54
Other Types of Studies 56
Systematic Reviews 56
Meta-Analyses 56
Network Meta-Analyses 56
Conclusion 56
References 57
5 Pathology of Drug-Eluting Stents in Humans 59
Key Points 59
Introduction 59
Endothelial Coverage as a Morphometric Predictor for Late and Very Late Stent Thrombosis 59
Delayed Arterial Healing in First-Generation Drug-Eluting Stents Implanted for Acute Myocardial Infarction 60
Culprit Stent Thrombosis Sites in Patients Treated with Drug-Eluting Stents for Acute Myocardial Infarction Compared with Stable Angina 60
Culprit Sites Compared with Nonculprit Sites 60
Fibrous Cap Thickness and Stent Strut Coverage 60
Pathologic Findings in Bifurcation Stenting 63
Impact of Stent Fracture on Adverse Pathologic Findings 64
Coronary Responses and Differential Mechanisms of Late and Very Late Stent Thrombosis Attributed to Sirolimus-Eluting Stents and Paclitaxel-Eluting Stents 64
Late Increases in Neointima after Drug-Eluting Stent Implantation 67
Comparative Pathology of Neoatherosclerosis after Bare Metal Stent or Drug-Eluting Stent Implantation 67
Conclusion 69
References 69
6 Bioresorbable Coronary Scaffolds 71
Key Points 71
Potential Advantages of Bioresorbable Scaffolds 71
Bioresorbable Scaffold Technologies 72
Igaki-Tamai Bioabsorbable Scaffold 72
Bioabsorbable Magnesium Stent 72
ABSORB Everolimus-Eluting Bioresorbable Vascular Scaffold 73
Cohort A Design and Outcomes 73
Cohort B Design and Outcomes 74
Side Branches 75
Future Studies 75
REVA Bioabsorbable Stent 75
Elixir Bioresorbable Scaffold 75
Arterial Remodeling Technologies 76
Summary 77
References 77
Three Clinical Use 79
7 Efficacy and Safety of Bare Metal and Drug-Eluting Stents 81
Key Points 81
Introduction 81
Bare Metal Stents 81
Drug-Eluting Stents 82
First-Generation Drug-Eluting Stents 82
Sirolimus-Eluting Stent 82
Paclitaxel-Eluting Stent 83
Second-Generation Drug-Eluting Stents 83
Everolimus-Eluting Stents 84
Xience V/Promus 84
Promus Element 84
Zotarolimus-Eluting Stents 84
Endeavor 84
Resolute 87
Biolimus A9-Eluting Stents 87
Comparisons of Drug-Eluting Stents versus Bare Metal Stents and Concerns Regarding Safety of Drug-Eluting Stents 88
Conclusion: Balancing Safety and Efficacy 89
References 90
8 Clinical Presentation, Evaluation, and Treatment of Restenosis 93
Key Points 93
Introduction 93
Definition 93
Pathophysiology 93
Factors Contributing to Restenosis 94
Biologic Factors 94
Drug Resistance 94
Hypersensitivity 94
Mechanical Factors 94
Stent Underexpansion 94
Nonuniform Drug Distribution 95
Stent Fracture 95
Technical Factors 96
Geographic Miss and Barotrauma Outside Stented Segment 96
Stent Gap 96
Incidence 96
Bare Metal Stents 96
Drug-Eluting Stents 96
First-Generation Drug-Eluting Stents 96
Sirolimus-Eluting Stent 96
Paclitaxel-Eluting Stent 96
Second-Generation Drug-Eluting Stents 96
Zotarolimus-Eluting Stent 96
Everolimus-Eluting Stent 96
Predictors of Restenosis 98
Patient-Related Factors 98
Lesion-Related Factors 98
Procedure-Related Factors 98
Clinical Presentation 98
Bare Metal Stent Restenosis 98
Drug-Eluting Stent Restenosis 99
TIMEFRAME FOR DEVELOPMENT OF IN-STENT RESTENOSIS 99
Evaluation 99
Noninvasive Evaluation of in-Stent Restenosis 99
Invasive Evaluation of in-Stent Restenosis 99
Patterns of in-Stent Restenosis 100
Prognosis 100
Treatment 101
Preventive Therapy 101
Cilostazol 101
Pioglitazone 101
Treatment of in-Stent Restenosis 101
Treatment of Bare Metal Stent Restenosis 101
Treatment of Drug-Eluting Stent Restenosis 102
Same Drug-Eluting Stent or Different Drug-Eluting Stent 102
Vascular Brachytherapy 102
Drug-Eluting Balloon Catheters 102
Conclusion 103
References 103
9 Intravascular Ultrasound–Guided Coronary Stent Implantation 107
Key Points 107
Introduction 107
Criteria for Optimal Stent Implantation 107
Intravascular Ultrasound–Guided Implantation of Bare Metal Stents 108
Impact of Intravascular Ultrasound on Bare Metal Stent Restenosis and Target Lesion Revascularization 108
Clinical Trials of Intravascular Ultrasound–Guided Percutaneous Coronary Intervention with Bare Metal Stents 108
Meta-analyses 109
Impact of Intravascular Ultrasound on Bare Metal Stent Thrombosis 109
Predictors of Stent Thrombosis 109
Cost-Effectiveness of Intravascular Ultrasound during Percutaneous Coronary Intervention with Bare Metal Stents 109
Intravascular Ultrasound–Guided Implantation of Drug-Eluting Stents 111
Impact of Intravascular Ultrasound on Drug-Eluting Stent Restenosis 111
Other Mechanisms of Drug-Eluting Stent Restenosis 112
Nominal Balloon Inflation Pressure and Predicted Minimal Stent Diameter 112
Drug-Eluting Stent Treatment of Bare Metal In-Stent Restenosis 112
Impact of Intravascular Ultrasound on Stent Thrombosis 112
Early Drug-Eluting Stent Thrombosis 112
Late and Very Late Stent Thrombosis 113
Clinical Impact of Intravascular Ultrasound Guidance for Drug-Eluting Stent Implantation 113
Observational Registries 113
Randomized Trials 114
Guideline Recommendations 114
Conclusion 114
References 115
10 Optical Coherence Tomography: 116
Key Points 116
Introduction 116
Basic Principles of Optical Coherence Tomography 116
Axial and Lateral Resolution 116
Time-Domain and Frequency-Domain Optical Coherence Tomography 116
Optical Coherence Tomography–Guided Coronary Intervention 116
Image Acquisition 116
Vessel and Stent Assessment 118
Safety of Optical Coherence Tomography 120
Imaging Artifacts 120
Stent Analysis and Evaluation 121
Z-Offset 121
Assessment of Optical Coherence Tomography Stent Images at the Level of a Single Frame 121
Stent Strut Appearance by Optical Coherence Tomography 121
Stent Expansion and Malapposition 121
Dissections 122
Tissue Prolapse 122
Assessment of Optical Coherence Tomography Stent Images at the Level of the Stent Strut 122
Stent Strut Classification 122
Determining Malapposition 122
Special Situations 123
Bifurcations 123
Overlap 123
Future Considerations 123
References 124
11 Fractional Flow Reserve–Guided Percutaneous Coronary Intervention 126
Key Points 126
Concept and Definition of Fractional Flow Reserve 126
Deferring Percutaneous Coronary Intervention Based on Fractional Flow Reserve 126
Fractional Flow Reserve in Specific Lesion Subsets 127
Left Main Disease 127
Bifurcation Side Branches 128
Serial Lesions 128
Diffuse Disease 128
Fractional Flow Reserve in Multivessel Disease 128
Limitations of Fractional Flow Reserve 130
References 131
12 Optimal Antithrombotic Therapy 133
Key Points 133
Pathophysiology of Atherothrombosis 133
Antiplatelet Therapy 133
Cyclooxygenase Inhibitor: Aspirin 133
Mechanisms of Action 133
Indications 135
Side Effects 136
P2Y12 Inhibitors 136
Mechanisms of Action 136
Four Specific Lesion Subsets 153
13 The Role of Drug-Eluting Stents or Cardiac Bypass Surgery in the Treatment of Multivessel Coronary Artery Disease 155
Key Points 155
Observational Studies Comparing Drug-Eluting Stents with Cardiac Surgery 155
Modern Randomized Clinical Trials of Stenting Versus Surgery 156
Multicenter Registries with Historical Coronary Artery Bypass Grafting Controls from Earlier Randomized Trials 156
ARTS II 156
ERACI III 156
Prospective, Randomized Clinical Trials 157
SYNTAX Trial 157
Design and Patient Characteristics 157
Clinical Outcomes 158
Special Populations: Diabetes 158
CARDia Trial 158
Design and Patient Characteristics 158
Clinical Outcomes 160
FREEDOM Trial 161
Risk Prediction Models for Percutaneous Coronary Intervention and Coronary Artery Bypass Grafting 161
Risk Scores Incorporating Clinical Variables Alone 161
Age, Creatinine, and Ejection Fraction Score 161
EuroSCORE 163
Mayo Clinic Risk Score 163
Risk Scores Incorporating Anatomic Variables Alone 163
SYNTAX Score 163
Functional SYNTAX score 163
Risk Scores Incorporating Anatomic and Clinical Variables 163
Global Risk Classification 163
Clinical SYNTAX Score 163
Society of Thoracic Surgery Score 163
Summary of Using Risk Stratification Scores to Select Appropriate Revascularization Strategy 164
Society Guidelines 164
Future Directions 164
Conclusion 165
References 165
14 Left Main Coronary Artery Stenting 167
Key Points 167
Current Guidelines 167
Risk Stratification 167
Percutaneous Coronary Intervention Versus Coronary Artery Bypass Grafting 167
Lesion Assessment and Imaging 169
Lesion Subsets and Stenting Techniques 169
Type of Stent 172
Further Considerations 172
Hemodynamic Support 172
Dual Antiplatelet Therapy 173
Surveillance 173
Conclusion 174
References 174
15 Stenting Approaches to the Bifurcation Lesion 176
Key Points 176
Introduction and Historical Perspective 176
Atherosclerosis in Coronary Bifurcations 176
Distribution 176
Endothelial Shear Stress 177
Blood Flow Patterns 177
Endothelial Shear Stress and Arterial Plaque Formation 177
Vascular Profiling 178
Bifurcation Lesion Definition, Geometry, and Classification 178
Definition 178
Bifurcation Geometry and Reference Vessel Size Prediction 179
Lesion Classification 179
Medina Classification 179
Movahed Classification 179
Classification of the Left Main Bifurcation 179
Bifurcation Stenting Techniques 180
Technique Classification 180
Initial Strategy and Decision Making 181
Main Branch Stenting Only 183
Provisional Side Branch Stenting 183
Two-Stent Strategy 183
Procedural Considerations 184
Arterial Access and Guiding Catheter 184
Arterial Approach 184
Choice of Coronary Guidewires and Wiring Techniques 184
Dedicated Two-Stent Techniques 184
T Stenting 184
Classic T Stenting 184
Modified T Stenting 184
Reverse T Stenting 184
T Stenting and Protrusion 184
Culotte Technique 185
Crush Technique 185
Step Crush Technique 186
Reverse Crush Technique 186
Double Kissing Crush Technique 186
V-Stent, Simultaneous Kissing Stent, and Trouser Simultaneous Kissing Stent Techniques 187
Clinical Outcomes of Bifurcation Stenting 188
Provisional Stenting Versus Double Stenting 188
Final Kissing Balloon Inflation and Outcomes 190
Plaque Modification 190
Treatment of Unprotected Left Main Coronary Artery Bifurcation 190
Bare Metal Stents 190
Bare Metal Stents Versus Drug-Eluting Stents 190
Complications of Bifurcation Stenting 191
Side Branch Closure 191
Side Branch Restenosis 191
Fracture of a Jailed Wire 191
Stent Embolization 191
Stent Thrombosis 191
Dedicated Bifurcation Stents 192
Classification of Dedicated Bifurcation Stent Devices 192
Intravascular Imaging and Functional Assessment 192
Intravascular Ultrasound 192
Left Main Bifurcation Percutaneous Coronary Intervention 192
Non–Left Main Bifurcation Percutaneous Coronary Intervention 192
Virtual Histology 192
Optical Coherence Tomography 193
Fractional Flow Reserve 193
Conclusion 194
References 194
16 Chronic Total Occlusions 197
Key Points 197
Background 197
Barriers to CTO-PCI 197
Quality of Life 197
Quantity of Life 197
Complications of Chronic Total Occlusion Intervention 198
Fundamentals of Percutaneous Coronary Intervention for Chronic Total Occlusions 198
Procedural Planning 198
Diagnostic Angiography 198
Vascular Access and Guide Catheters 198
Procedural Anticoagulation 199
Strategic Approach to the Chronic Total Occlusion 199
Coronary Wires 199
Anterograde Wiring 200
Anterograde Dissection and Reentry 201
Bridgepoint 201
CrossBoss Catheter. 201
Stingray Balloon. 202
Stingray Wire. 202
Retrograde Approach 203
Indications for a Retrograde Approach and Appropriate Case Selection 203
Setting Up For Success 204
Review of the Diagnostic Angiogram. 204
Guiding Catheter Selection and Setup. 204
Collateral Angiography. 204
Retrograde Approach Equipment. 204
Wiring Coronary Collaterals. 205
Lesion Crossing. 205
Controlled Anterograde and Retrograde Tracking. 205
Retrograde Recanalization Techniques. 206
Retrieval of Retrograde Equipment. 207
Conclusion 207
References 207
17 Bypass Graft Intervention 209
Key Points 209
Natural History and Pathology of Vein Graft Disease 209
Approach to Ischemia Following Bypass Surgery 209
Stages of Ischemia after Coronary Artery Bypass Grafting 209
Very Early Ischemia 209
Early Ischemia 209
Late Ischemia 209
Chronic Occlusions 210
Percutaneous Balloon Angioplasty and Stenting 210
Balloon Angioplasty 210
Stenting 210
Bare Metal Stents 210
Drug-Eluting Stents 210
Direct Stenting 211
Adjunctive Devices 211
Embolic Protection 211
Other Devices and Procedural Approaches 212
Rheolytic Thrombectomy 212
Laser Angioplasty 212
Atherectomy 212
Brachytherapy 214
Covered Stents 214
Adjunctive Pharmacotherapy 214
Antithrombotic Strategy 214
Glycoprotein IIB/IIIA Inhibitors 214
Vasodilators 214
Adenosine 215
Nitroprusside 215
Verapamil 215
Nicardipine 215
Fibrinolytics 215
Treatment of Acutely Failed Grafts 215
Conclusions 217
References 217
18 Stenting in Acute Myocardial Infarction 219
Key Points 219
Bare Metal Stents 219
Stent Trials 219
STENT-PAMI Trial 219
CADILLAC Trial 219
ZWOLLE II Trial 220
Meta-Analyses 220
First-Generation Drug-Eluting Stents 222
Randomized Trials 222
Strategy 222
TYPHOON Trial 224
MULTISTRATEGY Trial 224
HORIZONS AMI Trial 225
Meta-Analysis 225
Temporal Differences in Thrombotic Events 227
Newer Generation Drug-Eluting Stents 229
Everolimus-Eluting Stents 229
Biolimus-Eluting Stents 230
Duration of Dual Antiplatelet Therapy after Coronary Stenting 230
Conclusion 230
References 232
Index 233
A 233
B 233
C 234
D 234
E 235
F 235
G 235
H 235
I 235
J 235
K 235
L 235
M 235
N 235
O 236
P 236
Q 236
R 236
S 237
T 237
U 237
V 237
W 238
X 238
Y 238
Z 238
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