Cardiovascular Trials Review Cardiovascular Trials Review - Diegori.it

Cardiovascular 

Trials Review 

Eighth Edition 

Acute Myocardial Infarction 

Acute Treatment of Stroke 

Unstable Angina/Non-Q-Wave Infarction 

Stable Angina Pectoris and Silent 

Ischemia—Medical Therapy 

Interventional Cardiology 

Hypertension 

Congestive Heart Failure 

Lipid-Lowering Studies 

Arrhythmia 

Anticoagulation for Atrial Fibrillation 

Deep Vein Thrombosis/Pulmonary Embolism 

Coronary Artery Disease, Atherosclerosis, 

Prevention of Progression 

Valvular Heart Disease 

Preliminary Reports 

EDITORS: 

ROBERT A. KLONER, MD, PhD 

YOCHAI BIRNBAUM, MD 

& Jason S. Chi, BS

Cardiovascular Trials Review 

8th Edition 

Edited by: 

Robert A. Kloner, MD, PhD 

Yochai Birnbaum, MD 

Studies compiled by: 



Contributions by: 

Jason S. Chi, BS 


Director of Research, Heart Institute, 

Good Samaritan Hospital 

Professor of Medicine, Cardiovascular Division 

University of Southern California 

Los Angeles, CA 


Medical Director, Cardiac Intensive Care Unit 

Medical Director, Heart Station 

Professor of Medicine, 

Division of Cardiology, 

University of Texas Medical Branch 

Galveston, TX 


University of Illinois at Chicago 

College of Medicine, Chicago, IL

Dedicated to the memory of Philip Kloner 

1925–1997 

Cardiovascular Trials Review, 8th Edition 

Copyright © 2003 by Le Jacq Communications, Inc. 

All rights reserved. 

1st Edition Copyright © 1996, 2nd Edition Copyright © 1997, 3rd Edition 

Copyright © 1998, 4th Edition Copyright © 1999, Millenium (5th) Edition 

Copyright © 2000, 6th Edition Copyright © 2001, 7th Edition Copyright © 2002 

by Le Jacq Communications, Inc. 

Reproduction or translation of any part of this work without permission 

of the copyright owner is unlawful. Requests for permission or further 

information should be addressed to the Permissions Department, Le Jacq 

Communications, Inc., 3 Parklands Drive, Darien, CT 06820. 

The facts, opinions, and ideas expressed in this book are those of the 

authors and do not necessarily reflect those of the publisher. The opinions 

and information presented in this book are attributed to the authors and not 

to the publisher. No responsibility is assumed by the publisher for any damage 

and/or injury of any nature occurring from any use, misuse, or omission 

of any of the information contained in this book. 

ISBN 1-929660-13-8 

Printed in the United States of America. 

ii 

Contents

Table of Contents 

Contents 

Subjects 

-v- 

Trials Listing 

-vii- 

Introduction 

-xxxiii- 

Trials 1 

Trials Index 

(in alphabetical order) 

1205 

Contents 

iii

Subjects 

Contents 

Section 

Page 

1. Acute Myocardial Infarction 

a. Thrombolytic Therapy 1 

b. Percutaneous Transluminal Coronary Angioplasty vs 

Stenting vs Thrombolytic Therapy 

31 

c. Anticoagulation/Antiplatelet 71 

d. Early vs Late Intervention After Acute Myocardial Infarction 139 

e. Remodeling After Infarction 143 

f. Miscellaneous and Adjunctive Therapy 157 

2. Acute Treatment of Stroke 193 

3. Unstable Angina/Non-Q-Wave Infarction/Non-ST-Elevation 207 

Myocardial Infarction or Acute Coronary Syndrome 

4. Stable Angina Pectoris and Silent Ischemia—Medical Therapy 307 

5. Interventional Cardiology 

a. Percutaneous Transluminal Coronary Angioplasty 

(and/or stenting) vs Coronary Artery Bypass Graft Surgery 

339 

b. Percutaneous Transluminal Coronary Angioplasty vs Stenting 

vs Other Percutaneous Devices, IVUS Guided Stenting 

367 

c. Medical Therapy, Brachytherapy, Drug-Eluting Stents to 467 

Prevent Restenosis and/or Complications After Intracoronary 

Interventions or Occlusion After Coronary Artery Bypass Grafting 

d. Other Therapy Including Transmyocardial Laser Revascularization 595 

6. Hypertension 615 

7. Congestive Heart Failure 697 

8. Lipid-Lowering Studies 783 

9. Arrhythmia 905 

Contents 

v

Section 

Page 

10. Anticoagulation for Atrial Fibrillation 1009 

11. Deep Vein Thrombosis/ Pulmonary Embolism 1019 

12. Coronary Artery Disease, Atherosclerosis, 1055 

Prevention of Progression 

13. Valvular Heart Disease 1145 

14. Preliminary Reports 

a. Acute Myocardial Infarction 1157 

b. Unstable Angina, Non-Q-Wave Myocardial Infarction 1163 

c. Hypertension 1169 

d. Congestive Heart Failure 1173 

e. Arrhythmia 1181 

f. Interventional Cardiology 1189 

vi 

Contents

Page 

Acronym/Title 

Trials Listing 

Contents 

1a. Acute Myocardial Infarction — Thrombolytic Therapy 

2 GUSTO-III (1 Year) – Global Utilization of Streptokinase and tPA for 

Occluded Coronary Arteries-III 

4 SPEED (GUSTO-IV Pilot) – Early Percutaneous Coronary Intervention 

Strategies for Patency Enhancement in the Emergency Department. 

Global Use of Strategies to Open Occluded Coronary Arteries IV 

6 SPEED – Strategies for Patency Enhancement in the Emergency 

Department. Global Use of Strategies to Open Occluded Arteries 

(GUSTO-IV Pilot) 

8 GUSTO V – Global Utilization of Strategies to Open Occluded 

Coronary Arteries V 

11 GUSTO V – Global Utilization of Strategies to Open Occluded 

Coronary Arteries V 

13 TIMI-4 – Thrombolysis in Myocardial Infarction-4 

15 InTIME-II – Intravenous nPA for Treatment of Infarcting Myocardium 

Early-II 

18 ASSENT (Substudy) – Assessment of the Safety and Efficacy of a New 

Thrombolytic Agent 

20 ASSENT-2 – Assessment of the Safety and Efficacy of a New Thrombolytic-2 

22 ASSENT-3 – Assessment of the Safety and Efficacy of a New Thrombolytic 

Regimen-3 

25 TUCC – Randomized Trial Confirming the Efficacy of Reduced Dose 

Recombinant Tissue Plasminogen Activator in a Chinese Myocardial 

Infarction Population and Demonstrating Superiority to Usual Dose 

Urokinase 

27 ER-TIMI – Results of the Early Retavase-Thrombolysis In Myocardial 

Infarction (ER-TIMI) 19 Trial 

1b. Acute Myocardial Infarction — Percutaneous 

Transluminal Coronary Angioplasty vs Stenting vs 

Thrombolytic Therapy 

32 Stent-PAMI – Stent-Primary Angioplasty in Myocardial Infarction 

34 Long-Term Benefit of Primary Angioplasty as Compared with 

Thrombolytic Therapy for Acute Myocardial Infarction 

Contents 

vii

Page 


36 PACT – Plasminogen Activator Angioplasty Compatibility Trial 

38 CCP – Cooperative Cardiovascular Project 

40 PRAGUE – Primary Angioplasty in Patients Transferred from General 

Community Hospitals to Specialized PTCA Units with or Without 

Emergency Thrombolysis 

43 STOPAMI – Stent vs Thrombolysis for Occluded Coronary Arteries in 

Patients with Acute Myocardial Infarction 

45 STAT – Stenting vs Thrombolysis in Acute Myocardial Trial 

47 SHOCK – Should We Emergently Revascularize Occluded Coronaries 

for Cardiogenic Shock 

50 Stenting vs Balloon Angioplasty for Acute Myocardial Infarction 

52 Randomized Comparison of Direct Stenting with Conventional Stent 

Implantation in Selected Patients with Acute Myocardial Infarction 

54 STENTIM-2 – Stenting in Acute Myocardial Infarction-2 

57 C-PORT – The Atlantic Cardiovascular Patient Outcomes Research 

Team 

59 TIMI Frame Count 

61 Air PAMI – Air Primary Angioplasty in Myocardial Infarction Study 

63 Randomized Comparison of Primary Angioplasty and Thrombolytic 

Therapy 

65 CAPTIM – Comparison of Angioplasty and Prehospital Thrombolysis 

in Acute Myocardial Infarction 

68 PRAGUE-2 – Primary Angioplasty in Patients Transported from 

General Community Hospitals to Specialized PTCA Units with or 

Without Emergency Thrombolysis-2 

1c. Acute Myocardial Infarction — Anticoagulation/ 

Antiplatelet 

72 CARS (Substudy) – Coumadin Aspirin Reinfarction Study (Substudy) 

74 TIMI-14 (Substudy) – Thrombolysis in Myocardial Infarction-14 

76 MINT – Myocardial Infarction with Novastan and tPA 

78 ESCALAT – Efegatran and Streptokinase to Canalize Arteries Like 

Accelerated Tissue Plasminogen Activator 

81 ISAR-2 – Intracoronary Stenting and Antithrombotic Regimen-2 

83 HEAP – Heparin in Early Patency 

viii 

Contents

Page 


Contents 

85 HIT-4 – Hirudin for the Improvement of Thrombolysis-4 

87 TIM – Triflusal in Myocardial Infarction 

89 Eptifibatide vs Placebo in Patients Receiving Thrombolytic Therapy 

91 JAMIS – Japanese Antiplatelet Myocardial Infarction Study 

93 STAMI – Study of Ticlopidine vs Aspirin in Myocardial Infarction 

95 ADMIRAL – Abciximab Before Direct Angioplasty and Stenting in 

Myocardial Infarction Regarding Acute and Long-Term Follow-Up 

98 INTRO AMI – Integrilin and Low-Dose Thrombolysis in Acute 

Myocardial Infarction Study 

100 CHAMP – Combination Hemotherapy and Mortality Prevention 

102 HART II – Second Trial of Heparin and Aspirin Reperfusion Therapy 

104 ENTIRE-TIMI-23 – Enoxaparin and TNK-tPA With or Without GP 

IIIb/IIIa Inhibitor as Reperfusion Strategy in ST Evaluation MI— 

Thrombolysis in Myocardial Infarction-23 

106 HERO-2 – Hirulog and Early Reperfusion or Occlusion-2 Trial 

108 PENTALYSE – Pentasaccharide, as an Adjunct to Fibrinolysis in ST 

Elevation Acute Myocardial Infarction 

111 CADILLAC – Controlled Abciximab and Device Investigation to Lower 

Late Angioplasty Complications 

115 PRIME – Promotion of Reperfusion in Myocardial Infarction Evolution 

118 VITAL – Vasoflux International Trial for Acute Myocardial Infarction 

Lysis 

120 Enoxaparin vs Unfractionated Heparin After Thrombolytic Therapy for 

Acute Myocardial Infarction 

122 ASPECT-2 – Antithrombotics in the Secondary Prevention of Events in 

Coronary Thrombosis-2 

124 AMI-SK – Acute Myocardial Infarction Streptokinase 

127 ASSENT Plus – Assessment of the Safety and Efficacy of a New 

Thrombolytic Plus 

129 TIGER-PA – Tirofiban Given in the Emergency Room Before Primary 

Angioplasty Pilot Trial 

131 Intracoronary vs Intravenous Abciximab in Acute Coronary Syndromes 

133 APRICOT-2 – Antithrombotics in the Prevention of Reocclusion in 

Coronary Thrombolysis Trial-2 

136 Warfarin, Aspirin, or Both After Myocardial Infarction 

Contents 

ix

Page 


1d. Acute Myocardial Infarction — Early vs Late Intervention 

After Acute Myocardial Infarction 

140 Early Revascularization in 14-Day Survivors of Acute Myocardial 

Infarction 

1e. Acute Myocardial Infarction — Remodeling After 

Infarction 

144 GISSI-3 Substudy – Gruppo Italiano per lo Studio della Sopravvivenza 

nell’Infarto Miocardico-3 

146 TRACE (Update) – Trandolapril Cardiac Evaluation 

148 TRACE (Diabetic Substudy) – Trandolapril Cardiac Evaluation Study 

150 CAPRICORN – Carvedilol Post-Infarct Survival Control in LV 

Dysfunction 

152 OPTIMAAL – Optimal Trial In Myocardial Infarction with the 

Angiotensin II Antagonist Losartan 

155 SMILE-2 – Survival of Myocardial Infarction Long-Term Evaluation-2 

1f. Acute Myocardial Infarction — Miscellaneous and 

Adjunctive Therapy 

158 DECREASE – Dutch Echocardiographic Cardiac Risk Evaluation 

Applying Stress Echocardiography Study Group 

160 NEHDP – National Exercise and Heart Disease Project 

162 AMISTAD – Acute Myocardial Infarction Study of Adenosine Trial 

164 INTERCEPT – Incomplete Infarction Trial of European Research 

Collaborators Evaluating Progress Post-Thrombolysis 

166 Cariporide in Patients with Acute Anterior Myocardial Infarction 

168 EMIP-FR – European Myocardial Infarction Project—Free Radicals 

170 LIMIT AMI – Limitation of Myocardial Infarction Following 

Thrombolysis in Acute Myocardial Infarction Study 

172 GISSI-Prevenzione Trial – Gruppo Italiano per lo Studio della 

Sopravvivenza nell’Infarto Miocardico 

174 GISSI-Prevenzione – Gruppo Italiano per lo Studio della 

Sopravvivenza nell’Infarto Miocardico—Prevenzione 

x 

Contents

Page 


Contents 

176 ESCAMI – Evaluation of the Safety and Cardioprotective Effects of 

Eniporide in Acute Myocardial Infarction 

179 Does Angina Pectoris the Week Before Protect Against First Acute 

Myocardial Infarction in Patients with Diabetes Mellitus 

181 HALT-MI – Hu23F2G Anti-Adhesion to Limit Cytotoxic Injury 

Following AMI 

184 MAGIC – Magnesium in Coronaries 

186 FLORIDA – Fluvastatin on Risk Diminishment After Acute Myocardial 

Infarction 

189 SADHART – Sertraline Antidepressant Heart Attack Randomized Trial 

2. Acute Treatment of Stroke 

194 NINDS – Neurological Disorders and Stroke Recombinant Tissue 

Plasminogen Activator Stroke Study 

196 STAT – Stroke Treatment with Ancord Trial 

198 ATLANTIS – Alteplase Thrombolysis for Acute Noninterventional 

Therapy in Ischemic Stroke 

200 PROCAT II – Prolyse in Acute Cerebral Thromboembolism II 

203 Aptiganel Hydrochloride in Acute Ischemic Stroke 

205 WARSS – Warfarin Aspirin Recurrent Stroke Study 

3. Unstable Angina/Non-Q-Wave Infarction/ 

Non-ST-Elevation Myocardial Infarction or Acute 

Coronary Syndrome 

208 HASI (Update) – Bivalirudin Angioplasty Study (Hirulog Angioplasty 

Study) 

211 PRISM-PLUS – Platelet Receptor Inhibition in Ischemic Syndrome 

Management in Patients Limited by Unstable Signs and Symptoms 

213 PRISM-PLUS (Angiographic Results) – Platelet Receptor Inhibition 

for Ischemic Syndrome Management in Patients Limited by Unstable 

Signs and Symptoms 

215 PRISM-PLUS (Diabetic Substudy) – Platelet Receptor Inhibition in 

Ischemic Syndrome Management in Patients Limited by Unstable Signs 

and Symptoms 

Contents 

xi

Page 


217 VANQWISH Trial (Non-Q-Wave Myocardial Infarction Following 

Thrombolysis) – Veterans Affairs Non-Q-Wave Infarction Strategies 

In-Hospital 

219 PARAGON B – Platelet IIb/IIIa Antagonist for the Reduction of Acute 

Coronary Syndrome Events in a Global Organization Network B 

221 PARAGON B (Troponin T Substudy) – Platelet IIb/IIIa Antagonism 

for the Reduction of Acute Coronary Syndrome Events in a Global 

Organization Network 

223 PURSUIT – Platelet Glycoprotein IIb/IIIa in Unstable Angina: Receptor 

Suppression Using Integrilin Therapy 

225 PURSUIT (Substudy) – Platelet Glycoprotein IIb/IIIa in Unstable 

Angina: Receptor Suppression Using Integrilin Therapy 





231 PURSUIT (Subanalysis) – Platelet IIb/IIIa in Unstable Angina: 

Receptor Suppression Using Integrilin Therapy 

233 FRISC II – Fragmin and Fast Revascularisation During Instability in 

Coronary Artery Disease II 

238 FRISC II (Substudy) – Fragmin and Fast Revascularization During 

Instability in Coronary Artery Disease II 

240 FRAX.I.S – Fraxiparine in Ischemic Syndrome 

243 TIMI-11B – Thrombolysis in Myocardial Infarction-11B 

245 Randomized Trial Comparing IV Nitroglycerin and Heparin for 

Treatment of Unstable Angina Secondary to Restenosis After Coronary 

Artery Angioplasty 

247 Efegatran in Unstable Angina 

250 SYMPHONY – Sibrafiban vs Aspirin to Yield Maximum Protection 

from Ischemic Heart Events Post-Acute Coronary Syndromes 

252 2nd SYMPHONY – Sibrafiban vs Aspirin to Yield Maximum Protection 

from Ischemic Heart Events Post-Acute Coronary Syndromes 

254 OPUS-TIMI-16 – Oral Glycoprotein IIb/IIIa Inhibition with Orbofiban 

in Patients with Unstable Coronary Syndromes 

256 ESSENCE (ST Segment Monitoring Substudy) – Efficacy and Safety 

of Subcutaneous Enoxaparin in Non-Q-Wave Coronary Events 

258 ESSENCE (1-Year Results) – Efficacy and Safety of Subcutaneous 

Enoxaparin in Non-Q-Wave Coronary Events 

xii 

Contents

Page 


Contents 

260 APLAUD – Antiplatelet Useful Dose 

262 GUARDIAN – Guard During Ischemia Against Necrosis 

264 FROST – Fibrinogen Receptor Occupancy Study 

267 GUSTO IV-ACS – Global Utilization of Strategies to Open Occluded 

Coronary Arteries IV—Acute Coronary Syndromes 

270 GUSTO IV – Global Use of Strategies to Open Occluded Coronary 

Arteries IV—Acute Coronary Syndrome (1-Year Follow-Up) 

272 TACTICS-TIMI-18 – Treat Angina with Aggrastat and Determine Cost 

of Therapy with an Invasive or Conservative Strategy—Thrombolysis 

in Myocardial Infarction-18 

275 TACTICS-TIMI 18 (Substudy) – Treat Angina with Aggrastat and 

Determine Cost of Therapy with an Invasive or Conservative 

Strategy—Thrombolysis in Myocardial Infarction-18 

277 CURE – Clopidogrel in Unstable Angina to Prevent Recurrent Events 

280 CURE – Clopidogrel in Unstable Angina To Prevent Recurrent Events 

(Substudy) 

282 CURE – Clopidogrel in Unstable Angina to Prevent Recurrent Events 

Trial (Substudy) 

285 PCI-CURE – Clopidogrel in Unstable Angina to Prevent Recurrent 

Events—Percutaneous Coronary Intervention Substudy 

288 VINO – Value of First Day Coronary Angiography/Angioplasty in 

Evolving Non-ST Segment Elevation Myocardial Infarction. An Open 

Multicenter Randomized Trial 

290 ACE Inhibitors in Acute Coronary Syndrome 

292 INTERACT – Integrilin and Enoxaparin Randomized Assessment of 

Acute Coronary Syndrome Treatment 

295 Women Do Have an Improved Long-Term Outcome After Non-ST- 

Elevation Acute Coronary Syndromes Treated Very Early and 

Predominantly with Percutaneous Coronary Intervention 

297 ACUTE 2 – Antithombolic Combination Using Tirofiban and Enoxaparin 

299 RITA 3 – Randomized Intervention Trial of Unstable Angina 

302 NUT-2 – The Nonsteroidal Anti-Inflammatory Drugs in Unstable Angina 

Treatment-2 Pilot Study 

305 AZACS – Azithromycin in Acute Coronary Syndrome 

Contents 

xiii

Page 


4. Stable Angina Pectoris and Silent Ischemia—Medical 

Therapy 

308 EMIT – European Mivazerol Trial 

310 New Pharmacological Treatment for Intermittent Claudication: Results 

of a Randomized, Multicenter Trial 

312 MUST-EECP – Multicenter Study of Enhanced External 

Counterpulsation 

314 QUO VADIS – Quinapril on Vascular ACE and Determinants of 

Ischemia 

316 PATCH – Program to Assess Alternative Treatment Strategies to 

Achieve Cardiac Health 

318 FIRST – FGF Initiating Revascularization Trial 

320 TRIMPOL II – Trimetazidine in Poland II 

322 PISA – Persantin in Stable Angina 

324 TIME – Trial of Invasive vs Medical Therapy in Elderly Patients 

326 IONA – Impact of Nicorandil in Angina 

328 Dutch Echocardiographic Cardiac Risk Evaluation Applying Stress 

Echocardiography 

330 Antianginal and Anti-Ischemic Effects of Ivabradine, an I f Inhibitor, in 

Stable Angina 

333 CAPE II Trial – Circadian Anti-Ischemic Program in Europe II 

336 Effects of Oral Magnesium Therapy on Exercise Tolerance, Exercise- 

Induced Chest Pain, and Quality of Life in Patients with Coronary 

Artery Disease 

5a. Interventional Cardiology — Percutaneous Transluminal 

Coronary Angioplasty (and/or stenting) vs Coronary 

Artery Bypass Graft Surgery 

340 Cognitive Outcome After Off-Pump and On-Pump Coronary Artery 

Bypass Graft Surgery. A Randomized Trial 

342 Octopus Study 

344 Octopus Study 

346 BHACAS (1 & 2) – Beating Heart Against Cardioplegic Arrest Studies 

1 & 2 

xiv 

Contents

Page 


Contents 

348 EAST (8-Year Mortality Data) – Emory Angioplasty vs Surgery Trial 

350 BARI (7-Year Outcome, Diabetics) – Bypass Angioplasty 

Revascularization Investigation 

352 Arterial Revascularization Therapies Study 

354 ERACI II – Argentine Randomized Trial of Percutaneous Transluminal 

Coronary Angioplasty vs Coronary Artery Bypass Surgery in Multivessel 

Disease II 

357 ARTS – Arterial Revascularization Therapy Study 

359 AWESOME – Angina with Extremely Serious Operative Mortality 

Evaluation 

361 Comparison of Stenting with Minimally Invasive Bypass Surgery for 

Stenosis of the Left Anterior Descending Coronary Artery 

364 SOS – Stent or Surgery 

5b. Interventional Cardiology — Percutaneous Transluminal 

Coronary Angioplasty vs Stenting vs Other Percutaneous 

Devices, IVUS Guided Stenting 

368 BENESTENT-I (5-Year Follow-Up) – Belgium Netherlands Stent 

370 STRESS (Diabetic Substudy) – Stent Restenosis Study 

372 TOSCA – Total Occlusion Study of Canada 

374 START (Stent vs Atherectomy) – Stent vs Directional Coronary 

Atherectomy Randomized Trial 

376 START (Stenting vs PTCA) – Stent Implantation and Balloon 

Angioplasty in the Treatment of De Novo Coronary Artery Lesions 

378 ABACAS – Adjunctive Balloon Angioplasty After Coronary 

Atherectomy Study 

380 FROST – French Randomized Optimal Stenting Trial 

382 Comparison of GR-II Stent and Palmaz-Schatz Stent 

384 CRUISE – Can Routine Ultrasound Influence Stent Expansion 

386 COBRA – Comparison of Balloon Angioplasty vs Rotational 

Atherectomy 

388 PARAGON Stent Study – Platelet IIb/IIIa Antagonism for the 

Reduction of Acute Coronary Syndrome Events in a Global 

Organization Network 

390 Stent Implantation in Small Coronary Arteries 

Contents 

xv

Page 


392 High-Pressure Stenting vs Balloon Angioplasty 

394 NIRVANA – NIR Vascular Advanced North American Trial 

396 STRATAS – Study to Determine Rotablator and Transluminal 

Angioplasty Strategy 

399 BET – Benefit Evaluation of Direct Coronary Stenting 

401 BET – Benefit Evaluation of Direct Coronary Stenting 

403 ASCENT – ACS MultiLink Stent Clinical Equivalence in De Novo 

Lesions Trial 

405 DESTINI – Doppler End Point Stenting International Investigation 

407 DEBATE II – Doppler End Points Balloon Angioplasty Trial Europe II 

409 DEBATE II (Substudy) – Doppler End Points Balloon Angioplasty 

Trial Europe II 

411 ISAR-SMART – Intracoronary Stenting or Angioplasty for Restenosis 

Reduction in Small Arteries 

413 ISAR-SMART Trial (Substudy) – Intracoronary Stenting or 

Angioplasty for Restenosis Reduction in Small Arteries 

415 WIDEST – Wiktor Stent in De Novo Stenosis 

417 OPUS-1 – Optimum Percutaneous Transluminal Coronary Angioplasty 

vs Routine Stenting-1 

419 ADVANCE – Additional Value of NIR Stents for Treatment of Long 

Coronary Lesions 

421 ARTIST – Angioplasty vs Rotational Atherectomy for Treatment of 

Diffuse In-Stent Restenosis Trial 

423 ARTIST (Substudy) – Angioplasty Versus Rotational Atherectomy for 

the Treatment of Diffuse In-Stent Restenosis Trial 

425 SISA – Stent in Small Arteries 

427 OPTICUS – Optimization with ICUS (Intracoronary Ultrasound) to 

Reduce Stent Restenosis 

429 Cutting Balloon Angioplasty 

431 SCORES – Stent Comparative Restenosis 

433 BESMART – Bestent in Small Arteries 

435 SAFE – Saphenous Vein Graft Angioplasty Free of Emboli 

437 Magic 5L – Magic 5L Wallstent Study 

439 CAPAS – Cutting Balloon Angioplasty vs Plain Old Balloon Angioplasty 

Randomized Study in Type B/C Lesions 

441 SISCA – Stenting in Small Coronary Arteries 

xvi 

Contents

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Contents 

443 PREDICT – Predilatation vs Direct Stenting in Coronary Treatment 

446 DIRECT – Comparison of Direct Stenting vs Stenting with Predilation 

for the Treatment of Selected Coronary Narrowings 

449 SWIBAP – Stent Without Balloon Predilation 

452 Cutting Balloon Global Randomized Trial 

455 Direct Coronary Stenting Versus Predilatation Followed by Stent 

Placement 

458 ISAR-STEREO-2 – Intracoronary Stenting and Angiographic Results: 

Strut Thickness Effect on Restenosis Outcome Trial 

460 DANSTENT – The Danish Multicenter Stent Study 

462 TENISS – The Tenax vs NIR Stent Study 

464 MultiLink Long Stents for Long Coronary Lesions 

5c. Interventional Cardiology — Medical Therapy, 

Brachytherapy, Drug-Eluting Stents to Prevent Restenosis 

and/or Complications After Intracoronary Interventions 

or Occlusion After Coronary Artery Bypass Grafting 

468 IMPACT-II (Substudy) – Integrilin to Minimize Platelet Aggregation 

and Coronary Thrombosis-II 

470 EPISTENT – Evaluation of Platelet IIb/IIIa Inhibition in Stenting 

472 EPISTENT (6-Month Outcome) – Evaluation of Platelet IIb/IIIa 

Inhibition in Stenting 

474 EPISTENT (Diabetic Substudy) – Evaluation of Platelet IIb/IIIa 

Inhibition in Stenting 

476 ERASER – The Evaluation of ReoPro and Stenting to Eliminate 

Restenosis 

478 3-Year Clinical and Angiographic Follow-Up After Intracoronary 

Radiation 

480 VIP – Visipaque in Percutaneous Transluminal Coronary Angioplasty 

482 EXCITE – Evaluation of Oral Xemilofiban in Controlling Thrombotic 

Events 

484 Clopidogrel as Adjunctive Antiplatelet Therapy During Coronary 

Stenting 

486 Clopidogrel vs Ticlopidine After Intracoronary Stent Placement 

488 Minimal Heparinization in Coronary Angioplasty 

Contents 

xvii

Page 


490 TREAT – Tranilast Restenosis Following Angioplasty Trial 

492 TREAT-2 – Tranilast Restenosis Angioplasty Trial-2 

495 CAPARES – Coronary Angioplasty Amlodipine Restenosis Study 

498 WRIST – Washington Radiation for In-Stent Restenosis Trial 

500 COURT – Contrast Media Utilization in High-Risk PTCA 

502 Gamma-1 Trial 

504 Gamma-1 Study (Intravascular Ultrasound Analysis) 

506 β-Radiation Therapy—Dose-Finding Study 

508 CLASSICS – Clopidogrel Aspirin Stent International Cooperative Study 

510 PREVENT (Radiotherapy) – Proliferation Reduction with Vascular 

Energy Trial 

512 ESPRIT – Enhanced Suppression of the Platelet IIb/IIIa Receptor with 

Integrilin Therapy 

515 ESPRIT (Substudy) – Enhanced Suppression of the Platelet IIb/IIIa 

Receptor with Integrilin Therapy 

517 ESPRIT (Substudy) – Enhanced Suppression of the Platelet IIb/IIIa 

Receptor with Integrilin Therapy 

519 IMPRESS – Intramural Infusion of Low-Molecular-Weight Heparin to 

Prevent Restenosis After Stent Implantation 

521 PRICE – Prairie ReoPro vs Integrilin Cost Evaluation 

523 NICOLE – Nisoldipine in Coronary Artery Disease in Leuven 

525 PARIS – Effect of ACE Inhibitors on Angiographic Restenosis from 

PARIS Investigators 

527 POLONIA Study – Polish-American Local Lovenox NIR Assessment 

Study 

529 ISAR – Intracoronary Stenting and Antithrombotic Regimen 

531 ISAR-3 – Intracoronary Stenting and Antithrombotic Regimen-3 

533 Brachytherapy for Femoropopliteal Angioplasty 

535 TARGET – Do Tirofiban and ReoPro Give Similar Efficacy Trial 

537 TARGET (Subanalysis) – Do Tirofiban and ReoPro Give Similar 

Efficacy Outcomes 

539 TARGET – Do Tirofiban and ReoPro Give Similar Efficacy Outcome 

Trial 

541 Sirolimus-Eluting Stents 

xviii 

Contents

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Contents 

543 Intravascular Gamma Radiation for In-Stent Restenosis in Saphenous 

Vein Bypass Grafts 

545 ITALICS – Randomized Investigation by the Thoraxcenter of Antisense 

DNA Using Local Delivery and IVUS After Coronary Stenting Trial 

547 RAVEL – Randomized Study with the Sirolimus-Coated Bx Velocity 

Balloon-Expandable Stent in the Treatment of Patients with De Novo 

Native Coronary Artery Lesions 

549 RAVEL – Randomized Study with the Sirolimus-Eluting Velocity 

Balloon-Expandable Stent in the Treatment of Patients with De Novo 

Native Coronary Artery Lesions 

552 RAVEL (Angiographic Findings) – Randomized Study with the 

Sirolimus-Eluting Bx Velocity Balloon-Expandable Stent 

554 RAVEL – Randomized, Double-Blind Study with the Sirolimus-Eluting 

Bx Velocity Balloon Expandable Stent in the Treatment of Patients with 

de Novo Native Coronary Artery Lesions. (Substudy) 

557 TRAPIST – Trapidil for Prevention of In-Stent Stenosis 

559 ATLAST – Randomized, Placebo-Controlled Trial of Enoxaparin After 

High-Risk Coronary Stenting 

562 Homocysteine and Restenosis 

564 VeGAS 2 – Vein Graft AngioJet Study 2 

566 CART-1 – Canadian Antioxidant Restenosis Trial 

569 COAST – Heparin-Coated Stents in Small Coronary Arteries Trial 

572 CREDO – Clopidogrel for the Reduction of Events During Observation 

575 IMPRESS – Immunosuppressive Therapy for the Prevention of 

Restenosis After Coronary Artery Stent Implantation 

578 TOPSTAR – Troponin in Planned PTCA/Stent Implantation with or 

Without Administration of the Glycoprotein IIb/IIIa Receptor 

Antagonist Tirofiban 

581 The Swiss Heart Study 

583 ASPECT – Asian Paclitaxel-Eluting Stent Clinical Trial 

585 ASPECT (Substudy) – Asian Paclitaxel-Eluting Stent Clinical Trial 

587 BAAS – Balloon Angioplasty and Anticoagulation Study 

590 ESPRIT – Esapent for Prevention of Restenosis Italian Study 

592 PRESTO – Prevention of Restenosis with Tranilast and Its Outcomes 

Contents 

xix

Page 


5d. Interventional Cardiology — Other Therapy Including 

Transmyocardial Laser Revascularization 

596 LARS – Laser Angioplasty of Restenosed Stents 

598 ATLANTIC – Angina Treatments—Lasers and Normal Therapies in 

Comparison 

601 Transmyocardial Revascularization with CO2 Laser in Patients with 

Refractory Angina Pectoris. Clinical Results from the Norwegian 

Randomized Trial 

603 TOTAL – Total Occlusion Trial with Angioplasty by Using Laser Guide 

Wire 

605 PACIFIC – Potential Angina Class Improvement from Intramyocardial 

Channels 

607 Norwegian Randomized Trial with Transmyocardial Revascularization 

609 Percutaneous Transmyocardial Lasers in Chronic Total Occlusion 

611 A Randomized, Controlled Trial of the Use of Pulmonary Artery 

Catheters in High-Risk Surgical Patients 

6. Hypertension 

616 SHEP (Subanalysis) – Systolic Hypertension in the Elderly Program 

618 STOP-Hypertension-2 (Update) – Swedish Trial in Old Patients with 

Hypertension-2 

620 Syst-Eur – Systolic Hypertension-Europe 

623 Syst-Eur (Substudy) – Systolic Hypertension-Europe 

625 TONE – Trial of Nonpharmacologic Interventions in the Elderly 

627 ARIC – Atherosclerosis Risk in Communities 

629 DRASTIC – Dutch Renal Artery Stenosis Intervention Cooperative 

Study 

631 ALLHAT – Antihypertensive and Lipid-Lowering Treatment to Prevent 

Heart Attack Trial 

634 ALLHAT – The Antihypertensive and Lipid-Lowering Treatment to 

Prevent Heart Attack Trial 

639 Comparison of ACE Inhibitors, Calcium Antagonists, β-Blockers, and 

Diuretic Agents on Reactive Hyperemia in Patients with Essential 

Hypertension: A Multicenter Study 

xx 

Contents

Page 


Contents 

641 CANDLE – Candesartan vs Losartan Efficacy Comparison Study 

643 Long-Term Effects of Weight Loss and Dietary Sodium Reduction on 

Incidence of Hypertension 

645 NORDIL – Nordic Diltiazem Study 

647 INSIGHT – International Nifedipine GITS Study: Intervention as a Goal 

in Hypertensive Treatment 

649 DASH – Dietary Approaches to Stop Hypertension—(Reduced Dietary 

Sodium Study) 

651 Drug Classes in Black Hypertensives 

653 CASTLE – Candesartan and Amlodipine for Safety, Tolerability and 

Efficacy 

655 ABC Trial – Association of Black Cardiologists 

657 TOHP-II – Trials of Hypertension Prevention-II 

659 AASK – African American Study of Kidney Disease and Hypertension 

662 AASK – The African American Study of Kidney Disease and 

Hypertension 

666 IRMA II – Irbesartan in Patients with Type 2 Diabetes and 

Microalbuminuria Study II 

668 RENAAL – Reduction of End Points in NIDDM (Non-Insulin 

Dependent Diabetes Mellitus) with Angiotensin II Antagonist Losartan 

670 IDNT – Irbesartan Diabetic Nephropathy Trial 

672 IDNT – Irbesartan Diabetic Nephropathy Trial 

674 PROGRESS – Perindopril Protection Against Recurrent Stroke Study 

677 PROGRESS (Substudy) – Perindopril Protection Against Recurrent 

Stroke Study 

679 LIFE – Losartan Intervention for End Point Reduction 

682 LIFE (Diabetes Mellitus Substudy) – Losartan Intervention for End 

Point Reduction 

684 LIFE – Losartan Intervention for End Point Reduction (Substudy) 

686 A Comparison of Outcomes with Angiotensin-Converting-Enzyme 

Inhibitors and Diuretics for Hypertension in the Elderly 

689 COOPERATE – Combination Treatment of Angiotensin-II Receptor 

Blocker And Angiotensin-Converting-Enzyme Inhibitor in Non-Diabetic 

Renal Disease 

691 SUCCESS-VII – Successive Celecoxib Clinical Efficacy and Safety 

Studies 

Contents 

xxi

Page 


694 MARVAL – Microalbuminuria Reduction with Valsartan 

7. Congestive Heart Failure 

698 PRAISE – Prospective Randomized Amlodipine Survival Evaluation 

701 PRAISE (Substudy) – Prospective Randomized Amlodipine Survival 

Evaluation 

703 ELITE II – Evaluation of Losartan in the Elderly II 

705 DIAMOND-CHF – Danish Investigations of Arrhythmia and Mortality 

on Dofetilide in Congestive Heart Failure 

707 RALES – Randomized Aldactone Evaluation Study Investigators 

709 ATLAS – Assessment of Treatment with Lisinopril and Survival 

711 RESOLVD – Randomized Evaluation of Strategies for Left Ventricular 

Dysfunction 

713 RESOLVD (Metoprolol Study) – Randomized Evaluation of Strategies 

for Left Ventricular Dysfunction 

715 STRETCH – Symptom, Tolerability, Response to Exercise Trial of 

Candesartan Cilexetil in Heart Failure 

717 MERIT-HF – Metoprolol CR/XL Randomised Intervention Trial in 

Congestive Heart Failure 

721 MERIT-HF (Substudy) – Metoprolol CR/XL Randomized Intervention 

Trial in Heart Failure 

723 MERIT-HF (Substudy) – Metoprolol CR/XL Randomized Intervention 

Trial in Chronic Heart Failure 

725 Metoprolol vs Carvedilol in Heart Failure 

727 MUSTIC – Multisite Stimulation in Cardiomyopathies 

729 MUSTIC (Long-Term Analysis) – The Multisite Stimulation In 

Cardiomyopathies 

731 IMPRESS – Inhibition of Metalloproteinase BMS-186716, Omipatrilat, 

in a Randomized Exercise and Symptom Study with Heart Failure 

733 High Enalapril Dose Study 

735 MACH 1 – Mortality Assessment in Congestive Heart Failure 1 

737 COPERNICUS – Carvedilol Prospective Randomized Cumulative 

Survival Study 


Survival 

xxii 

Contents

Page 


Contents 


Survival Study 

744 BEST – The β-Blocker Evaluation of Survival Trial 

746 BREATHE-1 – Bosentan Randomized Trial of Endothelin Antagonist 

Therapy-1 

748 VMAC – Vasodilation in the Management of Acute Congestive Heart 

Failure 

750 OPTIME-CHF – Outcomes of a Prospective Trial of Intravenous 

Milrinone for Exacerbations of Chronic Heart Failure 

752 Dobutamine vs Nesiritide on Arrhythmias 

754 Immunosuppressive Treatment of Inflammatory Dilated Cardiomyopathy 

756 ALPHABET – Arterial Pulmonary Hypertension and Beraprost 

European Trial 

758 MIRACLE – Multicenter InSync Randomized Clinical Evaluation 

760 Val-HeFT – Valsartan Heart Failure Trial 

762 Val-HeFT Echocardiographic Study – Valsartan Benefits Left 

Ventricular Structure and Function in Heart Failure 

764 REMATCH – Randomized Evaluation of Mechanical Assistance for the 

Treatment of Congestive Heart Failure 

766 SOLVD – Studies of Left Ventricular Dysfunction (Substudy) 

768 LIDO – Levosimendan Infusion Versus Dobutamine 

770 RUSSLAN – Randomized Study on Safety and Effectiveness of 

Levosimendan in Patients with Left Ventricular Failure Due to an Acute 

Myocardial Infarct 

773 The MIRACLE ICD Trial – The Multicenter InSync Randomized 

Clinical Evaluation-Implantable Cardioverter Defibrillator Trial 

775 RITZ-4 – Randomized Intravenous Tezosentan Study-4 

777 OVERTURE – Omapatrilat Versus Enalapril Randomized Trial of Utility 

in Reducing Events 

780 EPHESUS – Eplerenone Post-Acute Myocardial Infarction Heart Failure 

Efficacy and Survival Study 

8. Lipid-Lowering Studies 

784 HATS – HDL-Atherosclerosis Treatment Study 

Contents 

xxiii

Page 


786 Comparison of the Effects of Atorvastatin Versus Simvastatin on 

Subclinical Atherosclerosis in Primary Prevention as Determined by 

Electron Beam Tomography 

788 4S – Scandinavian Simvastatin Survival Study 

793 4S (Substudy) – Scandinavian Simvastatin Survival Study 

795 WOSCOPS – Prevention of Coronary Heart Disease with Pravastatin 

in Men with Hypercholesterolemia: West of Scotland Coronary 

Prevention Study 

798 WOSCOPS (Substudy) – West of Scotland Coronary Prevention Study 

800 CARE – Cholesterol and Recurrent Events 

804 CARE (Substudy) – Cholesterol and Recurrent Events 

806 CARE (Substudy) – Cholesterol and Recurrent Events 

808 AFCAPS/TexCAPS – AFCAPS/TexCAPS C-Reactive Protein Substudy: 

Air Force/Texas Coronary Atherosclerosis Prevention Study 

810 LIPID (Substudy) – Long-Term Intervention with Pravastatin in 

Ischemic Disease 

813 LIPID Substudy (Effect In Women) – Long-Term Intervention with 

Pravastatin in Ischemic Disease 

815 LIPID (Incidence of Stroke) – Long-Term Intervention with 

Pravastatin in Ischemic Disease 

817 VA-HIT – Veterans Affairs High-Density Lipoprotein Cholesterol 

Intervention Trial 

819 VA-HIT (Update) – Veterans Affairs High-Density Lipoprotein 

Cholesterol Intervention Trial 

821 VA-HIT (Stroke Substudy) – Veterans Affairs HDL Intervention Trial 

822 VA-HIT – Veterans Affairs High-Density Lipoprotein Intervention Trial 

(Substudy) 

825 Cerivastatin in Primary Hypercholesterolemia 

827 Extended Release Niacin vs Gemfibrozil for the Treatment of Low 

Levels of High-Density Lipoprotein Cholesterol 

829 LISA – Lescol in Severe Atherosclerosis 

831 BIP – Bezafibrate Infarction Prevention 

833 Post-CABG – Post-Coronary Artery Bypass Graft Trial (7.5-Year Follow- 

Up) 

835 ASAP – Atorvastatin vs Simvastatin on Atherosclerosis Progression 

xxiv 

Contents

Page 


Contents 

837 MIRACL – Myocardial Ischemia Reduction with Aggressive 

Cholesterol Lowering 

839 MIRACL – Myocardial Ischemia Reduction with Aggressive 

Cholesterol Lowering (Substudy) 

841 RIKS-HIA – Register of Information and Knowledge About Swedish 

Heart Intensive Care Admissions 

843 ASSET – Atorvastatin Simvastatin Safety and Efficacy Trial 

845 Statin, Restenosis and the PlA2 Polymorphism of the Platelet 

Glycoprotein IIIa Gene 

847 ADMIT – Arterial Disease Multiple Intervention Trial 

849 L-CAD – Lipid-Coronary Artery Disease Study 

851 WATCH – Women’s Atorvastatin Trial on Cholesterol 

853 Comparison of Effects on Low-Density Lipoprotein Cholesterol and 

High-Density Lipoprotein Cholesterol with Rosuvastatin vs Atorvastatin 

in Patients with Type IIa or IIb Hypercholesterolemia 

855 Atorvastatin vs Cerivastatin 

857 PRINCE – Pravastatin Inflammation CRP Evaluation 

859 GAIN – German Atorvastatin Intravascular Ultrasound Study 

861 Vascular Basis for the Treatment of Myocardial Ischemia 

863 GREACE – Greek Atorvastatin and Coronary Heart Disease Evaluation 

865 CHALLENGE – Comparison of Efficacy and Safety of Atorvastatin and 

Simvastatin in Patients with Dyslipidemia With and Without Coronary 

Heart Disease 

868 Niacin-ER/Lovastatin Combination for Hyperlipidemia 

870 FAST – Fukuoka Atherosclerosis Trial 

873 ALLHAT-LLT – The Antihypertensive and Lipid-Lowering Treatment 

to Prevent Heart Attack Trial—Lipid Lowering Trial 

876 ADVENT – The Assessment of Diabetes Control and Evaluation of the 

Efficacy of Niaspan Trial 

880 Efficacy and Safety of a Potent New Selective Cholesterol Absorption 

Inhibitor, Ezetimibe, in Patients with Primary Hypercholesterolemia 

882 Efficacy and Safety of Ezetimibe Added to Ongoing Statin Therapy for 

Treatment of Patients with Primary Hypercholesterolemia 

885 Long-Term Persistence in Use of Statin Therapy in Elderly Patients 

887 STRRIDE – Studies of Targeted Risk Reduction Interventions Through 

Defined Exercise (Substudy) 

Contents 

xxv

Page 


890 ASCOT-LLA – Anglo-Scandinavian Cardiac Outcomes Trial—Lipid 

Lowering Arm 

892 ADVOCATE – The Advicor Versus Other Cholesterol-Modulating- 

Agents Trial Evaluation 

895 Ezetimibe 

897 Ezetimibe-Pravastatin 

899 Rosuvastatin vs Pravastatin and Simvastatin 

901 Rosuvastatin vs Atorvastatin 

903 PROSPER – Prospective Study of Pravastatin in the Elderly at Risk 

9. Arrhythmia 

906 MADIT-II – Multicenter Automatic Defibrillator Implantation Trial-II 

908 AVID – Antiarrhythmics vs Implantable Defibrillators 

910 AVID (β-Blocker Substudy) – Antiarrhythmics vs Implantable 

Defibrillators 

912 Prevention of Implantable Defibrillator Shocks by Treatment with 

Sotalol 

914 Facilitating Transthoracic Cardioversion of Atrial Fibrillation with 

Ibutilide Pretreatment 

916 French Active Compression-Decompression Cardiopulmonary 

Resuscitation Study 

918 MUSTT – Multicenter Unsustained Tachycardia Trial Investigation 

920 MUSTT – Multicenter Unsustained Tachycardia Trial (Substudy) 

923 CTAF – Canadian Trial of Atrial Fibrillation 

925 CIDS – Canadian Implantable Defibrillator Study 

927 TRACE (Atrial Fibrillation Substudy) – Trandolapril Cardiac 

Evaluation 

929 ARCH – Amiodarone Reduction in Coronary Heart Trial 

931 Oral d,1 Sotalol Reduces the Incidence of Postoperative Atrial 

Fibrillation in Coronary Artery Bypass Surgery Patients: A Randomized, 

Double-Blind, Placebo-Controlled Study 

933 Efficacy and Safety of Ibutilide Fumarate for the Conversion of Atrial 

Arrhythmias After Cardiac Surgery 

936 GEMICA – Grupo de Estudios Multricentricos en Argentina 

xxvi 

Contents

Page 


Contents 

939 CTOPP – Canadian Trial of Physiologic Pacing 

941 Effective Prevention of Atrial Fibrillation by Continuous Atrial 

Overdrive Pacing After Coronary Artery Bypass Surgery 

943 Atrial Pacing for the Prevention of Atrial Fibrillation After 

Cardiovascular Surgery 

945 Cardiopulmonary Resuscitation by Chest Compression Alone or with 

Mouth-to-Mouth Ventilation 

947 ARREST – Amiodarone in Out-of-Hospital Resuscitation of Refractory 

Sustained Ventricular Tachyarrhythmias 

949 CASH – Cardiac Arrest Study: Hamburg 

951 PIAF – Pharmacologic Intervention in Atrial Fibrillation 

954 AFIST – Atrial Fibrillation Suppression Trial 

957 DIAMOND – Danish Investigations of Arrhythmia and Mortality on 

Dofetilide 

960 DIAMOND (Substudy) – Danish Investigations of Arrhythmia and 

Mortality on Dofetilide 

962 Metoprolol CR/XL to Maintain Sinus Rhythm After Conversion from 

Atrial Fibrillation 

964 SVA-3 – Azimilide Supraventricular Arrhythmia Program-3 

966 Amiodarone for Prevention of Atrial Fibrillation Post-CABG 

968 SAFIRE-D – Symptomatic Atrial Fibrillation Investigative Research on 

Dofetilide Study 

970 ORCA – Optimized Response to Cardiac Arrest 

972 CAT – Cardiomyopathy Trial 

974 tPA in Cardiac Arrest 

976 Hypothermia After Cardiac Arrest Study 

978 Hypothermia in Cardiac Arrest 

980 MOST – Mode Selection Trial in Sinus-Node Dysfunction 

982 ALIVE – Amiodarone vs Lidocaine in Prehospital Ventricular 

Fibrillation Evaluation 

984 AFFIRM – The Atrial Fibrillation Follow-up Investigation of Rhythm 

Management 

987 Delaying Defibrillation to Give Basic Cardiopulmonary Resuscitation 

to Patients with Out-of-Hospital Ventricular Fibrillation 

990 ERAFT – European Rythmol/Rytmonorm Atrial Fibrillation Trial 

Contents 

xxvii

Page 


993 UKPACE – United Kingdom Pacing and Cardiovascular Events Trial 

995 BLOS – The β-Blocker Length of Stay 

997 DAVID – Dual Chamber and VVI Implantable Defibrillator Trial 

999 DEBUT – Defibrillator vs β-Blocker for Unexplained Death in Thailand 

1001 VPS II – Second Vasovagal Pacemaker Study 

1003 STAF – The Strategies of Treatment of Atrial Fibrillation 

1005 AIRCRAFT – Australian Intervention Randomized Control of Rate in 

Atrial Fibrillation Trial 

1007 AMIOVIRT – Amiodarone vs Implantable Cardioverter-Defibrillator 

10. Anticoagulation for Atrial Fibrillation 

1010 AFASAK 2 – Copenhagen Atrial Fibrillation, Aspirin and 

Anticoagulation 2 

1012 ACUTE – Assessment of Cardioversion Using Transesophageal 

Echocardiography 

1014 PATAF – Primary Prevention of Arterial Thromboembolism in 

Nonrheumatic Atrial Fibrillation 

1017 SPORTIF II – Stroke Prevention by Oral Thrombin Inhibitors in Atrial 

Fibrillation 

11. Deep Vein Thrombosis/ Pulmonary Embolism 

1020 MEDENOX – Prophylaxis in Medical Patients with Enoxaparin Study 

1022 NAFT-North American Fragmin Trial – Low-Molecular-Weight 

Heparin Prophylaxis vs Warfarin in Hip Arthroplasty 

1024 NAFT-North American Fragmin Trial – Dalteparin Extended Outof-Hospital 

vs In-Hospital Warfarin/Out-of-Hospital Placebo, in Hip 

Arthroplasty 

1026 DOTAVK – Duree Optimale du Traitement Antivitamines K 

1028 ENOXACAN II – Enoxaparin and Cancer 

1030 Pentasaccharide in Hip-Fracture Surgery Group 

1032 Ximelagatran Prophylaxis Against Venous Thromboembolism 

1034 Pentasaccharide in Major Knee Surgery Study 

1036 Warfarin Optimal Duration Italian Trial 

xxviii 

Contents

Page 


Contents 

1038 PENTATHLON 2000 – Fondaparinux vs Enoxaparin for Prevention of 

Venous Thromboembolism After Hip-Replacement Surgery 

1040 EPHESUS – European Pentasaccharide Hip Elective Surgery Study 

1043 METHRO II – Melagatran for Thrombin Inhibition in Orthopaedic 

Surgery 

1046 Prolonged Thromboprophylaxis with Oral Anticoagulants After Total 

Hip Arthroplasty 

1048 SACRE – Study Comparing Oral Anticoagulants with Reviparin 

1050 PREVENT – Prevention of Recurrent Venous Thromboembolism 

1052 Heparin Plus Alteplase Compared with Heparin Alone in Patients with 

Submassive Pulmonary Embolism 

12. Coronary Artery Disease, Atherosclerosis, Prevention of 

Progression 

1056 ACADEMIC – Azithromycin in Coronary Artery Disease: Elimination of 

Myocardial Infection with Chlamydia Study 

1058 AVERT – Atorvastatin vs Revascularization Treatment 

1060 HOPE (Ramipril Study) – Heart Outcomes Prevention Evaluation 

1062 HOPE (Substudy) – Heart Outcomes Prevention Evaluation 

1064 HOPE (Substudy) – Heart Outcomes Prevention Evaluation 

1066 HOPE – Heart Outcomes Prevention Evaluation Study (Substudy) 

1068 HOPE – Heart Outcomes Prevention Evaluation (Substudy) 

1070 HOPE (Vitamin E Study) – Heart Outcomes Prevention Evaluation 

1072 MICRO-HOPE – Microalbuminuria, Cardiovascular and Renal 

Outcomes— Heart Outcomes Prevention Evaluation 

1075 APRES – ACE Inhibition Post-Revascularization Study 

1077 Physicians’ Health Study – (Post-Trial Aspirin Substudy) 

1079 QUIET (Angiographic Study) – Quinapril Ischemic Event Trial 

1081 QUIET – Quinapril Ischemic Event Trial 

1083 Estrogen Replacement and Atheroclerosis Trial 

1085 BCAPS – β-Blocker Cholesterol-Lowering Asymptomatic Plaque Study 

1087 SCAT – Simvastatin/Enalapril Coronary Atherosclerosis Trial 

1089 PREVENT – Prospective Randomized Evaluation of the Vascular 

Effects of Norvasc Trial 

Contents 

xxix

Page 


1091 PREVENT (Post Hoc Analysis) – Prospective Randomized Evaluation 

of the Vascular Effects of Norvasc Trial 

1093 PART-2 – Prevention of Atherosclerosis with Ramipril Trial-2 

1095 PPP – Primary Prevention Project 

1098 SECURE – Study to Evaluate Carotid Ultrasound Changes in Patients 

Treated with Ramipril and Vitamin E 

1100 DAIS – Diabetes Atherosclerosis Intervention Study 

1102 ETICA – Exercise Training Intervention After Coronary Angioplasty 

1104 MORE – Multiple Outcomes of Raloxifene Evaluation (Secondary 

Analysis) 

1106 CLARIFY – Clarithromycin Acute Coronary Syndrome Patients in 

Finland 

1108 ADAM – Aneurysm Detection and Management Veterans Affairs 

Cooperative Study 

1110 United Kingdom Small Aneurysm Trial Participants 

1112 TPT (Angina) – Thrombosis Prevention Trial 

1114 CUDAS – Perth Carotid Ultrasound Disease Assessment Study 

1116 CAPRIE – Clopidogrel versus Aspirin in Patients at Risk of Ischemic 

Events (Substudy) 

1118 ELSA – European Lacidipine Study on Atherosclerosis 

1121 ENCORE I – Evaluation of Nifedipine and Cerivastatin on Recovery of 

Coronary Endothelial Function 

1124 Women’s Health Initiative Observational Study 

1127 VEAPS – The Vitamin E Atherosclerosis Prevention Study 

1129 WAVE – Women’s Angiographic Vitamin and Estrogen Trial 

1132 Indo-Mediterranean Diet Heart Study 

1134 SUAVIS–Arterial Arm – Sulodexide Arterial Venous Italian Study— 

Arterial Arm 

1136 PACIFIC – Prevention with a Combined Inhibitor and Folic Acid in 

Coronary Heart Disease 

1138 HERS II – Heart and Estrogen/Progestin Replacement Substudy 

1140 HERS II – Heart and Estrogen/Progestin Replacement Study Follow-up 

1142 WHI – Women’s Health Initiative 

xxx 

Contents

Page 


Contents 

13. Valvular Heart Disease 

1146 Low-Molecular-Weight Heparin After Mechanical Heart Valve 

Replacement 

1148 Early and Long-Term (1 Year) Effects of the Association of Aspirin and 

Oral Anticoagulant on Thrombi and Morbidity After Replacement of 

the Mitral Valve with the St. Jude Medical Prosthesis 

1150 SCT – Smoking Cessation Therapy (Fenfluramine Analysis) 

1152 Mechanical vs Bioprosthetic Valves 

1154 Clinical and Echocardiographic Follow-up of Patients Previously 

Treated with Dexfenfluramine or Phentermine/Fenfluramine 

14a. Preliminary Reports — Acute Myocardial Infarction 

1158 ANTIBIO (Preliminary Report) – Antibiotic Therapy in Patients 

After an Acute Myocardial Infarction 

1160 TETAMI – Treatment with Enoxaparin and Tirofiban in Acute 

Myocardial Infarction 

14b. Preliminary Reports — Unstable Angina, Non-Q-Wave 

Myocardial Infarction 

1164 A-to-Z – Aggrastat to Zocor 

1166 SYNERGY – Superior Yield of the New Strategy of Enoxaparin, 

Revascularization and GlYcoprotein IIb/IIIa inhibitors 

14c. Preliminary Reports — Hypertension 

1170 INVEST – International Verapamil SR/Trandolapril Study 

14d. Preliminary Reports — Congestive Heart Failure 

1174 EARTH (Preliminary Report) – Endothelin A Receptor Antagonist 

Trial in Heart Failure 

Contents 

xxxi

Page 


1176 XSOLVD – Extended Studies of Left Ventricular Dysfunction 

Preliminary Report 

1178 COMPANION – Comparison of Medical Therapy, Pacing, and 

Defibrillation in Chronic Heart Failure 

14e. Preliminary Reports — Arrhythmia 

1182 PAFAC (Preliminary Report) – Prevention of Atrial Fibrillation After 

Cardioversion 

1184 SPORTIF III – Stroke Prevention Using Oral Thrombin Inhibitor in 

Atrial Fibrillation 

1186 AF-CHF – The Atrial Fibrillation and Congestive Heart Failure Trial 

14f. Preliminary Reports — Interventional Cardiology 

1190 X-TRACT – X-Sizer for Treatment of Thrombus and Atherosclerosis in 

Coronary Interventions Trial 

1192 BRITE II – Beta Radiation to Reduce In-Stent Restenosis II 

1194 OctoStent 

1196 Abciximab in Patients Undergoing Stenting After Loading with High- 

Dose Clopidogrel 

1198 DELIVER – The RX ACHIEVE Drug-Eluting Coronary Stent System in 

the Treatment of Patients with de novo Native Coronary Lesions 

1200 TAXUS II – Paclitaxel-Eluting Stent Study 

1202 FACIT – Folate After Coronary Intervention Trial 

xxxii 

Contents

Introduction 

The purpose of Cardiovascular Trials Review, Eighth Edition, is to review 

those trials that have made a major impact on the practice of clinical cardiology 

within the last 5 years. We have included only studies that were published 

in English and concentrated mainly on publications that have appeared since 

1999 and have studied either pharmacological or device therapy. The text is 

divided into major headings of diseases such as myocardial infarction and unstable 

angina. In general, we gave priority to prospective randomized trials with 

preference to multicenter studies. In this eighth edition, we have added more 

than 130 new entries and concentrated on trials from 2002–2003. We have 

included some smaller studies that describe the new drug-eluting stents. 

The front section of the book concentrates on articles already in print. The preliminary 

reports section concentrates on studies that have been presented or discussed 

in abstract or other form at major cardiology meetings within the last year. Some of 

these studies are ongoing clinical trials. The Trials Listing sets forth studies by disease 

categories, which are in the Subjects section. The Trials Index at the back of 

the book alphabetically lists acronyms and the corresponding pages on which the 

trials can be found, followed by the names of trials without acronyms. 

We continue to be amazed by the increasing number of new, large clinical trials 

in the literature. Since the early ’90s there has been a virtual explosion of growth 

in the number of these trials. An article by Cheng (Am Heart J. 1999;137:726–765) 

listed more than 2250 cardiology trials with acronyms. It is common for some 

acronyms to be used for more than one study (example: PREVENT). 

Because the seventh edition exceeded 1500 pages, we had to eliminate many 

studies prior to 1999 to make room for those published in the last 1–2 years. 

These earlier studies can be found in the seventh edition of Cardiovascular 

Trials Review. 

Unfortunately, we were not able to include all studies in this text. There are many 

excellent studies that may not appear in this book. However, a review of the trials 

included in this book should give readers a flavor of the types and designs of 

major clinical trials that have influenced the practice of clinical cardiology. 

The drugs, indications for drugs, and drug dosages may or may not be approved 

for general use by the US Food and Drug Administration. Physicians should consult 

the package inserts and/or the Physicians’ Desk Reference for drug indications, 

contraindications, side effects, and dosages as recommended. 

Robert A. Kloner, MD, PhD Los Angeles, July 2003 



xxxiii

xxxiv

MIRACL 

Myocardial Ischemia Reduction with Aggressive Cholesterol 

Lowering (Substudy) 

Title 

Authors 

Effects of atorvastatin on stroke in patients with unstable 

angina or non-Q-wave myocardial infarction. 

Waters DD, Schwartz GG, Olsson AG, et al. 

Reference Circulation 2002;106:1690–1695. 

Disease 

Purpose 

Design 

Patients 

Follow-up 

Regimen 

Hypercholesterolemia; unstable angina, non-Q-wave 

myocardial infarction; stroke. 

To determine whether aggressive lowering of lipid levels 

with a statin reduces the incidence of nonfatal stroke 

in patients who have had an acute coronary syndrome. 

Substudy of a randomized, placebo-controlled trial. 

As per MIRACL. 

16 weeks. 

Patients were randomized to atorvastatin (n=1538) 

80mg/d or placebo (n=1548) for 16 weeks. All patients 

were counseled on adherence to the National Cholesterol 

Education Program Step I diet. 

Section 8 


839

MIRACL 

Myocardial Ischemia Reduction with Aggressive Cholesterol 

Lowering (Substudy) 

(continued) 

Results 

Conclusions 

The end point of this substudy was the incidence of fatal 

and nonfatal stroke. At study entry, the lipid levels between 

the two groups were similar; the mean level of total cholesterol 

was 206 mg/dL, 124 mg/dL for LDL cholesterol, 46 

mg/dL for HDL cholesterol, and 182 mg/dL for triglycerides. 

The total and LDL cholesterol had increased slightly in the 

placebo group at the end of the study. LDL cholesterol had 

increased 12% in the placebo group, and decreased by 40% 

in the atorvastatin group. Nonfatal stroke occurred in 22 

patients in the placebo group and 9 in the atorvastatin 

group (relative risk [RR] 0.40; 95% CI=0.19–0.88; p=0.02). 

Fatal and nonfatal stroke occurred in 24 patients in the 

placebo group and 12 in the atorvastatin group (RR 0.49; 

95% CI=0.24–0.98, p=0.04). 3 strokes were classified as 

hemorrhagic; all were in the placebo group. 8 strokes were 

classified as either hemorrhagic or undetermined; 5 of these 

were in the placebo group. All other strokes were either 

thrombotic or embolic. Patients who developed stroke 

were older than those who did not, were more likely to be 

women, and more likely to have a history of heart failure, 

cerebrovascular disease, or MI. Lipid levels at baseline were 

similar in patients who developed stroke and those who did 

not. Cox proportional hazards analysis revealed that 2 variables 

were associated with an increased risk of nonfatal 

stroke: history of cerebrovascular disease (RR 3.44; 95% 

CI=1.50–7.87; p=0.004); and previous MI (RR 1.99; 95% 

CI=0.96–4.15; p=0.065). Treatment with atorvastatin had a 

RR of 0.41 (95% CI=0.19–0.89; p=0.024) and current smoking 

had a RR of 0.28 (95% CI=0.08–0.92; p=0.36). However, 

further analysis showed that current smokers in the study 

were younger and less likely to have diabetes, hypertension, 

history of heart failure, or previous coronary revascularization, 

which may account for this finding. 

Aggressive lowering of lipid levels with atorvastatin in 

patients with an acute coronary syndrome was associated 

with a significantly reduced risk of stroke in the shortterm 

(16 weeks) follow-up period. 

840 8. Lipid-Lowering Studies

ASCOT-LLA 

Anglo-Scandinavian Cardiac Outcomes Trial—Lipid 

Lowering Arm 


Authors 

Prevention of coronary and stroke events with atorvastatin 

in hypertensive patients who have average or lower-thanaverage 

cholesterol concentrations, in the Anglo- 

Scandinavian Cardiac Outcomes Trial—Lipid Lowering Arm 

(ASCOT-LLA): a multicentre randomised controlled trial. 

Sever PS, Dahlof B, Poulter NR, et al. 

Reference Lancet 2003;361:1149–1158. 

Disease 

Purpose 

Design 

Patients 

Hypertension, hypercholesterolemia (mild). 

To study the cardiovascular effects of atorvastatin in hypertensive 

patients with total cholesterol of ≤6.5 mmol/L. 

Randomized, 2 × 2 factorial design, double-blind, multicenter. 

The antihypertensive arm is designed as Prospective 

Randomized Open Blinded end points (PROBE) trial. 

10,305 patients, 40–79 years old, with untreated hypertension 

(≥160/100 mm Hg) or treated hypertension with blood 

pressure ≥140/90 mm Hg, who had also serum total cholesterol 

of ≤6.5 mmol/L and were not currently taking a 

fibrate or a statin. In addition, patients had to have ≥3 of the 

following risk factors (left ventricular hypertrophy, abnormal 

ECG, type 2 diabetes, peripheral vascular disease, 

previous TIA or stroke, male sex, age ≥55 years, microalbuminuria 

or proteinuria, smoking, total cholesterol/HDL 

cholesterol ratio of ≥6, or premature family history of coronary 

heart disease). Patients with previous myocardial 

infarction, angina, a stroke within the preceding 3 months, 

serum triglycerides >4.5 mmol/L, congestive heart failure, 

uncontrolled arrhythmia or any routine laboratory test 

showing important hematological or biochemical abnormality 

were excluded. 

890 8. Lipid-Lowering Studies

ASCOT-LLA 

Anglo-Scandinavian Cardiac Outcomes Trial—Lipid 

Lowering Arm 

(continued) 

Follow-up 

Regimen 

Results 

Conclusions 

Median 3.3 years. 

After a 4-week run-in phase, 19,342 patients were randomized 

to β-blockers ± diuretics or to amlodipine ± ACE 

inhibitor. In addition, the eligible patients for the lipid-lowering 

arm were randomized to atorvastatin 10 mg/d 

(n=5168) or placebo (n=5137). 

The study was terminated prematurely by the Data and 

Safety Monitoring Board. Compared with placebo, atorvastatin 

reduced total cholesterol by 1.3 mmol/L, LDL 

cholesterol by 1.2 mmol/L, and triglycerides by 0.3 

mmol/L at 1 year. HDL cholesterol levels were comparable 

between the groups. The primary end point of the 

study (nonfatal MI or coronary heart disease death) 

occurred in 1.9% in the atorvastatin group and in 3.0% 

in the placebo group (hazard ratio [HR] 0.64; 95% CI= 

0.50–0.83; p=0.0005). All-cause mortality was 3.6% and 

4.1%, respectively (p=0.165). Cardiovascular mortality 

was 1.4% and 1.6%, respectively (p=0.51). Stroke 

occurred in 1.7% and 2.4%, respectively (HR 0.73; 95% 

CI=0.56–0.96; p=0.024), and MI in 1.7% and 2.7%, 

respectively (HR 0.62; 95% CI= 0.47–0.81; p=0.0005). 

Total cardiovascular events and procedures occurred in 

7.5% and 9.5% of the patients, respectively (HR 0.79; 95% 

CI=0.69–0.90; p=0.0005). Coronary events occurred in 

3.4% in the atorvastatin and 4.8% in the placebo group 

(HR 0.71; 95% CI=0.59–0.86; p=0.0005). The rates of 

serious adverse events and liver-enzyme elevation were 

comparable between the atorvastatin and placebo 

groups. 

Atorvastatin 10 mg/d reduced major cardiovascular 

events and stroke in hypertensive patients with high-risk 

features for cardiovascular disease and normal or only 

mildly elevated serum cholesterol levels. 

Section 8 


891

Comparison of the Effects of Atorvastatin Versus 

Simvastatin on Subclinical Atherosclerosis in Primary 

Prevention as Determined by Electron Beam Tomography 


Authors 

Comparison of the effects of atorvastatin versus simvastatin 

on subclinical atherosclerosis in primary prevention 

as determined by electron beam tomography. 

Hecht HS, Harman SM. 

Reference Am J Cardiol 2003;91:42–45. 

Disease 

Purpose 

Design 

Patients 

Coronary artery disease. 

To determine the comparative effects of atorvastatin and 

simvastatin on progression of calcified plaque as determined 

by electron beam tomography (EBT) in patients 

without symptomatic coronary artery disease. 

Observational. 

103 patients in the atorvastatin group and 46 in the simvastatin 

group. No patients had a history of symptomatic 

CAD. In each group, mean age was approximately 59 

years, approximately 27% had hypertension, approximately 

5% were smokers, and 60% had a family history 

of CAD. 2% and 9% of patients in the atorvastatin and simvastatin 

groups were diabetic, respectively. All differences 

between the 2 groups were nonsignificant. Total 

cholesterol and LDL cholesterol were significantly higher 

in the atorvastatin group at study start than in the simvastatin 

group (p

Comparison of the Effects of Atorvastatin Versus 

Simvastatin on Subclinical Atherosclerosis in Primary 

Prevention as Determined by Electron Beam Tomography 

(continued) 

Follow-up 

Regimen 

Results 

Conclusions 

1.2 years. 

Statin treatment to lower LDL cholesterol as described 

above and niacin treatment to increase HDL and lower 

triglycerides as above. Diet, weight loss, exercise, smoking 

cessation, and aspirin were recommended to all 

patients. 

The EBT calcium score and volume score at study start 

were similar between the 2 groups. The baseline LDL cholesterol, 

total, and non-HDL cholesterol levels were significantly 

higher in the atorvastatin group. The EBT 

percentile was significantly higher in the atorvastatin 

cohort. The change in total cholesterol in the atorvastatin 

and simvastatin groups, respectively, was –26.2% and 

–22.2%; for LDL cholesterol: –39.8% and –34.7%; for HDL: 

+15.6% and +14.9%; for triglycerides: –22.1% and –18.8%; 

none of these differences were significant between the 

statin groups. The change in calcium scores was +10.8% 

and +7.5%, and the change in volume scores was +8.5% 

and +7.8% in the atorvastatin and simvastatin groups, 

respectively, with no significant differences between the 

groups. The calcium score and volume score were similar 

between the groups at the end of the study. 

Treatment with atorvastatin and simvastatin in patients 

who are asymptomatic for CAD produced an equal progression 

of calcified plaques as determined by EBT. 

Section 8 


787

CAPE II Trial 

Circadian Anti-Ischemic Program in Europe II 


Authors 

Medical treatment of myocardial ischemia in coronary 

artery disease: effect of drug regime and irregular dosing 

in the CAPE II trial. 

Deanfield JE, Detry J-M, Sellier P, et al. 

Reference J Am Coll Cardiol 2002;40:917–925. 

Disease 

Purpose 

Design 

Patients 

Follow-up 

Regimen 

Coronary artery disease. 

To determine the efficacy of amlodipine and diltiazem in preventing 

ischemia when an irregular dosing pattern is used. 

Double-blind, randomized, multicenter. 

250 patients, 128 in the amlodipine group, 122 in diltiazem 

group. Patients age 21–80 years were eligible if they had a 

history of stable angina (≥2 attacks/week and no change in 

symptoms for ≥1 month), positive exercise test, and at least 

one other objective finding of coronary artery disease. 

Exclusion criteria were: congestive heart failure, uncontrolled 

arrhythmia or hypertension, standing systolic blood 

pressure

CAPE II Trial 


(continued) 

ambulatory ECG monitoring and exercise testing were performed 

two weeks after the dosage increase. Both groups 

were given a placebo pill on the third day of ECG monitoring 

to simulate a missed dose, with exercise testing performed 

again thereafter. Atenolol, 50 mg once a day, was 

then added to patients in the amlodipine group and isosorbide 

5-mononitrate, 50 mg once a day, was added to 

patients in the diltiazem group. After 2 weeks of this combined 

treatment, the dosages of atenolol and isosorbide 

were each increased to 100 mg daily. At 14 weeks, (total 6 

weeks combined treatment) patients underwent 72-hour 

ambulatory ECG monitoring and exercise testing, with a 

placebo pill again given for the last 24 hours. 

Results 

Age, gender, angina history, incidence of previous MI or 

revascularization, heart rate, or BP were not significantly 

different between the 2 groups. Many of the patients 

were already being treated with aspirin and ACEIs, and 

use of lipid-lowering drugs was common. The primary 

outcome measures determined by the ECG records were: 

total number of ST-segment episodes, total duration of 

such episodes, and peak ST-segment depression, all 

recorded during the 48-hour monitoring period while on 

active drug therapy. Secondary outcome measures were: 

ECG records from the 24-hour off-medication period, 

exercise test results, and daily angina diary data. Ischemic 

events at baseline were similar between the 2 groups. 

Among the primary outcome measures, there was a significant 

reduction in transient ST-segment depression 

events in both groups when compared with baseline, 

and there was no significant difference between the 2 

groups. During the medication-free period, ischemic 

suppression was maintained in the amlodipine group; 

patients in the diltiazem group showed a significantly 

higher number (p

CAPE II Trial 


(continued) 

isosorbide 5-mononitrate and diltiazem resulted in a nonsignificant 

reduction in these measures. During the drug 

holiday, the amlodipine/atenolol group showed less 

ischemia than the diltiazem/isosorbide 5-mononitrate 

group, demonstrated by fewer episodes of ST segment 

depression (p=0.02) and peak ST segment depression 

(p=0.02). The atenolol/amlodipine combination resulted 

in a significant reduction in ischemia in the 24-hour 

drug holiday period (p

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