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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:

Robert A. Kloner, MD, PhD

Yochai Birnbaum, MD

Contributions by:

Jason S. Chi, BS

Robert A. Kloner, MD, PhD

Director of Research, Heart Institute,

Good Samaritan Hospital

Professor of Medicine, Cardiovascular Division

University of Southern California

Los Angeles, CA

Yochai Birnbaum, MD

Medical Director, Cardiac Intensive Care Unit

Medical Director, Heart Station

Professor of Medicine,

Division of Cardiology,

University of Texas Medical Branch

Galveston, TX

Jason S. Chi, BS

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

Acronym/Title

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

Acronym/Title

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

Acronym/Title

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

Acronym/Title

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

Acronym/Title

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

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

Angina: Receptor Suppression Using Integrilin Therapy

229 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

Acronym/Title

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

Acronym/Title

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

Acronym/Title

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

Acronym/Title

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


Page

Acronym/Title

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

Acronym/Title

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


Page

Acronym/Title

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

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Page

Acronym/Title

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

Acronym/Title

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

Acronym/Title

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

739 COPERNICUS – Carvedilol Prospective Randomized Cumulative

Survival

xxii

Contents


Page

Acronym/Title

Contents

741 COPERNICUS – Carvedilol Prospective Randomized Cumulative

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

Acronym/Title

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

Acronym/Title

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

Acronym/Title

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

Acronym/Title

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

Acronym/Title

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

Acronym/Title

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

Acronym/Title

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

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Contents


Page

Acronym/Title

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

Acronym/Title

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

Yochai Birnbaum, MD

Jason S. Chi, BS

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

8. Lipid-Lowering Studies

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

Title

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

8. Lipid-Lowering Studies

891


Comparison of the Effects of Atorvastatin Versus

Simvastatin on Subclinical Atherosclerosis in Primary

Prevention as Determined by Electron Beam Tomography

Title

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

8. Lipid-Lowering Studies

787


CAPE II Trial

Circadian Anti-Ischemic Program in Europe II

Title

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

Circadian Anti-Ischemic Program in Europe II

(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

Circadian Anti-Ischemic Program in Europe II

(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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