Lessons learned from recent cardiovascular clinical trials: Part I.

T his is the first installment in a 4-part series of articles about our experiences with cardiovascular clinical research during the past 2 decades. From our vantage points as statistical and clinical researchers, we derive a series of lessons from recent clinical trials and incorporate them into principles designed to guide the practicing clinician who cares for patients with heart diseases. rational for

[1]  D. Julian Treatment for survivors of acute myocardial infarction: What have we learned from large intervention trials? , 1995, Cardiovascular Drugs and Therapy.

[2]  B. Dahlof,et al.  Cardiovascular morbidity and mortality in the losartan intervention for end point reduction in hypertension study (LIFE): a randomised trial against atenolol☆ , 2002 .

[3]  D. DeMets,et al.  Considerations in the evaluation of surrogate endpoints in clinical trials. summary of a National Institutes of Health workshop. , 2001, Controlled clinical trials.

[4]  C. Yancy,et al.  Race and the response to adrenergic blockade with carvedilol in patients with chronic heart failure. , 2001, New England Journal of Medicine.

[5]  M. Schwerzmann,et al.  Quantitative contrast echocardiographic assessment of collateral derived myocardial perfusion during elective coronary angioplasty , 2001, Heart.

[6]  H. Pereira,et al.  Reperfusion therapy for acute myocardial infarction with fibrinolytic therapy or combination reduced fibrinolytic therapy and platelet glycoprotein IIb/IIIa inhibition: the GUSTO V randomised trial , 2001, The Lancet.

[7]  D. DeMets,et al.  Effect of carvedilol on survival in severe chronic heart failure. , 2001, The New England journal of medicine.

[8]  R. Collins,et al.  Reliable assessment of the effects of treatment on mortality and major morbidity, I: clinical trials , 2001, The Lancet.

[9]  T. R. I. Nvestigators A TRIAL OF THE BETA-BLOCKER BUCINDOLOL IN PATIENTS WITH ADVANCED CHRONIC HEART FAILURE , 2001 .

[10]  Michael J. Goodman,et al.  Contraindicated use of cisapride: impact of food and drug administration regulatory action. , 2000, JAMA.

[11]  The Esprit investigators Novel dosing regimen of eptifibatide in planned coronary stent implantation (ESPRIT): a randomised, placebo-controlled trial , 2000, The Lancet.

[12]  John Wikstrand,et al.  Effects of Controlled-Release Metoprolol on Total Mortality, Hospitalizations, and Well-being in Patients with Heart Failure: The Metoprolol CR/XL Randomized Intervention Trial in Congestive Heart Failure (MERIT-HF) , 2000 .

[13]  A. Keech,et al.  Effect of Pravastatin on Coronary Disease Events in Subgroups Defined by Coronary Risk Factors: The Prospective Pravastatin Pooling Project , 2000, Circulation.

[14]  L. Newby,et al.  Oral platelet glycoprotein IIb/IIIa inhibition , 2000, Current Cardiology Reports.

[15]  C. O'connor,et al.  Circadian rhythm and sudden death in heart failure: results from Prospective Randomized Amlodipine Survival Trial. , 2000, Journal of the American College of Cardiology.

[16]  Salim Yusuf,et al.  Long-term ACE-inhibitor therapy in patients with heart failure or left-ventricular dysfunction: a systematic overview of data from individual patients , 2000, The Lancet.

[17]  T. Fleming Surrogate end points in cardiovascular disease trials. , 2000, American heart journal.

[18]  Rian,et al.  A DOSE-DEPENDENT INCREASE IN MORTALITY WITH VESNARINONE AMONG PATIENTS WITH SEVERE HEART FAILURE , 2000 .

[19]  Eric J. Eichhorn Experience with beta blockers in heart failure mortality trials. , 1999, Clinical cardiology.

[20]  R. Temple,et al.  Are surrogate markers adequate to assess cardiovascular disease drugs? , 1999, JAMA.

[21]  CIBIS-II Investigators and Committees The Cardiac Insufficiency Bisoprolol Study II (CIBIS-II): a randomised trial , 1999, The Lancet.

[22]  G Barbash,et al.  Single-bolus tenecteplase compared with front-loaded alteplase in acute myocardial infarction: the ASSENT-2 double-blind randomised trial , 1999, The Lancet.

[23]  D. DeMets,et al.  A dose-dependent increase in mortality with vesnarinone among patients with severe heart failure. Vesnarinone Trial Investigators. , 1999, The New England journal of medicine.

[24]  R. Norton,et al.  Life-threatening interaction of mibefradil and beta-blockers with dihydropyridine calcium channel blockers. , 1998, JAMA.

[25]  H. Suryapranata,et al.  Angiographic assessment of myocardial reperfusion in patients treated with primary angioplasty for acute myocardial infarction: myocardial blush grade. Zwolle Myocardial Infarction Study Group. , 1998, Circulation.

[26]  A. Gotto,et al.  Primary prevention of acute coronary events with lovastatin in men and women with average cholesterol levels: results of AFCAPS/TexCAPS. Air Force/Texas Coronary Atherosclerosis Prevention Study. , 1998, JAMA.

[27]  A comparison of aspirin plus tirofiban with aspirin plus heparin for unstable angina. , 1998, The New England journal of medicine.

[28]  Inhibition of the platelet glycoprotein IIb/IIIa receptor with tirofiban in unstable angina and non-Q-wave myocardial infarction. , 1998, The New England journal of medicine.

[29]  W. V. Mieghem,et al.  International, randomized, controlled trial of lamifiban (a platelet glycoprotein IIb/IIIa inhibitor), heparin, or both in unstable angina. The PARAGON Investigators. Platelet IIb/IIIa Antagonism for the Reduction of Acute coronary syndrome events in a Global Organization Network. , 1998, Circulation.

[30]  Inhibition of platelet glycoprotein IIb/IIIa with eptifibatide in patients with acute coronary syndromes. , 1998, The New England journal of medicine.

[31]  D. DeMets,et al.  Rationale, design, and organization of the metoprolol CR/XL randomized intervention trial in heart failure (MERIT-HF) , 1997 .

[32]  M. Savage,et al.  Frequency and outcome of development of coronary artery aneurysm after intracoronary stent placement and angioplasty. STRESS Trial Investigators. , 1997, The American journal of cardiology.

[33]  R. Califf,et al.  Pragmatic and mechanistic trials. , 1997, European heart journal.

[34]  C M O'Connor,et al.  Effect of amlodipine on morbidity and mortality in severe chronic heart failure. Prospective Randomized Amlodipine Survival Evaluation Study Group. , 1996, The New England journal of medicine.

[35]  D. DeMets,et al.  Surrogate End Points in Clinical Trials: Are We Being Misled? , 1996, Annals of Internal Medicine.

[36]  B. Davis,et al.  Experimental approaches to determining the choice of first-step therapy for patients with hypertension. The ALLHAT Research Group Antihypertensive and Lipid-Lowering Treatment to Prevent Heart Attack Trial. , 1996, Clinical and experimental hypertension.

[37]  Scandinavian Simvastatin Survival Study Group Randomised trial of cholesterol lowering in 4444 patients with coronary heart disease: the Scandinavian Simvastatin Survival Study (4S) , 1994, The Lancet.

[38]  W Rutsch,et al.  A comparison of balloon-expandable-stent implantation with balloon angioplasty in patients with coronary artery disease. Benestent Study Group. , 1994, The New England journal of medicine.

[39]  L. Shaw,et al.  Gender Differences in the Noninvasive Evaluation and Management of Patients with Suspected Coronary Artery Disease , 1994, Annals of Internal Medicine.

[40]  R. Bain,et al.  Effects of vesnarinone on morbidity and mortality in patients with heart failure , 1993 .

[41]  Robert Lemery,et al.  Effect of the antiarrhythmic agent moricizine on survival after myocardial infarction. , 1992, The New England journal of medicine.

[42]  D. DeMets,et al.  Effect of oral milrinone on mortality in severe chronic heart failure. The PROMISE Study Research Group. , 1991, The New England journal of medicine.

[43]  M. Weir,et al.  The Cardiac Arrhythmia Suppression Trial Investigators: Preliminary Report: Effect of Encainide and Flecainide on Mortality in a Randomized Trial of Arrhythmia Suppression After Myocardial Infarction. , 1990 .

[44]  R. Prentice Surrogate endpoints in clinical trials: definition and operational criteria. , 1989, Statistics in medicine.

[45]  L. Bolognese,et al.  RANDOMISED TRIAL OF INTRAVENOUS STREPTOKINASE, ORAL ASPIRIN, BOTH, OR NEITHER AMONG 17 187 CASES OF SUSPECTED ACUTE MYOCARDIAL INFARCTION: ISIS-2 , 1988, The Lancet.

[46]  R Peto,et al.  Why do we need some large, simple randomized trials? , 1984, Statistics in medicine.