Document Detail

A tale of two trials: a comparison of the post-acute coronary syndrome lipid-lowering trials A to Z and PROVE IT-TIMI 22.
MedLine Citation:
PMID:  16534008     Owner:  NLM     Status:  MEDLINE    
BACKGROUND: The Aggrastat to Zocor (A to Z) and Pravastatin or Atorvastatin Evaluation and Infection Therapy (PROVE IT) trials compared intensive and moderate statin therapy after acute coronary syndromes, with seemingly disparate results. We analyzed the design, implementation, and results of the two trials in an attempt to clarify the effects of early intensive statin therapy. METHODS AND RESULTS: Study design, end points, and definitions were compared. In each trial, comparisons were made between intensive and moderate arms for both trials' primary end points and death/myocardial infarction. Analyses were performed over various time points: at the end of the trials, < or =4 months, and >4 months. Subjects in A to Z had higher-risk demographics. More PROVE IT subjects were enrolled in the United States and underwent prerandomization revascularization. The low-density lipoprotein (LDL) difference was greater in A to Z than in PROVE IT early (< or =4 months) but less late. Significant C-reactive protein reduction was earlier in PROVE IT. With common end points, event rates were higher in A to Z, and early favorable separation of event curves was seen in PROVE IT but not in A to Z. Clinical end point rates and reductions were similar in both trials after 4 months. CONCLUSIONS: An early benefit was seen in PROVE IT but not in A to Z. Late-phase results were similar. Factors that may explain this disparity include the intensity of therapy in the early phase, timing, and magnitude of LDL and C-reactive protein lowering, differences in early revascularization, and the play of chance. Taken together, the results of these trials support a strategy of early intensive statin therapy coupled with revascularization when appropriate in patients after acute coronary syndrome.
Stephen D Wiviott; James A de Lemos; Christopher P Cannon; Michael Blazing; Sabina A Murphy; Carolyn H McCabe; Robert Califf; Eugene Braunwald
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Publication Detail:
Type:  Comparative Study; Journal Article; Research Support, Non-U.S. Gov't     Date:  2006-03-13
Journal Detail:
Title:  Circulation     Volume:  113     ISSN:  1524-4539     ISO Abbreviation:  Circulation     Publication Date:  2006 Mar 
Date Detail:
Created Date:  2006-03-21     Completed Date:  2006-04-20     Revised Date:  2009-11-19    
Medline Journal Info:
Nlm Unique ID:  0147763     Medline TA:  Circulation     Country:  United States    
Other Details:
Languages:  eng     Pagination:  1406-14     Citation Subset:  AIM; IM    
The TIMI Study Group, Cardiovascular Division, Department of Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, MA, USA.
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MeSH Terms
Angina, Unstable / epidemiology
C-Reactive Protein / analysis
Cardiovascular Diseases / mortality
Case Management
Confounding Factors (Epidemiology)
Dose-Response Relationship, Drug
Drug-Induced Liver Injury / etiology
Endpoint Determination
Heptanoic Acids / administration & dosage,  adverse effects,  therapeutic use*
Hospitalization / statistics & numerical data
Hydroxymethylglutaryl-CoA Reductase Inhibitors / administration & dosage,  adverse effects,  therapeutic use*
Life Tables
Lipids / blood
Middle Aged
Multicenter Studies as Topic
Myocardial Infarction / epidemiology
Myocardial Ischemia / blood,  drug therapy*,  therapy
Myocardial Revascularization / utilization
Pravastatin / administration & dosage,  adverse effects,  therapeutic use*
Pyrroles / administration & dosage,  adverse effects,  therapeutic use*
Randomized Controlled Trials as Topic* / methods
Research Design*
Risk Factors
Simvastatin / administration & dosage,  adverse effects,  therapeutic use*
Stroke / epidemiology
Treatment Outcome
Tyrosine / adverse effects,  analogs & derivatives*,  therapeutic use
Reg. No./Substance:
0/Heptanoic Acids; 0/Hydroxymethylglutaryl-CoA Reductase Inhibitors; 0/Lipids; 0/Pyrroles; 110862-48-1/atorvastatin; 144494-65-5/tirofiban; 55520-40-6/Tyrosine; 79902-63-9/Simvastatin; 81093-37-0/Pravastatin; 9007-41-4/C-Reactive Protein
Comment In:
Circulation. 2006 Mar 21;113(11):1382-4   [PMID:  16549649 ]

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