CLINICAL STUDIES
Pravastatin prevents clinical events in revascularized patients with average cholesterol concentrations
Greg C. Flaker, MD, FACC*,
J. Wayne Warnica, MD, FACC ,
Frank M. Sacks, MD ,
Lemuel A. Moyé, MD, PhD ,
Barry R. Davis, MD, PhD ,
Jean L. Rouleau, MD||,
Richard R. Webel, MD*,
Marc A. Pfeffer, MD, PhD ,
Eugene Braunwald, MD for the Cholesterol and Recurrent Events CARE Investigators**
* University of Missouri, Columbia, Missouri, USA
Foothills Hospital, Calgary, Alberta, Canada
University of Texas School of Public Health, Houston, Texas, USA
Brigham and Womens Hospital and Harvard Medical School, Boston, Massachusetts, USA
|| Montreal Heart Institute, Montreal, Quebec, Canada
Manuscript received October 26, 1998;
revised manuscript received February 2, 1999,
accepted March 15, 1999.
Reprint requests and correspondence: Dr. Greg Flaker, University of Missouri Hospital and Clinics, Department of Cardiology, Room MC-501, One Hospital Drive, Columbia, Missouri 65212 greg_flaker{at}muccmail.hsc.missouri.edu
OBJECTIVES
This analysis was carried out to determine if revascularized patients derive benefit from the 3-hydroxy-3 methylglutaryl coenzyme A (HMG-CoA) reductase inhibitor pravastatin.
BACKGROUND
The HMG-CoA reductase inhibitors result in substantial reductions in serum cholesterol and stabilization of atherosclerotic plaques in patients with coronary artery disease.
METHODS
Pravastatin was found to reduce clinical cardiovascular events in the Cholesterol and Recurrent Events (CARE) trial consisting of 4,159 patients with a documented myocardial infarction and an average cholesterol level (mean 209 mg/dl and all <240 mg/dl). A total of 2,245 patients underwent coronary revascularization before randomization including 1,154 patients with percutaneous transluminal coronary angioplasty (PTCA) alone, 876 patients with coronary artery bypass graft (CABG) alone, and 215 patients with both procedures. Clinical events in revascularized patients were compared between patients on placebo and on pravastatin.
RESULTS
In the 2,245 patients who had undergone revascularization, the primary endpoint of coronary heart disease death or nonfatal myocardial infarction (MI) was reduced by 4.1% with pravastatin (relative risk [RR] reduction 36%, 95% confidence interval [CI] 17 to 51, p = 0.001). Fatal or nonfatal MI was reduced by 3.3% (RR reduction 39%, 95% CI 16 to 55, p = 0.002), postrandomization repeat revascularization was reduced by 2.6% (RR reduction 18%, 95% CI 1 to 33, p = 0.068) and stroke was reduced by 1.5% (RR reduction 39%, 95% CI 3 to 62, p = 0.037) with pravastatin. Pravastatin was beneficial in both the 1,154 PTCA patients and in the 1,091 CABG patients who had undergone revascularization before randomization.
CONCLUSIONS
Pravastatin reduced clinical events in revascularized postinfarction patients with average cholesterol levels. This therapy was well tolerated and its use should be considered in most patients following coronary revascularization.
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Abbreviations and Acronyms
| | CABG | = coronary artery bypass graft | | CARE | = Cholesterol and Recurrent Events trial | | CHD | = coronary heart disease | | CHF | = congestive heart failure | | CPK | = creatine phosphokinase | | HDL-C | = high density lipoprotein cholesterol | | HMG-CoA | = 3-hydroxy-3 methylglutaryl coenzyme A | | LDL-C | = low density lipoprotein cholesterol | | MI | = myocardial infarction | | PTCA | = percutaneous transluminal coronary angioplasty |
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