Sarah Goodwin

Kathi Ovnic
Holly Korschun
July 7, 1999

EMBARGOED FOR RELEASE until 4 p.m., E.S.T., Wed., July 7, 1999




Aggressively lowering "bad" cholesterol "is at least as good or better" than angioplasty/usual care for preventing and delaying certain cardiac events in selected patients with stable coronary artery disease, report researchers from Emory University and elsewhere in this week's New England Journal of Medicine. The authors report results of the Atorvastatin Versus Revascularization Treatment (AVERT) trial -- the first study to directly compare cholesterol-lowering therapy to balloon angioplasty.

Researchers from 37 medical centers in North America and Europe entered into the study 341 patients with stable coronary artery disease. Study subjects were randomized to either receive aggressive cholesterol-lowering therapy with atorvastatin (brand name Lipitor) or to undergo balloon angioplasty and receive "usual" medical care, which may or may not have included some form of cholesterol-lowering therapy.

Taking 80 mg of atorvastatin daily reduced low-density lipoprotein (LDL or "bad") cholesterol levels 46 percent, to an average of 77 mg/dl, among subjects randomized to the "drug" group. Thirteen percent (22) of the 164 patients assigned to receive the cholesterol-lowering drug went on to experience an ischemic event during the 18-month study period compared to 21 percent (37) of the 177 subjects assigned to the angioplasty/usual care group. This represents a 36 percent reduction in the medically (drug) treated group versus the revascularization group. Ischemic events included cardiac arrest, nonfatal heart attack, cerebrovascular accident (stroke), bypass surgery, angioplasty or cardiac death. In addition, onset of cardiac events was significantly delayed in subjects receiving the cholesterol-lowering agent compared to those in the angioplasty/usual care group, the authors report.

"These results are important for doctors as well as their patients with mild coronary artery disease," says co-author W. Virgil Brown, M.D., the Charles Howard Candler Professor of Medicine at the Emory University School of Medicine and chief of medicine at the Veterans Affairs Medical Center in Atlanta. Dr. Brown was involved in the first study to show the benefits of cholesterol-lowering therapy in heart disease prevention and treatment. "Findings from the AVERT trial give physicians more data to use when deciding whether angioplasty or medical (drug) therapy is more appropriate for individual patients."

Dr. Brown emphasizes that only persons with stable coronary artery disease were entered into the AVERT trial and that findings cannot be applied to persons with more severe disease. AVERT patients had one or two coronary arteries that were at least 50 percent occluded, LDL cholesterol levels of at least 115 mg/dl and triglyceride levels of 500 mg/dl or fewer. They had stable angina ­ meaning any chest pain they did experience was not disabling ­ and among other criteria, they were able to complete at least four minutes of treadmill or bicycle exercise testing without measurable problems.

"Until further long-term trials in a larger number of patients are available, this study suggests that aggressive lipid (blood fat; cholesterol) lowering with atorvastatin is safe and as good or better than angioplasty plus usual care in reducing ischemic events," the authors conclude. "It appears that in patients with relatively normal left ventricular function who are not severely symptomatic, choosing an initial strategy of aggressive lipid lowering with atorvastatin will reduce ischemic events and thereby delay or prevent the need for revascularization.

"If at any time symptoms worsen and/or exercise performance deteriorates such that it interferes with their lifestyle, patients may elect to undergo revascularization without any apparent penalty for their initial decision. The adoption of this strategy should result in long-term patient benefit without any apparent risk."

The study was supported by a grant from Parke-Davis Pharmaceutical Research, a division of Warner-Lambert Company.