August 9, 1999
Volume 51, No. 37
New study finds drug as good or better than angioplasty
Aggressively lowering "bad" cholesterol is at least as good or better than angioplasty or usual care for preventing and delaying certain cardiac events in selected patients with stable coronary artery disease, reported Emory researchers and others in the New England Journal of Medicine last month.
The authors released the 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 341 patients with stable coronary artery disease into the study. Subjects were randomized to either receive aggressive cholesterol-lowering therapy with the drug atorvastatin (brand name Lipitor) or 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 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--a 36 percent reduction. Ischemic events included cardiac arrest, nonfatal heart attack, 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 reported.
"These results are important for doctors as well as their patients with mild coronary artery disease," said co-author Virgil Brown, Charles Howard Candler Professor of Medicine and chief of medicine at the V.A. Medical Center. 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 [drug] therapy is more appropriate for individual patients."
Brown emphasized that only patients with stable coronary artery disease were entered into the AVERT trial and that findings cannot be applied to those with more severe disease. AVERT patients had one or two coronary arteries that were at least 50 percent blocked, LDL cholesterol levels of at least 115 mg/dl and triglyceride levels of 500 mg/dl or fewer. They had stable angina--any chest pain they'd experienced was not disabling--and, among other criteria, they were able to complete at least four minutes of treadmill or bicycle exercise without measurable problems.
"Until further long-term trials in a larger number of patients are available, this study suggests that aggressive [cholesterol] lowering with atorvastatin is safe and as good or better than angioplasty plus usual care in reducing ischemic events," the authors concluded. "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 Co.