TY - JOUR
T1 - Vascular basis for the treatment of myocardial ischemia study
T2 - Trial design and baseline characteristics
AU - Stone, Peter H.
AU - Lloyd-Jones, Donald M.
AU - Johnstone, Michael
AU - Carlson, William
AU - Rubenstein, Joel
AU - Creager, Mark
AU - Frei, Balz
AU - Sopko, George
AU - Clark, Maureen E.
AU - MacCallum, Gail
AU - Kinlay, Scott
AU - Orav, John
AU - Selwyn, Andrew P.
PY - 2004/5
Y1 - 2004/5
N2 - Background Increased low-density lipoprotein (LDL) and oxidized LDL cholesterol levels adversely affect endothelial function in patients with stable coronary artery disease (CAD). Statin drugs are efficacious in primary and secondary prevention of clinical CAD events, but they have not been extensively studied as a treatment for ischemia during routine daily activities or during exercise, indicators of high-risk in patients with stable CAD. The purpose of the Vascular Basis for the Treatment of Myocardial Ischemia study is to determine whether aggressive lowering of LDL cholesterol level with atorvastatin, with or without supplemental antioxidant vitamins C and E, can improve endothelial function and ischemia during ambulatory electrocardiogram (AECG) monitoring and exercise treadmill testing (ETT). Methods Patients are eligible when they have ischemia during an ETT and AECG monitoring and when their fasting total cholesterol level is ≤250 mg/dL. Eligible patients are randomized to receive 1 of 3 treatments: intensive atorvastatin to reduce LDL cholesterol level to ≤80 mg/dL, intensive atorvastatin to reduce LDL cholesterol level to ≤80 mg/dL plus antioxidant vitamins C and E, and control of diet and low-dose lovastatin, when needed, to reduce LDL cholesterol level ≤ to 130 mg/dL. Patients undergo endothelial function testing, 48-hour AECG monitoring, and ETT at randomization and at 6 and 12 months. Results A total of 300 patients have been randomized: 101 to receive atorvastatin alone, 103 to receive atorvastatin plus antioxidant vitamins, and 96 to receive placebo. Baseline characteristics are similar across treatment groups. Conclusions The Vascular Basis study will provide important insight on the effects of aggressive management of dyslipidemia with statin drugs and antioxidant vitamins in patients with stable but high-risk CAD.
AB - Background Increased low-density lipoprotein (LDL) and oxidized LDL cholesterol levels adversely affect endothelial function in patients with stable coronary artery disease (CAD). Statin drugs are efficacious in primary and secondary prevention of clinical CAD events, but they have not been extensively studied as a treatment for ischemia during routine daily activities or during exercise, indicators of high-risk in patients with stable CAD. The purpose of the Vascular Basis for the Treatment of Myocardial Ischemia study is to determine whether aggressive lowering of LDL cholesterol level with atorvastatin, with or without supplemental antioxidant vitamins C and E, can improve endothelial function and ischemia during ambulatory electrocardiogram (AECG) monitoring and exercise treadmill testing (ETT). Methods Patients are eligible when they have ischemia during an ETT and AECG monitoring and when their fasting total cholesterol level is ≤250 mg/dL. Eligible patients are randomized to receive 1 of 3 treatments: intensive atorvastatin to reduce LDL cholesterol level to ≤80 mg/dL, intensive atorvastatin to reduce LDL cholesterol level to ≤80 mg/dL plus antioxidant vitamins C and E, and control of diet and low-dose lovastatin, when needed, to reduce LDL cholesterol level ≤ to 130 mg/dL. Patients undergo endothelial function testing, 48-hour AECG monitoring, and ETT at randomization and at 6 and 12 months. Results A total of 300 patients have been randomized: 101 to receive atorvastatin alone, 103 to receive atorvastatin plus antioxidant vitamins, and 96 to receive placebo. Baseline characteristics are similar across treatment groups. Conclusions The Vascular Basis study will provide important insight on the effects of aggressive management of dyslipidemia with statin drugs and antioxidant vitamins in patients with stable but high-risk CAD.
UR - http://www.scopus.com/inward/record.url?scp=3042852154&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=3042852154&partnerID=8YFLogxK
U2 - 10.1016/j.ahj.2003.10.046
DO - 10.1016/j.ahj.2003.10.046
M3 - Article
C2 - 15131545
AN - SCOPUS:3042852154
SN - 0002-8703
VL - 147
SP - 875
EP - 882
JO - American heart journal
JF - American heart journal
IS - 5
ER -