Vascular basis for the treatment of myocardial ischemia study: trial design and baseline characteristics.
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 < or =250 mg/dL. Eligible patients are randomized to receive 1 of 3 treatments: intensive atorvastatin to reduce LDL cholesterol level to < or =80 mg/dL, intensive atorvastatin to reduce LDL cholesterol level to < or =80 mg/dL plus antioxidant vitamins C and E, and control of diet and low-dose lovastatin, when needed, to reduce LDL cholesterol level < or = 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.
Stone
Peter H
PH
Cardiovascular Division, Brigham & Women's Hospital, Boston, Mass 02115, USA. pstone@partners.org
Lloyd-Jones
Donald M
DM
Johnstone
Michael
M
Carlson
William
W
Rubenstein
Joel
J
Creager
Mark
M
Frei
Balz
B
Sopko
George
G
Clark
Maureen E
ME
Maccallum
Gail
G
Kinlay
Scott
S
Orav
John
J
Selwyn
Andrew P
AP
D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000924:Anticholesteremic Agents / Q000627:therapeutic use*; D000975:Antioxidants / Q000627:therapeutic use*; D001205:Ascorbic Acid / Q000627:therapeutic use*; D000069059:Atorvastatin; D001916:Brachial Artery / Q000000981:diagnostic imaging; D008078:Cholesterol, LDL / Q000097:blood*; D004311:Double-Blind Method; D005260:Female; D006538:Heptanoic Acids / Q000627:therapeutic use*; D006801:Humans; D008297:Male; D008875:Middle Aged; D017202:Myocardial Ischemia / Q000097:blood* / Q000188:drug therapy*; D011758:Pyrroles / Q000627:therapeutic use*; D012039:Regional Blood Flow; D014463:Ultrasonography; D014664:Vasodilation; D014810:Vitamin E / Q000627:therapeutic use*
D000924:Anticholesteremic Agents; D000975:Antioxidants; D008078:Cholesterol, LDL; D006538:Heptanoic Acids; D011758:Pyrroles; D014810:Vitamin E; D000069059:Atorvastatin; D001205:Ascorbic Acid