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Vascular basis for the treatment of myocardial ischemia study: trial design and baseline characteristics
Peter H Stone1, Donald M Lloyd-Jones, Michael Johnstone
1Cardiovascular Division, Brigham & Women's Hospital, Boston, Mass 02115, USA. pstone@partners.org
Insights
This study investigates if aggressive LDL cholesterol lowering with atorvastatin, with or without vitamins C and E, improves endothelial function and ischemia in stable coronary artery disease (CAD) patients. Results will inform dyslipidemia management strategies.
Area of Science:
- Cardiology
- Pharmacology
- Clinical Research
Background:
- Elevated low-density lipoprotein (LDL) and oxidized LDL cholesterol negatively impact endothelial function in stable coronary artery disease (CAD).
- Statins are effective for CAD event prevention but their impact on ischemia during daily activities or exercise in high-risk patients is less studied.
Purpose of the Study:
- To determine if intensive LDL cholesterol reduction with atorvastatin, alone or with antioxidant vitamins C and E, improves endothelial function and reduces ischemia.
- To assess the efficacy of aggressive dyslipidemia management in high-risk stable CAD patients.
Main Methods:
- 300 patients with ischemia during exercise treadmill testing (ETT) and ambulatory electrocardiogram (AECG) monitoring were randomized.
- Treatment groups included intensive atorvastatin (LDL < or = 80 mg/dL), atorvastatin plus vitamins C and E, or diet/lovastatin (LDL < or = 130 mg/dL).
- Endothelial function, 48-hour AECG, and ETT were assessed at baseline and 6/12 months.
Main Results:
- 101 patients received atorvastatin, 103 received atorvastatin plus vitamins, and 96 received placebo.
- Baseline characteristics were comparable across all randomized groups.
Conclusions:
- The Vascular Basis study aims to provide crucial insights into the effects of aggressive statin and antioxidant vitamin therapy.
- Findings will guide the management of dyslipidemia in stable, high-risk CAD patients.
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.
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