Measuring Effects on Intima Media Thickness: An Evaluation of Rosuvastatin in Subclinical Atherosclerosis—The Rationale and Methodology of the METEOR Study

Abstract

Summary. Background: Increased carotid intima media thickness (IMT) is associated with established coronary heart disease (CHD) and is a marker of atherosclerosis.Statins are an effective treatment for dyslipidaemia, and have been shown to retard progression or promote carotid IMT regression in patients at high risk of CHD. Rosuvastatin is a highly efficacious statin, and the Measuring Effects on intima media Thickness: an Evaluation Of Rosuvastatin (METEOR) study is designed to assess the impact of rosuvastatin on carotid IMT progression in low risk subjects with signs of subclinical atherosclerosis.Methods: In this randomised, parallel-group study, asymptomatic subjects at low risk of cardiovascular disease, but with evidence of atherosclerosis (defined as carotid IMT ≥1.2 mm and <3.5 mm), will receive rosuvastatin (40 mg/day) or placebo for 104 weeks. The study will enrol 840 European and US subjects randomised 5:2 between rosuvastatin and placebo. The primary end point will be the change in carotid IMT from baseline to study end, measured using B-mode ultrasonography. Other efficacy end points include changes in the serum lipid profile and C-reactive protein. Safety parameters will also be assessed. Conclusion:The METEOR study will evaluate whether long-term rosuvastatin treatment promotes regression, or slows progression, of subclinical atherosclerosis in asymptomatic subjects at low risk of cardiovascular disease.

Manual or semi‐automated edge detection of the maximal far wall common carotid intima–media thickness: a direct comparison

“…The rationale, study design and main results of METEOR have been reported in detail before [18,19]. In summary, METEOR was a randomized, double-blind, placebocontrolled trial designed to assess the impact of rosuvastatin 40 mg daily versus placebo on the rate of change in CIMT over 2 years of follow-up.…”

“…Ultrasound images were taken from three predefined carotid segments: the common carotid artery, the carotid bifurcation and the internal carotid artery, each providing near and far wall data for the right and left carotid arteries. Real-time image sequences of these 12 artery segments were collected from five circumferential angles and recorded to SVHS videotape and shipped to one of the two regional CIMT core laboratories for offline reading as described before [18].…”

“…When interpreting the results of the present study, it should be noticed that all our analyses were based on CIMT measurements from the far wall of the common carotid artery per ultrasound examination and not on measurements from the near wall of the common carotid artery and near and far wall from the carotid bifurcation and internal carotid artery measurements as were included in the original METEOR protocol [18]. Although the reproducibility, relations to cardiovascular risk factors and rates of change in CIMT were largely similar with both approaches when the far wall common CIMT images were evaluated, findings might be different when are the other measurements were included.…”

Automated measurement of mean wall thickness in the common carotid artery by MRI: A comparison to intima‐media thickness by B‐mode ultrasound

“…Furthermore, in a landmark paper by O'Leary et al (5), increases in carotid IMT were directly associated with an increased risk of myocardial infarction and stroke in older adults with no history of cardiovascular disease. Consequently, carotid IMT has emerged as a marker for cardiovascular disease (6) and has been used as an endpoint in clinical trials assessing the effect of pharmacological treatment of systemic atherosclerosis (7)(8)(9)(10).…”

The Use of Plaque Score Measurements to Assess Changes in Atherosclerotic Plaque Burden Induced by Lipid-Lowering Therapy Over Time: The METEOR Study

“…The rationale, design, and main findings of METEOR have been reported in detail previously 21,22) . In essence, METEOR was a randomized, doubleblind, placebo-controlled trial among 984 individuals from Europe and North America.…”