Article
Quantification of antihypertensive treatment effects on carotid atherosclerosis by 3-dimensional ultrasound: first report from the MORE-trial
Quantifizierung der antihypertensiven Behandlungseffekte auf die Karotis-Arteriosklerose durch dreidimensionalen Ultraschall: erster Bericht über die MORE-Studie
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Published: | August 10, 2005 |
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Objective: 3-dimensional (3-D) ultrasound (US) allows more accurate measurement of carotid artery (CA) plaque (PLQ) volume (V) than 2-D US. The Multicenter Olmesartan Atherosclerosis Regression Evaluation (MORE) trial is testing the hypothesis that for the same level of blood pressure (BP) control the AT1-receptor blocker olmesartan (O) is superior to the beta-blocker atenolol (A) in reversing or slowing progression of CA atherosclerosis by measuring PLQ volume (V) changes with a new 3-D US-technique.
Methods: Double-blind, randomized, in 5 European countries, 14 US centers, prospective 2-year comparison in hypertensives with high risk of CV events (i.e., one or more a priori defined risk factors) and at least one CA-plaque (volume > 4 <500 mm³). Patients are randomized to either O (20-40mg, o.d.) or A (50-100mg, o.d.). HCTZ (12.5-25mg) is added if required to achieve BP control. A newly developed US system (Voluson 530D-MT-3D CFM) providing both 3-D- and 2-D-imaging is used to measure V of CA-PLQ and CA-intima-media thickness (IMT). The end-points are changes in V CA-PLQ and CA-IMT at 2-year follow-up.
Results: Through February 04 a total of 441 patients had been screened and 176 had been randomized. At baseline CA-PLQ-V ranged from 10 to 350 mm³ and CA-IMT from 0.6 to 1.5 mm. There were no correlations between PLQ-V and IMT and PLQ-V and BP. Intra- and inter-observer 3-D US-measurement reliabilities were 95.2 % and 93 %, respectively, indicating high accuracy of the measurements.
Conclusion: The MORE is the first trial to demonstrate feasibility and reliability of a new non-invasive 3-D US-method for direct visualization of CA-PLQ and serial monitoring of PLQ-changes with treatment. The study has succesfully included a large number of high CV-risk hypertensives with CA-PLQ. 1-year treatment data from a blinded interim analysis of 135 patients will be available by November 04, and the results will be reported.