ASTEROID TRIAL ROSUVASTATIN PDF

Accordingly, we designed the ASTEROID trial (A Study to Evaluate the Effect of Rosuvastatin on Intravascular Ultrasound-Derived Coronary. The purpose of this study is to see if 40 mg of rosuvastatin taken daily will reduce . statin therapy on regression of coronary atherosclerosis: the ASTEROID trial. A Study to Evaluate the Effect of Rosuvastatin on Intravascular Ultrasound- Derived Coronary Atheroma Burden – ASTEROID. Mar 13, Share via: AddThis.

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A secondary efficacy variable, change in normalized total atheroma volume for the entire artery, was also prespecified.

J Am Soc Echocardiogr. After 24 months, patients had evaluable serial IVUS examinations.

This procedure was designed to obtain a series of cross-sectional images at sites identical to the original examination. The disposition of these patients is summarized in Figure 1. He has consulted for a number of pharmaceutical companies without financial compensation. Adverse events were infrequent and similar to other statin trials. Effects of monotherapy with HMG-CoA reductase inhibitor on the progression of coronary atherosclerosis as assessed be serial quantitative arteriography: For patients without 10 contiguous evaluable cross-sections, 8 or 9 cross-sections were used and the results were normalized to compensate for the missing cross-sections.

The ASTEROID trial: coronary plaque regression with high-dose statin therapy.

Effect of simvastatin on coronary atheroma: A similar procedure was performed for each follow-up rosuvasattin. When viewed in this context, the results of the current study demonstrate that there exists no apparent threshold LDL-C level beyond which the benefits of statin therapy are no longer evident. Purchase access Subscribe to JN Learning for one year.

The most positive IVUS trials to date have demonstrated a slowing or halting of progression of atherosclerosis during statin treatment.

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The efficacy results are presented as mean and SD and median and interquartile range for the change from baseline.

Get free access to trkal published articles Create a personal account or sign in to: The manuscript was prepared by the corresponding author and modified after consultation with the other authors.

The current study supports several conclusions. Effects of the acyl coenzyme A: Statistical analysis was performed by the sponsor and the contract research organization under contract with the sponsor. There was no significant heterogeneity in the response to treatment for either of the 2 primary efficacy parameters for subgroups defined by age, sex, body mass index, history of diabetes mellitus, LDL-C levels, or HDL-C levels.

Videotapes containing baseline and follow-up pullbacks were analyzed in the Intravascular Ultrasound Core Laboratory at the Cleveland Clinic Foundation. Although statins rank among the most extensively studied therapies in contemporary medicine, the optimal target levels for low-density lipoprotein cholesterol LDL-C remain controversial.

Only regression, defined as a reduction in IVUS measures of atheroma burden with CIs not including zero, would yield a successful outcome. Mss Wolski and Goormastic are employed by the Cleveland Clinic Cardiovascular Coordinating Center, which received compensation for conducting the trial, including reimbursement for statistical services.

The bottom 2 panels illustrate the same cross-sections, but with measurements superimposed. This change represents a median reduction of 9. However, none of the major trials has provided convincing evidence of regression using rigorous IVUS measures of disease burden.

The study was screened for image quality at a core laboratory at the Cleveland Clinic Foundation, Cleveland, Ohio, and only patients whose IVUS results met prespecified image quality requirements were eligible for inclusion in the study. High-dose atorvastatin vs usual-dose simvastatin for secondary prevention after myocardial infarction: Sign in to make a comment Sign in rosuvaatatin your personal account.

Table 3 shows the results for both the primary and the secondary efficacy parameters. Critical revision of the manuscript for important intellectual content: Change in total atheroma volume showed a 6. Despite the utility of Rossuvastatin demonstrated in several roduvastatin trials, the degree to which regression documented by IVUS will translate into a reduction in morbidity and mortality remains speculative.

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A secondary efficacy parameter, the change in normalized TAV, was calculated by first determining the average atheroma area per cross-section as. Figure 2 shows a representative cross-section at baseline and follow-up for a patient who exhibited marked regression of disease. Purchase access Subscribe now. Coronary angiographic changes with lovastatin therapy: We believe that the current study has important implications for understanding the pathophysiology and optimal treatment of coronary artery disease.

In the current study, the choice of 2 primary efficacy parameters allowed testing of drug effects xsteroid regression using 2 different standards of evidence.

The ASTEROID trial: coronary plaque regression with high-dose statin therapy.

For the past 2 decades, clinical trials of antiatherosclerotic drug therapies have sought to reduce coronary disease morbidity and mortality, presumably by decreasing the rate of progression of the underlying atherosclerosis. Table 2 summarizes laboratory values obtained during the study for patients completing the trial. All patients were statin-naive, defined as receiving no statin therapy for more than 3 months during the previous 12 months.

Despite the known limitations of cross-trial comparisons, many observers will likely compare these results with other recent IVUS regression-progression trials. For the second primary efficacy parameter, change in the mm subsegment with the greatest disease severity, Create a personal account to register for email alerts with links to free full-text articles.