Lead Investigator: David Schade, NM Non profit Society to Prevent Symptomatic Heart Disease
Title of Proposal Research: Development of an Atherosclerosis Reversal Calculator
Vivli Data Request: 8436
Funding Source: None
Potential Conflicts of Interest: None
Summary of the Proposed Research:
Atherosclerosis is the number one cause of death in the United States, more than all cancers combined. Recent studies have demonstrated, using the invasive technique of intravascular ultrasound (IVUS), that atherosclerosis is reversible. This information is critical to the practicing physician who can now prevent heart attacks and strokes in his/her patients. Unfortunately, there are no non-invasive procedures to permit the physician to predict if his/her patient is reversing their atherosclerosis with statin treatment.
The basis of the SATURN clinical trial was a comparison of rosuvastatin versus atorvastatin in their ability to reverse atherosclerosis as measured by the negative change in percent atherosclerosis volume (PAV). Although this difference between these two medications did not reach statistical significance of p<0.05 (the difference was p<0.07), it was evident that rosuvastatin was statistically superior to atorvastatin in many secondary endpoints (e.g., total atherosclerosis volume (TAV)). Both rosuvastatin and atorvastatin did significantly reverse atherosclerosis in the majority of patients (p<0.01). Our proposal proposes an in depth regression analysis of cardiovascular risk factors demonstrating reduction in plaque content relating to the degree of reduction in cardiovascular risk factors effected by a patient’s response to rosuvastatin.
We will then use this analysis to develop an Atherosclerosis Reversal Calculator, which will be of great importance to the clinician in demonstrating to the patient that the rosuvastatin-induced reduction in cholesterol, LDL, CRP, etc., is reversing his/her vessels’ plaque. This tool will permit the clinician to assess the likelihood of his/her patient to begin to reverse their atherosclerosis within two years. A calculator approach has previously been done to predict cardiovascular risk (but not plaque reversal) by Framingham and the American Heart Association/American College of Cardiology. These risk calculators are referred to as Pooled Cohort Equations (PCE) and are available on the internet at no charge.
CRESTOR Athero Imaging Head to Head IVUS Study (SATURN)
Data Contributor: AstraZeneca
Study ID: NCT00620542
Sponsor ID: NCT00620542
Update: This data request was withdrawn on 12-Oct-2023 by the researcher.