Abstract #301841

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JSM 2003 Abstract #301841
Activity Number: 376
Type: Contributed
Date/Time: Wednesday, August 6, 2003 : 10:30 AM to 12:20 PM
Sponsor: Biopharmaceutical Section
Abstract - #301841
Title: Statistical Analysis of Cardiac Allograft Vasculopathy Using Intravascular Ultrasound
Author(s): Kamal H. Abeywickrama*+
Companies: Novartis Pharmaceuticals
Address: S 210 537, Basle, , CH-4002, Switzerland
Keywords: Intravascular Ultrasound ; cardiac allograft vasculopathy ; clinical trials
Abstract:

Transplant coronary artery disease is a serious impediment to long-term graft survival. Intravascular Ultrasound (IVUS) is an invasive procedure that detects thickening in the walls of the coronary arteries. IVUS measurements have been a well recognized medical procedure for several years. In individual patients, IVUS methodology was able to show clearly the changes in plaque formation within the cardiac arteries. However, there had been little success with analysing aggregated data to show clear statistically advantageous results. This paper will suggest how it is possible to construct suitable statistical hypotheses with IVUS methodology to examine changes in arteries over time using measures such as changes in Maximal Intimal Thickness, Intimal Area, Intimal Volume and Percentage Area of Stenosis, and collect data appropriate to the hypotheses. Results of a large controlled double blind randomized trial where these methods using IVUS were applied to evaluate the efficacy of Everolimus (Certican®) to reduce cardiac vasculopathy, will be presented. Statistically significant results were obtained in every measure used.

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