1 / 5

AGENT-3 Trial

A multicenter, randomized trial evaluating the efficacy and safety of Ad5FGF-4 gene therapy in patients with angina not responsive to traditional revascularization options. Presented at ACC 2005.

mjoelle
Download Presentation

AGENT-3 Trial

An Image/Link below is provided (as is) to download presentation Download Policy: Content on the Website is provided to you AS IS for your information and personal use and may not be sold / licensed / shared on other websites without getting consent from its author. Content is provided to you AS IS for your information and personal use only. Download presentation by click this link. While downloading, if for some reason you are not able to download a presentation, the publisher may have deleted the file from their server. During download, if you can't get a presentation, the file might be deleted by the publisher.

E N D

Presentation Transcript

  1. AGENT-3 Trial A Multicenter, Prospective, Randomized Trial of Intracoronary Administration of Ad5FGF-4 in Patients With No Revascularization Options (AGENT-3) Trial Presented at The American College of Cardiology Scientific Sessions 2005 Presented by Dr. Timothy Henry

  2. AGENT-3 Trial 415 patients with CCS Class 2-4 angina despite optimal medical treatment not in need of immediate traditional revascularizationstrategies, able to walk between 3 & 10 minutes with inducible ST depression of at least 1 mm and variability between successive exercise tests of 20% or less, at least 1 proximal vessel with <70% stenosis Placebo controlled, randomized, blinded, mean follow-up 5 years (data reported for 1 year) Amino Acid Protein Ad5FGF-4 1*109 virus particles n=150 Amino Acid Protein Ad5FGF-4 1*1010 virus particles n=150 Control n=150 Primary Endpoint:Change in exercise tolerance test (ETT) time from baseline to 12 weeks and the proportion of patients with 30% greater increase in treadmill exercise duration in 12 weeks. Secondary Endpoint:Time to a number of patients with coronary events (non-fatal MI, unplanned hospitalization or revascularization for myocardial ischemia), death at 12 months, time to ST depression, angina, and quality of life parameters. Presented at ACC2005

  3. AGENT-3 Trial: Primary Endpoint Primary endpoint of change in ETT duration • The primary endpoint of change in ETT duration at 12 weeks was not significant. There was also no change in exercise duration at 6 months. • In a pre-specified analysis, older patients (>55 years) with more severe angina (CCS Class 3 or 4) had a significantly greater increase in ETT at 12 weeks (p=0.02 high-dose, p=0.08 low-dose) and 6 months (p=0.08 high-dose, p=0.07 low-dose). • Similarly, older patients (>55years) with exercise time 300 seconds or less had a significantly greater increase in ETT time at 12 weeks (p=0.03 high-dose, p=0.06 low-dose) and 6 months (p=0.017 high-dose, p=0.03 low-dose). Presented at ACC 2005

  4. AGENT-3 Trial: Subgroup Analysis p=NS • The combined endpoint of coronary events or death at 1 year in patients completing 12 month follow-up did not differ significantly among the three groups. % Presented at ACC 2005

  5. AGENT-3 Trial: Summary • This study is the largest randomized gene therapy trial for myocardial angiogenesis. • Ad5FGF-4 was not associated with increased exercise time compared to placebo • The favorable safety profile of this drug seen in this trial makes further evaluation using higher doses possible. • The beneficial effect demonstrated in the pre-specified subgroup analysis of higher risk patients warrants further study. Presented at ACC 2005

More Related