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| * These
news are selected from 'TCT Daily (2004)' provided
by Cardiovascular Research Foundation (CRF). |
The human adenovirus Ad5FGF-4
was not successful in increasing exercise duration
in patients with stable angina at the 12-week interim
analysis of the AGENT-3 trial presented by Tim Henry,
MD, of the Minneapolis Heart Institute. Subgroup
analysis showed interesting trends in exercise duration
and coronary event rate, but statistical significance
was not reached and enrollment in the study was
stopped early.
Patients in the placebo group had a mean change
in exercise duration of 71 seconds vs. 72 seconds
(P=.80) and 69 seconds (P=.82) in the low- and high-dose
Ad5FGF-4 groups. Patients assigned placebo had a
24.3% rate of coronary events or death vs. 20.0%
and 16.4% (P=.31) for the low- and high-dose groups.
The study was designed to enroll 450 patients in
66 centers, but was stopped after enrolling 415
when an interim analysis indicated futility for
the study’s primary endpoint of exercise duration
improvement.
There was no primary outcome improvement in the
overall cohort, there were trends for improvement
in all high-risk subgroups. Patients with angina
class .2, women, and those with exercise duration
of <300 seconds showed more exercise duration
improvement. For patients older than 55 and with
exercise duration of <300 seconds (Figure 2),
the high-dose group showed an average improvement
of 73 seconds vs. 25 seconds for the placebo group
(P=.015).
AGENT 3, which is the largest gene therapy trial
for myocardial angiogenesis to date, was a multicenter,
randomized, double-blind placebo-controlled study
of patients with stable angina who did not respond
to optimum medical treatment and were not in immediate
need of CABG or PCI. The mean age of patients was
62 and approximately 90% were white. There were
more women in the placebo group; 45% of patients
had class 2 angina, and <15% had class 4 angina.
Patients were randomized to placebo (n=123), low-dose
injection of Ad5FGF-4 (1 X 109 viral particles,
n=118) or high-dose injection of the virus (1 X
1010 viral particles, n=116). The E1-deleted type
5 adenovirus codes for the angiogenic FGF-4 gene.
The primary endpoints were change in exercise duration
and the proportion of patients with >30% in treadmill
duration. Secondary endpoints included all-cause
mortality, unplanned hospitalization and/or revascularization
due to myocardial ischemia and nonfatal MI. |
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