What is the clinical evidence from this study?

Study design: RCT. Population: chronic angina pectoris (n=532). Intervention: Ad5FGF-4 (alferminogene tadenovec) vs. placebo. Primary outcome: change from baseline in total ETT time at 12 weeks.

What question did this study set out to answer?

To evaluate the clinical efficacy of angiogenic gene therapy using Ad5FGF-4 and assess potential subgroup treatment responses in patients with chronic stable angina.

May 11, 2026Journal of the American College of Cardiology

Effects of Ad5FGF-4 in Patients With Angina

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Key result

Ad5FGF-4 fails to improve exercise treadmill time overall but shows selective benefits in women.

n=532

Why the study?

Preclinical and preliminary clinical studies suggested that intracoronary Ad5FGF-4 could induce angiogenesis and improve exercise capacity in chronic angina, but definitive clinical efficacy was uncertain.

Does intracoronary Ad5FGF-4 improve exercise treadmill test time in patients with chronic angina pectoris?

Key Points

To evaluate the clinical efficacy of angiogenic gene therapy using Ad5FGF-4 and assess potential subgroup treatment responses in patients with chronic stable angina.
Conducted a pooled data analysis of two randomized, double-blind, placebo-controlled trials (AGENT-3 and AGENT-4; NCT00346437, NCT00185263, NCT000438867) enrolling 532 patients across the U.S. and other countries.
Administered low- or high-dose intracoronary Ad5FGF-4 versus placebo, with studies halted after an interim analysis projected the primary endpoint of 12-week exercise treadmill test (ETT) time change would not reach significance.
Analyzed primary and secondary efficacy endpoints across prespecified demographic subgroups.
Placebo response was substantial in men and not significantly different from active treatment, while the placebo effect in women was negligible.
Active Ad5FGF-4 therapy produced a statistically significant, sex-specific benefit over placebo exclusively in female patients.
Significant improvements in women were demonstrated across total ETT time, time to 1 mm ST-segment depression, time to angina onset, and Canadian Cardiovascular Society functional class.

Study Design

Type

RCT (n=532)

Blinding

double-blind

Randomization

randomized

Multicenter

Yes

Structured PICO

Does intracoronary Ad5FGF-4 improve exercise treadmill test time in patients with chronic angina pectoris?

Population

532 patients with chronic angina enrolled in two randomized, double-blind, placebo-controlled trials, with outcomes assessed at 12 weeks.

Intervention

Intracoronary administration of Ad5FGF-4 (alferminogene tadenovec) at low and high doses

Comparator

Placebo

Outcome

Change from baseline in total exercise treadmill test (ETT) time at 12 weekssurrogate

Discussion

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Implication

Intracoronary Ad5FGF-4 did not improve exercise capacity overall in patients with chronic angina, but may have a gender-specific beneficial effect in women.

Cite This Study

Henry et al. (2007) conducted an RCT in chronic angina pectoris (n=532). Ad5FGF-4 (alferminogene tadenovec) vs. placebo was evaluated on change from baseline in total ETT time at 12 weeks. Ad5FGF-4 did not significantly improve total ETT time overall, but demonstrated a significant beneficial effect on total ETT time, time to angina, and CCS class in women.

synapsesocial.com/papers/6a0247c110c286f4f661f337 https://doi.org/10.1016/j.jacc.2007.06.010

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Implication

Intracoronary Ad5FGF-4 did not improve exercise capacity overall in patients with chronic angina, but may have a gender-specific beneficial effect in women.

Effects of Ad5FGF-4 in Patients With Angina

Key Points

Study Design

Structured PICO

Discussion

Implication

Cite This Study

Effects of Ad5FGF-4 in Patients With Angina

Key Points

Study Design

Structured PICO

Discussion

Implication

Cite This Study

Also Consider

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