Effects of AGI-1067 and Probucol After Percutaneous Coronary Interventions
Key result
AGI-1067 280 mg once daily significantly increased luminal area at the PCI site at 6 months compared to placebo (3.36 vs 2.66 mm2; P<=0.05) without prolonging the QTc interval.
Why the study?
Does AGI-1067 or probucol reduce restenosis assessed by IVUS in patients undergoing percutaneous coronary intervention?
Population
305 patients undergoing percutaneous coronary intervention (PCI), with stents used in 85% of patients.
Comparison
AGI-1067 or probucol administered 2 weeks before… vs Placebo administered 2 weeks before and 4 weeks…
Design
RCT, Randomly assigned to 1 of 5 treatment groups, Blinded core laboratory for…
Follow-up
6 months
Authors
Discussion
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Implication
Supports AGI-1067 for post-PCI restenosis prevention without QTc risk; extends probucol data via randomized IVUS assessment.
Key Points
- To assess whether AGI-1067 reduces restenosis after percutaneous coronary intervention (PCI) as measured by intravascular ultrasound (IVUS) compared with placebo and probucol.
- In a multicenter randomized trial, 305 patients scheduled for PCI were randomly assigned 2 weeks prior to intervention to placebo, probucol (500 mg BID), or AGI-1067 (70, 140, or 280 mg daily).
- Treatments were continued for 4 weeks post-PCI, with stents deployed in 85% of patients.
- IVUS imaging performed at baseline and at 6-month follow-up was analyzed by a blinded core laboratory.
- Follow-up lumen area at the PCI site was 2.66±1.58 mm² for placebo, 3.69±2.69 mm² for probucol, 2.75±1.76 mm² for AGI-1067 70 mg, 3.17±2.26 mm² for AGI-1067 140 mg, and 3.36±2.12 mm² for AGI-1067 280 mg (P=0.02 for dose response; P≤0.05 for AGI-1067 280 mg and probucol vs placebo).
- Reference segment lumen volume narrowed by 5.3 mm³ in the placebo arm but enlarged in the AGI-1067 140 mg (P=0.05) and 280 mg treatment groups.
- QTc interval prolongation >60 ms occurred in 17.4% of probucol-treated patients, compared with 4.8% on placebo and 4.8%, 2.4%, and 2.5% across the respective AGI-1067 dosing groups (P=0.02).
Study Design
Type
RCT (n=305)
Blinding
Blinded core laboratory
Randomization
Randomly assigned
Multicenter
Yes
Structured PICO
Does AGI-1067 or probucol reduce restenosis assessed by IVUS in patients undergoing percutaneous coronary intervention?
P
Population
305 patients undergoing percutaneous coronary intervention, treated for 2 weeks before and 4 weeks after PCI, with 6-month follow-up.
I
Intervention
AGI-1067 (70, 140, or 280 mg once daily) or probucol (500 mg BID) administered 2 weeks before and 4 weeks after PCI.
C
Comparator
Placebo administered 2 weeks before and 4 weeks after PCI.
O
Outcome
Restenosis assessed by luminal area at the PCI site using intravascular ultrasound (IVUS) at 6-month follow-up.surrogate
Main Result
Absolute Event Rate: 3.36% vs 2.66%
p-value: p=<=0.05
AGI-1067, a probucol analogue, reduces restenosis after PCI and improves reference segment lumen dimensions without the QTc prolongation associated with probucol.
Cite This Study
Tardif et al. (2003) conducted an RCT in Restenosis after percutaneous coronary intervention (n=305). AGI-1067 vs. Placebo and probucol (500 mg BID) was evaluated on Luminal area at the PCI site at 6-month follow-up (p=<=0.05). AGI-1067 280 mg once daily significantly increased luminal area at the PCI site at 6 months compared to placebo (3.36 vs 2.66 mm2; P<=0.05) without prolonging the QTc interval.