Results of Prevention of REStenosis with Tranilast and its Outcomes (PRESTO) Trial
Key result
Tranilast did not reduce the 9-month incidence of death, MI, or target vessel revascularization compared to placebo (15.5-16.1% vs 15.8%, P=0.77-0.81).
Why the study?
Does tranilast reduce the composite of death, myocardial infarction, or ischemia-driven target vessel revascularization in patients after successful PCI?
Population
11,484 patients enrolled within 4 hours after successful percutaneous coronary intervention of at least 1…
Comparison
Tranilast oral 300 mg or 450 mg BID for 1 or 3… vs Placebo
Design
RCT, randomized, double-blind, placebo-controlled
Follow-up
9 months
Authors
Discussion
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Implication
Tranilast confers no benefit after PCI; challenges prior limited trial suggestions of reduced restenosis.
Study Design
Type
RCT (n=11,484)
Blinding
Double-blind
Randomization
Randomized
Structured PICO
Does tranilast reduce the composite of death, myocardial infarction, or ischemia-driven target vessel revascularization in patients after successful PCI?
P
Population
11,484 patients enrolled within 4 hours after successful percutaneous coronary intervention (PCI) of at least 1 vessel.
I
Intervention
Tranilast oral 300 mg or 450 mg BID for 1 or 3 months, initiated within 4 hours after successful PCI.
C
Comparator
Placebo
O
Outcome
First occurrence of death, myocardial infarction, or ischemia-driven target vessel revascularization within 9 monthscomposite
Main Result
p-value: p=0.77 to 0.81
Tranilast does not improve clinical or angiographic outcomes of restenosis after percutaneous coronary intervention.
Cite This Study
Holmes et al. (2002) conducted an RCT in Restenosis after percutaneous coronary intervention (n=11,484). Tranilast vs. Placebo was evaluated on First occurrence of death, myocardial infarction, or ischemia-driven target vessel revascularization within 9 months (p=0.77 to 0.81). Tranilast did not reduce the 9-month incidence of death, MI, or target vessel revascularization compared to placebo (15.5-16.1% vs 15.8%, P=0.77-0.81).