Results of Prevention of REStenosis with Tranilast and its Outcomes (PRESTO) Trial. - PRESTO

May 01, 2003
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Date Presented:
01/01/2002
Date Published:
01/01/2002
Date Updated:
05/01/2003
Original Posted Date:
05/01/2003
References

Description:

The goal of this study was to assess the safety and efficacy of the oral agent tranilast in decreasing the frequency of angiographic restenosis among patients receiving percutaneous coronary intervention (PCI).

Study Design

Study Design:

Patients Enrolled: 11,484

Primary Endpoints:

first occurence of death, myocardial infarction, or ischemia-driven target vessel revascularization within 9 months

Drug/Procedures Used:

The study design was a double-blind, randomized, placebo-controlled trial of tranilast (300 and 450 mg BID for 1 or 3 months). 11,484 patients were enrolled within 4 hours after successful PCI of at least 1 vessel. The primary end point was the first occurrence of death, myocardial infarction, or ischemia-driven target vessel revascularization within 9 months.

Principal Findings:

The incidence of the primary end point was 15.8% in the placebo group and 15.5% (300 mg)(p=0.77) and 16.1% (450 mg)(p=0.81) in the two tranilast groups. Tranilast tended to be associated with a reduction in myocardial infarction (450 mg BID for 3 months): 1.1% versus 1.8% with placebo (P=0.061 for intent-to-treat population). In the angiographic substudy of 2018 patients, minimal lumen diameter (MLD) was measured by quantitative coronary angiography. At follow-up, MLD was 1.76 ± 0.77 mm in the placebo group, not significantly different from MLD in the tranilast groups (1.72 to 1.78±0.76 to 80 mm, P=0.49 to 0.89). In a subset of these patients (n=1107), intravascular ultrasound was performed at follow-up. The measured plaque volume was not different between the placebo and tranilast groups (39.3 versus 37.5 - 46.1 mm3,; P=0.16 to 0.72).

Interpretation:

Among patients with percutaneous coronary intervention (PCI), tranilast is not associated with an improvement in post PCI lumen geometry (either on the angiogram or on ultrasound) or clinical adverse events. This multicenter, large, randomized clinical trial, demonstrated that tranilast in 2 different doses for 2 different durations was not associated with a benefit in either angiographic or clinical restenosis compared to placebo. Preliminary data from animal models indicated a possible impact on restenosis by tranilast. Additionally, 2 small double- blind, placebo-controlled trials with dilatation showed 51% and 67% reduction in restenosis with tranilast administration. It was also evaluated with concurrent controls in stented patients and found to be associated with a 40% reduction in restenosis. In an evaluation of patients undergoing directional atherectomy, tranilast demonstrated a 70% reduction in restenosis at 3-month follow-up compared to control. Tranilast has now joined the long list of compounds that had shown promise in preclinical and small pilot studies but no evidence of benefit in a large randomized trial.

References:

Holmes DR, Savage M, LaBlanche JM, et al. Results of Prevention of REStenosis with Tranilast and its Outcomes (PRESTO) Trial. Circulation 2002; 106: 1243-50.

Keywords: Myocardial Infarction, Follow-Up Studies, Platelet Aggregation Inhibitors, Coronary Restenosis, Atherectomy, Dilatation, Calcium Channel Blockers, Percutaneous Coronary Intervention, Coronary Angiography, ortho-Aminobenzoates


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