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

Abstract:

BACKGROUND:Restenosis after percutaneous coronary intervention (PCI) is a major problem affecting 15% to 30% of patients after stent placement. No oral agent has shown a beneficial effect on restenosis or on associated major adverse cardiovascular events. In limited trials, the oral agent tranilast has been shown to decrease the frequency of angiographic restenosis after PCI. METHODS AND RESULTS:In this double-blind, randomized, placebo-controlled trial of tranilast (300 and 450 mg BID for 1 or 3 months), 11 484 patients were enrolled. Enrollment and drug were initiated 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 and was 15.8% in the placebo group and 15.5% to 16.1% in the tranilast groups (P=0.77 to 0.81). Myocardial infarction was the only component of major adverse cardiovascular events to show some evidence of a reduction with tranilast (450 mg BID for 3 months): 1.1% versus 1.8% with placebo (P=0.061 for intent-to-treat population). The primary reason for not completing treatment was > or =1 hepatic laboratory test abnormality (11.4% versus 0.2% with placebo, P<0.01). In the angiographic substudy composed 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, which was not 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. Plaque volume was not different between the placebo and tranilast groups (39.3 versus 37.5 to 46.1 mm(3), respectively; P=0.16 to 0.72). CONCLUSIONS:Tranilast does not improve the quantitative measures of restenosis (angiographic and intravascular ultrasound) or its clinical sequelae.

journal_name

Circulation

journal_title

Circulation

authors

Holmes DR Jr,Savage M,LaBlanche JM,Grip L,Serruys PW,Fitzgerald P,Fischman D,Goldberg S,Brinker JA,Zeiher AM,Shapiro LM,Willerson J,Davis BR,Ferguson JJ,Popma J,King SB 3rd,Lincoff AM,Tcheng JE,Chan R,Granett JR,P

doi

10.1161/01.cir.0000028335.31300.da

subject

Has Abstract

pub_date

2002-09-03 00:00:00

pages

1243-50

issue

10

eissn

0009-7322

issn

1524-4539

journal_volume

106

pub_type

临床试验,杂志文章,多中心研究,随机对照试验
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