Results of prevention of REStenosis with tranilast and its outcomes (PRESTO) trial

• Published in: Circulation (New York, N.Y.) N.Y.), 2002-09, Vol.106 (10), p.1243-1250
• Main Authors: HOLMES, David R, SAVAGE, Michael, SHAPIRO, Leonard M, WILLERSON, James, DAVIS, Barry R, FERGUSON, James J, POPMA, Jeffrey, KING, Spencer B, LINCOFF, A. Michael, TCHENG, James E, CHAN, Robert, GRANETT, Jeffrey R, LABLANCHE, J.-M, POLAND, Marcia, GRIP, Lars, SERRUYS, P. W, FITZGERALD, Peter, FISCHMAN, David, GOLDBERG, Sheldon, BRINKER, Jeffrey A, ZEIHER, A. M
• Format: Article
• Language: English
• Subjects: Administration, Oral; Angioplasty, Balloon, Coronary; Biological and medical sciences; Cardiovascular Agents - administration & dosage; Cardiovascular Agents - adverse effects; Cardiovascular Agents - therapeutic use; Coronary Angiography; Coronary Restenosis - diagnostic imaging; Coronary Restenosis - prevention & control; Diseases of the cardiovascular system; Double-Blind Method; Female; Follow-Up Studies; Humans; Male; Medical sciences; Middle Aged; Myocardial Infarction - prevention & control; ortho-Aminobenzoates - administration & dosage; ortho-Aminobenzoates - adverse effects; ortho-Aminobenzoates - therapeutic use; Radiotherapy. Instrumental treatment. Physiotherapy. Reeducation. Rehabilitation, orthophony, crenotherapy. Diet therapy and various other treatments (general aspects); Treatment Outcome; Ultrasonography
• ISSN: 0009-7322; 1524-4539
• DOI: 10.1161/01.CIR.0000028335.31300.DA

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. 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