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

David Holmes, Michael Savage, J. M. LaBlanche, Lars Grip, P. W. Serruys, Peter Fitzgerald, David Fischman, Sheldon Goldberg, Jeffrey A. Brinker, A. M. Zeiher, Leonard M. Shapiro, James Willerson, Barry R. Davis, James J. Ferguson, Jeffrey Popma, Spencer B. King, A. Michael Lincoff, James E. Tcheng, Robert Chan, Jeffrey R. GranettMarcia Poland

Research output: Contribution to journalArticle

222 Citations (Scopus)

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 ≥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 mm3, 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.

Original languageEnglish (US)
Pages (from-to)1243-1250
Number of pages8
JournalCirculation
Volume106
Issue number10
DOIs
StatePublished - Sep 3 2002

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Placebos
Percutaneous Coronary Intervention
Myocardial Infarction
tranilast
Coronary Angiography
Stents
Myocardial Ischemia
Randomized Controlled Trials
Liver
Pharmaceutical Preparations
Population
Therapeutics

Keywords

  • Angiography
  • Percutaneous coronary intervention
  • Restenosis
  • Revascularization
  • Tranilast

ASJC Scopus subject areas

  • Cardiology and Cardiovascular Medicine
  • Physiology (medical)

Cite this

Holmes, D., Savage, M., LaBlanche, J. M., Grip, L., Serruys, P. W., Fitzgerald, P., ... Poland, M. (2002). Results of prevention of REStenosis with tranilast and its outcomes (PRESTO) trial. Circulation, 106(10), 1243-1250. https://doi.org/10.1161/01.CIR.0000028335.31300.DA

Results of prevention of REStenosis with tranilast and its outcomes (PRESTO) trial. / Holmes, David; Savage, Michael; LaBlanche, J. M.; Grip, Lars; Serruys, P. W.; Fitzgerald, Peter; Fischman, David; Goldberg, Sheldon; Brinker, Jeffrey A.; Zeiher, A. M.; 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.; Poland, Marcia.

In: Circulation, Vol. 106, No. 10, 03.09.2002, p. 1243-1250.

Research output: Contribution to journalArticle

Holmes, D, 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, Lincoff, AM, Tcheng, JE, Chan, R, Granett, JR & Poland, M 2002, 'Results of prevention of REStenosis with tranilast and its outcomes (PRESTO) trial', Circulation, vol. 106, no. 10, pp. 1243-1250. https://doi.org/10.1161/01.CIR.0000028335.31300.DA
Holmes, David ; Savage, Michael ; LaBlanche, J. M. ; Grip, Lars ; Serruys, P. W. ; Fitzgerald, Peter ; Fischman, David ; Goldberg, Sheldon ; Brinker, Jeffrey A. ; Zeiher, A. M. ; 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. ; Poland, Marcia. / Results of prevention of REStenosis with tranilast and its outcomes (PRESTO) trial. In: Circulation. 2002 ; Vol. 106, No. 10. pp. 1243-1250.
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T1 - Results of prevention of REStenosis with tranilast and its outcomes (PRESTO) trial

AU - Holmes, David

AU - Savage, Michael

AU - LaBlanche, J. M.

AU - Grip, Lars

AU - Serruys, P. W.

AU - Fitzgerald, Peter

AU - Fischman, David

AU - Goldberg, Sheldon

AU - Brinker, Jeffrey A.

AU - Zeiher, A. M.

AU - Shapiro, Leonard M.

AU - Willerson, James

AU - Davis, Barry R.

AU - Ferguson, James J.

AU - Popma, Jeffrey

AU - King, Spencer B.

AU - Lincoff, A. Michael

AU - Tcheng, James E.

AU - Chan, Robert

AU - Granett, Jeffrey R.

AU - Poland, Marcia

PY - 2002/9/3

Y1 - 2002/9/3

N2 - 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 ≥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 mm3, 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.

AB - 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 ≥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 mm3, 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.

KW - Angiography

KW - Percutaneous coronary intervention

KW - Restenosis

KW - Revascularization

KW - Tranilast

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