Published online before print August 19, 2002, doi: 10.1161/01.CIR.0000028335.31300.DA
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
(Circulation. 2002;106:1243.)
© 2002 American Heart Association, Inc.
Clinical Investigation and Reports |
Results of Prevention of REStenosis with Tranilast and its Outcomes (PRESTO) Trial
From the Mayo Clinic (D.R.H.), Rochester, Minn; Jefferson University Hospital (M.S.), Philadelphia, Pa; Hospital Cardiologique (J.-M.L.), Lille, France; Gothenburg University (L.G.), Gothenburg, Sweden; Heartcentre (P.W.S.), Rotterdam, the Netherlands; Stanford University (P.F.), Stanford, Calif; Jefferson University Angiography Core Lab (D.F.), Philadelphia, Pa; Cooper Hospital University Medical Center (S.G.), Camden, NJ; Johns Hopkins University Hospital (J.A.B.), Baltimore, Md; Johann-Wolfgang-Goethe Universitaet (A.M.Z.), Hesse, Germany; Papworth Hospital (L.M.S.), Cambridge, UK; University of Texas Medical School (J.W.), Texas Heart Institute (J.W., J.J.F.), and University of Texas School of Public Heath (B.R.D.), Houston, Tex; Brigham and Women’s Hospital (J.P.), Boston, Mass; Emory University Hospital (S.B.K.), Atlanta, Ga; Cleveland Clinic Foundation (A.M.L.), Cleveland, Ohio; Duke University (J.E.T.), Durham, NC; and GlaxoSmithKline (R.C., J.R.G., M.P.), Collegeville, Pa.
Reprint requests to David R. Holmes, Jr, MD, Division of Cardiovascular Diseases and Internal Medicine, Mayo Clinic, 200 First St SW, Rochester, MN 55905.
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.
Key Words: restenosis • revascularization • angiography • tranilast • percutaneous coronary intervention
This article has been cited by other articles:
 |
|
 |
|
  S. E. Nissen Pioglitazone to Reduce Restenosis After Bare-Metal Stent Placement? J. Am. Coll. Cardiol. Intv., June 1, 2009; 2(6): 532 - 533. [Full Text] [PDF]
|
|
|
|
 |
|
 P. A. Calvert and M. R. Bennett Restenosis Revisited Circ. Res., April 10, 2009; 104(7): 823 - 825. [Full Text] [PDF]
|
|
|
|
 |
|
 E.-H. Yao, N. Fukuda, T. Ueno, H. Matsuda, H. Nagase, Y. Matsumoto, H. Sugiyama, and K. Matsumoto A pyrrole-imidazole polyamide targeting transforming growth factor-{beta}1 inhibits restenosis and preserves endothelialization in the injured artery Cardiovasc Res, March 1, 2009; 81(4): 797 - 804. [Abstract] [Full Text] [PDF]
|
|
|
|
 |
|
 L. T. Newsome, M. A. Kutcher, and R. L. Royster Coronary Artery Stents: Part I. Evolution of Percutaneous Coronary Intervention Anesth. Analg., August 1, 2008; 107(2): 552 - 569. [Abstract] [Full Text] [PDF]
|
|
|
|
 |
|
 C.-Y. O. Chen, P. E. Milbury, F. W. Collins, and J. B. Blumberg Avenanthramides Are Bioavailable and Have Antioxidant Activity in Humans after Acute Consumption of an Enriched Mixture from Oats J. Nutr., June 1, 2007; 137(6): 1375 - 1382. [Abstract] [Full Text] [PDF]
|
|
|
|
|
|
R. Khan, A. Agrotis, and A. Bobik Understanding the role of transforming growth factor-{beta}1 in intimal thickening after vascular injury Cardiovasc Res, May 1, 2007; 74(2): 223 - 234. [Abstract] [Full Text] [PDF]
|
|
|
|
 |
|
 P. W. Serruys, M. J.B. Kutryk, and A. T.L. Ong Coronary-Artery Stents N. Engl. J. Med., February 2, 2006; 354(5): 483 - 495. [Full Text] [PDF]
|
|
|
|
 |
|
 H. Kelbaek, L. Thuesen, S. Helqvist, L. Klovgaard, E. Jorgensen, S. Aljabbari, K. Saunamaki, L. R. Krusell, G. V.H. Jensen, H. E. Botker, et al. The Stenting Coronary Arteries in Non-stress/benestent Disease (SCANDSTENT) Trial J. Am. Coll. Cardiol., January 17, 2006; 47(2): 449 - 455. [Abstract] [Full Text] [PDF]
|
|
|
|
|
|
M. Singh, B. A. Williams, B. J. Gersh, R. L. McClelland, K. K.L. Ho, J. T. Willerson, W. F. Penny, D. E. Cutlip, and D. R. Holmes Jr Geographical Differences in the Rates of Angiographic Restenosis and Ischemia-Driven Target Vessel Revascularization After Percutaneous Coronary Interventions: Results From the Prevention of Restenosis With Tranilast and its Outcomes (PRESTO) Trial J. Am. Coll. Cardiol., January 3, 2006; 47(1): 34 - 39. [Abstract] [Full Text] [PDF]
|
|
|
|
|
|
H. Kelbaek, L. Thuesen, S. Helqvist, L. Klovgaard, E. Jorgensen, S. Aljabbari, K. Saunamaki, L. R. Krusell, G. V.H. Jensen, H. E. Botker, et al. The Stenting Coronary Arteries in Non-stress/benestent Disease (SCANDSTENT) Trial J. Am. Coll. Cardiol., December 13, 2005; (2005) j.jacc.2005.10.045v1. [Abstract] [Full Text] [PDF]
|
|
|
|
 |
|
 A. Schomig, A. Kastrati, and R. Wessely Prevention of Restenosis by Systemic Drug Therapy: Back to the Future? Circulation, November 1, 2005; 112(18): 2759 - 2761. [Full Text] [PDF]
|
|
|
|
|
|
J. S. Douglas Jr, D. R. Holmes Jr, D. J. Kereiakes, C. L. Grines, E. Block, Z. M.B. Ghazzal, D. C. Morris, H. Liberman, K. Parker, C. Jurkovitz, et al. Coronary Stent Restenosis in Patients Treated With Cilostazol Circulation, November 1, 2005; 112(18): 2826 - 2832. [Abstract] [Full Text] [PDF]
|
|
|
|
|
|
P. Garot, T. Lefevre, M. Savage, Y. Louvard, W. R. Bamlet, J. T. Willerson, M.-C. Morice, and D. R. Holmes Jr Nine-Month Outcome of Patients Treated by Percutaneous Coronary Interventions for Bifurcation Lesions in the Recent Era: A Report From the Prevention of Restenosis With Tranilast and its Outcomes (PRESTO) Trial J. Am. Coll. Cardiol., August 16, 2005; 46(4): 606 - 612. [Abstract] [Full Text] [PDF]
|
|
|
|
|
|
D. O. Williams and J. D. Abbott Bifurcation Intervention: Is it Crush Time Yet? J. Am. Coll. Cardiol., August 16, 2005; 46(4): 621 - 624. [Full Text] [PDF]
|
|
|
|
|
|
M. A. Costa and D. I. Simon Molecular Basis of Restenosis and Drug-Eluting Stents Circulation, May 3, 2005; 111(17): 2257 - 2273. [Full Text] [PDF]
|
|
|
|
|
|
M. Singh, B. J. Gersh, R. L. McClelland, K. K.L. Ho, J. T. Willerson, W. F. Penny, and D. R. Holmes Jr Predictive factors for ischemic target vessel revascularization in the Prevention of Restenosis with Tranilast and its Outcomes (PRESTO) trial J. Am. Coll. Cardiol., January 18, 2005; 45(2): 198 - 203. [Abstract] [Full Text] [PDF]
|
|
|
|
|
|
J. J. Popma, M. B. Leon, J. W. Moses, D. R. Holmes Jr, N. Cox, M. Fitzpatrick, J. Douglas, C. Lambert, M. Mooney, S. Yakubov, et al. Quantitative Assessment of Angiographic Restenosis After Sirolimus-Eluting Stent Implantation in Native Coronary Arteries Circulation, December 21, 2004; 110(25): 3773 - 3780. [Abstract] [Full Text] [PDF]
|
|
|
|
|
|
G. Gennaro, C. Menard, S.-E. Michaud, D. Deblois, and A. Rivard Inhibition of Vascular Smooth Muscle Cell Proliferation and Neointimal Formation in Injured Arteries by a Novel, Oral Mitogen-Activated Protein Kinase/Extracellular Signal-Regulated Kinase Inhibitor Circulation, November 23, 2004; 110(21): 3367 - 3371. [Abstract] [Full Text] [PDF]
|
|
|
|
|
|
P. J.M. Best, P. B. Berger, B. R. Davis, C. L. Grines, H. M. Sadeghi, B. A. Williams, J. T. Willerson, J. R. Granett, D. R. Holmes Jr, and PRESTO Investigators Impact of mild or moderate chronic kidney disease on the frequency of restenosis: Results from the PRESTO trial J. Am. Coll. Cardiol., November 2, 2004; 44(9): 1786 - 1791. [Abstract] [Full Text] [PDF]
|
|
|
|
|
|
R. S. Schwartz, N. A. Chronos, and R. Virmani Preclinical restenosis models and drug-eluting stents: Still important, still much to learn J. Am. Coll. Cardiol., October 6, 2004; 44(7): 1373 - 1385. [Abstract] [Full Text] [PDF]
|
|
|
|
|
|
M. Singh, B. J. Gersh, R. L. McClelland, K. K.L. Ho, J. T. Willerson, W. F. Penny, and D. R. Holmes Jr Clinical and Angiographic Predictors of Restenosis After Percutaneous Coronary Intervention: Insights From the Prevention of Restenosis With Tranilast and Its Outcomes (PRESTO) Trial Circulation, June 8, 2004; 109(22): 2727 - 2731. [Abstract] [Full Text] [PDF]
|
|
|
|
|
|
D. R. Holmes Jr How Many Grails Do We Need? Circulation, May 11, 2004; 109(18): 2158 - 2159. [Full Text] [PDF]
|
|
|
|
 |
|
 C. Marcucci, P.-G. Chassot, J.-P. Gardaz, L. Magnusson, H.-B. Ris, A. Delabays, and D. R. Spahn Fatal myocardial infarction after lung resection in a patient with prophylactic preoperative coronary stenting{dagger} Br. J. Anaesth., May 1, 2004; 92(5): 743 - 747. [Abstract] [Full Text] [PDF]
|
|
|
|
|
|
O. Leppanen, J. Rutanen, M. O. Hiltunen, T. T. Rissanen, M. P. Turunen, T. Sjoblom, J. Bruggen, G. Backstrom, M. Carlsson, E. Buchdunger, et al. Oral Imatinib Mesylate (STI571/Gleevec) Improves the Efficacy of Local Intravascular Vascular Endothelial Growth Factor-C Gene Transfer in Reducing Neointimal Growth in Hypercholesterolemic Rabbits Circulation, March 9, 2004; 109(9): 1140 - 1146. [Abstract] [Full Text] [PDF]
|
|
|
|
|
|
S. A Doggrell and J. C Wanstall Vascular chymase: pathophysiological role and therapeutic potential of inhibition Cardiovasc Res, March 1, 2004; 61(4): 653 - 662. [Abstract] [Full Text] [PDF]
|
|
|
|
|
|
D. R. Holmes Jr, B. G. Firth, and D. L. Wood Paradigm shifts in cardiovascular medicine J. Am. Coll. Cardiol., February 18, 2004; 43(4): 507 - 512. [Abstract] [Full Text] [PDF]
|
|
|
|
|
|
D. Greenberg, A. Bakhai, and D. J. Cohen Can we afford to eliminate restenosis?: Can we afford not to? J. Am. Coll. Cardiol., February 18, 2004; 43(4): 513 - 518. [Abstract] [Full Text] [PDF]
|
|
|
|
|
|
P. W. Serruys, M. Degertekin, K. Tanabe, M. E. Russell, G. Guagliumi, J. Webb, J. Hamburger, W. Rutsch, C. Kaiser, R. Whitbourn, et al. Vascular Responses at Proximal and Distal Edges of Paclitaxel-Eluting Stents: Serial Intravascular Ultrasound Analysis From the TAXUS II Trial Circulation, February 10, 2004; 109(5): 627 - 633. [Abstract] [Full Text] [PDF]
|
|
|
|
|
|
D. R. Holmes Jr, M. B. Leon, J. W. Moses, J. J. Popma, D. Cutlip, P. J. Fitzgerald, C. Brown, T. Fischell, S. C. Wong, M. Midei, et al. Analysis of 1-Year Clinical Outcomes in the SIRIUS Trial: A Randomized Trial of a Sirolimus-Eluting Stent Versus a Standard Stent in Patients at High Risk for Coronary Restenosis Circulation, February 10, 2004; 109(5): 634 - 640. [Abstract] [Full Text] [PDF]
|
|
|
|
|
|
V. Mathew, B. J. Gersh, B. A. Williams, W. K. Laskey, J. T. Willerson, R. T. Tilbury, B. R. Davis, and D. R. Holmes Jr Outcomes in Patients With Diabetes Mellitus Undergoing Percutaneous Coronary Intervention in the Current Era: A Report From the Prevention of REStenosis with Tranilast and its Outcomes (PRESTO) Trial Circulation, February 3, 2004; 109(4): 476 - 480. [Abstract] [Full Text] [PDF]
|
|
|
|
 |
|
 D. R. Holmes Jr Risk Stratification and Interventional Cardiology: Robert L. Frye Lecture Mayo Clin. Proc., December 1, 2003; 78(12): 1507 - 1518. [Abstract] [PDF]
|
|
|
|
|
|
J. W. Moses, M. B. Leon, J. J. Popma, P. J. Fitzgerald, D. R. Holmes, C. O'Shaughnessy, R. P. Caputo, D. J. Kereiakes, D. O. Williams, P. S. Teirstein, et al. Sirolimus-Eluting Stents versus Standard Stents in Patients with Stenosis in a Native Coronary Artery N. Engl. J. Med., October 2, 2003; 349(14): 1315 - 1323. [Abstract] [Full Text] [PDF]
|
|
|
|
 |
|
 S. V. Dee and H. Samady Evolving Strategies for the Prevention and Treatment of Coronary Restenosis Seminars in Cardiothoracic and Vascular Anesthesia, September 1, 2003; 7(3): 281 - 293. [Abstract] [PDF]
|
|
|
|
 |
|
 B. J. Pearce and J. F. McKinsey Current Status of Intravascular Stents as Delivery Devices to Prevent Restenosis Vascular and Endovascular Surgery, July 1, 2003; 37(4): 231 - 237. [Abstract] [PDF]
|
|
|
|
|
|
J. E. Sousa, P. W. Serruys, and M. A. Costa New Frontiers in Cardiology: Drug-Eluting Stents: Part I Circulation, May 6, 2003; 107(17): 2274 - 2279. [Full Text] [PDF]
|
|
|
|
 |
|
 G. Mozes and P. Gloviczki Adjuvant Therapy in Lower Extremity Revascularization: Prevention of Early and Intermediate Failures Perspectives in Vascular Surgery and Endovascular Therapy, January 1, 2002; 15(2): 161 - 180. [Abstract] [PDF]
|
|