American Heart Journal
Volume 150, Issue 4 , Pages 643-649 , October 2005

The PRoject of Ex-vivo Vein graft ENgineering via Transfection IV (PREVENT IV) trial: Study rationale, design, and baseline patient characteristics

  • John H. Alexander, MD, MS

      Affiliations

    • Duke University Medical Center, Duke Clinical Research Institute, Durham, NC
    • Corresponding Author InformationReprint requests: John H. Alexander, MD, MS, Box 3300, Duke University Medical Center, Duke Clinical Research Institute, Durham, NC, 27715.
    • ,
  • T. Bruce Ferguson Jr., MD

      Affiliations

    • Louisiana State University, New Orleans, La
    • ,
  • Diane M. Joseph, BS

      Affiliations

    • Duke University Medical Center, Duke Clinical Research Institute, Durham, NC
    • ,
  • Michael J. Mack, MD

      Affiliations

    • Cardiopulmonary Research Science and Technology Institute, Dallas, Tex
    • ,
  • Randall K. Wolf, MD

      Affiliations

    • University of Cincinnati, Cincinnati, Ohio
    • ,
  • C. Michael Gibson, MD, MS

      Affiliations

    • PERFUSE Angiographic Laboratory, Beth Israel-Deaconess Medical Center, Boston, Mass
    • ,
  • Daniel Gennevois, MD

      Affiliations

    • Corgentech Inc., South San Francisco, Calif
    • ,
  • Todd J. Lorenz, MD

      Affiliations

    • Corgentech Inc., South San Francisco, Calif
    • ,
  • Robert A. Harrington, MD

      Affiliations

    • Duke University Medical Center, Duke Clinical Research Institute, Durham, NC
    • ,
  • Eric D. Peterson, MD, MPH

      Affiliations

    • Duke University Medical Center, Duke Clinical Research Institute, Durham, NC
    • ,
  • Kerry L. Lee, PhD

      Affiliations

    • Duke University Medical Center, Duke Clinical Research Institute, Durham, NC
    • ,
  • Robert M. Califf, MD

      Affiliations

    • Duke University Medical Center, Duke Clinical Research Institute, Durham, NC
    • ,
  • Nicholas T. Kouchoukos, MD

      Affiliations

    • Missouri Baptist Medical Center, St. Louis, Mo
    • ,
  • PREVENT IV Investigators

Received 27 February 2005 ,Accepted 17 May 2005.

References 

  1. American Heart Association. Heart and stroke facts. Dallas (TX): American Heart Association; 2003;
  2. Eagle KA, Guyton RA, Davidoff R, et al. ACC/AHA guidelines for coronary artery bypass graft surgery: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines. J Am Coll Cardiol. 1999;34:1262–1346
  3. Yusuf S, Zucker D, Peduzzi P, et al. Effect of coronary artery bypass graft surgery on survival: overview of 10-year results from randomized trials by the Coronary Artery Bypass Graft Surgery Trialists Collaboration. Lancet. 1994;344:563–570
  4. Campeau L, Enjalbert M, Lesperance J, et al. The relation of risk factors to the development of atherosclerosis in saphenous-vein bypass grafts and the progression of disease in the native circulation: a study 10 years after aortocoronary bypass surgery. N Engl J Med. 1984;311:1329–1332
  5. FitzGibbon GM, Leach AJ, Keon WJ, et al. Coronary bypass graft fate: angiographic study of 1,179 vein grafts early, one year, and five years after operation. J Thorac Cardiovasc Surg. 1986;91:773–778
  6. Desai ND, Cohen EA, Naylor CD, et al. A randomized comparison of radial-artery and saphenous-vein coronary bypass grafts. N Engl J Med. 2004;351:2302–2309
  7. Goldman S, Zadina K, Moritz T, et al. Long-term patency of saphenous vein and left internal mammary artery grafts after coronary artery bypass surgery: results from a Department of Veterans Affairs Cooperative Study. J Am Coll Cardiol. 2004;44:2149–2156
  8. Cameron J, Trivedi S, Stafford G, et al. Five-year angiographic patency of radial artery bypass grafts. Circulation. 2004;110(Suppl II):II23–II26
  9. Widimsky P, Straka Z, Stros P, et al. One-year coronary bypass graft patency. A randomized comparison between off-pump and on-pump surgery. Angiographic results of the PRAGUE-4 trial. Circulation. 2004;110:3418–3423
  10. Cameron A, Kemp HG, Green GE. Reoperation for coronary artery disease: 10 years of clinical follow-up. Circulation. 1988;78:I158–I162
  11. Loop FD, Lytle BW, Cosgrove DM, et al. Reoperation for coronary atherosclerosis: changing practice in 2,509 consecutive patients. Ann Surg. 1990;212:378–386
  12. Lefkovits J, Holmes DR, Califf RM, et al. Predictors and sequelae of distal embolization during saphenous vein graft intervention from the CAVEAT-II trial. Circulation. 1995;92:734–740
  13. Reeves F, Bonan R, Cote G, et al. Long-term angiographic follow-up after angioplasty of venous coronary bypass grafts. Am Heart J. 1991;122:620–627
  14. Savage MP, Douglas JS, Fischman DL, et al. Stent placement compared with balloon angioplasty for obstructed coronary bypass grafts. N Engl J Med. 1997;337:740–747
  15. Le May MR, Labinaz M, Marquis JF, et al. Predictors of long-term outcome after stent implantation in a saphenous vein graft. Am J Cardiol. 1999;83:681–686
  16. Grondin CM, Campeau L, Lesperance J, et al. Comparison of late changes in internal mammary artery and saphenous vein grafts in two consecutive series of patients 10 years after operation. Circulation. 1984;70:I208–I212
  17. Grondin CM, Campeau L, Thornton JC, et al. Coronary artery bypass grafting with saphenous vein. Circulation. 1989;79:I24–I29
  18. Reardon MJ, Conklin LD, Reardon PR, et al. Coronary artery bypass conduits: review of current status. J Cardiovasc Surg. 1997;38:201–209
  19. Motwani JG, Topol EJ. Aortocoronary saphenous vein graft disease: pathogenesis, predisposition, and prevention. Circulation. 1998;97:916–931
  20. Cox JL, Chaisson DA, Gotlieb AI. Stranger in a strange land: the pathogenesis of saphenous vein graft stenosis with emphasis on structural and functional differences between veins and arteries. Prog Cardiovasc Dis. 1991;34:45–68
  21. Zwolak RM, Adams MC, Clowes AW. Kinetics of vein graft hyperplasia: association with tangential stress. J Vasc Surg. 1987;5:126–136
  22. Mann MJ. Novel strategies for the prevention of bypass graft failure. BioDrugs. 2004;18:1–8
  23. DeGregori J, Kowalik T, Nevins JR. Cellular targets for activation by the E2F1 transcription factor include DNA synthesis- and G1/S-regulatory genes. Mol Cell Biol. 1995;15:4215–4224
  24. Mann MJ. Gene therapy for vein grafts. Curr Cardiol Rep. 2000;2:29–33
  25. Braun-Dullaeus RC, Mann MJ, Dzau VJ. Cell cycle progression: new therapeutic target for vascular proliferative disease. Circulation. 1998;98:82–89
  26. Mann MJ, Dzau VJ. Therapeutic applications of transcription factor decoy oligonucleotides. J Clin Invest. 2000;106:1071–1075
  27. Morishita R, Gibbons GH, Horiuchi M, et al. A gene therapy strategy using a transcription factor decoy of the E2F binding site inhibits smooth muscle proliferation in vivo. Proc Natl Acad Sci U S A. 1995;92:5855–5859
  28. Tomita N, Horiuchi M, Tomita S, et al. An oligonucleotide decoy for transcription factor E2F inhibits mesangial cell proliferation in vitro. Am J Physiol. 1998;275:F278–F284
  29. Mann MJ, Gibbons GH, Kernoff RS, et al. Genetic engineering of vein grafts resistant to atherosclerosis. Proc Natl Acad Sci U S A. 1995;92:4502–4506
  30. Ehsan A, Mann MJ, Dell'Acqua G, et al. Long-term stabilization of vein graft wall architecture and prolonged resistance to experimental atherosclerosis after E2F decoy oligonucleotide gene therapy. J Thorac Cardiovasc Surg. 2001;121:714–722
  31. Mann MJ, Whittemore AD, Donaldson MC, et al. Ex-vivo gene therapy of human vascular bypass grafts with E2F decoy: the PREVENT single-centre, randomised, controlled trial. Lancet. 1999;354:1493–1498
  32. Grube E. PRoject of Ex-vivo Vein graft ENgineering via Transfection (PREVENT) II trial. In: Presented at the annual American Heart Association Scientific Sessions; November 11-14, 2001; Anaheim, California. 2001;
  33. Mann MJ, Gibbons GH, Hutchinson H, et al. Pressure-mediated oligonucleotide transfection of rat and human cardiovascular tissues. Proc Natl Acad Sci U S A. 1999;96:6411–6416
  34. Halabi AR, Alexander JH, Shaw LK, et al. Clinical significance of early saphenous vein graft failure following coronary artery bypass surgery. Catheter Cardiovasc Interv. 2005;65:90–91
  35. Goldman S, Copeland J, Moritz T, et al. Improvement in early saphenous vein graft patency after coronary artery bypass surgery with antiplatelet therapy: results of a Veterans Administration Cooperative Study. Circulation. 1988;77:1324–1332
  36. Goldman S, Copeland J, Moritz T, et al. Saphenous vein graft patency 1 year after coronary artery bypass surgery and effects of antiplatelet therapy: results of a Veterans Administration Cooperative Study. Circulation. 1989;80:1190–1197
  37. van der Meer J, Hillege HL, Kootstra GJ, et al. Prevention of one-year vein-graft occlusion after aortocoronary-bypass surgery: a comparison of low-dose aspirin, low-dose aspirin plus dipyridamole, and oral anticoagulants. Lancet. 1993;342:257–264
  38. Stein PD, Dalen JE, Goldman S, et al. Antithrombotic therapy in patients with saphenous vein and internal mammary artery bypass grafts. Chest. 2001;119(1 Suppl):278S–282S
  39. The Post Coronary Artery Bypass Graft trial investigators. The effect of aggressive lowering of low-density lipoprotein cholesterol levels and low-dose anticoagulation on obstructive changes in saphenous-vein coronary-artery bypass grafts. N Engl J Med. 1997;336:153–162
  40. Chen SJ, Wilson JM, Muller DW. Adenovirus-mediated gene transfer of soluble vascular cell adhesion molecule to porcine interposition vein grafts. Circulation. 1994;89:1922–1928
  41. Satava RM, Wolf RK. Disruptive visions: biosurgery. Surg Endosc. 2003;17:1833–1836
  42. 21CFR314.510. Approval based on a surrogate endpoint or on an effect on a clinical endpoint other than survival or irreversible morbidity; April 1,2002.
  43. Weintraub WS, Jones EL, Craver JM, et al. Frequency of repeat coronary bypass or coronary angioplasty after coronary artery bypass surgery using saphenous venous grafts. Am J Cardiol. 1994;73:103–112

PII: S0002-8703(05)00524-7

doi: 10.1016/j.ahj.2005.05.021

American Heart Journal
Volume 150, Issue 4 , Pages 643-649 , October 2005

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