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

American Heart Journal

Volumn 150, Issue 4, 2005, Pages 643-649

  Alexander, John H ^a   Ferguson Jr , T Bruce ^b   Joseph, Diane M ^a   Mack, Michael J ^c   Wolf, Randall K ^d   Gibson, C Michael ^e   Gennevois, Daniel ^f   Lorenz, Todd J ^f   Harrington, Robert A ^a   Peterson, Eric D ^a   Lee, Kerry L ^a   Califf, Robert M ^a   Kouchoukos, Nicholas T ^g  

^a DUKE UNIVERSITY MEDICAL CENTER   (United States)

^b LOUISIANA STATE UNIVERSITY   (United States)

^c Cardiopulmonary Research Science and Technology Institute   (United States)

^d UNIVERSITY OF CINCINNATI   (United States)

^e BETH ISRAEL DEACONESS MEDICAL CENTER   (United States)

^f Department of Research   (United States)

^g MISSOURI BAPTIST MEDICAL CENTER   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

EDIFOLIGIDE; OLIGONUCLEOTIDE; UNCLASSIFIED DRUG;

ADULT; AGED; ANGIOGRAPHY; ARTERY INTIMA PROLIFERATION; ARTICLE; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; CORONARY ARTERY BYPASS GRAFT; DEATH; FEMALE; FOLLOW UP; GENETIC TRANSCRIPTION; GENETIC TRANSFECTION; HUMAN; MAJOR CLINICAL STUDY; MALE; PHASE 3 CLINICAL TRIAL; POPULATION RESEARCH; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL; STENOSIS; VEIN GRAFT DISEASE;

AGED; CORONARY ARTERY BYPASS; DNA; EQUIPMENT DESIGN; FEMALE; FOLLOW-UP STUDIES; HUMANS; HYPERPLASIA; INJECTIONS, INTRAVENOUS; MALE; MIDDLE AGED; MULTICENTER STUDIES; OLIGONUCLEOTIDES; POSTOPERATIVE COMPLICATIONS; RANDOMIZED CONTROLLED TRIALS; RESEARCH DESIGN; TUNICA INTIMA;

EID: 25844528525     PISSN: 00028703     EISSN: 10976744     Source Type: Journal    
DOI: 10.1016/j.ahj.2005.05.021     Document Type: Article

References (43)

1. American Heart Association Heart and stroke facts 2003 American Heart Association Dallas (TX)
2. K.A. Eagle, R.A. Guyton, and R. Davidoff 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 34 1999 1262 1346
3. S. Yusuf, D. Zucker, and P. Peduzzi 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 344 1994 563 570
4. L. Campeau, M. Enjalbert, and J. Lesperance 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 311 1984 1329 1332
5. G.M. FitzGibbon, A.J. Leach, and W.J. Keon Coronary bypass graft fate: angiographic study of 1,179 vein grafts early, one year, and five years after operation J Thorac Cardiovasc Surg 91 1986 773 778
6. N.D. Desai, E.A. Cohen, and C.D. Naylor A randomized comparison of radial-artery and saphenous-vein coronary bypass grafts N Engl J Med 351 2004 2302 2309
7. S. Goldman, K. Zadina, and T. Moritz 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 44 2004 2149 2156
8. J. Cameron, S. Trivedi, and G. Stafford Five-year angiographic patency of radial artery bypass grafts Circulation 110 Suppl II 2004 II23 II26
9. P. Widimsky, Z. Straka, and P. Stros One-year coronary bypass graft patency. A randomized comparison between off-pump and on-pump surgery. Angiographic results of the PRAGUE-4 trial Circulation 110 2004 3418 3423
10. A. Cameron, H.G. Kemp Jr., and G.E. Green Reoperation for coronary artery disease: 10 years of clinical follow-up Circulation 78 1988 I158 I162
11. F.D. Loop, B.W. Lytle, and D.M. Cosgrove Reoperation for coronary atherosclerosis: changing practice in 2,509 consecutive patients Ann Surg 212 1990 378 386
12. J. Lefkovits, D.R. Holmes, and R.M. Califf Predictors and sequelae of distal embolization during saphenous vein graft intervention from the CAVEAT-II trial Circulation 92 1995 734 740
13. F. Reeves, R. Bonan, and G. Cote Long-term angiographic follow-up after angioplasty of venous coronary bypass grafts Am Heart J 122 1991 620 627
14. M.P. Savage, J.S. Douglas Jr., and D.L. Fischman Stent placement compared with balloon angioplasty for obstructed coronary bypass grafts N Engl J Med 337 1997 740 747
15. M.R. Le May, M. Labinaz, and J.F. Marquis Predictors of long-term outcome after stent implantation in a saphenous vein graft Am J Cardiol 83 1999 681 686
16. C.M. Grondin, L. Campeau, and J. Lesperance Comparison of late changes in internal mammary artery and saphenous vein grafts in two consecutive series of patients 10 years after operation Circulation 70 1984 I208 I212
17. C.M. Grondin, L. Campeau, and J.C. Thornton Coronary artery bypass grafting with saphenous vein Circulation 79 1989 I24 I29
18. M.J. Reardon, L.D. Conklin, and P.R. Reardon Coronary artery bypass conduits: review of current status J Cardiovasc Surg 38 1997 201 209
19. J.G. Motwani, and E.J. Topol Aortocoronary saphenous vein graft disease: pathogenesis, predisposition, and prevention Circulation 97 1998 916 931
20. J.L. Cox, D.A. Chaisson, and A.I. Gotlieb 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 34 1991 45 68
21. R.M. Zwolak, M.C. Adams, and A.W. Clowes Kinetics of vein graft hyperplasia: association with tangential stress J Vasc Surg 5 1987 126 136
22. M.J. Mann Novel strategies for the prevention of bypass graft failure BioDrugs 18 2004 1 8
23. J. DeGregori, T. Kowalik, and J.R. Nevins Cellular targets for activation by the E2F1 transcription factor include DNA synthesis- and G1/S-regulatory genes Mol Cell Biol 15 1995 4215 4224
24. M.J. Mann Gene therapy for vein grafts Curr Cardiol Rep 2 2000 29 33
25. R.C. Braun-Dullaeus, M.J. Mann, and V.J. Dzau Cell cycle progression: new therapeutic target for vascular proliferative disease Circulation 98 1998 82 89
26. M.J. Mann, and V.J. Dzau Therapeutic applications of transcription factor decoy oligonucleotides J Clin Invest 106 2000 1071 1075
27. R. Morishita, G.H. Gibbons, and M. Horiuchi 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 92 1995 5855 5859
28. N. Tomita, M. Horiuchi, and S. Tomita An oligonucleotide decoy for transcription factor E2F inhibits mesangial cell proliferation in vitro Am J Physiol 275 1998 F278 F284
29. M.J. Mann, G.H. Gibbons, and R.S. Kernoff Genetic engineering of vein grafts resistant to atherosclerosis Proc Natl Acad Sci U S A 92 1995 4502 4506
30. A. Ehsan, M.J. Mann, and G. Dell'Acqua Long-term stabilization of vein graft wall architecture and prolonged resistance to experimental atherosclerosis after E2F decoy oligonucleotide gene therapy J Thorac Cardiovasc Surg 121 2001 714 722
31. M.J. Mann, A.D. Whittemore, and M.C. Donaldson Ex-vivo gene therapy of human vascular bypass grafts with E2F decoy: the PREVENT single-centre, randomised, controlled trial Lancet 354 1999 1493 1498
32. E. Grube PRoject of Ex-vivo Vein graft ENgineering via Transfection (PREVENT) II trial Presented at the annual American Heart Association Scientific Sessions; November 11-14, 2001; Anaheim, California 2001
33. M.J. Mann, G.H. Gibbons, and H. Hutchinson Pressure-mediated oligonucleotide transfection of rat and human cardiovascular tissues Proc Natl Acad Sci U S A 96 1999 6411 6416
34. A.R. Halabi, J.H. Alexander, and L.K. Shaw Clinical significance of early saphenous vein graft failure following coronary artery bypass surgery Catheter Cardiovasc Interv 65 2005 90 91
35. S. Goldman, J. Copeland, and T. Moritz Improvement in early saphenous vein graft patency after coronary artery bypass surgery with antiplatelet therapy: results of a Veterans Administration Cooperative Study Circulation 77 1988 1324 1332
36. S. Goldman, J. Copeland, and T. Moritz Saphenous vein graft patency 1 year after coronary artery bypass surgery and effects of antiplatelet therapy: results of a Veterans Administration Cooperative Study Circulation 80 1989 1190 1197
37. J. van der Meer, H.L. Hillege, and G.J. Kootstra 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 342 1993 257 264
38. P.D. Stein, J.E. Dalen, and S. Goldman Antithrombotic therapy in patients with saphenous vein and internal mammary artery bypass grafts Chest 119 1 Suppl 2001 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 336 1997 153 162
40. S.J. Chen, J.M. Wilson, and D.W. Muller Adenovirus-mediated gene transfer of soluble vascular cell adhesion molecule to porcine interposition vein grafts Circulation 89 1994 1922 1928
41. R.M. Satava, and R.K. Wolf Disruptive visions: biosurgery Surg Endosc 17 2003 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. W.S. Weintraub, E.L. Jones, and J.M. Craver Frequency of repeat coronary bypass or coronary angioplasty after coronary artery bypass surgery using saphenous venous grafts Am J Cardiol 73 1994 103 112