Outcomes after implantation of the taxus paclitaxel-eluting stent in saphenous vein graft lesions: Results from the ARRIVE (TAXUS Peri-Approval Registry: A Multicenter Safety Surveillance) program

JACC: Cardiovascular Interventions

Volumn 3, Issue 7, 2010, Pages 742-750

  Brilakis, Emmanouil S ^a   Lasala, John M ^b   Cox, David A ^c   Berger, Peter B ^d   Bowman, Thomas S ^e   Starzyk, Ruth M ^e   Dawkins, Keith D ^e  

^a UNIVERSITY OF TEXAS SOUTHWESTERN MEDICAL CENTER   (United States)

^b WASHINGTON UNIVERSITY SCHOOL OF MEDICINE   (United States)

^c LEHIGH VALLEY HOSPITAL   (United States)

^d GEISINGER MEDICAL CENTER   (United States)

^e BOSTON SCIENTIFIC CORPORATION   (United States)

Author keywords

coronary artery bypass graft surgery; paclitaxel eluting stent; percutaneous coronary intervention; saphenous vein graft

Indexed keywords

PACLITAXEL; CARDIOVASCULAR AGENT;

ADULT; AGED; ARTICLE; BARE METAL STENT; CONTROLLED CLINICAL TRIAL; DRUG ELUTING STENT; FEMALE; FOLLOW UP; GRAFT FAILURE; GRAFT OCCLUSION; HEART INFARCTION; HEART MUSCLE REVASCULARIZATION; HIGH RISK POPULATION; HUMAN; IMPLANTATION; IN-STENT RESTENOSIS; MAJOR CLINICAL STUDY; MALE; MORTALITY; MULTICENTER STUDY; PATIENT SELECTION; PERCUTANEOUS CORONARY INTERVENTION; PRIORITY JOURNAL; RETROSPECTIVE STUDY; SAPHENOUS VEIN GRAFT; STENT THROMBOSIS; TAXUS; CHI SQUARE DISTRIBUTION; CLINICAL TRIAL; CORONARY ARTERY BYPASS GRAFT; INSTRUMENTATION; KAPLAN MEIER METHOD; MIDDLE AGED; PROPORTIONAL HAZARDS MODEL; PROSTHESIS; REGISTER; RESTENOSIS; RISK ASSESSMENT; RISK FACTOR; SAPHENOUS VEIN; THROMBOSIS; TIME; TRANSLUMINAL CORONARY ANGIOPLASTY; TRANSPLANTATION; TREATMENT OUTCOME; UNITED STATES;

AGED; ANGIOPLASTY, TRANSLUMINAL, PERCUTANEOUS CORONARY; CARDIOVASCULAR AGENTS; CHI-SQUARE DISTRIBUTION; CORONARY ARTERY BYPASS; CORONARY RESTENOSIS; DRUG-ELUTING STENTS; FEMALE; GRAFT OCCLUSION, VASCULAR; HUMANS; KAPLAN-MEIERS ESTIMATE; MALE; MIDDLE AGED; PACLITAXEL; PROPORTIONAL HAZARDS MODELS; PROSTHESIS DESIGN; REGISTRIES; RISK ASSESSMENT; RISK FACTORS; SAPHENOUS VEIN; THROMBOSIS; TIME FACTORS; TREATMENT OUTCOME; UNITED STATES;

EID: 77958531414     PISSN: 19368798     EISSN: None     Source Type: Journal    
DOI: 10.1016/j.jcin.2010.04.012     Document Type: Article

References (54)

1. Nwasokwa ON. Coronary artery bypass graft disease. Ann Intern Med 1995;123:528-45.
2. Fitzgibbon GM, Kafka HP, Leach AJ, Keon WJ, Hooper GD, Burton JR. Coronary bypass graft fate and patient outcome: angiographic follow-up of 5,065 grafts related to survival and reoperation in 1,388 patients during 25 years. J Am Coll Cardiol 1996;28:616-26.
3. Motwani JG, Topol EJ. Aortocoronary saphenous vein graft disease: pathogenesis, predisposition, and prevention. Circulation 1998;97: 916-31.
4. Baim DS. Percutaneous treatment of saphenous vein graft disease: the ongoing challenge. J Am Coll Cardiol 2003;42:1370-2.
5. Alexander JH, Hafley G, Harrington RA, et al. Efficacy and safety of edifoligide, an E2F transcription factor decoy, for prevention of vein graft failure following coronary artery bypass graft surgery: PREVENT IV: a randomized controlled trial. JAMA 2005;294:2446-54.
6. Morrison DA, Sethi G, Sacks J, et al. Percutaneous coronary intervention versus repeat bypass surgery for patients with medically refractory myocardial ischemia: AWESOME randomized trial and registry experience with post-CABG patients. J Am Coll Cardiol 2002;40: 1951-4.
7. Brodie BR, Wilson H, Stuckey T, et al. Outcomes with drug-eluting versus bare-metal stents in saphenous vein graft intervention: results from the STENT (Strategic Transcatheter Evaluation of New Therapies) group. J Am Coll Cardiol Intv 2009;2:1105-12.
8. de Jaegere PP, van Domburg RT, Feyter PJ, et al. Long-term clinical outcome after stent implantation in saphenous vein grafts. J Am Coll Cardiol 1996;28:89-96.
9. Savage MP, Douglas JS Jr., Fischman DL, et al. Stent placement compared with balloon angioplasty for obstructed coronary bypass grafts. N Engl J Med 1997;337:740-7.
10. Keeley EC, Velez CA, O'Neill WW, Safian RD. Long-term clinical outcome and predictors of major adverse cardiac events after percutaneous interventions on saphenous vein grafts. J Am Coll Cardiol 2001;38:659-65.
11. Hanekamp CE, Koolen JJ, Den Heijer P, et al. Randomized study to compare balloon angioplasty and elective stent implantation in venous bypass grafts: the Venestent study. Catheter Cardiovasc Interv 2003; 60:452-7.
12. De Feyter PJ. Percutaneous treatment of saphenous vein bypass graft obstructions: a continuing obstinate problem. Circulation 2003;107: 2284-6.
13. King SB 3rd, Smith SC Jr., Hirshfeld JW Jr., et al. 2007 focused update of the ACC/AHA/SCAI 2005 guideline update for percutaneous coronary intervention: a report of the American College of Cardiology/ American Heart Association Task Force on Practice guidelines. J Am Coll Cardiol 2008;51:172-209.
14. Lee MS, Shah AP, Aragon J, et al. Drug-eluting stenting is superior to bare metal stenting in saphenous vein grafts. Catheter Cardiovasc Interv 2005;66:507-11.
15. Chu WW, Rha SW, Kuchulakanti PK, et al. Efficacy of sirolimus-eluting stents compared with bare metal stents for saphenous vein graft intervention. Am J Cardiol 2006;97:34-7.
16. Ellis SG, Kandzari D, Kereiakes DJ, et al. Utility of sirolimus-eluting Cypher stents to reduce 12-month target vessel revascularization in saphenous vein graft stenoses: results of a multicenter 350-patient case-control study. J Invasive Cardiol 2007;19:404-9.
17. Hoffmann R, Pohl T, Koster R, Blindt R, Boeckstegers P, Heitzer T. Implantation of paclitaxel-eluting stents in saphenous vein grafts: clinical and angiographic follow-up results from a multicentre study. Heart 2007;93:331-4.
18. Minutello RM, Bhagan S, Sharma A, et al. Long-term clinical benefit of sirolimus-eluting stents compared to bare metal stents in the treatment of saphenous vein graft disease. J Interv Cardiol 2007;20: 458-65.
19. Wohrle J, Nusser T, Kestler HA, Kochs M, Hombach V. Comparison of the slow-release polymerbased paclitaxel-eluting Taxus-Express stent with the bare-metal Express stent for saphenous vein graft interventions. Clin Res Cardiol 2007;96:70-6.
20. Kaplan S, Barlis P, Kiris A, Dimopoulos K, Celik S, Di Mario C. Immediate procedural and long-term clinical outcomes following drug-eluting stent implantation to ostial saphenous vein graft lesions. Acute Card Care 2008;10:88-92.
21. Bansal D, Muppidi R, Singla S, et al. Percutaneous intervention on the saphenous vein bypass grafts-long-term outcomes. Catheter Cardio-vasc Interv 2008;71:58-61.
22. Vignali L, Saia F, Manari A, et al. Long-term outcomes with drug-eluting stents versus bare metal stents in the treatment of saphenous vein graft disease (results from the REgistro Regionale AngiopLastiche Emilia-Romagna Registry). Am J Cardiol 2008;101: 947-52.
23. Okabe T, Lindsay J, Buch AN, et al. Drug-eluting stents versus bare metal stents for narrowing in saphenous vein grafts. Am J Cardiol 2008;102:530-4.
24. Gioia G, Benassi A, Mohendra R, Chowdhury K, Masood I, Matthai W. Lack of clinical long-term benefit with the use of a drug eluting stent compared to use of a bare metal stent in saphenous vein grafts. Catheter Cardiovasc Interv 2008;72:13-20.
25. Ramana RK, Ronan A, Cohoon K, et al. Long-term clinical outcomes of real-world experience using sirolimus-eluting stents in saphenous vein graft disease. Catheter Cardiovasc Interv 2008;71:886-93.
26. Applegate RJ, Sacrinty M, Kutcher M, Santos R, Gandhi S, Little W. Late outcomes of drug-eluting versus bare metal stents in saphenous vein grafts: propensity score analysis. Catheter Cardiovasc Interv 2008;72:7-12.
27. Assali A, Raz Y, Vaknin-Assa H, et al. Beneficial 2-years results of drug-eluting stents in saphenous vein graft lesions. EuroIntervention 2008;4:108-14.
28. van Twisk PH, Daemen J, Kukreja N, van Domburg RT, Serruys PW. Four-year safety and efficacy of the unrestricted use of sirolimus-and paclitaxel-eluting stents in coronary artery bypass grafts. EuroInterven-tion 2008;4:311-7.
29. Jeger RV, Schneiter S, Kaiser C, et al. Drug-eluting stents compared with bare metal stents improve late outcome after saphenous vein graft but not after large native vessel interventions. Cardiology 2009;112:49-55.
30. Vermeersch P, Agostoni P, Verheye S, et al. Randomized double-blind comparison of sirolimus-eluting stent versus bare-metal stent implantation in diseased saphenous vein grafts: six-month angiographic, intravascular ultrasound, and clinical follow-up of the RRISC Trial. J Am Coll Cardiol 2006;48:2423-31.
31. Vermeersch P, Agostoni P, Verheye S, et al. Increased late mortality after sirolimus-eluting stents versus bare-metal stents in diseased saphenous vein grafts: results from the randomized DELAYED RRISC Trial. J Am Coll Cardiol 2007;50:261-7.
32. Brilakis ES, Lichtenwalter C, de Lemos JA, et al. A randomized controlled trial of a paclitaxel-eluting stent versus a similar bare-metal stent in saphenous vein graft lesions the SOS (Stenting of Saphenous Vein Grafts) trial. J Am Coll Cardiol 2009;53:919-28.
33. Lasala JM, Cox DA, Dobies D, et al. Usage patterns and 2-year outcomes with the TAXUS express stent: results of the US ARRIVE 1 registry. Catheter Cardiovasc Interv 2008;72:433-45.
34. Lasala JM, Cox DA, Lewis SJ, et al. Expanded use of the TAXUS Express Stent: two-year safety insights from the 7,500 patient ARRIVE Registry programme. EuroIntervention 2009;5:67-77.
35. Lasala JM, Cox DA, Dobies D, et al. Drug-eluting stent thrombosis in routine clinical practice: two-year outcomes and predictors from the TAXUS ARRIVE registries. Circ Cardiovasc Interv 2009;2:285-93.
36. Cutlip DE, Windecker S, Mehran R, et al. Clinical end points in coronary stent trials: a case for standardized definitions. Circulation 2007;115:2344-51.
37. Stone GW, Ellis SG, Cox DA, et al. One-year clinical results with the slow-release, polymer-based, paclitaxel-eluting TAXUS stent: the TAXUS-IV trial. Circulation 2004;109:1942-7.
38. Stone GW, Moses JW, Ellis SG, et al. Safety and efficacy of sirolimus-and paclitaxel-eluting coronary stents. N Engl J Med 2007;356:998-1008.
39. Agostoni P, Vermeersch P, Semeraro O, et al. Intravascular ultrasound comparison of sirolimus-eluting stent versus bare metal stent implantation in diseased saphenous vein grafts (from the RRISC [Reduction of Restenosis In Saphenous Vein Grafts With Cypher Sirolimus-Eluting Stent] trial). Am J Cardiol 2007;100:52-8.
40. Lichtenwalter C, de Lemos JA, Roesle M, et al. Clinical presentation and angiographic characteristics of saphenous vein graft failure after stenting: insights from the SOS (Stenting Of Saphenous vein grafts) trial. J Am Coll Cardiol Intv 2009;2:855-60.
41. Pucelikova T, Mehran R, Kirtane AJ, et al. Short-and long-term outcomes after stent-assisted percutaneous treatment of saphenous vein grafts in the drug-eluting stent era. Am J Cardiol 2008;101:63-8.
42. Jim MH, Ho HH, Ko RL, et al. Paclitaxel-eluting stent long-term outcomes in percutaneous saphenous vein graft interventions (PELOPS) study. Am J Cardiol 2009;103:199-202.
43. Ge L, Iakovou I, Sangiorgi GM, et al. Treatment of saphenous vein graft lesions with drug-eluting stents: immediate and midterm outcome. J Am Coll Cardiol 2005;45:989-94.
44. Lozano I, Avanzas P, Rondan J. Stent implantation in saphenous vein grafts. Am J Cardiol 2009;103:1042-3.
45. Brilakis ES, Saeed B, Banerjee S. Drug-eluting stents in saphenous vein graft interventions: a systematic review. Eurointervention 2010;5: 722-30.
46. Mehta RH, Honeycutt E, Peterson ED, et al. Impact of internal mammary artery conduit on long-term outcomes after percutaneous intervention of saphenous vein graft. Circulation 2006;114:I396-401.
47. Leon MB, Allocco DJ, Dawkins KD, Baim DS. Late clinical events after drug-eluting stents: the interplay between stent-related and natural history-driven events. J Am Coll Cardiol Intv 2009;2:504-12.
48. Chacko R, Mulhearn M, Novack V, et al. Impact of target lesion and nontarget lesion cardiac events on 5-year clinical outcomes after sirolimus-eluting or bare-metal stenting. J Am Coll Cardiol Intv 2009;2:498-503.
49. Ellis SG, Brener SJ, DeLuca S, et al. Late myocardial ischemic events after saphenous vein graft intervention-importance of initially "nonsignificant" vein graft lesions. Am J Cardiol 1997;79:1460-4.
50. Knatterud GL, White C, Geller NL, et al. Angiographic changes in saphenous vein grafts are predictors of clinical outcomes. Am Heart J 2003;145:262-9.
51. Rodes-Cabau J, Facta A, Larose E, et al. Predictors of aorto-saphenous vein bypass narrowing late after coronary artery bypass grafting. Am J Cardiol 2007;100:640-5.
52. Rodes-Cabau J, Bertrand OF, Larose E, et al. Comparison of plaque sealing with paclitaxel-eluting stents versus medical therapy for the treatment of moderate nonsignificant saphenous vein graft lesions. The Moderate VEin Graft LEsion Stenting With the Taxus Stent and Intravascular Ultrasound (VELETI) pilot trial. Circulation 2009;120: 1978-86.
53. Coolong A, Baim DS, Kuntz RE, et al. Saphenous vein graft stenting and major adverse cardiac events: a predictive model derived from a pooled analysis of 3958 patients. Circulation 2008;117:790-7.
54. Brilakis ES, Berger PB. Should bare metal or drug-eluting stents be used during PCI of saphenous vein graft lesions: waiting for Godot? Catheter Cardiovasc Interv 2008;72:815-8.