Circulation. 2002;105:1285-1290
Published online before print February 25, 2002, doi: 10.1161/01.CIR.0000012783.63093.0C
Published online before print February 25, 2002, doi: 10.1161/01.CIR.0000012783.63093.0C
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(Circulation. 2002;105:1285.)
© 2002 American Heart Association, Inc.
Clinical Investigation and Reports |
Randomized Trial of a Distal Embolic Protection Device During Percutaneous Intervention of Saphenous Vein Aorto-Coronary Bypass Grafts
From the Division of Cardiovascular Diseases, Brigham and Women’s Hospital, Boston Mass (D.S.B., J.J.P., R.E.K.); Harvard Clinical Research Institute, Boston, Mass (D.S.B., D.E.C., U.K., K.K.L.H., R.E.K.); Riverside Hospital, Columbus, Ohio (B.G.); St Joseph’s Mercy Hospital, Ann Arbor, Mich (D.W.); Cardiovascular Research Foundation, Lenox Hill Hospital, New York, NY (M.B.L.); Florida Hospital, Orlando, Fla (J.G.); and Beth Israel Deaconess Medical Center, Boston, Mass (D.E.C., K.K.L.H.).
Correspondence to Donald S. Baim, MD, Brigham and Women’s Hospital, 75 Francis St, Boston, MA 02115. E-mail dbaim{at}partners.org
Background— Stents provide effective treatment for stenotic saphenous venous aorto-coronary bypass grafts, but their placement carries a 20% incidence of procedure-related complications, which potentially are related to the distal embolization of atherosclerotic debris. We report the first multicenter randomized trial to evaluate use of a distal embolic protection device during stenting of such lesions.
Methods and Results— Of 801 eligible patients, 406 were randomly assigned to stent placement over the shaft of the distal protection device, and 395 were assigned to stent placement over a conventional 0.014-inch angioplasty guidewire (control group). The primary end point—a composite of death, myocardial infarction, emergency bypass, or target lesion revascularization by 30 days—was observed in 65 patients (16.5%) assigned to the control group and 39 patients (9.6%) assigned to the embolic protection device (P=0.004). This 42% relative reduction in major adverse cardiac events was driven by myocardial infarction (8.6% versus 14.7%, P=0.008) and "no-reflow" phenomenon (3% versus 9%, P=0.02). Clinical benefit was seen even when platelet glycoprotein IIb/IIIa receptor blockers were administered (61% of patients), with composite end points occurring in 10.7% of protection device patients versus 19.4% of control patients (P=0.008).
Conclusions— Use of this distal protection device during stenting of stenotic venous grafts was associated with a highly significant reduction in major adverse events compared with stenting over a conventional angioplasty guidewire. This demonstrates the importance of distal embolization in causing major adverse cardiac events and the value of embolic protection devices in preventing such complications.
Key Words: embolism • grafting • stenosis • angioplasty • stents
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G. Stankovic, A. Colombo, P. Presbitero, F. van den Branden, L. Inglese, C. Cernigliaro, L. Niccoli, A. L. Bartorelli, P. Rubartelli, N. Reifart, et al. Randomized Evaluation of Polytetrafluoroethylene-Covered Stent in Saphenous Vein Grafts: The Randomized Evaluation of polytetrafluoroethylene COVERed stent in Saphenous vein grafts (RECOVERS) Trial Circulation, July 8, 2003; 108(1): 37 - 42. [Abstract] [Full Text] [PDF]
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P.J. de Feyter Percutaneous Treatment of Saphenous Vein Bypass Graft Obstructions: A Continuing Obstinate Problem Circulation, May 13, 2003; 107(18): 2284 - 2286. [Full Text] [PDF]
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M. Singh, U. Rosenschein, K. K.L. Ho, P. B. Berger, R. Kuntz, and D. R. Holmes, Jr Treatment of Saphenous Vein Bypass Grafts With Ultrasound Thrombolysis: A Randomized Study (ATLAS) Circulation, May 13, 2003; 107(18): 2331 - 2336. [Abstract] [Full Text] [PDF]
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D. T. Ashby, G. Dangas, E. A. Aymong, I. Iakovou, F. Kuepper, R. Mehran, G. W. Stone, M. B. Leon, and J. W. Moses Effect of percutaneous coronary interventions for in-stent restenosis in degenerated saphenous vein grafts without distal embolic protection J. Am. Coll. Cardiol., March 5, 2003; 41(5): 749 - 752. [Abstract] [Full Text] [PDF]
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D. J. Kereiakes Platelet Glycoprotein IIb/IIIa Inhibition and Atheroembolism During Bypass Graft Angioplasty: A Cup Half Full Circulation, December 10, 2002; 106(24): 2994 - 2996. [Full Text] [PDF]
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M. Roffi, D. Mukherjee, D. P. Chew, D. L. Bhatt, L. Cho, M. A. Robbins, K. M. Ziada, D. M. Brennan, S. G. Ellis, and E. J. Topol Lack of Benefit From Intravenous Platelet Glycoprotein IIb/IIIa Receptor Inhibition as Adjunctive Treatment for Percutaneous Interventions of Aortocoronary Bypass Grafts: A Pooled Analysis of Five Randomized Clinical Trials Circulation, December 10, 2002; 106(24): 3063 - 3067. [Abstract] [Full Text] [PDF]
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L. Leborgne, E. Cheneau, R. Waksman, D. S. Baim, R. E. Kuntz, J. J. Popma, D. E. Cutlip, U. Kaya, K. K.L. Ho, X. Chen, et al. Randomized Trial of a Distal Embolic Protection Device During Percutaneous Intervention of Saphenous Vein Aorto-Coronary Bypass Grafts * Response Circulation, October 8, 2002; 106 (15): e68 - e68. [Full Text] [PDF]
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A. Colombo, G. Stankovic, and J. W. Moses Selection of coronary stents J. Am. Coll. Cardiol., September 18, 2002; 40(6): 1021 - 1033. [Abstract] [Full Text] [PDF]
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M. Schluter, T. Tubler, D. G. Mathey, and J. Schofer Feasibility and efficacy of balloon-based neuroprotection during carotid artery stenting in a single-center setting J. Am. Coll. Cardiol., September 4, 2002; 40(5): 890 - 895. [Abstract] [Full Text] [PDF]
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F. Van de Werf and D. S. Baim Reperfusion for ST-Segment Elevation Myocardial Infarction: An Overview of Current Treatment Options Circulation, June 18, 2002; 105(24): 2813 - 2816. [Full Text] [PDF]
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