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Original Article
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Volume 337:740-747 September 11, 1997 Number 11
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Stent Placement Compared with Balloon Angioplasty for Obstructed Coronary Bypass Grafts
Michael P. Savage, M.D., John S. Douglas, M.D., David L. Fischman, M.D., Carl J. Pepine, M.D., Spencer B. King, M.D., Jeffrey A. Werner, M.D., Steven R. Bailey, M.D., Paul A. Overlie, M.D., Sarah H. Fenton, M.D., Jeffrey A. Brinker, M.D., Martin B. Leon, M.D., Sheldon Goldberg, M.D., Richard Heuser, M.D., Richard Smalling, M.D., Robert D. Safian, M.D., Michael Cleman, M.D., Maurice Buchbinder, M.D., David Snead, Randal C. Rake, B.S., Sharon Gebhardt, R.N., for The Saphenous Vein De Novo Trial Investigators

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ABSTRACT

Background Treatment of stenosis in saphenous-vein grafts after coronary-artery bypass surgery is a difficult challenge. The purpose of this study was to compare the effects of stent placement with those of balloon angioplasty on clinical and angiographic outcomes in patients with obstructive disease of saphenous-vein grafts.

Methods A total of 220 patients with new lesions in aortocoronary–venous bypass grafts were randomly assigned to placement of Palmaz–Schatz stents or standard balloon angioplasty. Coronary angiography was performed during the index procedure and six months later.

Results As compared with the patients assigned to angioplasty, those assigned to stenting had a higher rate of procedural efficacy, defined as a reduction in stenosis to less than 50 percent of the vessel diameter without a major cardiac complication (92 percent vs. 69 percent, P<0.001), but they had more frequent hemorrhagic complications (17 percent vs. 5 percent, P<0.01). Patients in the stent group had a larger mean (±SD) increase in luminal diameter immediately after the procedure (1.92±0.30 mm, as compared with 1.21±0.37 mm in the angioplasty group; P<0.001) and a greater mean net gain in luminal diameter at six months (0.85±0.96 vs. 0.54±0.91 mm, P = 0.002). Restenosis occurred in 37 percent of the patients in the stent group and in 46 percent of the patients in the angioplasty group (P = 0.24). The outcome in terms of freedom from death, myocardial infarction, repeated bypass surgery, or revascularization of the target lesion was significantly better in the stent group (73 percent vs. 58 percent, P = 0.03).

Conclusions As compared with balloon angioplasty, stenting of selected venous bypass-graft lesions resulted in superior procedural outcomes, a larger gain in luminal diameter, and a reduction in major cardiac events. However, there was no significant benefit in the rate of angiographic restenosis, which was the primary end point of the study.


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From Jefferson Medical College, Philadelphia (M.P.S., D.L.F., S.H.F.); Emory University Hospital, Atlanta (J.S.D., S.B.K.); the University of Florida, Gainesville (C.J.P.); Providence–Seattle Medical Centers, Seattle (J.A.W.); the University of Texas Health Science Center, San Antonio (S.R.B.); Cardiology Associates of Lubbock, Lubbock, Tex. (P.A.O.); Johns Hopkins Hospital, Baltimore (J.A.B.); Washington Hospital Center, Washington, D.C. (M.B.L.); and Massachusetts General Hospital, Boston (S.G.). Other authors were Richard Heuser, M.D. (Arizona Heart Institute, Phoenix), Richard Smalling, M.D. (University of Texas Health Science Center, Houston), Robert D. Safian, M.D. (William Beaumont Hospital, Royal Oak, Mich.), Michael Cleman, M.D. (Yale University Hospital, New Haven, Conn.), Maurice Buchbinder, M.D. (Scripps Clinic and Research Foundation, La Jolla, Calif.), David Snead (Johnson & Johnson Interventional Systems, Warren, N.J.), and Randal C. Rake, B.S., and Sharon Gebhardt, R.N. (Jefferson Medical College, Philadelphia).

Address reprint requests to Dr. Savage at the Division of Cardiology, Suite 410, College Bldg., Thomas Jefferson University, 1025 Walnut St., Philadelphia, PA 19107.

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Related Letters:

Stent Placement Compared with Balloon Angioplasty for Obstructed Coronary Bypass Grafts
Bloom J. M., Savage M. P., Fischman D. L., Goldberg S.
Extract | Full Text  
N Engl J Med 1998; 338:198-199, Jan 15, 1998. Correspondence

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