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
Background Treatment of stenosis in saphenous-vein grafts aftercoronary-artery bypass surgery is a difficult challenge. Thepurpose of this study was to compare the effects of stent placementwith those of balloon angioplasty on clinical and angiographicoutcomes in patients with obstructive disease of saphenous-veingrafts.
Methods A total of 220 patients with new lesions in aortocoronaryvenousbypass grafts were randomly assigned to placement of PalmazSchatzstents or standard balloon angioplasty. Coronary angiographywas 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 ofthe vessel diameter without a major cardiac complication (92percent vs. 69 percent, P<0.001), but they had more frequenthemorrhagic complications (17 percent vs. 5 percent, P<0.01).Patients in the stent group had a larger mean (±SD) increasein luminal diameter immediately after the procedure (1.92±0.30mm, as compared with 1.21±0.37 mm in the angioplastygroup; P<0.001) and a greater mean net gain in luminal diameterat six months (0.85±0.96 vs. 0.54±0.91 mm, P =0.002). Restenosis occurred in 37 percent of the patients inthe stent group and in 46 percent of the patients in the angioplastygroup (P = 0.24). The outcome in terms of freedom from death,myocardial infarction, repeated bypass surgery, or revascularizationof 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 ofselected venous bypass-graft lesions resulted in superior proceduraloutcomes, a larger gain in luminal diameter, and a reductionin major cardiac events. However, there was no significant benefitin the rate of angiographic restenosis, which was the primaryend point of the study.
Source Information
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.); ProvidenceSeattle 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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