Year: 1997
Type: article
Study designs: Randomized Controlled Trial, Clinical Trial
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.
Source: New England Journal of Medicine
Authors: Michael P. Savage, John S. Douglas, David L. Fischman, Carl J. Pepine, Spencer B. King, Jeffrey A. Werner, Steven R. Bailey, Paul A. Overlie, Sarah H. Fenton, Jeffrey A. Brinker, Martin B. Leon, Sheldon Goldberg, Richard Heuser, Richard Smalling, Robert D. Safian, Michael Cleman, Maurice Buchbinder, David Snead, Randal C. Rake, Sharon Gebhardt
Institutions: Thomas Jefferson University, Emory University, University of Florida, Emory University Hospital, The University of Texas at San Antonio Health Science Center, Asheville Cardiology Associates, Johns Hopkins University, Johns Hopkins Hospital, MedStar Washington Hospital Center, Harvard University, Massachusetts General Hospital, Arizona Heart Institute, The University of Texas Health Science Center at Houston, Beaumont Hospital, Troy, Yale University, Scripps Clinic
Language: English
Subfield: Cardiology and Cardiovascular Medicine
Field: Medicine
Domain: Health Sciences
Open Access status: green
OpenAlex ID: W2329072970