Stent placement compared with balloon angioplasty for obstructed coronary bypass grafts

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 Safian; Michael Cleman; Maurice Buchbinder; David Snead; Randal C. Rake; Sharon Gebhardt

doi:10.1056/NEJM199709113371103

Stent placement compared with balloon angioplasty for obstructed coronary bypass grafts

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 Safian, Michael Cleman, Maurice Buchbinder, David Snead, Randal C. Rake, Sharon Gebhardt

School of Medicine

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487 Scopus citations

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 aortacoronary-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.

Original language	English (US)
Pages (from-to)	740-747
Number of pages	8
Journal	New England Journal of Medicine
Volume	337
Issue number	11
DOIs	https://doi.org/10.1056/NEJM199709113371103
State	Published - Sep 11 1997

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General Medicine

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10.1056/NEJM199709113371103

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Savage, M. P., Douglas, J. S., Fischman, D. L., Pepine, C. J., King, S. B., Werner, J. A., Bailey, S. R., Overlie, P. A., Fenton, S. H., Brinker, J. A., Leon, M. B., Goldberg, S., Heuser, R., Smalling, R., Safian, R., Cleman, M., Buchbinder, M., Snead, D., Rake, R. C., & Gebhardt, S. (1997). Stent placement compared with balloon angioplasty for obstructed coronary bypass grafts. New England Journal of Medicine, 337(11), 740-747. https://doi.org/10.1056/NEJM199709113371103

Savage, MP, Douglas, JS, Fischman, DL, Pepine, CJ, King, SB, Werner, JA, Bailey, SR, Overlie, PA, Fenton, SH, Brinker, JA, Leon, MB, Goldberg, S, Heuser, R, Smalling, R, Safian, R, Cleman, M, Buchbinder, M, Snead, D, Rake, RC & Gebhardt, S 1997, 'Stent placement compared with balloon angioplasty for obstructed coronary bypass grafts', New England Journal of Medicine, vol. 337, no. 11, pp. 740-747. https://doi.org/10.1056/NEJM199709113371103

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title = "Stent placement compared with balloon angioplasty for obstructed coronary bypass grafts",

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 aortacoronary-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.",

author = "Savage, {Michael P.} and Douglas, {John S.} and Fischman, {David L.} and Pepine, {Carl J.} and King, {Spencer B.} and Werner, {Jeffrey A.} and Bailey, {Steven R.} and Overlie, {Paul A.} and Fenton, {Sarah H.} and Brinker, {Jeffrey A.} and Leon, {Martin B.} and Sheldon Goldberg and Richard Heuser and Richard Smalling and Robert Safian and Michael Cleman and Maurice Buchbinder and David Snead and Rake, {Randal C.} and Sharon Gebhardt",

year = "1997",

month = sep,

day = "11",

doi = "10.1056/NEJM199709113371103",

language = "English (US)",

volume = "337",

pages = "740--747",

journal = "New England Journal of Medicine",

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publisher = "Massachussetts Medical Society",

number = "11",

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TY - JOUR

T1 - Stent placement compared with balloon angioplasty for obstructed coronary bypass grafts

AU - Savage, Michael P.

AU - Douglas, John S.

AU - Fischman, David L.

AU - Pepine, Carl J.

AU - King, Spencer B.

AU - Werner, Jeffrey A.

AU - Bailey, Steven R.

AU - Overlie, Paul A.

AU - Fenton, Sarah H.

AU - Brinker, Jeffrey A.

AU - Leon, Martin B.

AU - Goldberg, Sheldon

AU - Heuser, Richard

AU - Smalling, Richard

AU - Safian, Robert

AU - Cleman, Michael

AU - Buchbinder, Maurice

AU - Snead, David

AU - Rake, Randal C.

AU - Gebhardt, Sharon

PY - 1997/9/11

Y1 - 1997/9/11

N2 - 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 aortacoronary-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.

AB - 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 aortacoronary-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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Stent placement compared with balloon angioplasty for obstructed coronary bypass grafts

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