Author + information
- Received December 29, 1994
- Revision received March 9, 1995
- Accepted April 12, 1995
- Published online September 1, 1995.
- S. Chiu Wong, MD, FACCa,
- Donald S. Baim, MD, FACC*,
- Richard A. Schatz, MD, FACC†,
- Paul S. Teirstein, MD, FACC†,
- Spencer B. King III, MD, FACC‡,
- R. Charles Curry Jr., MD, FACC§,
- Richard R. Heuser, MD, FACC‖,
- Stephen G. Ellis, MD, FACC¶,
- Michael W. Cleman, MD, FACC#,
- Paul Overlie, MD, FACC**,
- John W. Hirshfeld, MD, FACC††,
- Craig M. Walker, MD, FACC‡‡,
- Frank Litvack, MD, FACC§§,
- David Fish, MD, FACC‖‖,
- Jeffrey A. Brinker, MD, FACC¶¶,
- Maurice Buchbinder, MD, FACC##,
- Sheldon Goldberg, MD, FACC***,
- Ya Chien Chuang, PhDa,
- Martin B. Leon, MD, FACCa,*,
- Palmaz-Schatz Stent Study Group
- ↵*Address for correspondence: Dr. Martin B. Leon, Washington Hospital Center, Suite 4B-1, 110 Irving Street NW. Washington, D.C. 20010.
Objectives This study reports the multicenter registry experience evaluating the safety and efficacy of the Palmaz-Schatz stent in the treatment of saphenous vein graft disease.
Background Saphenous vein graft angioplasty is associated with frequent periprocedural complications and a high frequency of restenosis. Stent implantation has been shown to reduce restenosis, with improved long-term outcomes in the treatment of native coronary artery disease. Preliminary experience with stent placement in the treatment of saphenous vein graft lesions has been favorable.
Methods Twenty U.S. investigator sites enrolled a total of 589 symptomatic patients (624 lesions) for treatment of focal vein graft stenoses between January 1990 and April 1992. Follow-up angiography was performed at 6 months, and the clinical course of all study patients was prospectively collected at regular intervals for up to 12 months.
Results Stent delivery was successful in 98.8% of cases, and the procedural success rate was 97.1%. The lesion diameter stenosis decreased from 82 ± 12% (mean ± SD) before to 6.6 ± 10.2% after treatment. Major in-hospital complications occurred in 17 patients (2.9%); stent thrombosis was found in 8 (1.4%); and major vascular or bleeding complications were noted in 83 (14.3%). Six-month angiographic follow-up revealed an overall restenosis rate (≥50% diameter stenosis) of 29.7%. Multivariate logistic regression analysis indicated that 1) restenotic lesions, 2) smaller reference vessel size, 3) history of diabetes mellitus, and 4) higher percent poststent diameter stenosis were independent predictors of restenosis. The 12-month actuarial event-free survival was 76.3%.
Conclusions Stent implantation in patients with focal saphenous vein graft lesions can be achieved with a high rate of procedural success, acceptable major complications, reduced angiographic restenosis and favorable late clinical outcome compared with historical balloon angioplasty control series. The rigorous anticoagulation regimen after stent placement results in more frequent vascular and other bleeding complications. Future randomized studies comparing standard balloon angioplasty with stent implantation are warranted to properly assess the full impact of stent placement in the treatment of saphenous vein graft lesions.
This study was supported by a grant from the Johnson & Johnson Interventional Systems, a Johnson & Johnson Company, Warren, New Jersey and from the Cardiology Research Foundation, Washington, D.C. Drs. Leon and Goldberg are paid consultants of Johnson & Johnson Interventional Systems; Dr. Schatz has a royalty agreement with Johnson & Johnson.
- Received December 29, 1994.
- Revision received March 9, 1995.
- Accepted April 12, 1995.
- American College of Cardiology