IMMEDIATE RESULTS AND LATE OUTCOMES AFTER STENT IMPLANTATION IN SAPHENOUS-VEIN GRAFT LESIONS - THE MULTICENTER US PALMAZ-SCHATZ STENT EXPERIENCE

Objectives. This study reports the multicenter registry experience eva luating the safety and efficacy of the Palmaz-Schatz stent in the trea tment of saphenous vein graft disease. Background. Saphenous vein graf t 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 treatme nt of native coronary artery disease. Preliminary experience with sten t 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 gr aft stenoses between January 1990 and April 1992. Follow-up angiograph y was performed at 6 months, and the clinical course of all study pati ents was prospectively collected at regular intervals for up to 12 mon ths. Results. Stent delivery was successful in 98.8% of cases, and the procedural success rate was 97.1%. The lesion diameter stenosis decre ased hom 82 +/- 12% (mean +/- SD) before to 6.6 +/- 10.2% after treatm ent. Major in-hospital complications occurred in 17 patients (2.9%); s tent 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 (greater than or equal to 50% d iameter 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 dia meter stenosis were independent predictors of restenosis. The 12-month actuarial event-free survival was 76.3%. Conclusions. Stent implantat ion in patients with focal saphenous vein graft lesions can be achieve d with a high rate of procedural success, acceptable major complicatio ns, reduced angiographic restenosis and favorable late clinical outcom e compared with historical balloon angioplasty control series. The rig orous anticoagulation regimen after stent placement results in more fr equent vascular and other bleeding complications. Future randomized st udies comparing standard balloon angioplasty with stent implantation a re warranted to properly assess the full impact of stent placement in the treatment of saphenous vein graft lesions.