Immediate results and late outcomes after stent implantation in saphenous vein graft lesions: the multicenter U.S. Palmaz-Schatz stent experience. The Palmaz-Schatz Stent Study Group.
OBJECTIVE
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 (> or = 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.
Wong
S C
SC
Department of Internal Medicine (Division of Cardiology), Washington Hospital Center, Washington, D.C. 20010, USA.
Baim
D S
DS
Schatz
R A
RA
Teirstein
P S
PS
King
S B
SB
Curry
R C
RC
Heuser
R R
RR
Ellis
S G
SG
Cleman
M W
MW
Overlie
P
P
D000368:Aged; D000925:Anticoagulants / Q000008:administration & dosage; D003131:Combined Modality Therapy; D017023:Coronary Angiography; D003327:Coronary Disease / Q000150:complications / Q000000981:diagnostic imaging / Q000601:surgery; D005260:Female; D005500:Follow-Up Studies; D006083:Graft Occlusion, Vascular / Q000150:complications / Q000000981:diagnostic imaging / Q000628:therapy*; D006801:Humans; D016015:Logistic Models; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D012008:Recurrence; D012501:Saphenous Vein / Q000000981:diagnostic imaging / Q000637:transplantation*; D015607:Stents / Q000009:adverse effects / Q000706:statistics & numerical data; D013997:Time Factors; D016896:Treatment Outcome; D014481:United States
D000925:Anticoagulants