A randomized controlled trial of a paclitaxel-eluting stent versus a similar bare-metal stent in saphenous vein graft lesions the SOS (Stenting of Saphenous Vein Grafts) trial.
OBJECTIVE
The aim of this study was to compare the frequency of angiographic restenosis and clinical events between a paclitaxel-eluting stent (PES) and a similar bare-metal stent (BMS) in saphenous vein graft (SVG) lesions.


BACKGROUND
There are conflicting and mostly retrospective data on outcomes after drug-eluting stent implantation in SVGs.


METHODS
Patients requiring SVG lesion stenting were randomized to BMS or PES. The primary study end point was binary in-segment restenosis at 12-month follow-up quantitative coronary angiography. Secondary end points included death, myocardial infarction, ischemia-driven target vessel and lesion revascularization, and target vessel failure.


RESULTS
Eighty patients with 112 lesions in 88 SVGs were randomized to a BMS (39 patients, 43 grafts, 55 lesions) or PES (41 patients, 45 grafts, 57 lesions). Binary angiographic restenosis occurred in 51% of the BMS-treated lesions versus 9% of the PES-treated lesions (relative risk: 0.18; 95% confidence interval [CI]: 0.07 to 0.48, p < 0.0001). During a median follow-up of 1.5 years the PES patients had less target lesion revascularization (28% vs. 5%, hazard ratio: 0.38; 95% CI: 0.15 to 0.74, p = 0.003) and target vessel failure (46% vs. 22%, hazard ratio: 0.65; 95% CI: 0.42 to 0.96, p = 0.03), a trend toward less target vessel revascularization (31% vs. 15%, hazard ratio: 0.66; 95% CI: 0.39 to 1.05, p = 0.08) and myocardial infarction (31% vs. 15%, hazard ratio: 0.67; 95% CI: 0.40 to 1.08, p = 0.10), and similar mortality (5% vs. 12%, hazard ratio: 1.56; 95% CI: 0.72 to 4.11, p = 0.27).


CONCLUSIONS
In SVG lesions, PES are associated with lower rates of angiographic restenosis and target vessel failure than BMS.
Brilakis
Emmanouil S
ES
Veterans Affairs North Texas Healthcare System, Dallas, TX, USA.
Lichtenwalter
Christopher
C
de Lemos
James A
JA
Roesle
Michele
M
Obel
Owen
O
Haagen
Donald
D
Saeed
Bilal
B
Gadiparthi
Chiranjeevi
C
Bissett
Joseph K
JK
Sachdeva
Rajesh
R
Voudris
Vassilios V
VV
Karyofillis
Panagiotis
P
Kar
Biswajit
B
Rossen
James
J
Fasseas
Panayotis
P
Berger
Peter
P
Banerjee
Subhash
S
D000368:Aged; D000077144:Clopidogrel; D017023:Coronary Angiography; D003324:Coronary Artery Disease / Q000601:surgery*; D023903:Coronary Restenosis / Q000000981:diagnostic imaging / Q000453:epidemiology / Q000517:prevention & control*; D054855:Drug-Eluting Stents; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D017239:Paclitaxel / Q000008:administration & dosage*; D010975:Platelet Aggregation Inhibitors / Q000008:administration & dosage; D012501:Saphenous Vein / Q000637:transplantation*; D015607:Stents; D013988:Ticlopidine / Q000008:administration & dosage / Q000031:analogs & derivatives
D010975:Platelet Aggregation Inhibitors; D000077144:Clopidogrel; D013988:Ticlopidine; D017239:Paclitaxel