Clinical Research
Interventional Cardiology
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

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Objectives

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. (The SOS [Stenting Of Saphenous Vein Grafts] Randomized-Controlled Trial; NCT00247208)

Key Words

bare-metal stents
coronary artery bypass graft surgery
drug-eluting stents
outcomes
percutaneous coronary intervention
saphenous vein grafts

Abbreviations and Acronyms

ARC
Academic Research Consortium
BMS
bare-metal stent(s)
CI
confidence interval
CK-MB
creatine kinase-myocardial band
DES
drug-eluting stent(s)
EPD
embolic protection device
MI
myocardial infarction
MLD
minimal lumen diameter
PCI
percutaneous coronary intervention
PES
paclitaxel-eluting stent(s)
SES
sirolimus-eluting stent(s)
SVG
saphenous vein graft
TLR
target lesion revascularization
TVR
target vessel revascularization

Cited by (0)

The SOS (Stenting Of Saphenous Vein Grafts) trial was funded by a Veterans Affairs VISN-17 Startup Award, and by the Clark R. Gregg fund of the Harris Methodist Foundation to Dr. Brilakis. Dr. Brilakis has received speaker honoraria from St. Jude. Dr. Obel works predominantly with cardial rhythm devices and has speaker agreements with St. Jude, Medtronic, and Boston Scientific. Dr. Rossen participated in multicenter clinical studies supported by Boston Scientific. Dr. Berger has spoken at CME-approved scientific symposia supported by Bristol-Myers Squibb/Sanofi-Aventis, the Medicines Company, AstraZeneca, Medtronic, and Eli Lilly/Daiichi-Sankyo (each for <$10,000); served as a consultant to PlaCor, Eli Lilly, Accumetrics, The Medicines Company, and Eli Lilly/Daiichi-Sankyo (each for <$10,000); and owns equity in Lumen, Inc. (a company that is developing an embolic protection device) (>$10,000). Dr. Banerjee has served on the Speakers' Bureau for St. Jude Medical Center, Medtronic Corp., and Johnson & Johnson and has received a research grant from Boston Scientific. The SOS trial was presented as a late-breaking trial at the TCT 2008 meeting in Washington, DC, in October 2008.