TY - JOUR
T1 - 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
AU - Brilakis, Emmanouil S
AU - Lichtenwalter, Christopher
AU - de Lemos, James A
AU - Roesle, Michele
AU - Obel, Owen
AU - Haagen, Donald
AU - Saeed, Bilal
AU - Gadiparthi, Chiranjeevi
AU - Bissett, Joseph K.
AU - Sachdeva, Rajesh
AU - Voudris, Vassilios V.
AU - Karyofillis, Panagiotis
AU - Kar, Biswajit
AU - Rossen, James
AU - Fasseas, Panayotis
AU - Berger, Peter
AU - Banerjee, Subhash
N1 - Funding Information:
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). 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.
PY - 2009/3/17
Y1 - 2009/3/17
N2 - 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).
AB - 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).
KW - bare-metal stents
KW - coronary artery bypass graft surgery
KW - drug-eluting stents
KW - outcomes
KW - percutaneous coronary intervention
KW - saphenous vein grafts
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U2 - 10.1016/j.jacc.2008.11.029
DO - 10.1016/j.jacc.2008.11.029
M3 - Article
C2 - 19281920
AN - SCOPUS:61549089702
SN - 0735-1097
VL - 53
SP - 919
EP - 928
JO - Journal of the American College of Cardiology
JF - Journal of the American College of Cardiology
IS - 11
ER -