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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

Emmanouil S. Brilakis, MD, PhD^_*,,_*, Christopher Lichtenwalter, MD^_*,, James A. de Lemos, MD^_*,, Michele Roesle, RN^_*, Owen Obel, MD^_*,, Donald Haagen, RCIS^_*, Bilal Saeed, MD, Chiranjeevi Gadiparthi, MD^_*,, Joseph K. Bissett, MD, Rajesh Sachdeva, MD, Vassilios V. Voudris, MD, PhD^||, Panagiotis Karyofillis, MD^||, Biswajit Kar, MD^¶, James Rossen, MD^#, Panayotis Fasseas, MD^_**, Peter Berger, MD and Subhash Banerjee, MD^_*,

^_* Veterans Affairs North Texas Healthcare System, Dallas, Texas
University of Texas Southwestern Medical Center, Dallas, Texas
Department of Internal Medicine, University of Toledo, Toledo, Ohio
Central Arkansas Veterans Healthcare System and University of Arkansas for Medical Sciences, Little Rock, Arkansas
^|| Onassis Cardiac Surgery Center, Athens, Greece
^¶ Michael E. DeBakey Veterans Affairs Medical Center, Houston, Texas
^# Iowa City Veterans Affairs Medical Center, Iowa City, Iowa
^_** Wheaton Franciscan Medical Group, Racine, Wisconsin
Geisinger Clinic, Danville, Pennsylvania

Manuscript received October 2, 2008; revised manuscript received October 30, 2008, accepted November 3, 2008.

^_* Reprint requests and correspondence: Dr. Emmanouil S. Brilakis, Dallas VA Medical Center (111A), 4500 South Lancaster Road, Dallas, Texas 75216 (Email: esbrilakis{at}yahoo.com).

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 [ClinicalTrials.gov] )

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

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