Author + information
- Received July 11, 2010
- Revision received September 24, 2010
- Accepted October 5, 2010
- Published online February 1, 2011.
- Emmanouil S. Brilakis, MD, PhD⁎,†,⁎ (, )
- Christopher Lichtenwalter, MD⁎,†,
- Abdul-rahman R. Abdel-karim, MD⁎,†,
- James A. de Lemos, MD⁎,†,
- Owen Obel, MD⁎,†,
- Tayo Addo, MD⁎,†,
- Michele Roesle, RN⁎,
- Donald Haagen, RCIS⁎,
- Bavana V. Rangan, BDS, MPH⁎,
- Bilal Saeed, 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⁎,†
- ↵⁎Reprint request and correspondence:
Dr. Emmanouil S. Brilakis, Dallas VA Medical Center (111A), 4500 South Lancaster Road, Dallas, Texas 75216
Objectives This study sought to report the long-term outcomes after drug-eluting stent (DES) implantation in saphenous vein graft (SVG) lesions in the SOS (Stenting of Saphenous Vein Grafts) trial.
Background The long-term outcomes after DES implantation in SVGs are poorly studied. Apart from the SOS trial, the only other randomized trial comparing DES with bare-metal stents (BMS) in SVGs reported higher mortality in the DES group at 32 months.
Methods In the SOS trial, 80 patients with 112 lesions in 88 SVGs were randomized to a BMS or paclitaxel-eluting stent (PES) and demonstrated improved short-term angiographic and clinical outcomes with PES. Extended clinical follow-up was subsequently obtained.
Results Mean age was 67 ± 9 years, and all patients were men. The indications for stenting included acute coronary syndrome in 60% and stable angina in 31% of patients. The mean SVG age was 12 ± 6 years. The baseline characteristics of the patients in the 2 study groups were similar. Procedural success was achieved in 77 patients (96%). During a median follow-up of 35 months, compared with patients randomized to BMS, those receiving PES had a lower incidence of myocardial infarction (hazard ratio [HR]: 0.32, p = 0.01), target lesion revascularization (HR: 0.20, p = 0.004), target vessel revascularization (HR: 0.41, p = 0.03), and target vessel failure (HR: 0.34, p = 0.001) as well as a trend toward less definite or probable stent thrombosis (HR: 0.15, p = 0.08). All-cause mortality (HR: 2.04, p = 0.19) and cardiac mortality (HR: 0.62, p = 0.51) did not differ between groups.
Conclusions During long-term follow-up, use of PES was associated with significantly better clinical outcomes than BMS in SVG lesions. (Stenting of Saphenous Vein Grafts Trial [SOS]; NCT00247208)
- bare-metal stent(s)
- coronary artery bypass graft surgery
- drug-eluting stent(s)
- percutaneous coronary intervention
- saphenous vein grafts
The SOS trial was funded by the Department of Veterans Affairs VISN-17 Startup Award and by the Clark R. Gregg grant of the Harris Methodist Foundation to Dr. Brilakis. Dr. Brilakis has received speaker honoraria from St. Jude Medical; consulting fees from Medicure; his spouse is an employee of Medtronic. Dr. de Lemos has received speaker honoraria from Bristol-Myers Squibb/Sanofi-Aventis; and consulting income from Johnson & Johnson (<$10,000). Dr. Obel works predominantly with cardiac rhythm devices; and has speaker agreements with St. Jude Medical, Medtronic, and Boston Scientific. Dr. Addo has served on the Speakers' Bureau for Eli Lilly and Daiichi-Sankyo. Dr. Rossen participated in multicenter clinical studies supported by Boston Scientific. Dr. Berger has served as a consultant to AstraZeneca, Boehringer Ingelheim, Eli Lilly/Daiichi-Sankyo, Medicure, and Ortho McNeil (each for <$10,000) and has received research funding for Geisinger Clinic for studies on which he is the Principle Investigator from Thrombovision, Helena, Accumetrics, AstraZeneca, Haemoscope, The Medicines Company, and Corgenix/Aspirinworks (all for more than $10,000). He owns equity in Lumen, Inc. (a company that has an embolic protection device and aspiration catheter [greater than $10,000]). Dr. Banerjee is a consultant for Medtronic, Gilead, St. Jude Medical; and has received research grants from The Medicines Company and Boston Scientific; and Intellectual property: Mdcareglobal (spouse), Hygeiatel. All other authors have reported that they have no relationships to disclose.
- Received July 11, 2010.
- Revision received September 24, 2010.
- Accepted October 5, 2010.
- American College of Cardiology Foundation