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, Christopher Lichtenwalter, James A de Lemos, Michele Roesle, Owen Obel, Donald Haagen, Bilal Saeed, Chiranjeevi Gadiparthi, Joseph K. Bissett, Rajesh Sachdeva, Vassilios V. Voudris, Panagiotis Karyofillis, Biswajit Kar, James Rossen, Panayotis Fasseas, Peter Berger, Subhash Banerjee

Research output: Contribution to journalArticlepeer-review

179 Scopus citations

Abstract

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).

Original languageEnglish (US)
Pages (from-to)919-928
Number of pages10
JournalJournal of the American College of Cardiology
Volume53
Issue number11
DOIs
StatePublished - Mar 17 2009

Keywords

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

ASJC Scopus subject areas

  • Cardiology and Cardiovascular Medicine

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