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J Am Coll Cardiol. 2009 Mar 17;53(11):919-28. doi: 10.1016/j.jacc.2008.11.029.

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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1
Veterans Affairs North Texas Healthcare System, Dallas, TX, USA.

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.

TRIAL REGISTRATION:

ClinicalTrials.gov NCT00247208.

Comment in

PMID:
19281920
DOI:
10.1016/j.jacc.2008.11.029
[Indexed for MEDLINE]
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