Stenting of Saphenous Vein Grafts - SOS: Follow-up to 3 Years

Feb 21, 2011
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Author/Summarized by Author:
Anthony A. Bavry, MD, MPH, FACC
Summary Reviewer:
Deepak L. Bhatt, MD, MPH, MBA, FACC
Trial Sponsor:
Veterans Affairs VISN-17 Startup Award, Clark R. Gregg fund of the Harris Methodist Foundation
Date Updated:
02/21/2011
Original Posted Date:
02/21/2011
References

Description:

The goal of the trial was to evaluate percutaneous coronary intervention (PCI) of saphenous vein grafts with drug-eluting stents (DES) compared with bare-metal stents (BMS).

Hypothesis:

PCI of saphenous vein grafts with DES would improve angiographic restenosis.

Study Design

  • Randomized
  • Parallel

Patient Populations:

  • Patients at least 18 years of age with angina due to an saphenous vein graft lesion between 2.5 and 4 mm diameter

    Number of enrollees: 80
    Duration of follow-up: median 35 months
    Mean patient age: 66 years
    Percentage female: 0%
    Ejection fraction (EF): 51% of participants had EF ≥50%

Exclusions:

  • Prior brachytherapy
  • Left ventricular EF <25%
  • Hemorrhagic diathesis
  • Contraindication to any study medication
  • Allergy to contrast dye
  • Use of paclitaxel in the last 12 months or current use of colchicine
  • Serum creatinine >2.0 mg/dl
  • Leukocyte count <3,500/mm3
  • Platelet count <100,000/mm3
  • Pregnancy or breastfeeding
  • Limited life expectancy

Primary Endpoints:

  • Angiographic restenosis at 12 months

Secondary Endpoints:

  • Death
  • Myocardial infarction
  • Ischemia-driven target vessel revascularization
  • Ischemia-driven target lesion revascularization
  • Target vessel failure defined as cardiac death, myocardial infarction, or target vessel revascularization
  • Stent thrombosis

Drug/Procedures Used:

Patients with angina due to a saphenous vein graft lesion were randomized to a paclitaxel-eluting stent (n = 41) versus an Express2 bare-metal stent (n = 39).

Concomitant Medications:

Prior to PCI, patients received aspirin 325 mg and clopidogrel 300-600 mg. The use of a glycoprotein IIb/IIIa inhibitor was left to operator discretion.

Principal Findings:

Overall, 80 patients were randomized. In the paclitaxel-eluting stent group, the mean age was 66 years, 100% were men, 44% had diabetes, 29% were current smokers, mean age of saphenous vein grafts was 11 years, the indication for PCI was unstable angina in 39%, mean body mass index was 30 kg/m2, mean number of stents used per patient was 1.5, and an embolic protection device was used in 51%.

At 1 year, angiographic stenosis occurred in 9% of the DES group versus 51% of the BMS group (p < 0.0001).

At a median of 1.5 years of follow-up, target lesion revascularization was 5% versus 28% (p = 0.003), target vessel revascularization was 15% versus 31% (p = 0.08), target vessel failure was 22% versus 46% (p = 0.03), myocardial infarction was 15% versus 31% (p = 0.10), and all-cause mortality was 12% versus 5% (p = 0.27), respectively.

At a median of 2.9 years of follow-up, target lesion revascularization was 10% versus 41% (p = 0.004), target vessel revascularization was 22% versus 49% (p = 0.03), target vessel failure was 34% versus 72% (p = 0.001), myocardial infarction was 17% versus 46% (p = 0.01), and all-cause mortality was 24% versus 13% (p = 0.19), respectively.

Interpretation:

Among patients with angina due to a saphenous vein graft lesion, the use of a paclitaxel-eluting stent reduced angiographic restenosis and ischemia-driven target lesion revascularization compared with a BMS. Myocardial infarction was nonsignificantly reduced with DES at a median of 1.5 years, and significantly reduced at a median of 2.9 years of follow-up. All-cause mortality was nonsignificantly increased in the DES group.

It was somewhat surprising that only 51% of the DES group of SOS had PCI performed with an embolic protection device since this technology has been demonstrated to reduce periprocedural adverse events.

The numerically increased rate of deaths in the DES group could be attributable to chance from the small sample size; however, it is also in line with a significant increase in deaths in the only other randomized trial on the topic. The RRISC trial compared a sirolimus-eluting stent with a BMS and documented less restenosis among the DES group. This patient population remains significantly understudied, which will be addressed in the ongoing ISAR-CABG, BASKETSAVAGE, and DIVA trials.

References:

Brilakis ES, Lichtenwalter C, Abdel-karim AR, et al. Continued benefit from paclitaxel-eluting compared with bare-metal stent implantation in saphenous vein graft lesions during long-term follow-up of the SOS (Stenting of Saphenous Vein Grafts) Trial. JACC Cardiovasc Interv 2011;4:176-82.

Brilakis ES, Lichtenwalter C, de Lemos JA, et al. 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. J Am Coll Cardiol 2009;53:919-28.

Keywords: Myocardial Infarction, Follow-Up Studies, Drug-Eluting Stents, Sirolimus, Constriction, Pathologic, Percutaneous Coronary Intervention, Paclitaxel, Embolic Protection Devices, Body Mass Index, Metals, Saphenous Vein, Diabetes Mellitus


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