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 Feb;4(2):176-82. doi: 10.1016/j.jcin.2010.10.003.

Abstract

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).

Publication types

  • Comparative Study
  • Multicenter Study
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't
  • Research Support, U.S. Gov't, Non-P.H.S.

MeSH terms

  • Aged
  • Angioplasty, Balloon, Coronary / adverse effects
  • Angioplasty, Balloon, Coronary / instrumentation*
  • Angioplasty, Balloon, Coronary / mortality
  • Cardiovascular Agents / administration & dosage*
  • Coronary Angiography
  • Coronary Artery Bypass / adverse effects*
  • Coronary Artery Bypass / mortality
  • Drug-Eluting Stents*
  • Female
  • Graft Occlusion, Vascular / diagnostic imaging
  • Graft Occlusion, Vascular / etiology
  • Graft Occlusion, Vascular / mortality
  • Graft Occlusion, Vascular / therapy*
  • Humans
  • Kaplan-Meier Estimate
  • Male
  • Metals*
  • Middle Aged
  • Myocardial Infarction / etiology
  • Paclitaxel / administration & dosage*
  • Proportional Hazards Models
  • Prosthesis Design
  • Risk Assessment
  • Risk Factors
  • Saphenous Vein / transplantation*
  • Single-Blind Method
  • Stents*
  • Thrombosis / etiology
  • Time Factors
  • Treatment Outcome
  • United States

Substances

  • Cardiovascular Agents
  • Metals
  • Paclitaxel

Associated data

  • ClinicalTrials.gov/NCT00247208