Paclitaxel-Eluting Vs. Bare Metal Stent Implantation in Saphenous Vein Graft Lesions: Very Long-Term Follow-up of the SOS (Stenting of Saphenous Vein Grafts) Trial
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BACKGROUND: The very long-term (>3 year) outcomes after implantation of drug-eluting as compared with bare metal stents (BMS) in saphenous vein grafts (SVGs) have received limited study. METHODS: In the Stenting Of Saphenous vein grafts (SOS) trial 80 patients were randomized to BMS or paclitaxel-eluting stents (PES). During a median follow-up of 35 months use of PES was associated with better clinical outcomes. We report very long-term outcomes on 62 patients enrolled at the highest enrolling institution. RESULTS: Of the 62 studied patients 31 received a BMS and 31 a PES. Both study groups had similar baseline characteristics. During a median follow-up of 6.9 years the study patients experienced 116 major adverse cardiovascular events (MACE). Compared with patients who received BMS those who received PES had lower incidence of MACE (hazard ratio [HR]=0.56, P=0.04), target lesion revascularization (HR=0.20, P=0.001), target vessel revascularization (HR 0.41, P=0.02), target vessel failure (HR=0.35, P=0.001), and definite or probable stent thrombosis (HR=0.14, P=0.03). There was no significant difference in all-cause mortality (HR=1.77, P=0.15) and myocardial infarction (HR=0.52, P=0.10) between the two groups. CONCLUSION: The early benefit observed with use of PES vs BMS in SVGs persisted during very long-term follow-up.