Four-year safety and efficacy of the unrestricted use of sirolimus- and paclitaxel-eluting stents in coronary artery bypass grafts

Objectives: Recently, concerns were raised about the relative long-term safety and efficacy of drug-eluting stents (DES) in saphenous vein bypass grafts (SVG). Our objective was to assess the 4-year relative safety and efficacy of the unrestricted use of drug-eluting stents (DES) as compared to bare metal stents (BMS) in saphenous vein bypass grafts (SVG). Methods: Between April 16, 2002 and December 2005 a total of 122 consecutive patients were treated with either sirolimus- or paclitaxel-eluting stents for saphenous vein graft disease. These patients were compared with 128 consecutive patients treated with BMS in the immediate preceding period (January 1, 2000 to April 2002). Results: At 4-years the cumulative survival rate in the DES group was 77.5% versus 73.0% in the BMS group (adjusted HR 1.09; 95% CI 0.63-1.90, Logrank p=0.65). The cumulative survival free of major adverse cardiac events (MACE: death, myocardial infarction and target vessel revascularisation) was 61.5% vs. 46.8% in the DES and BMS groups respectively (adjusted HR 0.77, 95% CI; 0.51-1.16) due to a higher event free survival of clinically driven target vessel revascularisation in the DES group as compared to the BMS group (81.6% vs. 69.0%; adjusted HR 0.53; 95% CI 0.27-1.05). Conclusions: In the present study, the use of DES for SVG PCI was associated a similar safety profile and there was a trend towards lower rates of TVR and MACE at four years as compared to BMS.