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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.