Drug-eluting versus bare-metal stents for treating saphenous vein grafts.

Background: Current data show conflicting results regarding safety and efficacy of drug-eluting stents (DES) versus bare-metal stents (BMS) for treating saphenous vein grafts (SVG). Our objective was to compare DES with BMS for SVG intervention.

Methods: Patients undergoing stenting with DES or BMS to SVG from January 2000 to June 2007 were included. To eliminate any unobserved bias regarding stent selection, the BMS cohort was divided into pre- and post-2003 when DES became available. Adjusted Cox analysis compared DES with pre- and post-2003 BMS patients. The primary end point was a composite of all-cause mortality, myocardial infarction, or target lesion revascularization.

Results: Of the total 566 patients, 217 (38%) received DES, 110 (20%) received BMS post-2003, and 239 (42%) received BMS pre-2003. Median follow-up was 2.9 years (interquartile range 1.4-4.9 years). There was a trend toward lower primary end point with DES compared to post-2003 BMS (91 events, adjusted hazard ratio 0.61, 95% CI 0.35-1.07, P = .08). However, despite 179 events, DES use was not associated with lower primary end point compared with pre-2003 BMS (adjusted hazard ratio 0.61, 95% CI 0.28-1.35, P = .23).

Conclusions: Although DES showed a trend toward a lower primary end point when compared with BMS post-2003, this association was no longer present when DES was compared to pre-2003 BMS. These results are consistent with the preponderance of available data and indicate that unobserved bias in observational registries may explain the reported benefit of DES over BMS for treating SVG.