Second-generation versus first-generation drug-eluting stents in patients with and without diabetes mellitus: pooled analysis from the RESET and NEXT trials.

The impact of second-generation drug-eluting stent (G2-DES) implantations compared with first-generation drug-eluting stents (G1-DES) implantations on long-term clinical outcomes after percutaneous coronary intervention in patients with and without diabetes mellitus (DM) has not yet been adequately assessed. This pooled analysis compared 3-year clinical outcomes between G1- and G2-DES according to the presence or absence of DM, using individual patient-level data from the RESET and NEXT trials. Among 6431 patients, G1-DES and G2-DES were used in 713 and 2211 patients, respectively, in the DM stratum, and 887 and 2620 patients, respectively, in the non-DM stratum. Cumulative incidence of and adjusted hazard ratio (HR) for target-lesion revascularization (TLR) were not significantly different between G2- and G1-DES in both strata [DM, 8.7 versus 10.1%, adjusted HR: 0.80, 95% confidence interval (CI) 0.59-1.10, P = 0.17; non-DM, 5.7 versus 6.2%, adjusted HR: 0.86, 95% CI 0.62-1.22, P = 0.38]. In the insulin-treated DM (ITDM), G2-DES had a significantly lower adjusted HR for TLR compared with G1-DES, although there was no significant difference in the non-ITDM (ITDM, adjusted HR: 0.54, 95% CI 0.32-0.96, P = 0.04; non-ITDM, adjusted HR: 0.95, 95% CI 0.66-1.42, P = 0.81). G2-DES provided similar risk for TLR in non-ITDM and non-DM patients compared with G1-DES. However, G2-DES compared with G1-DES had a lower risk for TLR among ITDM patients.