In everyday practice the off label use of DES is widespread, but are SES as effective in reducing the need for revascularization when used on-label and do certain types of off-label use raise greater safety concerns?

The EVASTENT study is a matched cohort registry of 1 731 patients was designed to assess the efficacy and safety of the SES in diabetic patients with single or multiple vessel disease (SVD and MVD) compared to non-diabetic patients. Although on-label use of SES was required patients presenting with various categories of off-label lesions were included. The 3-year results (97% follow-up) are presented. All MACES (cardiac death, non-fatal myocardial infarction and Stent thrombosis ST according to Academic Research Consortium definitions) have been evaluated for safety and target lesion revascularisation (TLR) for efficacy. Because EVASTENT is a registry, we use two statistical methods to compare On and Off-label use of DES (Multivariate analysis and propensity score).

Most of the time, an off-label lesion was a bifurcation lesion, a lesion with thrombus, a very calcified lesion or an ostial lesion. Off-label SES implantation was associated with higher rates of cardiac death (5.3% vs 2.5%, p=0.008) and MACEs (10.6% vs 5.9%, p=0.005) with rates of ST acceptable (5.1% vs 3%, p=NS). In multivariate analysis off-label use remained an independent predictor of cardiac death and the occurrence of MACEs but no of ST. The same results were found with use propensity score. Efficacy results were the same in both groups. The TLR and TVR rate were very low and excellent, even for off-label use of DES (6.9 and 12.9%, respectively).

The clinical efficacy of SES in reducing the need for further revascularizations is confirmed by the low rates of TLR, even for off label use. However, our results show higher rates of cardiac death and MACEs, but no ST, when SES are used off-label.