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In everyday practice the off label use of DES is widespread, but are SES as effective in reducing the need for revascularisation when used on-label and do certain types of off-label use raise greater safety concerns? The EVASTENT nationwide matched cohort registry 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. 1731 pts were included (844 diabetic and 730 MVD patients). Although on-label use of SES was required patients presenting with various categories of off-label lesions were included. 428 (24% ) patients included and 514/ 2730 lesions (19%) treated were off-label: bifurcation lesions (n=182), lesions with thrombus (n=139), highly calcified lesions (n=134), ostial lesions (n=102), very long (>30 mm) lesions (n=15), left-main stenosis n=11), EF<0.30 (n=7). In 73 cases the lesion was off-label for more than one reason. Complete interim one year follow-up data are available for 98% of the patients and in October 2007 most patients will have been followed for 3 years. All MACES (cardiac death, non-fatal myocardial infarction and Stent thrombosis ST) have been evaluated by an independent critical events committee and cases of ST have been classified according to the ARC criteria.
Results: off-label use was not more frequent in diabetic patients but occurred more often in MVD patients. Table 1
shows the one-year comparison between on and off-label use. Subgroup analysis suggests that highly calcified, bifurcation and ostial lesions are particularly at risk for ST. In multivariate analysis off-label use remained an independent predictor of death and the occurrence of MACEs.
Conclusion: Off-label use of SES does not reduce the efficacy of the SES, but increases the risk of death and ST. This safety concern must be taken into consideration when designing studies to evaluate new indications for these DES.
On and Off-Label comparison
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