Abstract 3238: Off-Label and Untested Use of Drug Eluting Stents: Six Month Outcomes from the DEScover Registry
Background: To determine the safety and efficacy of drug eluting stents (DES) for off-label (Off) and untested (Untested) indications, 6 month outcomes were evaluated in the real-world DEScover Registry.
Methods: The population consisted of 5,851 PCI-patients from 140 US hospitals. Patients received DES (Cypher ® or Taxus TM ) but no other device. Off label (n=1338), Untested (n=1127), and Standard (n=3068) indications were able to be determined in 5,533 pts constituting the study population. Indications were defined by the device IFU. For Cypher: Off label use included: restenotic lesion, bypass graft, lesion length > 30 mm, reference vessel < 2.5 mm or > 3.5 mm. For Taxus, criteria were identical except lesion length > 28 mm and reference vessel diameter < 2.5 mm or > 3.75 mm. For both stents, Untested use included: left main, acute MI, ostial, bifurcation, or total occlusions. Adjustment was made for demographics, clinical presentation, medications, procedural characteristics and lesion complexity.
Results: Mean follow up was179 ± 80 days. Compared to standard DES use, adjusted hazard ratios (HR) did not differ for Death, MI, Stent Thrombosis or the composite endpoint Death/MI/CABG. However, there was a significant independent increased risk for repeat PCI (HR: Off 1.6, p=.003, Untested 1.4, p=.03), CABG/PCI (HR: Off 1.5, p=.008 and Untested 1.5, p=.003), and CABG (Untested: HR: 2.2, p=.03).
Conclusions: Off-label and Untested use of DES is safe without increased risk of death or MI. However, there is a significant 45–54% increased risk for repeat PCI or CABG. The increased need for repeat revascularization persists for at least 6 months following index PCI and is evident early.