Abstract 4555: Long-term Outcomes of Drug-eluting vs Bare-metal Stents in Off-label Lesions: Results From the National Cardiovascular Database Registry (NCDR)
Background: Drug eluting stents (DES) are commonly used in the community for non-FDA approved indications. The long term outcomes of DES vs Bare Metal Stents (BMS) in these ‘off-label’ indications has not been closely evaluated, particularly in anatomic subgroups.
Methods: Using clinical data from NCDR linked to Medicare claims data, a longitudinal record was constructed for 262,700 patients over 65 years old undergoing PCI from 2004 to 2006, and examined for use in an “off-label” indication (defined as one or more of the anatomic features in Table⇓). Mean follow-up was 15 months. Inverse probability weighted estimators and Cox proportional hazards models were used to adjust comparisons for measured potential confounders.
Results: Overall, DES were used in 83% of all off-label anatomic lesions; however, a lower proportion of DES use (50%) involved off-label lesions compared with BMS (64%). Examination of outcomes by specific subgroups before and after propensity adjustment (see Table⇓) revealed a complex pattern. In left main lesions, and arterial and venous grafts, DES showed no benefit for any outcome examined. In chronic total occlusions and bifurcations, DES were associated with reduced mortality and MI but not revascularization. In restenotic lesions DES reduced MI but not revascularization or death. Only in high risk lesions and small vessels did DES show improvement in all 3 outcomes, while in large vessels DES were associated with higher death rates and no reduction in MI or revascularization.
Conclusions: Compared to BMS, DES appears to be safe in elderly patients for most off-label anatomic groups, although the need for any subsequent revascularization was reduced in few subgroups. The type of stent should be selected carefully, and further evaluation of DES vs BMS in large vessels is warranted.