Abstract 15720: Patient Selection for Bare Metal Stent Placement and Associated Longitudinal Outcomes Before and After the FDA Drug-Eluting Stent Advisory
Background: Drug-eluting stents (DES) widely replaced bare metal stents (BMS) during PCI until a 2006 FDA advisory highlighted concerns of a small, but significant, risk of late DES thrombosis. How patient selection for and outcomes after BMS placement changed after the advisory is unknown.
Methods: We identified 382,776 patients aged ≥65 from the NCDR®’s CathPCI Registry® linked to Medicare claims data at 946 U.S. hospitals who underwent PCI in the 2 years before and after the FDA advisory (Sept 2006). Predicted risks of target vessel revascularization (TVR) and bleeding were derived from patient and lesion characteristics using previously validated risk models; high TVR risk was defined as ≥15% per year and high bleeding risk was defined as ≥5%. Multivariable regression compared post- vs. pre-advisory risks of death, repeat revascularization, and MI.
Results: BMSs were placed in 26,590/166,458 (15.8%) of pre-advisory and 88,426/216,318 (40.9%) of post-advisory PCI patients. Compared with pre-advisory BMS recipients, post-advisory BMS was used less frequently in those with a prior MI (23.9 vs. 28.8%, p<0.001), and in patients undergoing elective (40.5 vs. 45.7%, p<0.001) or multi-vessel PCI (14.5 vs. 19.0%, p<0.001). Compared with pre-advisory BMS patients, post-advisory patients were less likely to have a high predicted TVR risk (16.7 vs. 19.5%, p<0.001), but more likely to have a high predicted bleeding risk (14.6% vs. 12.3%, p<0.001). Post-advisory BMS use was associated with lower adjusted risks of repeat revascularization and death (Figure).
Conclusion: The use of BMS increased substantially after the FDA advisory with improvement in post- vs. pre-advisory BMS patient outcomes. This improvement may be due, in part, to differences in patient selection following the advisory, favoring BMS placement in patients at low risk for TVR or high risk for bleeding with lengthy dual antiplatelet therapy.
- © 2012 by American Heart Association, Inc.