Abstract 6030: United States (US) and Outside US Outcomes of the Off-label use of Bare Metal Stents compared to Drug Eluting Stents: A Meta-Analysis
Background: Whether US and Outside US (OUS) outcomes of Off-label PCI utilizing bare metal stents (BMS) or drug eluting stents (DES) differ is unclear.
Methods: Using a meta-analytical approach we evaluated 44,845 patients (149 studies, BMS n=14,399, DES n=30,446), from May 2000- April 2008 for the safety and efficacy of US and OUS outcomes of DES compared to BMS. Off-label use for BMS and DES was defined by information for use definitions for DES. Registry databases and randomized clinical trials reporting specific lesion sub-type outcomes with a minimum follow up of 6–12 months were included. Lesion subtypes were left main, ostial, bifurcation, in-stent restenosis, saphenous vein graft, long lesions, small vessels, total occlusions and calcified lesions. Analyses were performed using SAS® version 9.1.
Results: 1 Year Outcomes of DES vs. BMS in Off-Label Use (mean%, 95% CI)
Conclusions: In this meta-analysis comparing US and OUS DES to BMS for Off-label PCI: 1. For Off-label use in the US, DES death and thrombosis rate were similar to BMS, however, the death or MI, TLR and MACE rates were lower for DES compared to BMS. 2. For Off-label use OUS, DES thrombosis rates were similar to BMS, however death, death or MI, TLR and MACE rates were higher for DES compared to BMS. 3. Comparing US to OUS for DES, Off-label usage showed higher death, death or MI, and MACE rates, but lower thrombosis and TLR rates. 4. Comparing US to OUS for BMS, Off-label usage showed similar death, death or MI, thrombosis and TLR rates but higher MACE rates. These results suggest that important differences may exist in Off-label PCI based on geographical distribution. These may be related to operator, health care delivery and patient level differences and merit further investigation.