PURPOSE: Recent reports regarding combined late (LST) and very late stent thrombosis (VLST) have caused patients anxiety and physicians concern resulting in a significant shift from the use of drug eluting stents (DES) to bare metal stents (BMS) despite the proven morbidity benefits of DES. The purpose of this investigation is to review all the published randomized controlled trials (RCT) and registry data to obtain insight into this issue.
METHODS: A compilation of data from RCT of DES vs BMS with at least one year follow-up and all available DES registries found in the National Library of Medicine, National Institute of Health and Cochrane Central review was performed (Table 1). Registry data was analyzed separately based on probable vs definite stent thrombosis. We did find a comparable number of LST 0.22% (6) in BMS and 0.45% (12) with p=NS in the RCT. VLST was only noted in the DES arm 0.56% (15) with a p=0.001. No difference was found on registries with definite stent thrombosis 0.9% (6) vs 0.7% (342) BMS and DES respectively.
RESULTS: We could not run any analysis in registries with probable definition of LST and VLST, because they did not have available data for the BMS.
CONCLUSION: In conclusion, despite a significant increase in VLST there was no difference in LST in randomized clinical trials. However, registry reports, likely reflective of broader patient subsets representative of clinical practice, did not show any difference, which may be from pooling of LST and VLST events.
CLINICAL IMPLICATIONS: 1. RAVEL, SIRIUS, C-SIRIUS, E-SIRIUS, TAXUS I, TAXUS II, TAXUS IV, TAXUS V, TAXUS VI 2. RESEARCH/T-SEARCH, ESTROFA, BASKET -LATE, DESCOVER, NHLBI, Ong, US e-CYPHER, OUS e-CYPHER3. Iakovou, ARRIVE.
DISCLOSURE: Manish Gupta, No Financial Disclosure Information; No Product/Research Disclosure Information