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To derive summary estimates of all-cause mortality, MI, and TVR in studies with ≥1 year of follow-up.We therefore sought to perform a systematic review and meta-analysis of DES vs.Are the benefits of DES in reducing TVR as robust in the real-world as in the RCTs, given the impact of routine angio FU and the oculostenotic reflex in many RCTs? *Stone et al, Kastrati et al, Spaulding et al, Mauri et al N Engl J Med 2007 356(10).Are DES safe in higher risk off-label pts and in the unregulated environment of real-world use?.While some of the alarm generated after ESC 2006 has been mitigated by analyses of patient-level data from the “on-label” RCTs*, there remains concern regarding DES outcomes in “off-label” patients and lesions, and with uncontrolled use.just ACS or high risk), and the duration of clinical FU Registry outcomes may also vary based upon the types of patients enrolled (e.g.BMS registries are heterogeneous, with differences in design and analysis methodology (e.g. While more generalizable than RCTs, the DES vs.The outcomes from these studies have varied.In order to address issues of both sample size as well as generalizability to the “real-world”, numerous observational and registry comparisons of DES vs.
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“off-label”), the amount of routine angiographic FU, and with the duration of clinical FU RCT outcomes may vary based upon differences in enrollment criteria (e.g.RCTs, particularly the pivotal RCTs leading to regulatory approval, have been criticized for not reflecting “real-world” DES use.However, individual RCTs are underpowered to assess low frequency endpoints.In most individual RCTs, DES have reduced the rates of TLR and TVR compared to BMS, with no significant differences in death or MI.Research grants from Boston Scientific and Abbott Vascular.Consultant/Speaker: Medtronic Vascular, Abbott Vascular (modest).Past honorarium from Boston Scientific Corporation (modest).BMS Randomized Trials and Registries Ajay J.