BACKGROUND: Recently published randomized trials comparing BMS to DES with a focus on shortened dual-antiplatelet therapy reported incidences of stent thrombosis (ST) and bleeding complications (LEADERS FREE) in favor of drug eluting stents (DES).
METHODS: Data of previously published large-sale, international, single-armed, multicenter, observational studies of ultra-thin PF-SES, and BMS were propensity score (PS) matched for selected lesion morphological and cardiovascular risk factors to compare target lesion revascularization (TLR), myocardial infarction, cardiac death, major adverse cardiac events (MACE), bleeding complications and ST rates. Primary endpoint in both studies was TLR at 9 months.
RESULTS: At 9 months the rates of TLR was significantly lower in the PF-SES group as compared with patients treated with the BMS analogue of identical stent design (1.4% vs. 4.6%, P = 0.005). Likewise the 9-month MACE rates were lower in the PF-SES group (3.2% vs. 8.7%, P = 0.001) whereas there were no differences in the accumulated ST rates (0.5% vs. 1.5%, P = 0.109). Overall accumulated bleeding incidences (BARC 1-5) were not significantly different between PF-SES and BMS patients (1.8% vs. 2.7%, p = 0.388).
CONCLUSIONS: PF-SES are superior over analogue BMS of identical stent architecture in daily clinical routine with lower rates of TLR and MACE in a PS-matched, unselected patient population without differences in accumulated ST rates and bleeding frequencies given the currently favored postprocedural comedication (ClinicalTrials.gov Identifier NCT02629575).
OBJECTIVES:: The aim was to investigate their dynamic characteristics and create a relationship between these dynamic data and the prescription of foot.
STUDY DESIGN:: Experimental Assessment.
METHODS:: This article presents the modal analysis results of the full range of Össur Flex-Run™ running feet that are commercially available (1LO-9LO) using experimental modal analysis technique under a constant mass at 53 kg and boundary condition.
RESULTS:: It was shown that both the undamped natural frequency and stiffness increase linearly from the lowest to the highest stiffness category of foot which allows for a more informed prescription of foot when tuning to a matched natural frequency. The low damping characteristics determined experimentally that ranged between 1.5% and 2.0% indicates that the feet require less input energy to maintain the steady-state cyclic motion before take-off from the ground. An analysis of the mode shapes also showed a unique design feature of these feet that is hypothesised to enhance their performance.
CONCLUSION:: A better understanding of dynamic characteristics of the feet can help tune the feet to the user's requirements in promoting a better gait performance.
CLINICAL RELEVANCE: The dynamic data determined from this study are needed to better inform the amputees in predicting the natural frequency of the foot prescribed. The amputees can intuitively tune the cyclic body rhythm during walking or running to match with the natural frequency. This could eventually promote a better gait performance.