Endothelial progenitor cell capture stent: safety and effectiveness

The endothelial progenitor cell (EPC) capture stent is an innovative device that makes use of the ability of bone marrow-derived EPCs to migrate to injured arterial segments to facilitate healing. The EPC antibody surface, consisting of a covalently coupled polysaccharide intermediate coating with anti-human CD34 antibodies, is attached to a stainless steel stent. Upon stent placement, the anti-human CD34 antibodies will attract circulating EPCs, which are expected to develop into mature functional endothelium. This accelerated healing strategy aims to lower the risk of restenosis and stent thrombosis, as well as obviate prolonged dual antiplatelet therapy. Since the first-in-man study in 2003, a number of small-to-medium size registry and postmarketing studies that confirmed the good safety profile of the EPC capture stent have been published. However, due to lack of large-scale randomized trials, its effectiveness, compared with bare metal stents and drug-eluting stents, cannot be ascertained. Based on restudy angiographic data, instent late loss was approximately 0.7-0.9 mm, which compares unfavorably with that of drug-eluting stents. In order to improve the effectiveness of the EPC capture stent in reducing restenosis-while maintaining its pro-healing property-a bioengineered sirolimus-eluting stent known as the Combo stent was recently designed to combine the EPC capture technology with the abluminal elution of sirolimus. Data from animal studies have been encouraging. The first-in-man study of the Combo stent has been completed and results were presented. (J Interven Cardiol 2012;25:493-500).     

Prediction of successful dose reduction or discontinuation of adalimumab,etanercept, or infliximab in rheumatoid arthritis patients using serum drug levels and antidrug antibody measurement

Background: To evaluate if TNF inhibitor serum drug levels (DL) or anti-drug antibodies (ADAb) can predict successful dose reduction (in patients with high DL) or discontinuation (in patients with no/low DL or ADAb) in rheumatoid arthritis (RA) patients.

Research design and methods: RA patients that were using adalimumab (n = 42), etanercept (n = 76) or infliximab (n = 51) and were doing well, were tapered until discontinuation or flare (1–1.5 year follow up). Random timed DL for adalimumab and etanercept and trough DL for infliximab were measured before dose reduction: Receiver-Operator-Curves (ROC) analyses with optimal cut-off DL were determined.

Results: No predictive value of adalimumab and infliximab DL for all outcomes were found, except for an inverse association of lower etanercept DL and higher chance for successful dose reduction (Area Under the Curve (AUC) 0.36, 95% CI 0.23–0.49; cut-off <2.6 mg/l). In sub analyses, higher adalimumab trough DL predicted successful dose reduction (AUC 0.86, 0.58–1.00; cut-off >7.8). ADAb were infrequent and not predictive of successful discontinuation.

Conclusions: No predictive value of baseline adalimumab, etanercept and infliximab DL or ADAb for successful dose reduction or discontinuation in RA was found in this context, with the possible exception of high adalimumab trough levels for successful dose reduction.