Key result
EPC capture stents show feasibility in de novo CAD with a 9-month MACCE rate of 6.3%.
Why the study?
A pro-healing approach using rapid endothelialization of stents with functional endothelium is theorized to prevent stent thrombosis and reduce restenosis, but clinical evaluation was needed.
Is the implantation of endothelial progenitor cell capture stents safe and feasible in patients with de novo coronary artery disease?
Is the implantation of endothelial progenitor cell capture stents safe and feasible in patients with de novo coronary artery disease?
Answers are grounded in this paper and cite their sources.
Captured external expert commentary on this paper, strongest first. Original sources are linked where available.
“The first report of late stent thrombosis leading to acute myocardial infarction in patients receiving the new CD34 antibody coated endothelial progenitor cell (EPC) capture stent may cast doubts on this technology.... Drawbacks with EPC capture stents should not lead to condemning this strategy in general, but rather stimulate research efforts to develop more suited capture molecules and more sophisticated coatings for the post-DES era towards more biological coatings which mimicry progenitor cell homing factors for rapid vascular wall regeneration.”
“Perhaps somewhat naively, they hypothesised that endothelial progenitor cell capture could prevent at one and the same time both thrombosis and restenosis. It should be remembered that in those early days of stenting, the issues were immediate stent thrombosis and early restenosis, at rates of 20% each! Nobody at that time was anticipating that late thrombotic events would plague the future anti-restenosis solutions, initially vascular brachytherapy and now drug-elution.”
“These data demonstrate the effectiveness of the capture of CD34+ cells for endothelialization and the prevention of thrombosis.”
The first human clinical investigation of EPC capture coronary stents demonstrates they are safe and feasible for treating de novo coronary artery disease.
OBJECTIVES: This study was designed to evaluate whether rapid endothelialization of stainless steel stents with a functional endothelium prevents stent thrombosis and reduces the restenotic process. BACKGROUND: A "pro-healing" approach for prevention of post-stenting restenosis is theoretically favored over the use of cytotoxic or cytostatic local pharmacologic therapies. It is believed that the central role of the vascular endothelium is to maintain quiescence of the underlying media and adventitia. METHODS: Sixteen patients with de novo coronary artery disease were successfully treated with implantation of endothelial progenitor cell (EPC) capture stents. RESULTS: Complete procedural and angiographic success was achieved in all 16 patients. The nine-month composite major adverse cardiac and cerebrovascular events (MACCE) rate was 6.3% as a result of a symptom-driven target vessel revascularization in a single patient. There were no other MACCE despite only one month of clopidogrel treatment. At six-month follow-up, mean angiographic late luminal loss was 0.63 +/- 0.52 mm, and percent stent volume obstruction by intravascular ultrasound analysis was 27.2 +/- 20.9%. CONCLUSIONS: This first human clinical investigation of this technology demonstrates that the EPC capture coronary stent is safe and feasible for the treatment of de novo coronary artery disease. Further developments in this technology are warranted to evaluate the efficacy of this device for the treatment of coronary artery disease.
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Aoki et al. (2005) studied de novo coronary artery disease (n=16). Endothelial progenitor cell (EPC) capture stents was evaluated on Composite major adverse cardiac and cerebrovascular events (MACCE) at nine months. Implantation of endothelial progenitor cell capture stents in patients with de novo coronary artery disease was safe and feasible, with a 9-month MACCE rate of 6.3%.
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