title: Applying the National Institute for Clinical Excellence criteria to patients treated with the Genous™ Bio-engineered R stent™: a sub-study of the e-HEALING (Healthy Endothelial Accelerated Lining Inhibits Neointimal Growth) worldwide registry.
abstract: The National Institute for Clinical Excellence (NICE) guidelines recommend the use of bare-metal stents (BMS) in non-complex lesions with a low risk of restenosis (diameter ≥3 mm and lesion length ≤15 mm) and the use of drug-eluting stents (DES) in more complex lesions with a high risk of restenosis (diameter <3.0 mm or lesion length >15 mm). However, the guidelines were created based on studies evaluating BMS and DES only. We performed an analysis of patients undergoing non-urgent percutaneous coronary intervention with the novel endothelial cell capturing stent (ECS). The ECS is coated with CD34(+) antibodies that attract circulating endothelial progenitor cells to the stent surface, thereby accelerating the endothelialization of the stented area. We analyzed all patients enrolled in the worldwide e-HEALING registry that met the NICE criteria for either low-risk or high-risk lesions and were treated with ≥1 ECS. The main study outcome was target vessel failure (TVF) at 12-month follow-up, defined as the composite of cardiac death or MI and target vessel revascularization (TVR). A total of 4,241 patients were assessed in the current analysis. At 12-month follow-up, TVF occurred in 7.0% of the patients with low-risk lesions and in 8.8% of the patients with high-risk lesions (p = 0.045). When evaluating the diabetic patients versus the non-diabetic patients per risk group, no significant differences were found in TVF, MI or TVR in either risk group. The ECS shows good clinical outcomes in lesions carrying either a high or a low risk of restenosis according to the NICE guidelines with comparable rates of cardiac death, myocardial infarction, and stent thrombosis. The TVF rate with ECS was slightly higher in patients with high-risk lesions, driven by higher clinically driven TLR. The risk of restenosis with ECS in patients carrying high-risk lesions needs to be carefully considered relative to other risks associated with DES. Furthermore, the presence of diabetes mellitus did not influence the incidence of TVF in either risk group.
authors: Department of Cardiology, Cardiac Catheterization Laboratory, B2-137 Academic Medical Center, University of Amsterdam, Meibergdreef 9, 1105 AZ Amsterdam, The Netherlands.
authors: Margo
authors: M
authors: Klomp
authors: Peter
authors: P
authors: Damman
authors: Marcel A M
authors: MA
authors: Beijk
authors: Sigmund
authors: S
authors: Silber
authors: Manfred
authors: M
authors: Grisold
authors: Expedito E
authors: EE
authors: Ribeiro
authors: Harry
authors: H
authors: Suryapranata
authors: Jaroslaw
authors: J
authors: Wòjcik
authors: Kui Hian
authors: KH
authors: Sim
authors: Jan G P
authors: JG
authors: Tijssen
authors: Robbert J
authors: RJ
authors: de Winter
mesh_terms: D000368:Aged; D015906:Angioplasty, Balloon, Coronary / Q000009:adverse effects / Q000295:instrumentation* / Q000401:mortality / Q000592:standards*; D000906:Antibodies / Q000008:administration & dosage; D018952:Antigens, CD34 / Q000276:immunology; D020099:Coated Materials, Biocompatible / Q000592:standards; D023903:Coronary Restenosis / Q000209:etiology / Q000401:mortality / Q000473:pathology / Q000517:prevention & control*; D023921:Coronary Stenosis / Q000401:mortality / Q000473:pathology / Q000628:therapy*; D003331:Coronary Vessels / Q000276:immunology / Q000473:pathology*; D042783:Endothelial Cells / Q000276:immunology / Q000473:pathology*; D005260:Female; D006077:Government Agencies / Q000592:standards*; D019983:Guideline Adherence / Q000592:standards; D006801:Humans; D053208:Kaplan-Meier Estimate; D008297:Male; D008875:Middle Aged; D009203:Myocardial Infarction / Q000209:etiology; D058426:Neointima; D018579:Patient Selection; D017410:Practice Guidelines as Topic / Q000592:standards; D011358:Product Surveillance, Postmarketing; D016016:Proportional Hazards Models; D011474:Prosthesis Design; D012042:Registries; D012189:Retrospective Studies; D018570:Risk Assessment; D012307:Risk Factors; D013234:Stem Cells / Q000276:immunology / Q000473:pathology*; D015607:Stents / Q000592:standards*; D013927:Thrombosis / Q000209:etiology; D013997:Time Factors; D016896:Treatment Outcome
chemical_list: D000906:Antibodies; D018952:Antigens, CD34; D020099:Coated Materials, Biocompatible