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Five‐year follow‐up of the endothelial progenitor cell capturing stent versus the paxlitaxel‐eluting stent in de novo coronary lesions with a high risk of coronary restenosis
Author(s) -
Woudstra Pier,
Kalkman Deborah N.,
Beijk Marcel A.,
Klomp Margo,
Damman Peter,
Koch Karel T.,
Henriques Jose P. S.,
Baan Jan,
Vis Marije M.,
Piek Jan J.,
Tijssen Jan G. P.,
de Winter Robbert J.
Publication year - 2018
Publication title -
catheterization and cardiovascular interventions
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.988
H-Index - 116
eISSN - 1522-726X
pISSN - 1522-1946
DOI - 10.1002/ccd.27249
Subject(s) - medicine , restenosis , stent , endothelial progenitor cell , cardiology , confidence interval , bare metal stent , paclitaxel , drug eluting stent , conventional pci , progenitor cell , surgery , chemotherapy , myocardial infarction , stem cell , biology , genetics
Objectives To assess the long‐term safety and clinical efficacy of the Genous endothelial progenitor cell capturing stent (ECS) compared with the TAXUS Liberté paclitaxel‐eluting stent (PES) in lesions with a high risk of restenosis. Background Instead of the use of cytotoxic or cytostatic drugs in drug‐eluting stents, a “pro‐healing” approach in ECS may overcome impeded healing response due to delayed functional endothelialization of the stent struts. Methods In the prospective, randomized TRIAS pilot study 193 patients with coronary artery lesions carrying a high risk of restenosis were included (ECS: n = 98, PES: n = 95). The primary focus of this analysis was target vessel failure (TVF) at 5 years. Dual antiplatelet therapy was prescribed for ≥1 month after ECS and for ≥6 months after PES. Results At 5 years follow‐up, no significant differences were found in TVF (ECS 24% vs. PES 29%, risk difference 95% confidence interval (RDCI) −17.3% to 7.4%). Between 2 and 5 years after the index procedure, low numbers of TVF were observed in ECS compared with PES (ECS 4% vs. PES 16%, RDCI −20.8% to −2.3%). There was no definite stent thrombosis in ECS compared with four patients in the PES group. Conclusion This is the first randomized study providing very long‐term clinical efficacy and safety of the ECS in lesions carrying a high risk of restenosis. At 5 years follow‐up, TVF rates in ECS group are numerically lower compared with PES due to an increase of events between 2 and 5 years after the index procedure.