Author(s):
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Baumbach, A.; Lansky, A.J.; Onuma, Y.; Asano, T.; Johnson, T.; Anderson, R.; Kiemeneij, F.; Zheng, M.;
Royen, N. van
; Slagboom, T.; Vlachojannis, G.; Xu, B.; Serruys, P.W.; Wijns, W.
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Subject:
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Radboudumc 16: Vascular damage RIMLS: Radboud Institute for Molecular Life Sciences Tijdelijke code tbv inlezen publicaties Radboudumc - Alleen voor gebruik door Radboudumc |
Abstract:
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AIMS: Durable polymer drug-eluting stents (DP-DES) may contribute to persistent inflammation, delayed endothelial healing and subsequent late DES thrombosis. The aim of this optical coherence tomography (OCT) substudy was to compare healing and neointimal coverage of a novel bioabsorbable polymer sirolimus-eluting stent (Firehawk(R)) (BP-DES) versus the DP-DES (XIENCE) at 90 days in an all-comers patient population. METHODS AND RESULTS: The TARGET All Comers study is a prospective multicentre randomised post-market trial of 1,656 patients randomised 1:1 to Firehawk or XIENCE at 21 centres in 10 European countries. The TARGET OCT substudy enrolled 36 consecutive patients with 52 lesions at six centres proficient in OCT. Follow-up OCT was performed at three months or prior to revascularisation when occurring before the three-month window. The substudy was designed for non-inferiority of the primary endpoint of neointimal thickness. At follow-up, the mean neointimal thickness by OCT (52 lesions: Firehawk, n=24; XIENCE, n=28), was not significantly different between groups (Firehawk 75.5 mum vs. XIENCE V 82.3 mum) meeting the primary endpoint of non-inferiority (pnoninferiority<0.001). The percentage of stent strut coverage was high in both groups (strut level: 99.9+/-0.3% vs. 100+/-0.1%, p=0.26), and the proportion of malapposed struts (1.0+/-1.6% vs. 1.2+/-2.0%, p=0.51) was low in both groups. CONCLUSIONS: Based on OCT, the Firehawk BP-DES has a similar healing response three months after implantation compared to the DP-DES, with near complete strut coverage, moderate neointima formation and minimal strut malapposition.
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