Temporal course of vascular healing and neoatherosclerosis after implantation of durable- or biodegradable-polymer drug-eluting stents

Abstract Aims Delayed healing and endothelial dysfunction may occur with drug-eluting stents (DES), promoting accelerated infiltration of lipids in the neointima and development of neoatherosclerosis (NA). Pathology data suggest durable polymer (DP) of DES to play a major role in this process. Wheth...

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Published in:	European heart journal Vol. 39; no. 26; pp. 2448 - 2456
Main Authors:	Guagliumi, Giulio, Shimamura, Kunihiro, Sirbu, Vasile, Garbo, Roberto, Boccuzzi, Giacomo, Vassileva, Angelina, Valsecchi, Orazio, Fiocca, Luigi, Canova, Paolo, Colombo, Francesco, Tensol Rodriguez Pereira, Gabriel, Nakamura, Daisuke, Attizzani, Guilherme F, Cereda, Alberto, Satogami, Keisuke, De Luca, Leonardo, Saia, Francesco, Capodanno, Davide
Format:	Journal Article
Language:	English
Published:	England Oxford University Press 07-07-2018
Subjects:	Optical coherence tomography Biodegradable polymer Drug-eluting stents
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Summary:	Abstract Aims Delayed healing and endothelial dysfunction may occur with drug-eluting stents (DES), promoting accelerated infiltration of lipids in the neointima and development of neoatherosclerosis (NA). Pathology data suggest durable polymer (DP) of DES to play a major role in this process. Whether biodegradable polymer (BP) may address these issues is uncertain. We compared in vivo vessel healing and NA of current generation BP- or DP-DES using serial optical coherence tomography (OCT) assessments. Methods and results Ninety patients with multivessel coronary artery disease were randomized 1:1 to BP everolimus-eluting stents (EES, Synergy) or DP zotarolimus-eluting stents (ZES, Resolute Integrity). Co-primary endpoints were the maximum length of uncovered struts at 3 months (powered for non-inferiority) and the percentage of patients presenting with frames of NA at 18 months (powered for superiority) as measured by OCT. The maximum length of uncovered struts at 3 months was 10 ± 8 mm in the BP-EES group and 11 ± 7 mm in the DP-ZES group (mean difference −1 mm; upper 97.5% confidence interval +2 mm; P = 0.05 for non-inferiority; P = 0.45 for superiority). The percentage of patients presenting with frames of NA at 18 months was low and similar between BP-EES and DP-ZES groups (11.6% vs. 15.9%; P = 0.56). There was no stent thrombosis in both groups at 24 months. Conclusion BP-EES and DP-ZES showed a similar healing response at 3 months and a low incidence of NA at 18 months. Biocompatible polymers, regardless of whether they are durable or biodegradable, may favourably impact the long-term vascular response to current-generation DES.
Bibliography:	ObjectType-Article-1 SourceType-Scholarly Journals-1 ObjectType-Feature-2 content type line 23
ISSN:	0195-668X 1522-9645
DOI:	10.1093/eurheartj/ehy273