First-In-Man 6-month results of Qvanteq Surface-modified Coronary Stent System in Native Coronary Stenosis.

Suwannasom, Pannipa; Sotomi, Yohei; Corti, Roberto; Kurz, David J; Roffi, Marco; von Birgelen, Clemens; Buzzi, Stefano; Zucker, Arik; Dijkstra, Jouke; Wykrzykowska, Joanna J; de Winter, Robbert J; Windecker, Stephan; Onuma, Yoshinobu; Serruys, Patrick W; Daemen, Joost; Räber, Lorenz (2017). First-In-Man 6-month results of Qvanteq Surface-modified Coronary Stent System in Native Coronary Stenosis. EuroIntervention, 12(17), pp. 2118-2127. Europa Digital & Publishing 10.4244/EIJ-D-16-00975

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AIMS

In pre-clinical studies, a bare metal cobalt-chromium stent with an active surface oxide layer modification (BMSmod) has shown to effectively inhibited neointimal hyperplasia. We sought to assess both clinical safety and feasibility of the BMSmod.

METHODS AND RESULTS

In this prospective, nonrandomized, first-in-man multicenter study, a total of 31 patients with de novo coronary lesions, reference lumen diameters of 2.5 - 3.5 mm and lesion length ≤16 mm were enrolled. Quantitative coronary angiography and optical coherence tomography(OCT) were performed at baseline and 6-month follow-up. Primary angiographic and OCT endpoints included in-stent late lumen loss (LLL) and mean neointimal thickness at 6 months, respectively. Device-oriented Composite Endpoint (DoCE) defined as cardiac death, myocardial infarction not clearly attributable to a non-intervention vessel, and clinically- indicated Target Lesion Revascularization[CI-TLR]) was analyzed according to the intention-to- treat principle. In 31 patients (33 lesions), procedural success rate was 93.5%. At 6 months, angiographic LLL was 0.91±0.45 mm and binary angiographic restenosis occurred in 23.3% of lesions. Out of 33 lesions, OCT was performed in 27 lesions at both time points. Mean neointimal thickness amounted to 348±116 µm. At 6 months, the DoCE was 19.4% due to the occurrence of CI-TLR in 5 patients (including one late definite stent thrombosis of non-study stent).

CONCLUSIONS

In contrast to previous pre-clinical pathophysiological work, the BMSmod did not prevent neointimal hyperplasia in a first-in-man clinical setting.

Item Type:	Journal Article (Original Article)
Division/Institute:	04 Faculty of Medicine > Department of Cardiovascular Disorders (DHGE) > Clinic of Cardiology
UniBE Contributor:	Windecker, Stephan, Räber, Lorenz
Subjects:	600 Technology > 610 Medicine & health
ISSN:	1774-024X
Publisher:	Europa Digital & Publishing
Language:	English
Submitter:	Judith Liniger
Date Deposited:	09 Feb 2017 10:50
Last Modified:	05 Dec 2022 15:01
Publisher DOI:	10.4244/EIJ-D-16-00975
PubMed ID:	27993758
URI:	https://boris.unibe.ch/id/eprint/93625