Universität zu Köln

Nef, Holger, Wiebe, Jens, Boeder, Niklas, Doerr, Oliver, Bauer, Timm, Hauptmann, Karl-Eugen, Latib, Azeem ORCID: 0000-0001-9035-343X, Colombo, Antonio, Fischer, Dieter, Rudolph, Tanja, Foin, Nicolas, Richardt, Gert and Hamm, Christian (2018). A multicenter post-marketing evaluation of the Elixir DESolve((R)) Novolimus-eluting bioresorbable coronary scaffold system: First results from the DESolve PMCF study. Catheter. Cardiovasc. Interv., 92 (6). S. 1021 - 1028. HOBOKEN: WILEY. ISSN 1522-726X

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Abstract

Objectives To date, experience with bioresorbable scaffolds (BRS) that elute agents other than everolimus is limited. Thus, a post-marketing clinical follow-up study was conducted to evaluate the continued safety and effectiveness of the DESolve (R) NOVOLIMUS (TM) Eluting BRS as treatment for patients with stable coronary artery disease. Background Methods The DESolve BRS combines a poly-l-lactide-based backbone with a biodegradable polylactide-based polymer and Novolimus, a macrocyclic lactone mTOR inhibitor. One hundred and two patients (mean age 62 years, 77.5% male) were enrolled at 10 European sites. Comparison of baseline and post-procedural angiographic assessment was performed, and a device-oriented composite endpoint (comprising cardiac death, target vessel myocardial infarction, and clinically driven target lesion revascularization) and rate of scaffold thrombosis at 12 months were examined. Results Conclusions The device was successfully delivered and deployed in 98.2% (107/109) of the lesions, with two failures to cross the lesion. A total of 100 patients (109 lesions) were treated with a DESolve BRS. Post-procedural angiographic assessment indicated an in-scaffold acute gain of 1.54 +/- 0.44 mm, with a reduction in % diameter stenosis from 61.00 +/- 11.29 to 12.69 +/- 0.44. At 12 months, the device-oriented composite endpoint had occurred in 3.0% (3/100) of patients, with 1.0% (1/100) experiencing scaffold thrombosis and myocardial infarction and 3.0% (3/100) undergoing target lesion revascularization. There were no cardiac deaths. Results through 12 months indicate that the DESolve BRS is a safe and effective treatment for coronary lesions, though larger, long-term prospective studies are needed.

Item Type:	Journal Article
Creators:	Creators Email ORCID ORCID Put Code Nef, Holger UNSPECIFIED UNSPECIFIED UNSPECIFIED Wiebe, Jens UNSPECIFIED UNSPECIFIED UNSPECIFIED Boeder, Niklas UNSPECIFIED UNSPECIFIED UNSPECIFIED Doerr, Oliver UNSPECIFIED UNSPECIFIED UNSPECIFIED Bauer, Timm UNSPECIFIED UNSPECIFIED UNSPECIFIED Hauptmann, Karl-Eugen UNSPECIFIED UNSPECIFIED UNSPECIFIED Latib, Azeem UNSPECIFIED orcid.org/0000-0001-9035-343X UNSPECIFIED Colombo, Antonio UNSPECIFIED UNSPECIFIED UNSPECIFIED Fischer, Dieter UNSPECIFIED UNSPECIFIED UNSPECIFIED Rudolph, Tanja UNSPECIFIED UNSPECIFIED UNSPECIFIED Foin, Nicolas UNSPECIFIED UNSPECIFIED UNSPECIFIED Richardt, Gert UNSPECIFIED UNSPECIFIED UNSPECIFIED Hamm, Christian UNSPECIFIED UNSPECIFIED UNSPECIFIED
URN:	urn:nbn:de:hbz:38-165642
DOI:	10.1002/ccd.27550
Journal or Publication Title:	Catheter. Cardiovasc. Interv.
Volume:	92
Number:	6
Page Range:	S. 1021 - 1028
Date:	2018
Publisher:	WILEY
Place of Publication:	HOBOKEN
ISSN:	1522-726X
Language:	English
Faculty:	Unspecified
Divisions:	Unspecified
Subjects:	no entry
Uncontrolled Keywords:	Keywords Language VASCULAR SCAFFOLDS; METALLIC STENTS; ACUTE GAIN; CLINICAL-OUTCOMES; ABSORB II; EVEROLIMUS; IMPLANTATION; THROMBOSIS; IMPACT; BENCH Multiple languages Cardiac & Cardiovascular Systems Multiple languages
Refereed:	Yes
URI:	http://kups.ub.uni-koeln.de/id/eprint/16564