Sustained safety and performance of the second-generation drug-eluting absorbable metal scaffold in patients with de novo coronary lesions: 12-month clinical results and angiographic findings of the BIOSOLVE-II first-in-man trial. (Record no. 3319)

MARC details
000 -LEADER
fixed length control field 03602nam a22004457a 4500
008 - FIXED-LENGTH DATA ELEMENTS--GENERAL INFORMATION
fixed length control field 170411s20162016 xxu||||| |||| 00| 0 eng d
022 ## - INTERNATIONAL STANDARD SERIAL NUMBER
International Standard Serial Number 0195-668X
040 ## - CATALOGING SOURCE
Original cataloging agency Ovid MEDLINE(R)
099 ## - LOCAL FREE-TEXT CALL NUMBER (OCLC)
PMID 27190094
245 ## - TITLE STATEMENT
Title Sustained safety and performance of the second-generation drug-eluting absorbable metal scaffold in patients with de novo coronary lesions: 12-month clinical results and angiographic findings of the BIOSOLVE-II first-in-man trial.
251 ## - Source
Source European Heart Journal. 37(35):2701-9, 2016 Sep 14
252 ## - Abbreviated Source
Abbreviated source Eur Heart J. 37(35):2701-9, 2016 Sep 14
253 ## - Journal Name
Journal name European heart journal
260 ## - PUBLICATION, DISTRIBUTION, ETC.
Year 2016
260 ## - PUBLICATION, DISTRIBUTION, ETC.
Manufacturer FY2017
266 ## - Date added to catalog
Date added to catalog 2017-05-24
501 ## - WITH NOTE
Local holdings Available online from MWHC library: 1996 - present (after 1 year), Available in print through MWHC library: 1999 - 2006
520 ## - SUMMARY, ETC.
Abstract AIMS: Metal absorbable scaffolds constitute a conceptually attractive alternative to polymeric scaffolds. Promising 6-month outcomes of a second-generation drug-eluting absorbable metal scaffold (DREAMS 2G), consisting of an absorbable magnesium scaffold backbone, have been reported. We assessed the 12-month safety and performance of this novel device.
520 ## - SUMMARY, ETC.
Abstract CLINICALTRIALSGOV IDENTIFIER: NCT01960504.
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Abstract CONCLUSION: The novel drug-eluting metal absorbable scaffold DREAMS 2G showed a continuous favourable safety profile up to 12 months and stable angiographic parameters between 6 and 12 months.
520 ## - SUMMARY, ETC.
Abstract Copyright (c) The Author 2016. Published by Oxford University Press on behalf of the European Society of Cardiology.
520 ## - SUMMARY, ETC.
Abstract METHODS AND RESULTS: The prospective, international, multi-centre, first-in-man BIOSOLVE-II trial enrolled 123 patients with up to two de novo lesions with a reference diameter between 2.2 and 3.7 mm. All patients were scheduled for angiographic follow-up at 6 months, and-if subjects consented-at 12 months. Dual antiplatelet therapy was recommended for 6 months. Quantitative coronary angiography (QCA) parameters remained stable from 6 to 12 months [paired data of 42 patients: in-segment late lumen loss 0.20 +/- 0.21 mm vs. 0.25 +/- 0.22 mm, P = 0.117, DELTA 0.05 +/- 0.21 mm (95% CI: -0.01;0.12); in-scaffold late lumen loss 0.37 +/- 0.25 mm vs. 0.39 +/- 0.27 mm, P = 0.446, DELTA 0.03 +/- 0.22 (95% CI: -0.04;0.10), respectively]. Intravascular ultrasound and optical coherence tomography findings corroborated the QCA results. Target lesion failure occurred in four patients (3.4%), consisting of one death of unknown cause, one target-vessel myocardial infarction, and two clinically driven target lesion revascularization. No additional event occurred beyond the 6-month follow-up. During the entire follow-up of 12 months, none of the patients experienced a definite or probable scaffold thrombosis.
546 ## - LANGUAGE NOTE
Language note English
650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM
Topical term or geographic name entry element *Drug-Eluting Stents
650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM
Topical term or geographic name entry element Absorbable Implants
650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM
Topical term or geographic name entry element Coronary Angiography
650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM
Topical term or geographic name entry element Coronary Artery Disease
650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM
Topical term or geographic name entry element Humans
650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM
Topical term or geographic name entry element Metals
650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM
Topical term or geographic name entry element Prospective Studies
650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM
Topical term or geographic name entry element Sirolimus
650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM
Topical term or geographic name entry element Treatment Outcome
651 ## - SUBJECT ADDED ENTRY--GEOGRAPHIC NAME
Institution MedStar Heart & Vascular Institute
657 ## - INDEX TERM--FUNCTION
Medline publication type Journal Article
700 ## - ADDED ENTRY--PERSONAL NAME
Local Authors Garcia-Garcia, Hector M
700 ## - ADDED ENTRY--PERSONAL NAME
Local Authors Waksman, Ron
790 ## - Authors
All authors Abizaid A, Christiansen EH, Eeckhout E, Escaned J, Garcia-Garcia HM, Haude M, Ince H, Kaiser C, Lemos PA, Lim ST, Neumann FJ, Onuma Y, Toelg R, von Birgelen C, Waksman R, Wijns W
856 ## - ELECTRONIC LOCATION AND ACCESS
DOI <a href="https://dx.doi.org/10.1093/eurheartj/ehw196">https://dx.doi.org/10.1093/eurheartj/ehw196</a>
Public note https://dx.doi.org/10.1093/eurheartj/ehw196
942 ## - ADDED ENTRY ELEMENTS (KOHA)
Koha item type Journal Article
Item type description Article
Holdings
Withdrawn status Lost status Damaged status Not for loan Collection Home library Current library Date acquired Total Checkouts Full call number Barcode Date last seen Date last checked out Price effective from Koha item type
          MedStar Authors Catalog MedStar Authors Catalog 05/24/2017 1 27190094 27190094 09/26/2017 09/26/2017 05/24/2017 Journal Article

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