Safety and performance of the second-generation drug-eluting absorbable metal scaffold in patients with de-novo coronary artery lesions (BIOSOLVE-II): 6 month results of a prospective, multicentre, non-randomised, first-in-man trial. (Record no. 1581)

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fixed length control field 04951nam a22007577a 4500
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fixed length control field 160212s20162016 xxu||||| |||| 00| 0 eng d
040 ## - CATALOGING SOURCE
Original cataloging agency Ovid MEDLINE(R)
099 ## - LOCAL FREE-TEXT CALL NUMBER (OCLC)
Classification number 26470647
022 ## - INTERNATIONAL STANDARD SERIAL NUMBER
International Standard Serial Number 0140-6736
190 ## -
-- Haude M
190 ## -
-- Ince H
190 ## -
-- Abizaid A
190 ## -
-- Toelg R
190 ## -
-- Lemos PA
190 ## -
-- von Birgelen C
190 ## -
-- Christiansen EH
190 ## -
-- Wijns W
190 ## -
-- Neumann FJ
190 ## -
-- Kaiser C
190 ## -
-- Eeckhout E
190 ## -
-- Lim ST
190 ## -
-- Escaned J
190 ## -
-- Garcia-Garcia HM
190 ## -
-- Waksman R
100 ## - MAIN ENTRY--PERSONAL NAME
Personal name Waksman, Ron
245 ## - TITLE STATEMENT
Title Safety and performance of the second-generation drug-eluting absorbable metal scaffold in patients with de-novo coronary artery lesions (BIOSOLVE-II): 6 month results of a prospective, multicentre, non-randomised, first-in-man trial.
251 ## -
-- Lancet. 387(10013):31-9, 2016 Jan 2.
252 ## -
-- Lancet. 387(10013):31-9, 2016 Jan 2.
253 ## -
-- Lancet (London, England)
501 ## - WITH NOTE
With note Available online from MWHC library: 1995 - present, Available in print through MWHC library: 1983 - 2007
504 ## - BIBLIOGRAPHY, ETC. NOTE
Bibliography, etc. note BACKGROUND: Absorbable scaffolds were designed to overcome the limitations of conventional, non-absorbable metal-based drug-eluting stents. So far, only polymeric absorbable scaffolds are commercially available. We aimed to assess the safety and performance of a novel second-generation drug-eluting absorbable metal scaffold (DREAMS 2G) in patients with de-novo coronary artery lesions.
504 ## - BIBLIOGRAPHY, ETC. NOTE
Bibliography, etc. note METHODS: We did this prospective, multicentre, non-randomised, first-in-man trial at 13 percutaneous coronary intervention centres in Belgium, Brazil, Denmark, Germany, Singapore, Spain, Switzerland, and the Netherlands. Eligible patients had stable or unstable angina or documented silent ischaemia, and a maximum of two de-novo lesions with a reference vessel diameter between 2.2 mm and 3.7 mm. Clinical follow-up was scheduled at months 1, 6, 12, 24, and 36. Patients were scheduled for angiographic follow-up at 6 months, and a subgroup of patients was scheduled for intravascular ultrasound, optical coherence tomography, and vasomotion assessment. All patients were recommended to take dual antiplatelet treatment for at least 6 months. The primary endpoint was in-segment late lumen loss at 6 months. We did analysis by intention to treat. This trial is registered with ClinicalTrials.gov, number NCT01960504.
504 ## - BIBLIOGRAPHY, ETC. NOTE
Bibliography, etc. note FINDINGS: Between Oct 8, 2013, and May 22, 2015, we enrolled 123 patients with 123 coronary target lesions. At 6 months, mean in-segment late lumen loss was 0.27 mm (SD 0.37), and angiographically discernable vasomotion was documented in 20 (80%) of 25 patients. Intravascular ultrasound assessments showed a preservation of the scaffold area (mean 6.24 mm(2) [SD 1.15] post-procedure vs 6.21 mm(2) [1.22] at 6 months) with a low mean neointimal area (0.08 mm(2) [0.09]), and optical coherence tomography did not detect any intraluminal mass. Target lesion failure occurred in four (3%) patients: one (<1%) patient died from cardiac death, one (<1%) patient had periprocedural myocardial infarction, and two (2%) patients needed clinically driven target lesion revascularisation. No definite or probable scaffold thrombosis was observed.
504 ## - BIBLIOGRAPHY, ETC. NOTE
Bibliography, etc. note INTERPRETATION: Our findings show that implantation of the DREAMS 2G device in de-novo coronary lesions is feasible, with favourable safety and performance outcomes at 6 months. This novel absorbable metal scaffold could be an alternative to absorbable polymeric scaffolds for treatment of obstructive coronary disease.
504 ## - BIBLIOGRAPHY, ETC. NOTE
Bibliography, etc. note FUNDING: Biotronik AG.Copyright © 2016 Elsevier Ltd. All rights reserved.
546 ## - LANGUAGE NOTE
Language note English
651 ## - SUBJECT ADDED ENTRY--GEOGRAPHIC NAME
Geographic name MedStar Heart & Vascular Institute
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 Aged
650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM
Topical term or geographic name entry element Alloys
650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM
Topical term or geographic name entry element *Antibiotics, Antineoplastic/tu [Therapeutic Use]
650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM
Topical term or geographic name entry element Cohort Studies
650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM
Topical term or geographic name entry element *Coronary Restenosis/pa [Pathology]
650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM
Topical term or geographic name entry element Coronary Restenosis/us [Ultrasonography]
650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM
Topical term or geographic name entry element *Coronary Stenosis/th [Therapy]
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 Endosonography
650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM
Topical term or geographic name entry element Female
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 Magnesium
650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM
Topical term or geographic name entry element Male
650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM
Topical term or geographic name entry element Middle Aged
650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM
Topical term or geographic name entry element Percutaneous Coronary Intervention
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/tu [Therapeutic Use]
650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM
Topical term or geographic name entry element *Tissue Scaffolds
650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM
Topical term or geographic name entry element Tomography, Optical Coherence
650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM
Topical term or geographic name entry element Treatment Outcome
657 ## - INDEX TERM--FUNCTION
Function Clinical Study
657 ## - INDEX TERM--FUNCTION
Function Journal Article
657 ## - INDEX TERM--FUNCTION
Function Multicenter Study
657 ## - INDEX TERM--FUNCTION
Function Research Support, Non-U.S. Gov't
857 ## -
-- http://dx.doi.org/10.1016/S0140-6736(15)00447-X
856 ## - ELECTRONIC LOCATION AND ACCESS
Uniform Resource Identifier https://www.clinicalkey.com/#!/content/playContent/1-s2.0-S014067361500447X?returnurl=null&referrer=null
942 ## - ADDED ENTRY ELEMENTS (KOHA)
Koha item type Journal Article
Holdings
Withdrawn status Lost status Damaged status Not for loan Collection code Permanent Location Current Location Date acquired Barcode Date last seen Price effective from Koha item type
          MedStar Authors Catalog MedStar Authors Catalog 2016-05-24 26470647 2016-05-24 2016-05-24 Journal Article

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