schliessen

Filtern

 

Bibliotheken

A bioresorbable everolimus-eluting scaffold versus a metallic everolimus-eluting stent for ischaemic heart disease caused by de-novo native coronary artery lesions (ABSORB II): an interim 1-year analysis of clinical and procedural secondary outcomes from a randomised controlled trial

Summary Background Despite rapid dissemination of an everolimus-eluting bioresorbable scaffold for treatment for coronary artery disease, no data from comparisons with its metallic stent counterpart are available. In a randomised controlled trial we aimed to compare an everolimus-eluting bioresorbab... Full description

Journal Title: The Lancet (British edition) 2015, Vol.385 (9962), p.43-54
Main Author: Serruys, Patrick W, Prof
Other Authors: Chevalier, Bernard, MD , Dudek, Dariusz, MD , Cequier, Angel, MD , Carrié, Didier, MD , Iniguez, Andres, MD , Dominici, Marcello, MD , van der Schaaf, René J, MD , Haude, Michael, MD , Wasungu, Luc, PhD , Veldhof, Susan, RN , Peng, Lei, MSc , Staehr, Peter, MD , Grundeken, Maik J, MD , Ishibashi, Yuki, MD , Garcia-Garcia, Hector M, MD , Onuma, Yoshinobu, MD
Format: Electronic Article Electronic Article
Language: English
Subjects:
Quelle: Alma/SFX Local Collection
Publisher: England: Elsevier Ltd
ID: ISSN: 0140-6736
Link: https://www.ncbi.nlm.nih.gov/pubmed/25230593
Zum Text:
SendSend as email Add to Book BagAdd to Book Bag
Staff View
recordid: cdi_proquest_miscellaneous_1652383161
title: A bioresorbable everolimus-eluting scaffold versus a metallic everolimus-eluting stent for ischaemic heart disease caused by de-novo native coronary artery lesions (ABSORB II): an interim 1-year analysis of clinical and procedural secondary outcomes from a randomised controlled trial
format: Article
creator:
  • Serruys, Patrick W, Prof
  • Chevalier, Bernard, MD
  • Dudek, Dariusz, MD
  • Cequier, Angel, MD
  • Carrié, Didier, MD
  • Iniguez, Andres, MD
  • Dominici, Marcello, MD
  • van der Schaaf, René J, MD
  • Haude, Michael, MD
  • Wasungu, Luc, PhD
  • Veldhof, Susan, RN
  • Peng, Lei, MSc
  • Staehr, Peter, MD
  • Grundeken, Maik J, MD
  • Ishibashi, Yuki, MD
  • Garcia-Garcia, Hector M, MD
  • Onuma, Yoshinobu, MD
subjects:
  • Abridged Index Medicus
  • Absorbable Implants
  • Adolescent
  • Adult
  • Aged
  • Aged, 80 and over
  • Biocompatible Materials - therapeutic use
  • Coronary Angiography
  • Coronary heart disease
  • Drug-Eluting Stents
  • Everolimus
  • Female
  • Humans
  • Immunosuppressive Agents - therapeutic use
  • Internal Medicine
  • Ischemia
  • Male
  • Middle Aged
  • Myocardial Ischemia - drug therapy
  • Myocardial Ischemia - surgery
  • Prospective Studies
  • Quality of Life
  • Single-Blind Method
  • Sirolimus - analogs & derivatives
  • Sirolimus - therapeutic use
  • Stent (Surgery)
  • Surveys and Questionnaires
  • Tissue Scaffolds
  • Treatment Outcome
  • Young Adult
ispartof: The Lancet (British edition), 2015, Vol.385 (9962), p.43-54
description: Summary Background Despite rapid dissemination of an everolimus-eluting bioresorbable scaffold for treatment for coronary artery disease, no data from comparisons with its metallic stent counterpart are available. In a randomised controlled trial we aimed to compare an everolimus-eluting bioresorbable scaffold with an everolimus-eluting metallic stent. Here we report secondary clinical and procedural outcomes after 1 year of follow-up. Methods In a single-blind, multicentre, randomised trial, we enrolled eligible patients aged 18–85 years with evidence of myocardial ischaemia and one or two de-novo native lesions in different epicardial vessels. We randomly assigned patients in a 2:1 ratio to receive treatment with an everolimus-eluting bioresorbable scaffold (Absorb, Abbott Vascular, Santa Clara, CA, USA) or treatment with an everolimus-eluting metallic stent (Xience, Abbott Vascular, Santa Clara, CA, USA). Randomisation was stratified by diabetes status and number of planned target lesions. The co-primary endpoints of this study are vasomotion (change in mean lumen diameter before and after nitrate administration at 3 years) and difference between minimum lumen diameter (after nitrate administration) after the index procedure and at 3 years. Secondary endpoints were procedural performance assessed by quantitative angiography and intravascular ultrasound; composite clinical endpoints based on death, myocardial infarction, and coronary revascularisation; device and procedural success; and angina status assessed by the Seattle Angina Questionnaire and exercise testing at 6 and 12 months. Cumulative angina rate based on adverse event reporting was analysed post hoc. This trial is registered at ClinicalTrials.gov , number NCT01425281. Findings Between Nov 28, 2011, and June 4, 2013, we enrolled 501 patients and randomly assigned them to the bioresorbable scaffold group (335 patients, 364 lesions) or the metallic stent group (166 patients, 182 lesions). Dilatation pressure and balloon diameter at the highest pressure during implantation or postdilatation were higher and larger in the metallic stent group, whereas the acute recoil post implantation was similar (0·19 mm for both, p=0·85). Acute lumen gain was lower for the bioresorbable scaffold by quantitative coronary angiography (1·15 mm vs 1·46 mm, p
language: eng
source: Alma/SFX Local Collection
identifier: ISSN: 0140-6736
fulltext: fulltext
issn:
  • 0140-6736
  • 1474-547X
url: Link


@attributes
NO1
SEARCH_ENGINEprimo_central_multiple_fe
SEARCH_ENGINE_TYPEPrimo Central Search Engine
RANK2.8238008
LOCALfalse
PrimoNMBib
record
control
sourceidgale_proqu
recordidTN_cdi_proquest_miscellaneous_1652383161
sourceformatXML
sourcesystemPC
galeidA522485750
sourcerecordidA522485750
originalsourceidFETCH-LOGICAL-1789t-7d3b313926317e017df27885a282f4f5e0a74355e4fb33a8641535fba302c08b3
addsrcrecordideNqVU21rFDEQXkWxtfoPVPJJWnA12SS7ewrKtfhSKBSsgp8M2ezkLjW7qclu4f69sz1bz1KosrBJJs88M5N5JsueMvqSUVa-OqFM0LyseLnLxF7JhJQ5vZttM1GJXIrq271s-wqylT1M6ZRSKkoqH2RbhSw4lTO-fefJnDQuREghNrrxQOAcYvCuG1MOfhxcvyDJaGuDbwlepTERTToYtPfO3IgeoB-IDZG4ZJYaOoQtQceBtC6BTkCMHhO0pFmRFvI-nAfS68Gd40WIoddxRRANuHhILvSJ7M73T44_75PDw73XRPfE9XjtOsLyFRKjRftVcokES4x3vTPao7ElZzEYaMeIxwQm9O3EHcbBhA4SsTF0WEtEZOjclBFCBizH43aITvtH2X2rfYLHv9ed7OuH918OPuVHxx8PD-ZHOavq2ZBXLW8447Oi5KwCyqrWFlVdS13UhRVWAtWV4FKCsA3nui4Fk1zaRnNaGFo3fCfbXfNiwj9HSIPCfAx4r3sIY1KsxH7VnJUMoS_X0IX2oFxvwxC1wa-dHjr0YB3a57IoRC0rSf_Vgc-quuKcTxGe3eCgNhmfbwCwtX5YpjB1H3v1d-gXG8BmTK6HhL_kFsshLVAF_w_fzFOu4SaGlCJYdYaawA4rRtU0IupiRNSkf8WEuhgRRf_UdzY2HbRXXpczgYA314iNG_RUHT6E87fSf197o5CNS1f0ujMYUAXt1NkYYTqr3uO-wTnS67fTlba8qIRC7WglZm01mYwyF_23dVOwGQZ4tw4AqMhzB1El46BHobsIZlBtcLem-PYaw-XU_IAVpNMwRpwolJ1KhaJrkomDiQsGyn8BOPlrgA
sourcetypeAggregation Database
isCDItrue
recordtypearticle
pqid1652383161
display
typearticle
titleA bioresorbable everolimus-eluting scaffold versus a metallic everolimus-eluting stent for ischaemic heart disease caused by de-novo native coronary artery lesions (ABSORB II): an interim 1-year analysis of clinical and procedural secondary outcomes from a randomised controlled trial
sourceAlma/SFX Local Collection
creatorSerruys, Patrick W, Prof ; Chevalier, Bernard, MD ; Dudek, Dariusz, MD ; Cequier, Angel, MD ; Carrié, Didier, MD ; Iniguez, Andres, MD ; Dominici, Marcello, MD ; van der Schaaf, René J, MD ; Haude, Michael, MD ; Wasungu, Luc, PhD ; Veldhof, Susan, RN ; Peng, Lei, MSc ; Staehr, Peter, MD ; Grundeken, Maik J, MD ; Ishibashi, Yuki, MD ; Garcia-Garcia, Hector M, MD ; Onuma, Yoshinobu, MD
creatorcontribSerruys, Patrick W, Prof ; Chevalier, Bernard, MD ; Dudek, Dariusz, MD ; Cequier, Angel, MD ; Carrié, Didier, MD ; Iniguez, Andres, MD ; Dominici, Marcello, MD ; van der Schaaf, René J, MD ; Haude, Michael, MD ; Wasungu, Luc, PhD ; Veldhof, Susan, RN ; Peng, Lei, MSc ; Staehr, Peter, MD ; Grundeken, Maik J, MD ; Ishibashi, Yuki, MD ; Garcia-Garcia, Hector M, MD ; Onuma, Yoshinobu, MD
descriptionSummary Background Despite rapid dissemination of an everolimus-eluting bioresorbable scaffold for treatment for coronary artery disease, no data from comparisons with its metallic stent counterpart are available. In a randomised controlled trial we aimed to compare an everolimus-eluting bioresorbable scaffold with an everolimus-eluting metallic stent. Here we report secondary clinical and procedural outcomes after 1 year of follow-up. Methods In a single-blind, multicentre, randomised trial, we enrolled eligible patients aged 18–85 years with evidence of myocardial ischaemia and one or two de-novo native lesions in different epicardial vessels. We randomly assigned patients in a 2:1 ratio to receive treatment with an everolimus-eluting bioresorbable scaffold (Absorb, Abbott Vascular, Santa Clara, CA, USA) or treatment with an everolimus-eluting metallic stent (Xience, Abbott Vascular, Santa Clara, CA, USA). Randomisation was stratified by diabetes status and number of planned target lesions. The co-primary endpoints of this study are vasomotion (change in mean lumen diameter before and after nitrate administration at 3 years) and difference between minimum lumen diameter (after nitrate administration) after the index procedure and at 3 years. Secondary endpoints were procedural performance assessed by quantitative angiography and intravascular ultrasound; composite clinical endpoints based on death, myocardial infarction, and coronary revascularisation; device and procedural success; and angina status assessed by the Seattle Angina Questionnaire and exercise testing at 6 and 12 months. Cumulative angina rate based on adverse event reporting was analysed post hoc. This trial is registered at ClinicalTrials.gov , number NCT01425281. Findings Between Nov 28, 2011, and June 4, 2013, we enrolled 501 patients and randomly assigned them to the bioresorbable scaffold group (335 patients, 364 lesions) or the metallic stent group (166 patients, 182 lesions). Dilatation pressure and balloon diameter at the highest pressure during implantation or postdilatation were higher and larger in the metallic stent group, whereas the acute recoil post implantation was similar (0·19 mm for both, p=0·85). Acute lumen gain was lower for the bioresorbable scaffold by quantitative coronary angiography (1·15 mm vs 1·46 mm, p<0·0001) and quantitative intravascular ultrasound (2·85 mm2 vs 3·60 mm2 , p<0·0001), resulting in a smaller lumen diameter or area post procedure. At 1 year, however, cumulative rates of first new or worsening angina from adverse event reporting were lower (72 patients [22%] in the bioresorbable scaffold group vs 50 [30%] in the metallic stent group, p=0·04), whereas performance during maximum exercise and angina status by SAQ were similar. The 1-year composite device orientated endpoint was similar between the bioresorbable scaffold and metallic stent groups (16 patients [5%] vs five patients [3%], p=0·35). Three patients in the bioresorbable scaffold group had definite or probable scaffold thromboses (one definite acute, one definite sub-acute, and one probable late), compared with no patients in the metallic stent group. There were 17 (5%) major cardiac adverse events in the bioresorbable scaffold group compared with five (3%) events in the metallic stent group, with the most common adverse events being myocardial infarction (15 cases [4%] vs two cases [1%], respectively) and clinically indicated target-lesion revascularisation (four cases [1%] vs three cases [2%], respectively). Interpretation The everolimus-eluting bioresorbable scaffold showed similar 1-year composite secondary clinical outcomes to the everolimus-eluting metallic stent. Funding Abbott Vascular.
identifier
0ISSN: 0140-6736
1EISSN: 1474-547X
2DOI: 10.1016/S0140-6736(14)61455-0
3PMID: 25230593
languageeng
publisherEngland: Elsevier Ltd
subjectAbridged Index Medicus ; Absorbable Implants ; Adolescent ; Adult ; Aged ; Aged, 80 and over ; Biocompatible Materials - therapeutic use ; Coronary Angiography ; Coronary heart disease ; Drug-Eluting Stents ; Everolimus ; Female ; Humans ; Immunosuppressive Agents - therapeutic use ; Internal Medicine ; Ischemia ; Male ; Middle Aged ; Myocardial Ischemia - drug therapy ; Myocardial Ischemia - surgery ; Prospective Studies ; Quality of Life ; Single-Blind Method ; Sirolimus - analogs & derivatives ; Sirolimus - therapeutic use ; Stent (Surgery) ; Surveys and Questionnaires ; Tissue Scaffolds ; Treatment Outcome ; Young Adult
ispartofThe Lancet (British edition), 2015, Vol.385 (9962), p.43-54
rights
0Elsevier Ltd
12015 Elsevier Ltd
2info:eu-repo/semantics/restrictedAccess
3Copyright © 2015 Elsevier Ltd. All rights reserved.
4COPYRIGHT 2015 Elsevier B.V.
lds50peer_reviewed
citedbyFETCH-LOGICAL-1789t-7d3b313926317e017df27885a282f4f5e0a74355e4fb33a8641535fba302c08b3
links
openurl$$Topenurl_article
openurlfulltext$$Topenurlfull_article
thumbnail$$Usyndetics_thumb_exl
backlink$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/25230593$$D View this record in MEDLINE/PubMed
search
creatorcontrib
0Serruys, Patrick W, Prof
1Chevalier, Bernard, MD
2Dudek, Dariusz, MD
3Cequier, Angel, MD
4Carrié, Didier, MD
5Iniguez, Andres, MD
6Dominici, Marcello, MD
7van der Schaaf, René J, MD
8Haude, Michael, MD
9Wasungu, Luc, PhD
10Veldhof, Susan, RN
11Peng, Lei, MSc
12Staehr, Peter, MD
13Grundeken, Maik J, MD
14Ishibashi, Yuki, MD
15Garcia-Garcia, Hector M, MD
16Onuma, Yoshinobu, MD
title
0A bioresorbable everolimus-eluting scaffold versus a metallic everolimus-eluting stent for ischaemic heart disease caused by de-novo native coronary artery lesions (ABSORB II): an interim 1-year analysis of clinical and procedural secondary outcomes from a randomised controlled trial
1The Lancet (British edition)
addtitleLancet
descriptionSummary Background Despite rapid dissemination of an everolimus-eluting bioresorbable scaffold for treatment for coronary artery disease, no data from comparisons with its metallic stent counterpart are available. In a randomised controlled trial we aimed to compare an everolimus-eluting bioresorbable scaffold with an everolimus-eluting metallic stent. Here we report secondary clinical and procedural outcomes after 1 year of follow-up. Methods In a single-blind, multicentre, randomised trial, we enrolled eligible patients aged 18–85 years with evidence of myocardial ischaemia and one or two de-novo native lesions in different epicardial vessels. We randomly assigned patients in a 2:1 ratio to receive treatment with an everolimus-eluting bioresorbable scaffold (Absorb, Abbott Vascular, Santa Clara, CA, USA) or treatment with an everolimus-eluting metallic stent (Xience, Abbott Vascular, Santa Clara, CA, USA). Randomisation was stratified by diabetes status and number of planned target lesions. The co-primary endpoints of this study are vasomotion (change in mean lumen diameter before and after nitrate administration at 3 years) and difference between minimum lumen diameter (after nitrate administration) after the index procedure and at 3 years. Secondary endpoints were procedural performance assessed by quantitative angiography and intravascular ultrasound; composite clinical endpoints based on death, myocardial infarction, and coronary revascularisation; device and procedural success; and angina status assessed by the Seattle Angina Questionnaire and exercise testing at 6 and 12 months. Cumulative angina rate based on adverse event reporting was analysed post hoc. This trial is registered at ClinicalTrials.gov , number NCT01425281. Findings Between Nov 28, 2011, and June 4, 2013, we enrolled 501 patients and randomly assigned them to the bioresorbable scaffold group (335 patients, 364 lesions) or the metallic stent group (166 patients, 182 lesions). Dilatation pressure and balloon diameter at the highest pressure during implantation or postdilatation were higher and larger in the metallic stent group, whereas the acute recoil post implantation was similar (0·19 mm for both, p=0·85). Acute lumen gain was lower for the bioresorbable scaffold by quantitative coronary angiography (1·15 mm vs 1·46 mm, p<0·0001) and quantitative intravascular ultrasound (2·85 mm2 vs 3·60 mm2 , p<0·0001), resulting in a smaller lumen diameter or area post procedure. At 1 year, however, cumulative rates of first new or worsening angina from adverse event reporting were lower (72 patients [22%] in the bioresorbable scaffold group vs 50 [30%] in the metallic stent group, p=0·04), whereas performance during maximum exercise and angina status by SAQ were similar. The 1-year composite device orientated endpoint was similar between the bioresorbable scaffold and metallic stent groups (16 patients [5%] vs five patients [3%], p=0·35). Three patients in the bioresorbable scaffold group had definite or probable scaffold thromboses (one definite acute, one definite sub-acute, and one probable late), compared with no patients in the metallic stent group. There were 17 (5%) major cardiac adverse events in the bioresorbable scaffold group compared with five (3%) events in the metallic stent group, with the most common adverse events being myocardial infarction (15 cases [4%] vs two cases [1%], respectively) and clinically indicated target-lesion revascularisation (four cases [1%] vs three cases [2%], respectively). Interpretation The everolimus-eluting bioresorbable scaffold showed similar 1-year composite secondary clinical outcomes to the everolimus-eluting metallic stent. Funding Abbott Vascular.
subject
0Abridged Index Medicus
1Absorbable Implants
2Adolescent
3Adult
4Aged
5Aged, 80 and over
6Biocompatible Materials - therapeutic use
7Coronary Angiography
8Coronary heart disease
9Drug-Eluting Stents
10Everolimus
11Female
12Humans
13Immunosuppressive Agents - therapeutic use
14Internal Medicine
15Ischemia
16Male
17Middle Aged
18Myocardial Ischemia - drug therapy
19Myocardial Ischemia - surgery
20Prospective Studies
21Quality of Life
22Single-Blind Method
23Sirolimus - analogs & derivatives
24Sirolimus - therapeutic use
25Stent (Surgery)
26Surveys and Questionnaires
27Tissue Scaffolds
28Treatment Outcome
29Young Adult
issn
00140-6736
11474-547X
fulltexttrue
rsrctypearticle
creationdate2015
recordtypearticle
recordideNqVU21rFDEQXkWxtfoPVPJJWnA12SS7ewrKtfhSKBSsgp8M2ezkLjW7qclu4f69sz1bz1KosrBJJs88M5N5JsueMvqSUVa-OqFM0LyseLnLxF7JhJQ5vZttM1GJXIrq271s-wqylT1M6ZRSKkoqH2RbhSw4lTO-fefJnDQuREghNrrxQOAcYvCuG1MOfhxcvyDJaGuDbwlepTERTToYtPfO3IgeoB-IDZG4ZJYaOoQtQceBtC6BTkCMHhO0pFmRFvI-nAfS68Gd40WIoddxRRANuHhILvSJ7M73T44_75PDw73XRPfE9XjtOsLyFRKjRftVcokES4x3vTPao7ElZzEYaMeIxwQm9O3EHcbBhA4SsTF0WEtEZOjclBFCBizH43aITvtH2X2rfYLHv9ed7OuH918OPuVHxx8PD-ZHOavq2ZBXLW8447Oi5KwCyqrWFlVdS13UhRVWAtWV4FKCsA3nui4Fk1zaRnNaGFo3fCfbXfNiwj9HSIPCfAx4r3sIY1KsxH7VnJUMoS_X0IX2oFxvwxC1wa-dHjr0YB3a57IoRC0rSf_Vgc-quuKcTxGe3eCgNhmfbwCwtX5YpjB1H3v1d-gXG8BmTK6HhL_kFsshLVAF_w_fzFOu4SaGlCJYdYaawA4rRtU0IupiRNSkf8WEuhgRRf_UdzY2HbRXXpczgYA314iNG_RUHT6E87fSf197o5CNS1f0ujMYUAXt1NkYYTqr3uO-wTnS67fTlba8qIRC7WglZm01mYwyF_23dVOwGQZ4tw4AqMhzB1El46BHobsIZlBtcLem-PYaw-XU_IAVpNMwRpwolJ1KhaJrkomDiQsGyn8BOPlrgA
startdate2015
enddate2015
creator
0Serruys, Patrick W, Prof
1Chevalier, Bernard, MD
2Dudek, Dariusz, MD
3Cequier, Angel, MD
4Carrié, Didier, MD
5Iniguez, Andres, MD
6Dominici, Marcello, MD
7van der Schaaf, René J, MD
8Haude, Michael, MD
9Wasungu, Luc, PhD
10Veldhof, Susan, RN
11Peng, Lei, MSc
12Staehr, Peter, MD
13Grundeken, Maik J, MD
14Ishibashi, Yuki, MD
15Garcia-Garcia, Hector M, MD
16Onuma, Yoshinobu, MD
general
0Elsevier Ltd
1Elsevier B.V
scope
05DI
15DJ
2QVL
3CGR
4CUY
5CVF
6ECM
7EIF
8NPM
9AAYXX
10CITATION
11BKMMT
12BSHEE
137X8
sort
creationdate2015
titleA bioresorbable everolimus-eluting scaffold versus a metallic everolimus-eluting stent for ischaemic heart disease caused by de-novo native coronary artery lesions (ABSORB II): an interim 1-year analysis of clinical and procedural secondary outcomes from a randomised controlled trial
authorSerruys, Patrick W, Prof ; Chevalier, Bernard, MD ; Dudek, Dariusz, MD ; Cequier, Angel, MD ; Carrié, Didier, MD ; Iniguez, Andres, MD ; Dominici, Marcello, MD ; van der Schaaf, René J, MD ; Haude, Michael, MD ; Wasungu, Luc, PhD ; Veldhof, Susan, RN ; Peng, Lei, MSc ; Staehr, Peter, MD ; Grundeken, Maik J, MD ; Ishibashi, Yuki, MD ; Garcia-Garcia, Hector M, MD ; Onuma, Yoshinobu, MD
facets
frbrtype5
frbrgroupidcdi_FETCH-LOGICAL-1789t-7d3b313926317e017df27885a282f4f5e0a74355e4fb33a8641535fba302c08b3
rsrctypearticles
prefilterarticles
languageeng
creationdate2015
topic
0Abridged Index Medicus
1Absorbable Implants
2Adolescent
3Adult
4Aged
5Aged, 80 and over
6Biocompatible Materials - therapeutic use
7Coronary Angiography
8Coronary heart disease
9Drug-Eluting Stents
10Everolimus
11Female
12Humans
13Immunosuppressive Agents - therapeutic use
14Internal Medicine
15Ischemia
16Male
17Middle Aged
18Myocardial Ischemia - drug therapy
19Myocardial Ischemia - surgery
20Prospective Studies
21Quality of Life
22Single-Blind Method
23Sirolimus - analogs & derivatives
24Sirolimus - therapeutic use
25Stent (Surgery)
26Surveys and Questionnaires
27Tissue Scaffolds
28Treatment Outcome
29Young Adult
toplevel
0peer_reviewed
1online_resources
creatorcontrib
0Serruys, Patrick W, Prof
1Chevalier, Bernard, MD
2Dudek, Dariusz, MD
3Cequier, Angel, MD
4Carrié, Didier, MD
5Iniguez, Andres, MD
6Dominici, Marcello, MD
7van der Schaaf, René J, MD
8Haude, Michael, MD
9Wasungu, Luc, PhD
10Veldhof, Susan, RN
11Peng, Lei, MSc
12Staehr, Peter, MD
13Grundeken, Maik J, MD
14Ishibashi, Yuki, MD
15Garcia-Garcia, Hector M, MD
16Onuma, Yoshinobu, MD
collection
0NARCIS
1NARCIS: Datasets
2NARCIS:Publications
3Medline
4MEDLINE
5MEDLINE (Ovid)
6MEDLINE
7MEDLINE
8PubMed
9CrossRef
10Gale General OneFile (A&I only)
11Academic OneFile (A&I only)
12MEDLINE - Academic
jtitleThe Lancet (British edition)
delivery
delcategoryRemote Search Resource
fulltextfulltext
addata
au
0Serruys, Patrick W, Prof
1Chevalier, Bernard, MD
2Dudek, Dariusz, MD
3Cequier, Angel, MD
4Carrié, Didier, MD
5Iniguez, Andres, MD
6Dominici, Marcello, MD
7van der Schaaf, René J, MD
8Haude, Michael, MD
9Wasungu, Luc, PhD
10Veldhof, Susan, RN
11Peng, Lei, MSc
12Staehr, Peter, MD
13Grundeken, Maik J, MD
14Ishibashi, Yuki, MD
15Garcia-Garcia, Hector M, MD
16Onuma, Yoshinobu, MD
formatjournal
genrearticle
ristypeJOUR
atitleA bioresorbable everolimus-eluting scaffold versus a metallic everolimus-eluting stent for ischaemic heart disease caused by de-novo native coronary artery lesions (ABSORB II): an interim 1-year analysis of clinical and procedural secondary outcomes from a randomised controlled trial
jtitleThe Lancet (British edition)
addtitleLancet
date2015
risdate2015
volume385
issue9962
spage43
epage54
pages43-54
issn0140-6736
eissn1474-547X
abstractSummary Background Despite rapid dissemination of an everolimus-eluting bioresorbable scaffold for treatment for coronary artery disease, no data from comparisons with its metallic stent counterpart are available. In a randomised controlled trial we aimed to compare an everolimus-eluting bioresorbable scaffold with an everolimus-eluting metallic stent. Here we report secondary clinical and procedural outcomes after 1 year of follow-up. Methods In a single-blind, multicentre, randomised trial, we enrolled eligible patients aged 18–85 years with evidence of myocardial ischaemia and one or two de-novo native lesions in different epicardial vessels. We randomly assigned patients in a 2:1 ratio to receive treatment with an everolimus-eluting bioresorbable scaffold (Absorb, Abbott Vascular, Santa Clara, CA, USA) or treatment with an everolimus-eluting metallic stent (Xience, Abbott Vascular, Santa Clara, CA, USA). Randomisation was stratified by diabetes status and number of planned target lesions. The co-primary endpoints of this study are vasomotion (change in mean lumen diameter before and after nitrate administration at 3 years) and difference between minimum lumen diameter (after nitrate administration) after the index procedure and at 3 years. Secondary endpoints were procedural performance assessed by quantitative angiography and intravascular ultrasound; composite clinical endpoints based on death, myocardial infarction, and coronary revascularisation; device and procedural success; and angina status assessed by the Seattle Angina Questionnaire and exercise testing at 6 and 12 months. Cumulative angina rate based on adverse event reporting was analysed post hoc. This trial is registered at ClinicalTrials.gov , number NCT01425281. Findings Between Nov 28, 2011, and June 4, 2013, we enrolled 501 patients and randomly assigned them to the bioresorbable scaffold group (335 patients, 364 lesions) or the metallic stent group (166 patients, 182 lesions). Dilatation pressure and balloon diameter at the highest pressure during implantation or postdilatation were higher and larger in the metallic stent group, whereas the acute recoil post implantation was similar (0·19 mm for both, p=0·85). Acute lumen gain was lower for the bioresorbable scaffold by quantitative coronary angiography (1·15 mm vs 1·46 mm, p<0·0001) and quantitative intravascular ultrasound (2·85 mm2 vs 3·60 mm2 , p<0·0001), resulting in a smaller lumen diameter or area post procedure. At 1 year, however, cumulative rates of first new or worsening angina from adverse event reporting were lower (72 patients [22%] in the bioresorbable scaffold group vs 50 [30%] in the metallic stent group, p=0·04), whereas performance during maximum exercise and angina status by SAQ were similar. The 1-year composite device orientated endpoint was similar between the bioresorbable scaffold and metallic stent groups (16 patients [5%] vs five patients [3%], p=0·35). Three patients in the bioresorbable scaffold group had definite or probable scaffold thromboses (one definite acute, one definite sub-acute, and one probable late), compared with no patients in the metallic stent group. There were 17 (5%) major cardiac adverse events in the bioresorbable scaffold group compared with five (3%) events in the metallic stent group, with the most common adverse events being myocardial infarction (15 cases [4%] vs two cases [1%], respectively) and clinically indicated target-lesion revascularisation (four cases [1%] vs three cases [2%], respectively). Interpretation The everolimus-eluting bioresorbable scaffold showed similar 1-year composite secondary clinical outcomes to the everolimus-eluting metallic stent. Funding Abbott Vascular.
copEngland
pubElsevier Ltd
pmid25230593
doi10.1016/S0140-6736(14)61455-0