Relation between bioresorbable scaffold sizing using QCA-Dmax and clinical outcomes at 1 year in 1,232 patients from 3 study cohorts (ABSORB Cohort B, ABSORB EXTEND, and ABSORB II)

© 2015 American College of Cardiology Foundation. Objectives This study sought to investigate the clinical outcomes based on the assessment of quantitative coronary angiography-maximal lumen diameter (Dmax). Background Assessment of pre-procedural Dmax of proximal and distal sites has been used for...

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Main Authors: Yuki Ishibashi, Shimpei Nakatani, Yohei Sotomi, Pannipa Suwannasom, Maik J. Grundeken, Hector M. Garcia-Garcia, Antonio L. Bartorelli, Robert Whitbourn, Bernard Chevalier, Alexandre Abizaid, John A. Ormiston, Richard J. Rapoza, Susan Veldhof, Yoshinobu Onuma, Patrick W. Serruys
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Published: 2018
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http://cmuir.cmu.ac.th/jspui/handle/6653943832/44122
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spelling th-cmuir.6653943832-441222018-04-25T07:45:53Z Relation between bioresorbable scaffold sizing using QCA-Dmax and clinical outcomes at 1 year in 1,232 patients from 3 study cohorts (ABSORB Cohort B, ABSORB EXTEND, and ABSORB II) Yuki Ishibashi Shimpei Nakatani Yohei Sotomi Pannipa Suwannasom Maik J. Grundeken Hector M. Garcia-Garcia Antonio L. Bartorelli Robert Whitbourn Bernard Chevalier Alexandre Abizaid John A. Ormiston Richard J. Rapoza Susan Veldhof Yoshinobu Onuma Patrick W. Serruys Agricultural and Biological Sciences © 2015 American College of Cardiology Foundation. Objectives This study sought to investigate the clinical outcomes based on the assessment of quantitative coronary angiography-maximal lumen diameter (Dmax). Background Assessment of pre-procedural Dmax of proximal and distal sites has been used for Absorb scaffold size selection in the ABSORB studies. Methods A total of 1,248 patients received Absorb scaffolds in the ABSORB Cohort B (ABSORB Clinical Investigation, Cohort B) study (N = 101), ABSORB EXTEND (ABSORB EXTEND Clinical Investigation) study (N = 812), and ABSORB II (ABSORB II Randomized Controlled Trial) trial (N = 335). The incidence of major adverse cardiac events (MACE) (a composite of cardiac death, any myocardial infarction [MI], and ischemia-driven target lesion revascularization) was analyzed according to the Dmax subclassification of scaffold oversize group versus scaffold nonoversize group. Results Of 1,248 patients, pre-procedural Dmax was assessed in 1,232 patients (98.7%). In 649 (52.7%) patients, both proximal and distal Dmax values were smaller than the nominal size of the implanted scaffold (scaffold oversize group), whereas in 583 (47.3%) of patients, the proximal and/or distal Dmax were larger than the implanted scaffold (scaffold nonoversize group). The rates of MACE and MI at 1 year were significantly higher in the scaffold oversize group than in the scaffold nonoversize group (MACE 6.6% vs. 3.3%; log-rank p < 0.01, all MI: 4.6% vs. 2.4%; log-rank p = 0.04), mainly driven by a higher MI rate within 1 month post-procedure (3.5% vs. 1.9%; p = 0.08). The independent MACE determinants were both Dmax smaller than the scaffold nominal size (odds ratio [OR]: 2.13, 95% confidence interval [CI] : 1.22 to 3.70; p < 0.01) and the implantation of overlapping scaffolds (OR: 2.10, 95% CI: 1.17 to 3.80; p = 0.01). Conclusions Implantation of an oversized Absorb scaffold in a relatively small vessel appears to be associated with a higher 1-year MACE rate driven by more frequent early MI. (ABSORB Clinical Investigation, Cohort B [ABSORB Cohort B], NCT00856856; ABSORB EXTEND Clinical Investigation [ABSORB EXTEND] , NCT01023789; ABSORB II Randomized Controlled Trial [ABSORB II], NCT01425281) 2018-01-24T04:38:19Z 2018-01-24T04:38:19Z 2015-11-01 Journal 18767605 19368798 2-s2.0-84942690536 10.1016/j.jcin.2015.07.026 https://www.scopus.com/inward/record.uri?partnerID=HzOxMe3b&scp=84942690536&origin=inward http://cmuir.cmu.ac.th/jspui/handle/6653943832/44122
institution Chiang Mai University
building Chiang Mai University Library
country Thailand
collection CMU Intellectual Repository
topic Agricultural and Biological Sciences
spellingShingle Agricultural and Biological Sciences
Yuki Ishibashi
Shimpei Nakatani
Yohei Sotomi
Pannipa Suwannasom
Maik J. Grundeken
Hector M. Garcia-Garcia
Antonio L. Bartorelli
Robert Whitbourn
Bernard Chevalier
Alexandre Abizaid
John A. Ormiston
Richard J. Rapoza
Susan Veldhof
Yoshinobu Onuma
Patrick W. Serruys
Relation between bioresorbable scaffold sizing using QCA-Dmax and clinical outcomes at 1 year in 1,232 patients from 3 study cohorts (ABSORB Cohort B, ABSORB EXTEND, and ABSORB II)
description © 2015 American College of Cardiology Foundation. Objectives This study sought to investigate the clinical outcomes based on the assessment of quantitative coronary angiography-maximal lumen diameter (Dmax). Background Assessment of pre-procedural Dmax of proximal and distal sites has been used for Absorb scaffold size selection in the ABSORB studies. Methods A total of 1,248 patients received Absorb scaffolds in the ABSORB Cohort B (ABSORB Clinical Investigation, Cohort B) study (N = 101), ABSORB EXTEND (ABSORB EXTEND Clinical Investigation) study (N = 812), and ABSORB II (ABSORB II Randomized Controlled Trial) trial (N = 335). The incidence of major adverse cardiac events (MACE) (a composite of cardiac death, any myocardial infarction [MI], and ischemia-driven target lesion revascularization) was analyzed according to the Dmax subclassification of scaffold oversize group versus scaffold nonoversize group. Results Of 1,248 patients, pre-procedural Dmax was assessed in 1,232 patients (98.7%). In 649 (52.7%) patients, both proximal and distal Dmax values were smaller than the nominal size of the implanted scaffold (scaffold oversize group), whereas in 583 (47.3%) of patients, the proximal and/or distal Dmax were larger than the implanted scaffold (scaffold nonoversize group). The rates of MACE and MI at 1 year were significantly higher in the scaffold oversize group than in the scaffold nonoversize group (MACE 6.6% vs. 3.3%; log-rank p < 0.01, all MI: 4.6% vs. 2.4%; log-rank p = 0.04), mainly driven by a higher MI rate within 1 month post-procedure (3.5% vs. 1.9%; p = 0.08). The independent MACE determinants were both Dmax smaller than the scaffold nominal size (odds ratio [OR]: 2.13, 95% confidence interval [CI] : 1.22 to 3.70; p < 0.01) and the implantation of overlapping scaffolds (OR: 2.10, 95% CI: 1.17 to 3.80; p = 0.01). Conclusions Implantation of an oversized Absorb scaffold in a relatively small vessel appears to be associated with a higher 1-year MACE rate driven by more frequent early MI. (ABSORB Clinical Investigation, Cohort B [ABSORB Cohort B], NCT00856856; ABSORB EXTEND Clinical Investigation [ABSORB EXTEND] , NCT01023789; ABSORB II Randomized Controlled Trial [ABSORB II], NCT01425281)
format Journal
author Yuki Ishibashi
Shimpei Nakatani
Yohei Sotomi
Pannipa Suwannasom
Maik J. Grundeken
Hector M. Garcia-Garcia
Antonio L. Bartorelli
Robert Whitbourn
Bernard Chevalier
Alexandre Abizaid
John A. Ormiston
Richard J. Rapoza
Susan Veldhof
Yoshinobu Onuma
Patrick W. Serruys
author_facet Yuki Ishibashi
Shimpei Nakatani
Yohei Sotomi
Pannipa Suwannasom
Maik J. Grundeken
Hector M. Garcia-Garcia
Antonio L. Bartorelli
Robert Whitbourn
Bernard Chevalier
Alexandre Abizaid
John A. Ormiston
Richard J. Rapoza
Susan Veldhof
Yoshinobu Onuma
Patrick W. Serruys
author_sort Yuki Ishibashi
title Relation between bioresorbable scaffold sizing using QCA-Dmax and clinical outcomes at 1 year in 1,232 patients from 3 study cohorts (ABSORB Cohort B, ABSORB EXTEND, and ABSORB II)
title_short Relation between bioresorbable scaffold sizing using QCA-Dmax and clinical outcomes at 1 year in 1,232 patients from 3 study cohorts (ABSORB Cohort B, ABSORB EXTEND, and ABSORB II)
title_full Relation between bioresorbable scaffold sizing using QCA-Dmax and clinical outcomes at 1 year in 1,232 patients from 3 study cohorts (ABSORB Cohort B, ABSORB EXTEND, and ABSORB II)
title_fullStr Relation between bioresorbable scaffold sizing using QCA-Dmax and clinical outcomes at 1 year in 1,232 patients from 3 study cohorts (ABSORB Cohort B, ABSORB EXTEND, and ABSORB II)
title_full_unstemmed Relation between bioresorbable scaffold sizing using QCA-Dmax and clinical outcomes at 1 year in 1,232 patients from 3 study cohorts (ABSORB Cohort B, ABSORB EXTEND, and ABSORB II)
title_sort relation between bioresorbable scaffold sizing using qca-dmax and clinical outcomes at 1 year in 1,232 patients from 3 study cohorts (absorb cohort b, absorb extend, and absorb ii)
publishDate 2018
url https://www.scopus.com/inward/record.uri?partnerID=HzOxMe3b&scp=84942690536&origin=inward
http://cmuir.cmu.ac.th/jspui/handle/6653943832/44122
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