The Impact of Post-Procedural Asymmetry, Expansion, and Eccentricity of Bioresorbable Everolimus-Eluting Scaffold and Metallic Everolimus-Eluting Stent on Clinical Outcomes in the ABSORB II Trial

© 2016 American College of Cardiology Foundation Objectives The study sought to investigate the relationship between post-procedural asymmetry, expansion, and eccentricity indices of metallic everolimus-eluting stent (EES) and bioresorbable vascular scaffold (BVS) and their respective impact on clin...

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Main Authors: Pannipa Suwannasom, Yohei Sotomi, Yuki Ishibashi, Rafael Cavalcante, Felipe N. Albuquerque, Carlos Macaya, John A. Ormiston, Jonathan Hill, Irene M. Lang, Mohaned Egred, Jean Fajadet, Maciej Lesiak, Jan G. Tijssen, Joanna J. Wykrzykowska, Robbert J. de Winter, Bernard Chevalier, Patrick W. Serruys, Yoshinobu Onuma
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Published: 2018
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http://cmuir.cmu.ac.th/jspui/handle/6653943832/56128
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spelling th-cmuir.6653943832-561282018-09-05T03:09:22Z The Impact of Post-Procedural Asymmetry, Expansion, and Eccentricity of Bioresorbable Everolimus-Eluting Scaffold and Metallic Everolimus-Eluting Stent on Clinical Outcomes in the ABSORB II Trial Pannipa Suwannasom Yohei Sotomi Yuki Ishibashi Rafael Cavalcante Felipe N. Albuquerque Carlos Macaya John A. Ormiston Jonathan Hill Irene M. Lang Mohaned Egred Jean Fajadet Maciej Lesiak Jan G. Tijssen Joanna J. Wykrzykowska Robbert J. de Winter Bernard Chevalier Patrick W. Serruys Yoshinobu Onuma Medicine © 2016 American College of Cardiology Foundation Objectives The study sought to investigate the relationship between post-procedural asymmetry, expansion, and eccentricity indices of metallic everolimus-eluting stent (EES) and bioresorbable vascular scaffold (BVS) and their respective impact on clinical events at 1-year follow-up. Background Mechanical properties of a fully BVS are inherently different from those of permanent metallic stent. Methods The ABSORB II (A bioresorbable everolimus-eluting scaffold versus a metallic everolimus-eluting stent for ischaemic heart disease caused by de-novo native coronary artery lesions) trial compared the BVS and metallic EES in the treatment of a de novo coronary artery stenosis. Protocol-mandated intravascular ultrasound imaging was performed pre- and post-procedure in 470 patients (162 metallic EES and 308 BVS). Asymmetry index (AI) was calculated per lesion as: (1 − minimum scaffold/stent diameter/maximum scaffold/stent diameter). Expansion index and optimal scaffold/stent expansion followed the definition of the MUSIC (Multicenter Ultrasound Stenting in Coronaries) study. Eccentricity index (EI) was calculated as the ratio of minimum and maximum scaffold/stent diameter per cross section. The incidence of device-oriented composite endpoint (DoCE) was collected. Results Post-procedure, the metallic EES group was more symmetric and concentric than the BVS group. Only 8.0% of the BVS arm and 20.0% of the metallic EES arm achieved optimal scaffold/stent expansion (p < 0.001). At 1 year, there was no difference in the DoCE between both devices (BVS 5.2% vs. EES 3.1%; p = 0.29). Post-procedural devices asymmetry and eccentricity were related to higher event rates while there was no relevance to the expansion status. Subsequent multivariate analysis identified that post-procedural AI >0.30 is an independent predictor of DoCE (hazard ratio: 3.43; 95% confidence interval: 1.08 to 10.92; p = 0.037). Conclusions BVS implantation is more frequently associated with post-procedural asymmetric and eccentric morphology compared to metallic EES. Post-procedural devices asymmetry were independently associated with DoCE following percutaneous coronary intervention. However, this approach should be viewed as hypothesis generating due to low event rates. (ABSORB II Randomized Controlled Trial [ABSORB II]; NCT01425281) 2018-09-05T03:09:22Z 2018-09-05T03:09:22Z 2016-06-27 Journal 18767605 19368798 2-s2.0-84976521324 10.1016/j.jcin.2016.03.027 https://www.scopus.com/inward/record.uri?partnerID=HzOxMe3b&scp=84976521324&origin=inward http://cmuir.cmu.ac.th/jspui/handle/6653943832/56128
institution Chiang Mai University
building Chiang Mai University Library
country Thailand
collection CMU Intellectual Repository
topic Medicine
spellingShingle Medicine
Pannipa Suwannasom
Yohei Sotomi
Yuki Ishibashi
Rafael Cavalcante
Felipe N. Albuquerque
Carlos Macaya
John A. Ormiston
Jonathan Hill
Irene M. Lang
Mohaned Egred
Jean Fajadet
Maciej Lesiak
Jan G. Tijssen
Joanna J. Wykrzykowska
Robbert J. de Winter
Bernard Chevalier
Patrick W. Serruys
Yoshinobu Onuma
The Impact of Post-Procedural Asymmetry, Expansion, and Eccentricity of Bioresorbable Everolimus-Eluting Scaffold and Metallic Everolimus-Eluting Stent on Clinical Outcomes in the ABSORB II Trial
description © 2016 American College of Cardiology Foundation Objectives The study sought to investigate the relationship between post-procedural asymmetry, expansion, and eccentricity indices of metallic everolimus-eluting stent (EES) and bioresorbable vascular scaffold (BVS) and their respective impact on clinical events at 1-year follow-up. Background Mechanical properties of a fully BVS are inherently different from those of permanent metallic stent. Methods The ABSORB II (A bioresorbable everolimus-eluting scaffold versus a metallic everolimus-eluting stent for ischaemic heart disease caused by de-novo native coronary artery lesions) trial compared the BVS and metallic EES in the treatment of a de novo coronary artery stenosis. Protocol-mandated intravascular ultrasound imaging was performed pre- and post-procedure in 470 patients (162 metallic EES and 308 BVS). Asymmetry index (AI) was calculated per lesion as: (1 − minimum scaffold/stent diameter/maximum scaffold/stent diameter). Expansion index and optimal scaffold/stent expansion followed the definition of the MUSIC (Multicenter Ultrasound Stenting in Coronaries) study. Eccentricity index (EI) was calculated as the ratio of minimum and maximum scaffold/stent diameter per cross section. The incidence of device-oriented composite endpoint (DoCE) was collected. Results Post-procedure, the metallic EES group was more symmetric and concentric than the BVS group. Only 8.0% of the BVS arm and 20.0% of the metallic EES arm achieved optimal scaffold/stent expansion (p < 0.001). At 1 year, there was no difference in the DoCE between both devices (BVS 5.2% vs. EES 3.1%; p = 0.29). Post-procedural devices asymmetry and eccentricity were related to higher event rates while there was no relevance to the expansion status. Subsequent multivariate analysis identified that post-procedural AI >0.30 is an independent predictor of DoCE (hazard ratio: 3.43; 95% confidence interval: 1.08 to 10.92; p = 0.037). Conclusions BVS implantation is more frequently associated with post-procedural asymmetric and eccentric morphology compared to metallic EES. Post-procedural devices asymmetry were independently associated with DoCE following percutaneous coronary intervention. However, this approach should be viewed as hypothesis generating due to low event rates. (ABSORB II Randomized Controlled Trial [ABSORB II]; NCT01425281)
format Journal
author Pannipa Suwannasom
Yohei Sotomi
Yuki Ishibashi
Rafael Cavalcante
Felipe N. Albuquerque
Carlos Macaya
John A. Ormiston
Jonathan Hill
Irene M. Lang
Mohaned Egred
Jean Fajadet
Maciej Lesiak
Jan G. Tijssen
Joanna J. Wykrzykowska
Robbert J. de Winter
Bernard Chevalier
Patrick W. Serruys
Yoshinobu Onuma
author_facet Pannipa Suwannasom
Yohei Sotomi
Yuki Ishibashi
Rafael Cavalcante
Felipe N. Albuquerque
Carlos Macaya
John A. Ormiston
Jonathan Hill
Irene M. Lang
Mohaned Egred
Jean Fajadet
Maciej Lesiak
Jan G. Tijssen
Joanna J. Wykrzykowska
Robbert J. de Winter
Bernard Chevalier
Patrick W. Serruys
Yoshinobu Onuma
author_sort Pannipa Suwannasom
title The Impact of Post-Procedural Asymmetry, Expansion, and Eccentricity of Bioresorbable Everolimus-Eluting Scaffold and Metallic Everolimus-Eluting Stent on Clinical Outcomes in the ABSORB II Trial
title_short The Impact of Post-Procedural Asymmetry, Expansion, and Eccentricity of Bioresorbable Everolimus-Eluting Scaffold and Metallic Everolimus-Eluting Stent on Clinical Outcomes in the ABSORB II Trial
title_full The Impact of Post-Procedural Asymmetry, Expansion, and Eccentricity of Bioresorbable Everolimus-Eluting Scaffold and Metallic Everolimus-Eluting Stent on Clinical Outcomes in the ABSORB II Trial
title_fullStr The Impact of Post-Procedural Asymmetry, Expansion, and Eccentricity of Bioresorbable Everolimus-Eluting Scaffold and Metallic Everolimus-Eluting Stent on Clinical Outcomes in the ABSORB II Trial
title_full_unstemmed The Impact of Post-Procedural Asymmetry, Expansion, and Eccentricity of Bioresorbable Everolimus-Eluting Scaffold and Metallic Everolimus-Eluting Stent on Clinical Outcomes in the ABSORB II Trial
title_sort impact of post-procedural asymmetry, expansion, and eccentricity of bioresorbable everolimus-eluting scaffold and metallic everolimus-eluting stent on clinical outcomes in the absorb ii trial
publishDate 2018
url https://www.scopus.com/inward/record.uri?partnerID=HzOxMe3b&scp=84976521324&origin=inward
http://cmuir.cmu.ac.th/jspui/handle/6653943832/56128
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