Skip to main content
Top
Published in: The International Journal of Cardiovascular Imaging 4/2020

01-04-2020 | Angiography | Original Paper

The influence of implantation techniques on lesion oriented-outcomes in Absorb BVS and Xience EES lesions treated in routine clinical practice at complete three year follow-up: AIDA trial QCA substudy

Authors: Ruben Y. G. Tijssen, Laura S. M. Kerkmeijer, Kuniaki Takahashi, Norihiro Kogame, Yuki Katagiri, Robin P. Kraak, Ply Chichareon, Rodrigo Modolo, Taku Asano, Martina Nassif, Deborah N. Kalkman, Yohei Sotomi, Carlos Collet, Sjoerd H. Hofma, Rene J. van der Schaaf, E. Karin Arkenbout, Auke P. J. D. Weevers, Jan J. Piek, Jan G. P. Tijssen, Jose P. Henriques, Robbert J. de Winter, Yoshinobu Onuma, Patrick W. Serruys, Joanna J. Wykrzykowska

Published in: The International Journal of Cardiovascular Imaging | Issue 4/2020

Login to get access

Abstract

It has been hypothesized that dedicated optimized Absorb BVS implantation techniques might mitigate the risk of adverse events such as target vessel failure and device thrombosis. In this explorative AIDA trial QCA substudy, we sought to investigate the influence of implantation techniques on lesion-oriented outcomes in both the Absorb BVS and Xience EES arm at complete 3-year follow-up. The current analysis includes 2152 study lesions treated with at least one study device, of which the baseline angiogram was suited for offline QCA analysis, including Dmax analysis. The lesion-oriented composite outcome (LOCE) of this analysis was a composite of definite device thrombosis, target lesion revascularization and target-vessel myocardial infarction. In Absorb BVS, the Lesion-oriented composite endpoint (LOCE) occurred numerically less in correctly QCA sized vessels when compared to incorrectly sized vessels 8.5% (58/696) versus 11.1% (39/358), p = 0.151. In Xience EES, LOCE had occurred more frequently in incorrectly sized devices according to device diameter/RVD matching; 2.2% (4/187) in correctly sized devices versus 7.1% (63/911) in incorrectly sized devices (p = 0.014). In this AIDA trial QCA substudy, rates of LOCE were significantly lower in Xience EES treated lesions in which devices were correctly sized according to the definitions of device diameter/RVD matching.
Appendix
Available only for authorised users
Literature
1.
go back to reference Serruys PW, Garcia-Garcia HM, Onuma Y (2012) From metallic cages to transient bioresorbable scaffolds: change in paradigm of coronary revascularization in the upcoming decade? Eur Heart J 33(1):16–25bCrossRef Serruys PW, Garcia-Garcia HM, Onuma Y (2012) From metallic cages to transient bioresorbable scaffolds: change in paradigm of coronary revascularization in the upcoming decade? Eur Heart J 33(1):16–25bCrossRef
2.
go back to reference Ali ZA, Serruys PW, Kimura T et al (2017) 2-year outcomes with the Absorb bioresorbable scaffold for treatment of coronary artery disease: a systematic review and meta-analysis of seven randomised trials with an individual patient data substudy. Lancet 390(10096):760–772CrossRef Ali ZA, Serruys PW, Kimura T et al (2017) 2-year outcomes with the Absorb bioresorbable scaffold for treatment of coronary artery disease: a systematic review and meta-analysis of seven randomised trials with an individual patient data substudy. Lancet 390(10096):760–772CrossRef
3.
go back to reference Serruys PW, Chevalier B, Sotomi Y et al (2016) Comparison of an everolimus-eluting bioresorbable scaffold with an everolimus-eluting metallic stent for the treatment of coronary artery stenosis (ABSORB II): a 3 year, randomised, controlled, single-blind, multicentre clinical trial. Lancet 388(10059):2479–2491CrossRef Serruys PW, Chevalier B, Sotomi Y et al (2016) Comparison of an everolimus-eluting bioresorbable scaffold with an everolimus-eluting metallic stent for the treatment of coronary artery stenosis (ABSORB II): a 3 year, randomised, controlled, single-blind, multicentre clinical trial. Lancet 388(10059):2479–2491CrossRef
4.
go back to reference Wykrzykowska JJ, Kraak RP, Hofma SH et al (2017) Bioresorbable scaffolds versus metallic stents in routine PCI. N Engl J Med. 376(24):2319–2328CrossRef Wykrzykowska JJ, Kraak RP, Hofma SH et al (2017) Bioresorbable scaffolds versus metallic stents in routine PCI. N Engl J Med. 376(24):2319–2328CrossRef
5.
go back to reference Ormiston JA, Webber B, Ubod B et al (2015) An independent bench comparison of two bioresorbable drug-eluting coronary scaffolds (Absorb and DESolve) with a durable metallic drug-eluting stent (ML8/Xpedition). EuroIntervention 11(1):60–67CrossRef Ormiston JA, Webber B, Ubod B et al (2015) An independent bench comparison of two bioresorbable drug-eluting coronary scaffolds (Absorb and DESolve) with a durable metallic drug-eluting stent (ML8/Xpedition). EuroIntervention 11(1):60–67CrossRef
6.
go back to reference Puricel S, Cuculi F, Weissner M et al (2016) Bioresorbable coronary scaffold thrombosis: multicenter comprehensive analysis of clinical presentation, mechanisms, and predictors. J Am Coll Cardiol 67(8):921–931CrossRef Puricel S, Cuculi F, Weissner M et al (2016) Bioresorbable coronary scaffold thrombosis: multicenter comprehensive analysis of clinical presentation, mechanisms, and predictors. J Am Coll Cardiol 67(8):921–931CrossRef
7.
go back to reference Suwannasom P, Sotomi Y, Ishibashi Y et al (2016) 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. JACC Cardiovasc Interv 9(12):1231–1242CrossRef Suwannasom P, Sotomi Y, Ishibashi Y et al (2016) 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. JACC Cardiovasc Interv 9(12):1231–1242CrossRef
8.
go back to reference Ortega-Paz L, Capodanno D, Gori T et al (2017) Predilation, sizing and post-dilation scoring in patients undergoing everolimus-eluting bioresorbable scaffold implantation for prediction of cardiac adverse events: development and internal validation of the PSP score. EuroIntervention 12(17):2110–2117CrossRef Ortega-Paz L, Capodanno D, Gori T et al (2017) Predilation, sizing and post-dilation scoring in patients undergoing everolimus-eluting bioresorbable scaffold implantation for prediction of cardiac adverse events: development and internal validation of the PSP score. EuroIntervention 12(17):2110–2117CrossRef
9.
go back to reference Stone GW, Abizaid A, Onuma Y et al (2017) Effect of technique on outcomes following bioresorbable vascular scaffold implantation: analysis from the ABSORB trials. J Am Coll Cardiol 70(23):2863–2874CrossRef Stone GW, Abizaid A, Onuma Y et al (2017) Effect of technique on outcomes following bioresorbable vascular scaffold implantation: analysis from the ABSORB trials. J Am Coll Cardiol 70(23):2863–2874CrossRef
10.
go back to reference Tijssen RYG, Kraak RP, Elias J et al (2018) Implantation techniques (predilatation, sizing, and post-dilatation) and the incidence of scaffold thrombosis and revascularisation in lesions treated with an everolimus-eluting bioresorbable vascular scaffold: insights from the AIDA trial. EuroIntervention 14(4):e434–e442CrossRef Tijssen RYG, Kraak RP, Elias J et al (2018) Implantation techniques (predilatation, sizing, and post-dilatation) and the incidence of scaffold thrombosis and revascularisation in lesions treated with an everolimus-eluting bioresorbable vascular scaffold: insights from the AIDA trial. EuroIntervention 14(4):e434–e442CrossRef
11.
go back to reference Woudstra P, Grundeken MJ, Kraak RP et al (2014) Amsterdam Investigator-initiateD Absorb strategy all-comers trial (AIDA trial): a clinical evaluation comparing the efficacy and performance of ABSORB everolimus-eluting bioresorbable vascular scaffold strategy vs the XIENCE family (XIENCE PRIME or XIENCE Xpedition) everolimus-eluting coronary stent strategy in the treatment of coronary lesions in consecutive all-comers: rationale and study design. Am Heart J 167(2):133–140CrossRef Woudstra P, Grundeken MJ, Kraak RP et al (2014) Amsterdam Investigator-initiateD Absorb strategy all-comers trial (AIDA trial): a clinical evaluation comparing the efficacy and performance of ABSORB everolimus-eluting bioresorbable vascular scaffold strategy vs the XIENCE family (XIENCE PRIME or XIENCE Xpedition) everolimus-eluting coronary stent strategy in the treatment of coronary lesions in consecutive all-comers: rationale and study design. Am Heart J 167(2):133–140CrossRef
12.
go back to reference Tijssen RYG, Kraak RP, Hofma SH et al (2018) Complete two-year follow-up with formal non-inferiority testing on primary outcomes of the AIDA trial comparing the Absorb bioresorbable scaffold with the XIENCE drug-eluting metallic stent in routine PCI. EuroIntervention 14(4):e426–e433CrossRef Tijssen RYG, Kraak RP, Hofma SH et al (2018) Complete two-year follow-up with formal non-inferiority testing on primary outcomes of the AIDA trial comparing the Absorb bioresorbable scaffold with the XIENCE drug-eluting metallic stent in routine PCI. EuroIntervention 14(4):e426–e433CrossRef
13.
go back to reference Farooq V, van Klaveren D, Steyerberg EW et al (2013) Anatomical and clinical characteristics to guide decision making between coronary artery bypass surgery and percutaneous coronary intervention for individual patients: development and validation of SYNTAX score II. Lancet 381(9867):639–650CrossRef Farooq V, van Klaveren D, Steyerberg EW et al (2013) Anatomical and clinical characteristics to guide decision making between coronary artery bypass surgery and percutaneous coronary intervention for individual patients: development and validation of SYNTAX score II. Lancet 381(9867):639–650CrossRef
14.
go back to reference Hayiroglu MI, Keskin M, Uzun AO et al (2018) Predictive value of SYNTAX score II for clinical outcomes in cardiogenic shock underwent primary percutaneous coronary intervention; a pilot study. Int J Cardiovasc Imaging 34(3):329–336CrossRef Hayiroglu MI, Keskin M, Uzun AO et al (2018) Predictive value of SYNTAX score II for clinical outcomes in cardiogenic shock underwent primary percutaneous coronary intervention; a pilot study. Int J Cardiovasc Imaging 34(3):329–336CrossRef
Metadata
Title
The influence of implantation techniques on lesion oriented-outcomes in Absorb BVS and Xience EES lesions treated in routine clinical practice at complete three year follow-up: AIDA trial QCA substudy
Authors
Ruben Y. G. Tijssen
Laura S. M. Kerkmeijer
Kuniaki Takahashi
Norihiro Kogame
Yuki Katagiri
Robin P. Kraak
Ply Chichareon
Rodrigo Modolo
Taku Asano
Martina Nassif
Deborah N. Kalkman
Yohei Sotomi
Carlos Collet
Sjoerd H. Hofma
Rene J. van der Schaaf
E. Karin Arkenbout
Auke P. J. D. Weevers
Jan J. Piek
Jan G. P. Tijssen
Jose P. Henriques
Robbert J. de Winter
Yoshinobu Onuma
Patrick W. Serruys
Joanna J. Wykrzykowska
Publication date
01-04-2020
Publisher
Springer Netherlands
Published in
The International Journal of Cardiovascular Imaging / Issue 4/2020
Print ISSN: 1569-5794
Electronic ISSN: 1875-8312
DOI
https://doi.org/10.1007/s10554-019-01756-w

Other articles of this Issue 4/2020

The International Journal of Cardiovascular Imaging 4/2020 Go to the issue