The relationship of pre-procedural Dmax based sizing to lesion level outcomes in Absorb BVS and Xience EES treated patients in the AIDA trial

Ruben Y. G. Tijssen, Laura S. M. Kerkmeijer, Yuki Katagiri, Robin P. Kraak, Kuniaki Takahashi, Norihiro Kogame, 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, Marcel A. M. Beijk, Jan J. Piek, Jan G. P. Tijssen & 5 others Jose P. Henriques, Robbert J. de Winter, Yoshinobu Onuma, Patrick W. Serruys, Joanna J. Wykrzykowska

Research output: Contribution to journalArticleAcademicpeer-review

Abstract

Due to expansion limits of the Absorb bioresorbable scaffold a meticulous implantation with correct sizing is required. We sought to investigate the clinical outcomes based on the sizing of the device related to the maximal lumen diameter measured by quantitative coronary angiography in Absorb BVS and Xience EES treated lesions in the AIDA trial. Sizing of Absorb bioresorbable vascular scaffold (BVS) and Xience everolimus eluting stent (EES) was graded according to the definitions of device non-oversize and device oversize on pre-procedural angiography. Lesion-oriented outcomes (LOCE) (device thrombosis, TLR and TVMI) that occurred during 2 years follow-up were related to device non-oversized or oversized status. In the Absorb BVS group, LOCE occurred in 48 (7.4%) lesions in the oversized group and in 32 (8.2%) lesions in the non-oversized group (HR 0.91; 95% CI 0.58–1.42; p = 0.681), whereas TLR occurred in 34 (5.3%) lesions and in 23 lesions (5.9%), respectively (HR 0.89; 95% CI 0.52–1.51; p = 0.666). Definite scaffold thrombosis occurred in 11 (1.7%) device oversized treated lesions against 16 (4.1%) device non-oversized treated lesions (HR 0.41; 95% CI 0.19–0.89; p = 0.020). There were no differences in event rates between oversized and non-oversized groups in lesions treated with Xience EES. There was no significant difference in LOCE between oversized and non-oversized treated Absorb BVS and Xience EES treated lesions. Non-oversized Absorb BVS implantation was associated with a higher risk of scaffold thrombosis at complete 2 years follow-up. The majority of very late scaffold thrombosis occurred in properly sized devices.
Original languageEnglish
JournalInternational Journal of Cardiovascular Imaging
DOIs
Publication statusPublished - 2019

Cite this

Tijssen, Ruben Y. G. ; Kerkmeijer, Laura S. M. ; Katagiri, Yuki ; Kraak, Robin P. ; Takahashi, Kuniaki ; Kogame, Norihiro ; Chichareon, Ply ; Modolo, Rodrigo ; Asano, Taku ; Nassif, Martina ; Kalkman, Deborah N. ; Sotomi, Yohei ; Collet, Carlos ; Hofma, Sjoerd H. ; van der Schaaf, Rene J. ; Arkenbout, E. Karin ; Weevers, Auke P. J. D. ; Beijk, Marcel A. M. ; Piek, Jan J. ; Tijssen, Jan G. P. ; Henriques, Jose P. ; de Winter, Robbert J. ; Onuma, Yoshinobu ; Serruys, Patrick W. ; Wykrzykowska, Joanna J. / The relationship of pre-procedural Dmax based sizing to lesion level outcomes in Absorb BVS and Xience EES treated patients in the AIDA trial. In: International Journal of Cardiovascular Imaging. 2019.
@article{6fcfe6b5d1f34d59b0963779257e846f,
title = "The relationship of pre-procedural Dmax based sizing to lesion level outcomes in Absorb BVS and Xience EES treated patients in the AIDA trial",
abstract = "Due to expansion limits of the Absorb bioresorbable scaffold a meticulous implantation with correct sizing is required. We sought to investigate the clinical outcomes based on the sizing of the device related to the maximal lumen diameter measured by quantitative coronary angiography in Absorb BVS and Xience EES treated lesions in the AIDA trial. Sizing of Absorb bioresorbable vascular scaffold (BVS) and Xience everolimus eluting stent (EES) was graded according to the definitions of device non-oversize and device oversize on pre-procedural angiography. Lesion-oriented outcomes (LOCE) (device thrombosis, TLR and TVMI) that occurred during 2 years follow-up were related to device non-oversized or oversized status. In the Absorb BVS group, LOCE occurred in 48 (7.4{\%}) lesions in the oversized group and in 32 (8.2{\%}) lesions in the non-oversized group (HR 0.91; 95{\%} CI 0.58–1.42; p = 0.681), whereas TLR occurred in 34 (5.3{\%}) lesions and in 23 lesions (5.9{\%}), respectively (HR 0.89; 95{\%} CI 0.52–1.51; p = 0.666). Definite scaffold thrombosis occurred in 11 (1.7{\%}) device oversized treated lesions against 16 (4.1{\%}) device non-oversized treated lesions (HR 0.41; 95{\%} CI 0.19–0.89; p = 0.020). There were no differences in event rates between oversized and non-oversized groups in lesions treated with Xience EES. There was no significant difference in LOCE between oversized and non-oversized treated Absorb BVS and Xience EES treated lesions. Non-oversized Absorb BVS implantation was associated with a higher risk of scaffold thrombosis at complete 2 years follow-up. The majority of very late scaffold thrombosis occurred in properly sized devices.",
author = "Tijssen, {Ruben Y. G.} and Kerkmeijer, {Laura S. M.} and Yuki Katagiri and Kraak, {Robin P.} and Kuniaki Takahashi and Norihiro Kogame and Ply Chichareon and Rodrigo Modolo and Taku Asano and Martina Nassif and Kalkman, {Deborah N.} and Yohei Sotomi and Carlos Collet and Hofma, {Sjoerd H.} and {van der Schaaf}, {Rene J.} and Arkenbout, {E. Karin} and Weevers, {Auke P. J. D.} and Beijk, {Marcel A. M.} and Piek, {Jan J.} and Tijssen, {Jan G. P.} and Henriques, {Jose P.} and {de Winter}, {Robbert J.} and Yoshinobu Onuma and Serruys, {Patrick W.} and Wykrzykowska, {Joanna J.}",
year = "2019",
doi = "10.1007/s10554-019-01576-y",
language = "English",
journal = "International Journal of Cardiovascular Imaging",
issn = "1569-5794",
publisher = "Springer Netherlands",

}

Tijssen, RYG, Kerkmeijer, LSM, Katagiri, Y, Kraak, RP, Takahashi, K, Kogame, N, Chichareon, P, Modolo, R, Asano, T, Nassif, M, Kalkman, DN, Sotomi, Y, Collet, C, Hofma, SH, van der Schaaf, RJ, Arkenbout, EK, Weevers, APJD, Beijk, MAM, Piek, JJ, Tijssen, JGP, Henriques, JP, de Winter, RJ, Onuma, Y, Serruys, PW & Wykrzykowska, JJ 2019, 'The relationship of pre-procedural Dmax based sizing to lesion level outcomes in Absorb BVS and Xience EES treated patients in the AIDA trial' International Journal of Cardiovascular Imaging. https://doi.org/10.1007/s10554-019-01576-y

The relationship of pre-procedural Dmax based sizing to lesion level outcomes in Absorb BVS and Xience EES treated patients in the AIDA trial. / Tijssen, Ruben Y. G.; Kerkmeijer, Laura S. M.; Katagiri, Yuki; Kraak, Robin P.; Takahashi, Kuniaki; Kogame, Norihiro; Chichareon, Ply; Modolo, Rodrigo; Asano, Taku; Nassif, Martina; Kalkman, Deborah N.; Sotomi, Yohei; Collet, Carlos; Hofma, Sjoerd H.; van der Schaaf, Rene J.; Arkenbout, E. Karin; Weevers, Auke P. J. D.; Beijk, Marcel A. M.; Piek, Jan J.; Tijssen, Jan G. P.; Henriques, Jose P.; de Winter, Robbert J.; Onuma, Yoshinobu; Serruys, Patrick W.; Wykrzykowska, Joanna J.

In: International Journal of Cardiovascular Imaging, 2019.

Research output: Contribution to journalArticleAcademicpeer-review

TY - JOUR

T1 - The relationship of pre-procedural Dmax based sizing to lesion level outcomes in Absorb BVS and Xience EES treated patients in the AIDA trial

AU - Tijssen, Ruben Y. G.

AU - Kerkmeijer, Laura S. M.

AU - Katagiri, Yuki

AU - Kraak, Robin P.

AU - Takahashi, Kuniaki

AU - Kogame, Norihiro

AU - Chichareon, Ply

AU - Modolo, Rodrigo

AU - Asano, Taku

AU - Nassif, Martina

AU - Kalkman, Deborah N.

AU - Sotomi, Yohei

AU - Collet, Carlos

AU - Hofma, Sjoerd H.

AU - van der Schaaf, Rene J.

AU - Arkenbout, E. Karin

AU - Weevers, Auke P. J. D.

AU - Beijk, Marcel A. M.

AU - Piek, Jan J.

AU - Tijssen, Jan G. P.

AU - Henriques, Jose P.

AU - de Winter, Robbert J.

AU - Onuma, Yoshinobu

AU - Serruys, Patrick W.

AU - Wykrzykowska, Joanna J.

PY - 2019

Y1 - 2019

N2 - Due to expansion limits of the Absorb bioresorbable scaffold a meticulous implantation with correct sizing is required. We sought to investigate the clinical outcomes based on the sizing of the device related to the maximal lumen diameter measured by quantitative coronary angiography in Absorb BVS and Xience EES treated lesions in the AIDA trial. Sizing of Absorb bioresorbable vascular scaffold (BVS) and Xience everolimus eluting stent (EES) was graded according to the definitions of device non-oversize and device oversize on pre-procedural angiography. Lesion-oriented outcomes (LOCE) (device thrombosis, TLR and TVMI) that occurred during 2 years follow-up were related to device non-oversized or oversized status. In the Absorb BVS group, LOCE occurred in 48 (7.4%) lesions in the oversized group and in 32 (8.2%) lesions in the non-oversized group (HR 0.91; 95% CI 0.58–1.42; p = 0.681), whereas TLR occurred in 34 (5.3%) lesions and in 23 lesions (5.9%), respectively (HR 0.89; 95% CI 0.52–1.51; p = 0.666). Definite scaffold thrombosis occurred in 11 (1.7%) device oversized treated lesions against 16 (4.1%) device non-oversized treated lesions (HR 0.41; 95% CI 0.19–0.89; p = 0.020). There were no differences in event rates between oversized and non-oversized groups in lesions treated with Xience EES. There was no significant difference in LOCE between oversized and non-oversized treated Absorb BVS and Xience EES treated lesions. Non-oversized Absorb BVS implantation was associated with a higher risk of scaffold thrombosis at complete 2 years follow-up. The majority of very late scaffold thrombosis occurred in properly sized devices.

AB - Due to expansion limits of the Absorb bioresorbable scaffold a meticulous implantation with correct sizing is required. We sought to investigate the clinical outcomes based on the sizing of the device related to the maximal lumen diameter measured by quantitative coronary angiography in Absorb BVS and Xience EES treated lesions in the AIDA trial. Sizing of Absorb bioresorbable vascular scaffold (BVS) and Xience everolimus eluting stent (EES) was graded according to the definitions of device non-oversize and device oversize on pre-procedural angiography. Lesion-oriented outcomes (LOCE) (device thrombosis, TLR and TVMI) that occurred during 2 years follow-up were related to device non-oversized or oversized status. In the Absorb BVS group, LOCE occurred in 48 (7.4%) lesions in the oversized group and in 32 (8.2%) lesions in the non-oversized group (HR 0.91; 95% CI 0.58–1.42; p = 0.681), whereas TLR occurred in 34 (5.3%) lesions and in 23 lesions (5.9%), respectively (HR 0.89; 95% CI 0.52–1.51; p = 0.666). Definite scaffold thrombosis occurred in 11 (1.7%) device oversized treated lesions against 16 (4.1%) device non-oversized treated lesions (HR 0.41; 95% CI 0.19–0.89; p = 0.020). There were no differences in event rates between oversized and non-oversized groups in lesions treated with Xience EES. There was no significant difference in LOCE between oversized and non-oversized treated Absorb BVS and Xience EES treated lesions. Non-oversized Absorb BVS implantation was associated with a higher risk of scaffold thrombosis at complete 2 years follow-up. The majority of very late scaffold thrombosis occurred in properly sized devices.

UR - https://www.scopus.com/inward/record.uri?partnerID=HzOxMe3b&scp=85064071213&origin=inward

UR - https://www.ncbi.nlm.nih.gov/pubmed/30911857

U2 - 10.1007/s10554-019-01576-y

DO - 10.1007/s10554-019-01576-y

M3 - Article

JO - International Journal of Cardiovascular Imaging

JF - International Journal of Cardiovascular Imaging

SN - 1569-5794

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