A paradox in sex-specific clinical outcomes after bioresorbable scaffold implantation: 2-year results from the AIDA trial

Laura S. M. Kerkmeijer, Ruben Y. G. Tijssen, Sjoerd H. Hofma, Tineke H. Pinxterhuis, Robin P. Kraak, Deborah N. Kalkman, Rene J. van der Schaaf, E. Karin Arkenbout, Auke P. J. D. Weevers, Marcel A. Beijk, Jan Baan, M. Marije Vis, Karel T. Koch, Jan G. P. Tijssen, Jan J. Piek, Jose P. S. Henriques, Robbert J. de Winter, Joanna J. Wykrzykowska

Research output: Contribution to journalArticleAcademicpeer-review

Abstract

Background: Females are underrepresented in clinical trials evaluating new stent technologies whilst results may differ between the sexes. Females are known to have smaller, more tortuous coronary arteries and have generally more comorbidities. On the other hand, they may have smaller plaque burden. This subgroup-analysis sought to assess sex-specific outcomes after Absorb bioresorbable vascular scaffold (BVS) or XIENCE everolimus-eluting stent (EES) implantation. Methods: The AIDA trial was an investigator-initiated, non-inferiority, all-comers trial, in which 1845 patients were randomly assigned to either Absorb BVS or XIENCE EES. Baseline clinical, angiography and procedural variables, as well as 2-year clinical outcomes were analyzed by sex and device modality. Results: Of the 1845 randomized patients, 475 (25.7%) were females. The 2-year rates of target vessel failure (TVF) with Absorb BVS versus XIENCE EES in females were 6.4% versus 10.6% (HR 0.59; 95% CI: 0.31–1.11; p = 0.10) and in males 12.7% versus 9.7% (HR 1.34; 95% CI: 0.98–1.85; p = 0.07). Males treated with Absorb BVS were at higher risk for TVF compared to females treated with Absorb BVS (HR 2.06; 95% CI 1.21–3.53; p = 0.007). Definite/probable device thrombosis occurred in females with Absorb BVS versus XIENCE EES in 1.6% versus 1.4% (HR 1.15; 95% CI: 0.26–5.12; p = 0.86) and in males 3.9% versus 0.7% (HR 5.55; 95% CI: 2.11–14.35; p < 0.001). A statistical significant interaction between sex and device was present for TVF (p = 0.02), but was not seen for definite/probable device thrombosis (p = 0.08). Conclusions: In this subgroup analysis, Absorb BVS used in routine practice tends to result in better clinical outcomes in females compared to males.
Original languageEnglish
JournalInternational Journal of Cardiology
DOIs
Publication statusPublished - 1 Jan 2019

Cite this

Kerkmeijer, L. S. M., Tijssen, R. Y. G., Hofma, S. H., Pinxterhuis, T. H., Kraak, R. P., Kalkman, D. N., ... Wykrzykowska, J. J. (2019). A paradox in sex-specific clinical outcomes after bioresorbable scaffold implantation: 2-year results from the AIDA trial. International Journal of Cardiology. https://doi.org/10.1016/j.ijcard.2019.08.045
Kerkmeijer, Laura S. M. ; Tijssen, Ruben Y. G. ; Hofma, Sjoerd H. ; Pinxterhuis, Tineke H. ; Kraak, Robin P. ; Kalkman, Deborah N. ; van der Schaaf, Rene J. ; Arkenbout, E. Karin ; Weevers, Auke P. J. D. ; Beijk, Marcel A. ; Baan, Jan ; Vis, M. Marije ; Koch, Karel T. ; Tijssen, Jan G. P. ; Piek, Jan J. ; Henriques, Jose P. S. ; de Winter, Robbert J. ; Wykrzykowska, Joanna J. / A paradox in sex-specific clinical outcomes after bioresorbable scaffold implantation: 2-year results from the AIDA trial. In: International Journal of Cardiology. 2019.
@article{603521a7269b4f53abe22b7989fd1ed1,
title = "A paradox in sex-specific clinical outcomes after bioresorbable scaffold implantation: 2-year results from the AIDA trial",
abstract = "Background: Females are underrepresented in clinical trials evaluating new stent technologies whilst results may differ between the sexes. Females are known to have smaller, more tortuous coronary arteries and have generally more comorbidities. On the other hand, they may have smaller plaque burden. This subgroup-analysis sought to assess sex-specific outcomes after Absorb bioresorbable vascular scaffold (BVS) or XIENCE everolimus-eluting stent (EES) implantation. Methods: The AIDA trial was an investigator-initiated, non-inferiority, all-comers trial, in which 1845 patients were randomly assigned to either Absorb BVS or XIENCE EES. Baseline clinical, angiography and procedural variables, as well as 2-year clinical outcomes were analyzed by sex and device modality. Results: Of the 1845 randomized patients, 475 (25.7{\%}) were females. The 2-year rates of target vessel failure (TVF) with Absorb BVS versus XIENCE EES in females were 6.4{\%} versus 10.6{\%} (HR 0.59; 95{\%} CI: 0.31–1.11; p = 0.10) and in males 12.7{\%} versus 9.7{\%} (HR 1.34; 95{\%} CI: 0.98–1.85; p = 0.07). Males treated with Absorb BVS were at higher risk for TVF compared to females treated with Absorb BVS (HR 2.06; 95{\%} CI 1.21–3.53; p = 0.007). Definite/probable device thrombosis occurred in females with Absorb BVS versus XIENCE EES in 1.6{\%} versus 1.4{\%} (HR 1.15; 95{\%} CI: 0.26–5.12; p = 0.86) and in males 3.9{\%} versus 0.7{\%} (HR 5.55; 95{\%} CI: 2.11–14.35; p < 0.001). A statistical significant interaction between sex and device was present for TVF (p = 0.02), but was not seen for definite/probable device thrombosis (p = 0.08). Conclusions: In this subgroup analysis, Absorb BVS used in routine practice tends to result in better clinical outcomes in females compared to males.",
author = "Kerkmeijer, {Laura S. M.} and Tijssen, {Ruben Y. G.} and Hofma, {Sjoerd H.} and Pinxterhuis, {Tineke H.} and Kraak, {Robin P.} and Kalkman, {Deborah N.} and {van der Schaaf}, {Rene J.} and Arkenbout, {E. Karin} and Weevers, {Auke P. J. D.} and Beijk, {Marcel A.} and Jan Baan and Vis, {M. Marije} and Koch, {Karel T.} and Tijssen, {Jan G. P.} and Piek, {Jan J.} and Henriques, {Jose P. S.} and {de Winter}, {Robbert J.} and Wykrzykowska, {Joanna J.}",
year = "2019",
month = "1",
day = "1",
doi = "10.1016/j.ijcard.2019.08.045",
language = "English",
journal = "International Journal of Cardiology",
issn = "0167-5273",
publisher = "Elsevier Ireland Ltd",

}

Kerkmeijer, LSM, Tijssen, RYG, Hofma, SH, Pinxterhuis, TH, Kraak, RP, Kalkman, DN, van der Schaaf, RJ, Arkenbout, EK, Weevers, APJD, Beijk, MA, Baan, J, Vis, MM, Koch, KT, Tijssen, JGP, Piek, JJ, Henriques, JPS, de Winter, RJ & Wykrzykowska, JJ 2019, 'A paradox in sex-specific clinical outcomes after bioresorbable scaffold implantation: 2-year results from the AIDA trial' International Journal of Cardiology. https://doi.org/10.1016/j.ijcard.2019.08.045

A paradox in sex-specific clinical outcomes after bioresorbable scaffold implantation: 2-year results from the AIDA trial. / Kerkmeijer, Laura S. M.; Tijssen, Ruben Y. G.; Hofma, Sjoerd H.; Pinxterhuis, Tineke H.; Kraak, Robin P.; Kalkman, Deborah N.; van der Schaaf, Rene J.; Arkenbout, E. Karin; Weevers, Auke P. J. D.; Beijk, Marcel A.; Baan, Jan; Vis, M. Marije; Koch, Karel T.; Tijssen, Jan G. P.; Piek, Jan J.; Henriques, Jose P. S.; de Winter, Robbert J.; Wykrzykowska, Joanna J.

In: International Journal of Cardiology, 01.01.2019.

Research output: Contribution to journalArticleAcademicpeer-review

TY - JOUR

T1 - A paradox in sex-specific clinical outcomes after bioresorbable scaffold implantation: 2-year results from the AIDA trial

AU - Kerkmeijer, Laura S. M.

AU - Tijssen, Ruben Y. G.

AU - Hofma, Sjoerd H.

AU - Pinxterhuis, Tineke H.

AU - Kraak, Robin P.

AU - Kalkman, Deborah N.

AU - van der Schaaf, Rene J.

AU - Arkenbout, E. Karin

AU - Weevers, Auke P. J. D.

AU - Beijk, Marcel A.

AU - Baan, Jan

AU - Vis, M. Marije

AU - Koch, Karel T.

AU - Tijssen, Jan G. P.

AU - Piek, Jan J.

AU - Henriques, Jose P. S.

AU - de Winter, Robbert J.

AU - Wykrzykowska, Joanna J.

PY - 2019/1/1

Y1 - 2019/1/1

N2 - Background: Females are underrepresented in clinical trials evaluating new stent technologies whilst results may differ between the sexes. Females are known to have smaller, more tortuous coronary arteries and have generally more comorbidities. On the other hand, they may have smaller plaque burden. This subgroup-analysis sought to assess sex-specific outcomes after Absorb bioresorbable vascular scaffold (BVS) or XIENCE everolimus-eluting stent (EES) implantation. Methods: The AIDA trial was an investigator-initiated, non-inferiority, all-comers trial, in which 1845 patients were randomly assigned to either Absorb BVS or XIENCE EES. Baseline clinical, angiography and procedural variables, as well as 2-year clinical outcomes were analyzed by sex and device modality. Results: Of the 1845 randomized patients, 475 (25.7%) were females. The 2-year rates of target vessel failure (TVF) with Absorb BVS versus XIENCE EES in females were 6.4% versus 10.6% (HR 0.59; 95% CI: 0.31–1.11; p = 0.10) and in males 12.7% versus 9.7% (HR 1.34; 95% CI: 0.98–1.85; p = 0.07). Males treated with Absorb BVS were at higher risk for TVF compared to females treated with Absorb BVS (HR 2.06; 95% CI 1.21–3.53; p = 0.007). Definite/probable device thrombosis occurred in females with Absorb BVS versus XIENCE EES in 1.6% versus 1.4% (HR 1.15; 95% CI: 0.26–5.12; p = 0.86) and in males 3.9% versus 0.7% (HR 5.55; 95% CI: 2.11–14.35; p < 0.001). A statistical significant interaction between sex and device was present for TVF (p = 0.02), but was not seen for definite/probable device thrombosis (p = 0.08). Conclusions: In this subgroup analysis, Absorb BVS used in routine practice tends to result in better clinical outcomes in females compared to males.

AB - Background: Females are underrepresented in clinical trials evaluating new stent technologies whilst results may differ between the sexes. Females are known to have smaller, more tortuous coronary arteries and have generally more comorbidities. On the other hand, they may have smaller plaque burden. This subgroup-analysis sought to assess sex-specific outcomes after Absorb bioresorbable vascular scaffold (BVS) or XIENCE everolimus-eluting stent (EES) implantation. Methods: The AIDA trial was an investigator-initiated, non-inferiority, all-comers trial, in which 1845 patients were randomly assigned to either Absorb BVS or XIENCE EES. Baseline clinical, angiography and procedural variables, as well as 2-year clinical outcomes were analyzed by sex and device modality. Results: Of the 1845 randomized patients, 475 (25.7%) were females. The 2-year rates of target vessel failure (TVF) with Absorb BVS versus XIENCE EES in females were 6.4% versus 10.6% (HR 0.59; 95% CI: 0.31–1.11; p = 0.10) and in males 12.7% versus 9.7% (HR 1.34; 95% CI: 0.98–1.85; p = 0.07). Males treated with Absorb BVS were at higher risk for TVF compared to females treated with Absorb BVS (HR 2.06; 95% CI 1.21–3.53; p = 0.007). Definite/probable device thrombosis occurred in females with Absorb BVS versus XIENCE EES in 1.6% versus 1.4% (HR 1.15; 95% CI: 0.26–5.12; p = 0.86) and in males 3.9% versus 0.7% (HR 5.55; 95% CI: 2.11–14.35; p < 0.001). A statistical significant interaction between sex and device was present for TVF (p = 0.02), but was not seen for definite/probable device thrombosis (p = 0.08). Conclusions: In this subgroup analysis, Absorb BVS used in routine practice tends to result in better clinical outcomes in females compared to males.

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UR - https://www.ncbi.nlm.nih.gov/pubmed/31511193

U2 - 10.1016/j.ijcard.2019.08.045

DO - 10.1016/j.ijcard.2019.08.045

M3 - Article

JO - International Journal of Cardiology

JF - International Journal of Cardiology

SN - 0167-5273

ER -