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
Pages (from-to)93-98
Number of pages6
JournalInternational Journal of Cardiology
Volume300
DOIs
Publication statusPublished - 1 Feb 2020
Externally publishedYes

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. (2020). A paradox in sex-specific clinical outcomes after bioresorbable scaffold implantation: 2-year results from the AIDA trial. International Journal of Cardiology, 300, 93-98. https://doi.org/10.1016/j.ijcard.2019.08.045