Sex differences in 1-year clinical outcomes after percutaneous coronary intervention with COMBO stents: From the COMBO collaboration

Chandrasekhar J 1 , Kerkmeijer LS 2 , Kalkman DN 2 , Sartori S 1 , Aquino MB 1 , Woudstra P 2 Show all authors , Beijk MA 2 , Tijssen JG 2 , Koch KT 2 , Hájek P 3 , Atzev B 4 , Hudec M 5 , Ong TK 6 , Mates M 7 , Borisov B 8 , Warda HM 9 , den Heijer P 10 , Wojcik J 11 , Iñiguez A 12 , Coufal Z 13 , Khashaba A 14 , Munawar M 15 , Gerber RT 16 , Yan BP 17 , Lee M 18 , Baber U 1 , Dangas GD 1 , Colombo A 19 , de Winter RJ 2 , Mehran R 1 , MASCOT and REMEDEE investigators (full list of collaborators shown in the Appendix)

Affiliations 

  • 1 Icahn School of Medicine at Mount Sinai Hospital, New York, USA
  • 2 Amsterdam UMC, Heart Center, Department of Clinical and Experimental Cardiology, Amsterdam Cardiovascular Sciences, Amsterdam, The Netherlands
  • 3 Motol University Hospital, Prague, Czech Republic
  • 4 University Hospital St. Ekaterina, Sofia, Bulgaria
  • 5 SUSCCH, a.s. Banska Bystrica, Slovakia
  • 6 Sarawak Heart Centre, Sarawak, Malaysia
  • 7 Nemocnice na Homolce-Kardiologie, Prague, Czech Republic
  • 8 MBAL St. Ivan Rilski, Bulgaria
  • 9 Alhyatt Cardiovascular Center, Alexandria and Tanta University Hospital, Tanta, Egypt
  • 10 Breda Amphia, Breda, The Netherlands
  • 11 Hospital of Invasive Cardiology IKARDIA, Lublin/Nałęczów, Poland
  • 12 Hospital Álvaro Cunqueiro, Vigo, Spain
  • 13 T. Bata Regional Hospital Zlin, Czech Republic
  • 14 Al-Dorrah Heart Center, Cairo, Egypt
  • 15 Bina Waluya Hospital, Jakarta, Indonesia
  • 16 Conquest Hospital, East Sussex, UK
  • 17 Department of Medicine and Therapeutics, The Chinese University of Hong Kong, Hong Kong
  • 18 Queen Elizabeth Hospital, Kowloon, Hong Kong
  • 19 San Raffaele Hospital, Milan, Italy
Catheter Cardiovasc Interv, 2021 04 01;97(5):797-804.
PMID: 32198837 DOI: 10.1002/ccd.28853

Abstract

BACKGROUND: The COMBO drug eluting stent is a novel device with luminal endothelial progenitor cell capture technology for rapid homogeneous endothelialization.

METHODS AND RESULTS: We examined for sex differences in 1-year outcomes after COMBO stenting from the COMBO collaboration, a pooled patient-level dataset from the MASCOT and REMEDEE multicenter registries. The primary endpoint was 1-year target lesion failure (TLF), composite of cardiac death, target vessel-myocardial infarction (TV-MI), or clinically driven target lesion revascularization (CD-TLR). Secondary outcomes included stent thrombosis (ST). Adjusted outcomes were assessed using Cox regression methods. The study included 861 (23.8%) women and 2,753 (76.2%) men. Women were older with higher prevalence of several comorbidities including diabetes mellitus. Risk of 1-year TLF was similar in both sexes (3.8% vs. 3.9%, HR 0.92, 95% CI 0.59-1.42, p = .70), without sex differences in the incidence of cardiac death (1.6% vs. 1.5%, p = .78), TV-MI (1.5% vs. 1.1%, p = .32), or CD-TLR (2.0% vs. 2.2%, p = .67). Definite or probable ST occurred in 0.4% women and 1.0% men (HR 0.26, 95% CI 0.06-1.11, p = .069).

CONCLUSIONS: Despite greater clinical risks at baseline, women treated with COMBO stents had similarly low 1-year TLF and other ischemic outcomes compared to men.

* Title and MeSH Headings from MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine.

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