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Observational Study
. 2023 Jul 24;16(14):1721-1729.
doi: 10.1016/j.jcin.2023.04.036. Epub 2023 Jul 5.

Sex Differences in pLVAD-Assisted High-Risk Percutaneous Coronary Intervention: Insights From the PROTECT III Study

Tayyab Shah  1 , Arsalan Abu-Much  2 , Wayne B Batchelor  3 , Cindy L Grines  4 , Suzanne J Baron  5 , Zhipeng Zhou  2 , Yanru Li  2 , Aneel S Maini  2 , Björn Redfors  6 , Yasin Hussain  1 , Jason R Wollmuth  7 , M Babar Basir  8 , William W O'Neill  8 , Alexandra J Lansky  9
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Free article
Observational Study

Sex Differences in pLVAD-Assisted High-Risk Percutaneous Coronary Intervention: Insights From the PROTECT III Study

Tayyab Shah et al. JACC Cardiovasc Interv. .
Free article

Abstract

Background: Prior studies have found that female patients have worse outcomes following high-risk percutaneous coronary intervention (HRPCI).

Objectives: The authors sought to evaluate sex-based differences in patient and procedural characteristics, clinical outcomes, and safety of Impella-supported HRPCI in the PROTECT III study.

Methods: We evaluated sex-based differences in the PROTECT III study; a prospective, multicenter, observational study of patients undergoing Impella-supported HRPCI. The primary outcome was 90-day major adverse cardiac and cerebrovascular events (MACCE)-the composite of all-cause death, myocardial infarction, stroke/transient ischemic attack, and repeat revascularization.

Results: From March 2017 to March 2020, 1,237 patients (27% female) were enrolled. Female patients were older, more often Black, more often anemic, and had more prior strokes and worse renal function, but higher ejection fractions compared to male patients. Preprocedural SYNTAX score was similar between sexes (28.0 ± 12.3). Female patients were more likely to present with acute myocardial infarction (40.7% vs 33.2%; P = 0.02) and more often had femoral access used for PCI and nonfemoral access used for Impella device implantation. Female patients had higher rates of immediate PCI-related coronary complications (4.2% vs 2.1%; P = 0.004) and a greater drop in SYNTAX score post-procedure (-22.6 vs -21.0; P = 0.04). There were no sex differences in 90-day MACCE, vascular complications requiring surgery, major bleeding, or acute limb ischemia. After adjustment using propensity matching and multivariable regression, immediate PCI-related complications was the only safety or clinical outcome that was significantly different by sex.

Conclusions: In this study, rates of 90-day MACCE compared favorably to prior cohorts of HRPCI patients and there was no significant sex differences. (The PROTECT III Study is a substudy of The Global cVAD Study [cVAD]; NCT04136392).

Keywords: PROTECT III; high-risk percutaneous coronary intervention; major adverse cardiovascular and cerebrovascular event(s); sex differences.

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Conflict of interest statement

Funding Support and Author Disclosures The PROTECT III study, as part of The Global cVAD study, was sponsored by Abiomed Inc. Dr Batchelor has received speaker honoraria from Boston Scientific, Abbott Medical, and Medtronic. Dr Grines has served on the advisory boards for Philips and Abiomed. Dr Baron has received consulting fees from Abbott, Abiomed, Edwards Lifesciences, and MitraLabs; has received speaker fees from Boston Scientific Corporation; and has served on an advisory board for Boston Scientific. Dr Wollmuth has received consulting fees/honoraria from Abbott Vascular, Abiomed, Biotronik, Boston Scientific, Cardiovascular Systems, Inc, and Shockwave Medical. Dr Basir has received consultant fees from Abbott Vascular, Abiomed, Cardiovascular Systems, Chiesi, and Zoll. Dr O’Neill has received grant/research support from St. Jude Medical, Edwards Lifesciences, and Biomed; has received consulting fees/honoraria from Medtronic and Abiomed; and has major stock shareholder/equity in Synecor, Accumed, Neovasc, Tendyne, and Mitral Align. Dr Lansky has received speaker fees from Keystone Heart. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose.

Comment in

  • Women and Men: Different But Equal?
    Sinning JM. Sinning JM. JACC Cardiovasc Interv. 2023 Jul 24;16(14):1730-1732. doi: 10.1016/j.jcin.2023.05.029. Epub 2023 Jul 5. JACC Cardiovasc Interv. 2023. PMID: 37409994 No abstract available.

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