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Sex Differences in pLVAD-Assisted High-Risk Percutaneous Coronary Intervention: Insights From the PROTECT III Study
Tayyab Shah1, Arsalan Abu-Much2, Wayne B Batchelor3
1Division of Cardiology, Yale School of Medicine, New Haven, Connecticut, USA.
Insights
This study found no significant sex differences in 90-day major adverse cardiac and cerebrovascular events (MACCE) for patients undergoing high-risk percutaneous coronary intervention (HRPCI) with Impella support. Immediate PCI-related complications were more common in females, but overall outcomes were similar.
Area of Science:
- Cardiology
- Interventional Cardiology
- Medical Devices
Background:
- Previous research indicates poorer outcomes for female patients undergoing high-risk percutaneous coronary intervention (HRPCI).
- The PROTECT III study aimed to investigate sex-based disparities in Impella-supported HRPCI.
Purpose of the Study:
- To evaluate sex-based differences in patient characteristics, procedural factors, clinical outcomes, and safety among patients undergoing Impella-supported HRPCI.
- To compare 90-day major adverse cardiac and cerebrovascular events (MACCE) between male and female patients.
Main Methods:
- A prospective, multicenter, observational study (PROTECT III) involving 1,237 patients receiving Impella-supported HRPCI.
- Analysis of sex-based differences in demographics, comorbidities, procedural details, and 90-day MACCE (all-cause death, myocardial infarction, stroke, repeat revascularization).
Main Results:
- Female patients were older, had more comorbidities like anemia and prior strokes, and worse renal function but higher ejection fractions.
- While females experienced higher rates of immediate PCI-related coronary complications, there were no significant sex differences in 90-day MACCE, vascular complications, bleeding, or acute limb ischemia after adjustment.
- Preprocedural SYNTAX scores were similar, but females were more likely to present with acute myocardial infarction and have specific access site utilization.
Conclusions:
- Impella-supported HRPCI showed favorable 90-day MACCE rates compared to previous cohorts, with no significant sex differences observed.
- Immediate PCI-related complications were the only safety outcome significantly differing by sex.
- The study highlights the need to consider sex-specific factors in managing female patients undergoing complex cardiac interventions.
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).
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