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Periprocedural outcomes of embolic protection device use in carotid artery stenting
Santiago Callegari1, Gaëlle Romain2, Odaly S Balasquide Odeh3
1Vascular Medicine Outcomes Program, Department of Internal Medicine, Section of Cardiovascular Medicine, Yale University, New Haven, CT; Department of Internal Medicine, Yale School of Medicine, New Haven, CT.
Insights
Carotid artery stenting (CAS) without embolic protection devices (EPDs) is linked to increased in-hospital and 30-day mortality. Real-world data suggest EPD use in CAS may improve patient survival outcomes.
Area of Science:
- Cardiovascular Interventions
- Vascular Surgery
- Medical Device Technology
Background:
- Carotid artery stenting (CAS) is a common procedure for managing carotid artery stenosis.
- The effectiveness of embolic protection devices (EPDs) in reducing mortality during CAS has been debated.
- This study investigates the association between EPD use and periprocedural outcomes in CAS.
Purpose of the Study:
- To assess the association between carotid artery stenting (CAS) with and without embolic protection devices (EPDs).
- To evaluate the impact of EPD use on periprocedural stroke and mortality rates.
- To provide real-world evidence for quality improvement in CAS practices.
Main Methods:
- Analysis of patients from the Vascular Quality Initiative registry (2015-2019) undergoing CAS.
- Exclusion of transcarotid artery revascularization procedures.
- Propensity score matching (1:1) to compare outcomes between CAS with successful EPD use versus no EPD or failed EPD attempt.
- Logistic regression and survival analyses (Kaplan-Meier, Cox-proportional hazards) for in-hospital and 30-day mortality and stroke/TIA outcomes.
Main Results:
- A total of 19,451 patients were analyzed, with 2062 per group after propensity score matching.
- CAS without EPD was associated with significantly higher odds of in-hospital mortality (OR, 2.40).
- No significant difference in stroke/transient ischemic attack rates was observed between groups (OR, 1.26).
- The 30-day mortality risk was doubled in patients without EPD compared to those with EPD (4.3% vs 2.0%).
Conclusions:
- Not using an embolic protection device (EPD) during carotid artery stenting (CAS) is associated with increased in-hospital and 30-day mortality.
- Real-world evidence supports the potential benefit of EPD use in improving CAS outcomes.
- The findings suggest considering EPD use as a quality metric for CAS procedures.
Background:
Carotid artery stenting (CAS) is frequently used in the management of carotid artery stenosis. Although the use of embolic protection devices (EPDs) is common, the association with lower mortality has been questioned. We aimed to assess the association between CAS with and without EPD and periprocedural stroke and mortality.
Methods:
We included patients from the nationwide Vascular Quality Initiative registry who underwent CAS between 2015 and 2019. Patients undergoing transcarotid artery revascularization were excluded. Outcomes after CAS with either no EPD attempted or failed vs successful use of any EPD (distal or proximal) were analyzed in propensity score 1:1 matching cohort. Logistic regression was used to assess in-hospital mortality and stroke and transient ischemic attack outcomes (odds ratio [OR] with 95% confidence interval [CI]). Kaplan-Meier and Cox-proportional hazards regression were used to derive 30-day mortality cumulative incidence and risk. Analyses were replicated using inverse propensity weighting as a sensitivity analysis.
Results:
A total of 19,451 patients were included, with 2062 per EPD group after 1:1 p propensity score matching (aged 67.1 ± 11.7 years; 41.4% female; 87.1% White). CAS without EPD was significantly associated with higher odds of in-hospital mortality (OR, 2.40; 95% CI, 1.50-3.85; P < .001), but not stroke/transient ischemia attack (OR, 1.26; 95% CI, 0.91-1.75; P = .160). The 30-day cumulative incidence and risk of death were twice as high in patients without vs with EPD (OR, 4.3% [95% CI, 3.5%-5.3%] vs OR, 2.0% [95% CI, 1.4%-2.7%]; P < .001; and hazard ratio, 2.21 [95% CI, 1.51-3.24]; P < .001). Sensitivity analysis revealed similar results.
Conclusions:
Not using an EPD was associated with higher in-hospital and 30-day mortality outcome in CAS when compared with EPD used. As the use of CAS increases, our real-world evidence highlights the risks of not using an EPD and the potential for including this metric as part of national quality improvement efforts for adequate CAS practices.
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