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Thirty-day outcomes for carotid artery stenting in 6320 patients from 2 prospective, multicenter, high-surgical-risk
William A Gray1, Seemant Chaturvedi, Patrick Verta
1Center for Interventional Vascular Therapy, Columbia University, New York, NY 10032, USA. wg2131@columbia.edu
Insights
Carotid artery stenting outcomes have improved, meeting American Heart Association guidelines for high-surgical-risk patients. This study shows reduced 30-day death and stroke rates in non-elderly individuals undergoing the procedure.
Area of Science:
- Vascular Surgery
- Interventional Cardiology
- Neurology
Background:
- The American Heart Association (AHA) has set benchmarks for 30-day mortality and stroke rates following carotid endarterectomy for severe carotid disease.
- Carotid artery stenting (CAS) has not previously met these AHA outcome standards in high-surgical-risk patients during multicenter, prospective evaluations.
- This highlights a critical need to assess current CAS safety and efficacy in contemporary practice.
Purpose of the Study:
- To evaluate the 30-day death and stroke rates associated with carotid artery stenting in high-surgical-risk patients.
- To determine if current CAS outcomes meet established American Heart Association guidelines.
- To analyze outcomes based on patient age and risk factors.
Main Methods:
- Analysis of pooled data from two prospective, multicenter, postmarket surveillance studies (EX and C2) involving 6,320 high-surgical-risk patients across 280 US sites.
- Inclusion of pre- and postprocedure neurological evaluations with independent adjudication of neurological events.
- Stratification of results by age (<80 years vs. ≥80 years) and lesion type (symptomatic vs. asymptomatic), including analysis of patients with unfavorable anatomy for surgery.
Main Results:
- The overall 30-day death and stroke rate was 4.1% for the EX study and 3.4% for the C2 study.
- In patients younger than 80 years, the combined 30-day death and stroke rate was 5.3% for symptomatic lesions and 2.9% for asymptomatic lesions.
- For patients with unfavorable anatomy for surgery, 30-day death and stroke rates were 1.7% (symptomatic) and 2.7% (asymptomatic), meeting AHA guidelines.
Conclusions:
- Carotid artery stenting outcomes in high-surgical-risk patients, particularly those under 80 years old, have improved significantly since initial pivotal trials.
- Current CAS procedures have achieved the American Heart Association's acceptable 30-day death and stroke rates for both symptomatic and asymptomatic carotid lesions.
- These findings support the safety and efficacy of CAS as a treatment option for selected high-surgical-risk patients.
Background:
The American Heart Association has established guidelines for acceptable 30-day death and stroke rates for patients with severe carotid disease undergoing standard-risk carotid endarterectomy: <3% for asymptomatic lesions and <6% for symptomatic lesions. To date, carotid artery stenting has not demonstrated these outcomes in multicenter, prospective assessments of high-surgical-risk patients.
Methods And Results:
Data from 2 prospective, multicenter (280 US sites, 672 operators), postmarket surveillance studies in high-surgical-risk patients were analyzed: 2145 patients from the Emboshield and Xact Post Approval Carotid Stent Trial (EX) and 4175 patients from the Carotid ACCULINK/ACCUNET Post Approval Trial to Uncover Rare Events (C2). Both studies had pre- and postprocedure neurological evaluation and independent adjudication of neurological events. The overall 30-day death and stroke rate was 4.1% (95% CI, 3.3% to 5.0%) for EX and 3.4% (95% CI, 2.9% to 4.0%) for C2. In the population comparable with American Heart Association guidelines (<80 years), the combined 30-day death and stroke rate was 5.3% (95% CI, 3.6% to 7.4%) for symptomatic patients and 2.9% (95% CI, 2.4% to 3.4%) for asymptomatic patients, independent of unfavorable risk factors (anatomic or physiologic); in patients >/=80 years, this rate was 10.5% (95% CI, 6.3% to 16.0%) and 4.4% (95% CI, 3.3% to 5.7%), respectively. In subjects with anatomic features unfavorable for surgery, the 30-day death and stroke rates were 1.7% (95% CI, 0.0% to 8.9%) and 2.7% (95% CI, 1.3% to 4.9%) for symptomatic and asymptomatic cohorts, respectively, independent of age.
Conclusions:
Outcomes for carotid artery stenting in nonoctogenarian high-surgical-risk patients have improved since the pivotal Food and Drug Administration approval trials, and have achieved American Heart Association standards in both symptomatic and asymptomatic lesions.