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Updated: Jan 20, 2026
Design of a Biocompatible Drug-Eluting Tracheal Stent in Mice with Laryngotracheal Stenosis
Published on: January 21, 2020
Peri-procedural stroke or death in stenting of symptomatic severe intracranial stenosis
Shadi Yaghi1, Pooja Khatri2, Adam de Havenon3
1Department of Neurology, New York Langone Health, New York, NY, USA.
Insights
In patients with symptomatic intracranial atherosclerosis undergoing stenting, smoking status and lesion length were modest predictors of 30-day stroke or death. However, these factors and FDA indication did not reliably predict outcomes, necessitating further research for better biomarkers.
Area of Science:
- Neurology
- Cardiovascular Research
- Interventional Cardiology
Background:
- Symptomatic intracranial atherosclerosis (sICAS) poses a risk for stroke.
- Stenting is a treatment option for sICAS, but predictors of post-procedural stroke or death are not well-established.
- Limited data exist on factors influencing 30-day outcomes after stenting for sICAS.
Purpose of the Study:
- To identify predictors of 30-day stroke or death in patients with sICAS undergoing stenting.
- To analyze patient-specific, lesion-specific, and procedure-specific variables.
- To evaluate the association of FDA-approved indications with outcomes.
Main Methods:
- Post-hoc analysis of the SAMMPRIS trial (stenting arm).
- Comparison of variables between patients with and without the primary outcome (30-day stroke or death).
- Logistic regression analysis to assess associations with the primary outcome.
Main Results:
- Smoking status and lesion length were associated with increased odds of 30-day stroke or death.
- Non-smokers had higher odds of stroke/death compared to smokers (adjusted OR 4.46).
- Increasing lesion length correlated with higher event odds (adjusted OR 1.20); event rates did not differ significantly based on FDA indication.
Conclusions:
- Neither clinical/neuroimaging variables nor FDA indication reliably predicted 30-day stroke or death in SAMMPRIS patients undergoing stenting.
- Further research is needed to identify reliable biomarkers for stroke/death in sICAS patients.
- This finding has implications for future clinical trial design in sICAS stenting.
Background And Purpose:
There are limited data on predictors of 30-day stroke or death in patients with symptomatic intracranial atherosclerosis (sICAS) undergoing stenting. We aim to determine the factors associated with stroke or death at 30 days in the stenting arm of the SAMMPRIS trial.
Methods:
This is a post-hoc analysis of the SAMMPRIS trial including patients who underwent angioplasty/stenting. We compared patient-specific variables, lesion-specific variables, procedure-specific variables, and FDA-approved indications between patients with and without the primary outcome (stroke or death at 30 days). Logistic regression analyses were performed to evaluate associations with the primary outcome.
Results:
We identified 213 patients, 30 of whom (14.1%) met the primary outcome. Smoking status and lesion length were associated with the primary outcome: the odds of stroke or death for non-smokers versus smokers (adjusted OR 4.46, 95% CI 1.79 to 11.1, p=0.001) and for increasing lesion length in millimeters (adjusted OR 1.20, 95% CI 1.02 to 1.39, p=0.029). These had a modest predictive value: absence of smoking history (sensitivity 66.7%, specificity 65.4%) and lesion length (area under curve 0.606). Furthermore, event rates were not significantly different between patients with and without the FDA-approved indication for stenting (15.9% vs 12%, p=0.437).
Conclusion:
In SAMMPRIS patients who underwent angioplasty/stenting, neither clinical and neuroimaging variables nor the FDA indication for stenting reliably predicted the primary outcome. Further work in identifying reliable biomarkers of stroke/death in patients with sICAS is needed before considering new clinical trials of stenting.
Trial Registration Number:
SAMMPRIS NCT00576693; Results.
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