Dataset Information

Diabetes Mellitus and Clinical Outcomes in Carotid Artery Revascularization Using Second-Generation, MicroNet-Covered Stents: Analysis from the PARADIGM Study.

ABSTRACT:

Introduction

Carotid artery stenting (CAS) using conventional (single-layer) stents is associated with worse clinical outcomes in diabetes mellitus (DM) vs. non-DM patients: an effect driven largely by lesion-related adverse events. CAS outcomes with MicroNet-covered stents (MCS) in diabetic patients have not been evaluated.

Aim

To compare short- and long-term clinical outcomes and restenosis rate in DM vs. non-DM patients with carotid stenosis treated using MCS.

Materials and methods

In a prospective study in all-comer symptomatic and increased-stroke-risk asymptomatic carotid stenosis, 101 consecutive patients (age 51-86 years, 41% diabetics) underwent 106 MCS-CAS. Clinical outcomes and duplex ultrasound velocities were assessed periprocedurally and at 30 days/12 months.

Results

Baseline characteristics of DM vs. non-DM patients were similar except for a higher prevalence of recent cerebral symptoms in DM. Type 1 and type 1+2 plaques were more prevalent in DM patients (26.7% vs. 9.8%, p = 0.02; 62.2% vs. 37.7%, p = 0.01). Proximal embolic protection was more prevalent in DM (60% vs. 36%; p = 0.015). 30-day clinical complications were limited to a single periprocedural minor stroke in DM (2.4% vs. 0%, p = 0.22). 12-month in-stent velocities and clinical outcomes were not different (death rate 4.8% vs. 3.3%; p = 0.69; no new strokes). Restenosis rate was not different (0% vs. 1.7%, p = 0.22).

Conclusions

MCS may offset the adverse impact of DM on periprocedural, 30-day, and 12-month clinical complications of CAS and minimize the risk of in-stent restenosis. In this increased-stroke-risk cohort, adverse event rate was low both in DM and non-DM. Further larger-scale clinical datasets including extended follow-ups are warranted.

SUBMITTER: Mazurek A

PROVIDER: S-EPMC9529505 | biostudies-literature | 2022

REPOSITORIES: biostudies-literature

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Publications

Diabetes Mellitus and Clinical Outcomes in Carotid Artery Revascularization Using Second-Generation, MicroNet-Covered Stents: Analysis from the PARADIGM Study.

Mazurek Adam A Borratynska Anna A Gancarczyk Urszula U Czyz Lukasz L Sikorska Martyna M Tekieli Lukasz L Sobien Bartosz B Jakiel Marcin M Trystula Mariusz M Drazkiewicz Tomasz T Podolec Piotr P Musialek Piotr P

Journal of diabetes research 20220926

<h4>Introduction</h4>Carotid artery stenting (CAS) using conventional (single-layer) stents is associated with worse clinical outcomes in diabetes mellitus (DM) vs. non-DM patients: an effect driven largely by lesion-related adverse events. CAS outcomes with MicroNet-covered stents (MCS) in diabetic patients have not been evaluated.<h4>Aim</h4>To compare short- and long-term clinical outcomes and restenosis rate in DM vs. non-DM patients with carotid stenosis treated using MCS.<h4>Materials and ...[more]

PMID: 36200003

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Project description:BackgroundThe presence of a contralateral carotid occlusion (CCO) is an established high-risk feature for patients undergoing carotid endarterectomy (CEA) and is traditionally an indication for carotid artery stenting (CAS). Recent observational data have called into question whether CCO remains a high-risk feature for CEA.ObjectivesThe purpose of this study was to determine the clinical impact of CCO among patients undergoing CEA and CAS in a contemporary nationwide registry.MethodsAll patients undergoing CEA or CAS from 2007 to 2019 in the NCDR CARE (National Cardiovascular Data Registry Carotid Artery Revascularization and Endarterectomy) and PVI (Peripheral Vascular Intervention) registries were included. The primary exposure was the presence of CCO. The outcome was a composite of in-hospital death, stroke, and myocardial infarction. Multivariable logistic regression and inverse-probability of treatment weighting were used to compare outcomes.ResultsAmong 58,423 patients who underwent carotid revascularization, 4,624 (7.9%) had a CCO. Of those, 68.9% (n = 3,185) underwent CAS and 31.1% (n = 1,439) underwent CEA. The average age of patients with CCO was 69.5 ± 9.7 years, 32.6% were women, 92.8% were Caucasian, 51.7% had a prior transient ischemic attack or stroke, and 45.4% presented with symptomatic disease. Over the study period, there was a 41.7% decrease in the prevalence of CCO among patients who underwent carotid revascularization (p < 0.001), but CAS remained the primary revascularization strategy. Unadjusted composite outcome rates were lower in patients with CCO after CAS (2.1%) than CEA (3.6%). Following adjustment, CCO was associated with a 71% increase in the odds of an adverse outcome after CEA (95% confidence interval: 1.27 to 2.30; p < 0.001) compared with no increase after CAS (adjusted odds ratio: 0.94; 95% confidence interval: 0.72 to 1.22; p = 0.64).ConclusionsCCO remains an important predictor of increased risk among patients undergoing CEA, but not CAS.

Project description:BackgroundIn appropriately selected patients with severe carotid stenosis, carotid revascularization reduces ischemic stroke. Prior clinical research has focused on the efficacy and safety of carotid revascularization, but few investigators have considered readmission as a clinically important outcome.ObjectivesThe aims of this study were to examine frequency, timing, and diagnoses of 30-day readmission following carotid revascularization; to assess differences in 30-day readmission between patients undergoing carotid endarterectomy (CEA) and carotid artery stenting (CAS); to describe hospital variation in risk-standardized readmission rates (RSRR); and to examine whether hospital variation in the choice of procedure (CEA vs. CAS) is associated with differences in RSRRs.MethodsWe used Medicare fee-for-service administrative claims data to identify acute care hospitalizations for CEA and CAS from 2009 to 2011. We calculated crude 30-day all-cause hospital readmissions following carotid revascularization. To assess differences in readmission after CAS compared with CEA, we used Kaplan-Meier survival curves and fitted mixed-effects logistic regression. We estimated hospital RSRRs using hierarchical generalized logistic regression. We stratified hospitals into 5 groups by their proportional CAS use and compared hospital group median RSRRs.ResultsOf 180,059 revascularizations from 2,287 hospitals, CEA and CAS were performed in 81.5% and 18.5% of cases, respectively. The unadjusted 30-day readmission rate following carotid revascularization was 9.6%. Readmission risk after CAS was greater than that after CEA. There was modest hospital-level variation in 30-day RSRRs (median: 9.5%; range 7.5% to 12.5%). Variation in proportional use of CAS was not associated with differences in hospital RSRR (range of median RSRR across hospital groups 9.49% to 9.55%; p = 0.771).ConclusionsAlmost 10% of Medicare patients undergoing carotid revascularization were readmitted within 30 days of discharge. Compared with CEA, CAS was associated with a greater readmission risk. However, hospitals' RSRR did not differ by their proportional CAS use.

Dataset Information

Diabetes Mellitus and Clinical Outcomes in Carotid Artery Revascularization Using Second-Generation, MicroNet-Covered Stents: Analysis from the PARADIGM Study.

Introduction

Aim

Materials and methods

Results

Conclusions

Publications

Diabetes Mellitus and Clinical Outcomes in Carotid Artery Revascularization Using Second-Generation, MicroNet-Covered Stents: Analysis from the PARADIGM Study.

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