CURRENT STATUS OF CAROTID STENTING: A COMPARATIVE STUDY WITH CAROTID ENDATERECTOMY POST‐CMS APPROVAL

Persistent Link:
http://hdl.handle.net/10150/528196
Title:
CURRENT STATUS OF CAROTID STENTING: A COMPARATIVE STUDY WITH CAROTID ENDATERECTOMY POST‐CMS APPROVAL
Author:
Hickle, Kelli
Affiliation:
The University of Arizona College of Medicine - Phoenix
Issue Date:
10-Apr-2015
Rights:
Copyright © is held by the author. Digital access to this material is made possible by the College of Medicine - Phoenix, University of Arizona. Further transmission, reproduction or presentation (such as public display or performance) of protected items is prohibited except with permission of the author.
Collection Information:
This item is part of the College of Medicine - Phoenix Scholarly Projects 2015 collection. For more information, contact the Phoenix Biomedical Campus Library at pbc-library@email.arizona.edu.
Publisher:
The University of Arizona.
Abstract:
In 2005, Centers for Medicare and Medicaid Services (CMS) expanded eligibility criteria for patients to receive carotid artery stenting (CAS) as an alternative to carotid endarterectomy (CEA). The goal of this study is to examine the outcomes of wider utilization of CAS and the sustainability of favorable outcomes reported in pre-marketing FDA approval trials. A cohort of 169 patients undergoing either CEA or CAS, at two institutions with CMS approval, and experience in both procedures was retrospectively analyzed for outcomes and their determinants. From 2007 to 2012, patients underwent either CEA (n = 70) or CAS (n = 99) at one of two institutions selected for study. The two groups had similar baseline characteristics with the exception of more symptomatic patients in the CEA group (55.7% CEA vs. 17.2 % CAS; p < 0.001) and previous stroke or transient ischemic attack (TIA) (72.5% CEA vs. 39.4%; p < 0.001). Lesion characteristics between the two groups differed in terms of the presence of a thrombus (16.0% CEA vs. 2.02% CAS; p = 0.002), stenosis 2: 80% (69.6% CEA vs. 95.0% CAS; p < 0.001) and length of lesion 2: 2cm (70.6% CEA vs. 24.4% CAS; p < 0.001). Major adverse events within 30-days of the procedure were higher in the CAS group (0% CEA vs. 5.05% CAS; p = 0.077), but not statistically significant. Three of the five patients who suffered a major adverse event had a stroke; all three patients were 2:80 years old, asymptomatic, and had 2: 80% stenosis. Acute neurologic events, including strokes and TIAs, were higher in the CAS group (1.4% CEA vs. 12.1% CAS; p = 0.016). No myocardial infarction occurred in either group. Minor adverse events occurred in 49.5% of CAS and 7.1% of CEA patients (p < 0.001). When total minor adverse events were subdivided by event type and analyzed, only hemodynamic instability was significantly different between the CEA and CAS group (1.4% CEA versus 41.4% CAS; p < 0.001). Asymptomatic CAS patients with high-grade stenosis (2: 80%) had more hemodynamic instability (p < 0.001) compared to matched CEA patients. Hemodynamic instability in CAS procedures correlated with embolic protection device performance issues (p = 0.004), successful stent placement (p = 0.018), and post-stenting dilation (p < 0.001). Post-market, real-world utilization of CAS results in higher rates of neurologic events and hemodynamic instability. However, overall stroke rate was comparable to that reported in pre-marketing FDA approval trials. CEA or CAS can be offered with a stroke rate ≤3% at institutions with large experience. CEA should remain the procedure of choice for asymptomatic carotid stenosis, particularly in elderly patients. Hemodynamic instability is a minor, but important, adverse event associated with CAS and should be further investigated.
MeSH Subjects:
Stents; Carotid; Endarterectomy, Carotid; Centers for Medicare and Medicaid Services (U.S.)
Description:
A Thesis submitted to The University of Arizona College of Medicine - Phoenix in partial fulfillment of the requirements for the Degree of Doctor of Medicine.
Mentor:
Shennib, Hani MD

Full metadata record

DC FieldValue Language
dc.language.isoen_USen
dc.titleCURRENT STATUS OF CAROTID STENTING: A COMPARATIVE STUDY WITH CAROTID ENDATERECTOMY POST‐CMS APPROVALen_US
dc.contributor.authorHickle, Kellien
dc.contributor.departmentThe University of Arizona College of Medicine - Phoenixen
dc.date.issued2015-04-10en
dc.rightsCopyright © is held by the author. Digital access to this material is made possible by the College of Medicine - Phoenix, University of Arizona. Further transmission, reproduction or presentation (such as public display or performance) of protected items is prohibited except with permission of the author.en
dc.description.collectioninformationThis item is part of the College of Medicine - Phoenix Scholarly Projects 2015 collection. For more information, contact the Phoenix Biomedical Campus Library at pbc-library@email.arizona.edu.en
dc.publisherThe University of Arizona.en
dc.description.abstractIn 2005, Centers for Medicare and Medicaid Services (CMS) expanded eligibility criteria for patients to receive carotid artery stenting (CAS) as an alternative to carotid endarterectomy (CEA). The goal of this study is to examine the outcomes of wider utilization of CAS and the sustainability of favorable outcomes reported in pre-marketing FDA approval trials. A cohort of 169 patients undergoing either CEA or CAS, at two institutions with CMS approval, and experience in both procedures was retrospectively analyzed for outcomes and their determinants. From 2007 to 2012, patients underwent either CEA (n = 70) or CAS (n = 99) at one of two institutions selected for study. The two groups had similar baseline characteristics with the exception of more symptomatic patients in the CEA group (55.7% CEA vs. 17.2 % CAS; p < 0.001) and previous stroke or transient ischemic attack (TIA) (72.5% CEA vs. 39.4%; p < 0.001). Lesion characteristics between the two groups differed in terms of the presence of a thrombus (16.0% CEA vs. 2.02% CAS; p = 0.002), stenosis 2: 80% (69.6% CEA vs. 95.0% CAS; p < 0.001) and length of lesion 2: 2cm (70.6% CEA vs. 24.4% CAS; p < 0.001). Major adverse events within 30-days of the procedure were higher in the CAS group (0% CEA vs. 5.05% CAS; p = 0.077), but not statistically significant. Three of the five patients who suffered a major adverse event had a stroke; all three patients were 2:80 years old, asymptomatic, and had 2: 80% stenosis. Acute neurologic events, including strokes and TIAs, were higher in the CAS group (1.4% CEA vs. 12.1% CAS; p = 0.016). No myocardial infarction occurred in either group. Minor adverse events occurred in 49.5% of CAS and 7.1% of CEA patients (p < 0.001). When total minor adverse events were subdivided by event type and analyzed, only hemodynamic instability was significantly different between the CEA and CAS group (1.4% CEA versus 41.4% CAS; p < 0.001). Asymptomatic CAS patients with high-grade stenosis (2: 80%) had more hemodynamic instability (p < 0.001) compared to matched CEA patients. Hemodynamic instability in CAS procedures correlated with embolic protection device performance issues (p = 0.004), successful stent placement (p = 0.018), and post-stenting dilation (p < 0.001). Post-market, real-world utilization of CAS results in higher rates of neurologic events and hemodynamic instability. However, overall stroke rate was comparable to that reported in pre-marketing FDA approval trials. CEA or CAS can be offered with a stroke rate ≤3% at institutions with large experience. CEA should remain the procedure of choice for asymptomatic carotid stenosis, particularly in elderly patients. Hemodynamic instability is a minor, but important, adverse event associated with CAS and should be further investigated.en
dc.typeThesisen
dc.subject.meshStentsen
dc.subject.meshCarotiden
dc.subject.meshEndarterectomy, Carotiden
dc.subject.meshCenters for Medicare and Medicaid Services (U.S.)en
dc.descriptionA Thesis submitted to The University of Arizona College of Medicine - Phoenix in partial fulfillment of the requirements for the Degree of Doctor of Medicine.en
dc.contributor.mentorShennib, Hani MDen
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