BlueCross and BlueShield of Montana Medical Policy/Codes
Extracranial Carotid Artery Stenting/Angioplasty
Chapter: Surgery: Procedures
Current Effective Date: October 25, 2013
Original Effective Date: May 01, 2006
Publish Date: October 25, 2013
Revised Dates: March 5, 2010; July 3, 2012; September 30, 2013
Description

Carotid artery angioplasty with stenting (CAS) is a treatment for carotid stenosis that is intended to prevent future stroke.  When an angioplasty is performed, a small balloon at the end of a catheter is inflated in the blood vessel at the blocked area.  The balloon pushes against the build-up of plaque and compresses or flattens it.  At the same time the balloon widens the blood vessel, the blocked vessel opens up and restores blood flow.  If a stent is used, it expands to the size and shape of the artery wall, designed to open the artery, restore blood flow and prevent future blockages. 

Combined with optimal medical management, carotid angioplasty with or without stenting has been evaluated as an alternative to carotid endarterectomy (CEA).  Carotid angioplasty and stenting (CAS) involves the introduction of coaxial systems of catheters, microcatheters, balloons, and other devices through the femoral artery and into the carotid artery.  The procedure typically takes 20–40 minutes.  Interventionalists almost uniformly use an embolic protection device (EPD) designed to reduce the risk of stroke caused by thromboembolic material dislodged during CAS.  Carotid angioplasty rarely is performed without stent placement. 

Proposed advantages of CAS over CEA include:

  • General anesthesia is not used (although CEA can be performed under local or regional anesthesia);
  • Cranial nerve palsies are infrequent sequelae (although almost all following CEA resolve over time);
  • Simultaneous procedures may be performed on the coronary and carotid arteries.

The U.S. Food and Drug Administration (FDA) have approved carotid artery stents and EPDs from various manufacturers.  Examples include:

  • Acculink™ and RX Acculink™ carotid stents and Accunet™ and RX Accunet™ cerebral protection filters, Guidant Corporation (approved August 2004);
  • Xact® RX carotid stent system and Emboshield® embolic protection system, Abbott Vascular Devices (approved September 2005);
  • Precise® nitinol carotid stent system and AngioGuard™ XP and RX emboli capture guidewire systems, Cordis Corporation (approved September 2006);
  • NexStent® carotid stent over-the-wire and monorail delivery systems, Endotex Interventional Systems; and FilterWire EZ™ embolic protection system, Boston Scientific Corporation (approved October 2006);
  • ProtégéRx® and SpideRx®, ev3 Inc, Arterial Evolution Technology.  (approved January 2007);
  • Carotid Wallstent®, Boston Scientific Corporation (approved October 2008);
  • GORE® Flow Reversal System (clearance February 2009);
  • Mo.Ma® Ultra Proximal Cerebral Protection Device, Invatec S.P.A. (clearance October 2009).

Each FDA-approved carotid stent is indicated for combined use with an EPD to reduce risk of stroke in patients considered to be at increased risk for periprocedural (occurring just before, during, or just after a medical procedure) complications from CEA who are symptomatic with greater than 50% stenosis, or asymptomatic with greater than 80% stenosis—degree of stenosis being assessed by ultrasound or angiogram with computed tomography (CT) angiography also sometimes used.  Patients are considered at increased risk for complications during CEA if affected by any item from a list of anatomic features and comorbid conditions included in each stent system’s “Information for Prescribers”.

The RX Acculink Carotid Stent System is also approved for use in conventional risk patients (not considered at increased risk for complications during CEA) with symptoms and ≥70% stenosis by ultrasound or ≥50% stenosis by angiogram, and asymptomatic patients with ≥70% stenosis by ultrasound or ≥60% stenosis by angiogram.

FDA-approved stents and EPDs differ in the deployment methods used once they reach the target lesion, with the RX (rapid exchange) devices designed for more rapid stent and filter expansion.  The Precise and AngioGuard devices were studied in a randomized, controlled trial (RCT).  Other devices were approved based on uncontrolled, single-arm trials or registries and comparison to historical controls.  The FDA has mandated postmarketing studies for these devices, including longer follow-up for patients already reported to the FDA and additional registry studies, primarily to compare outcomes as a function of clinician training and facility experience.  Each manufacturer’s system is available in various configurations (e.g., straight or tapered) and sizes (diameters and lengths) to match the vessel lumen that will receive the stent.

Policy

Each benefit plan, summary plan description or contract defines which services are covered, which services are excluded, and which services are subject to dollar caps or other limitations, conditions or exclusions.  Members and their providers have the responsibility for consulting the member's benefit plan, summary plan description or contract to determine if there are any exclusions or other benefit limitations applicable to this service or supply.  If there is a discrepancy between a Medical Policy and a member's benefit plan, summary plan description or contract, the benefit plan, summary plan description or contract will govern.

Coverage

Carotid angioplasty with associated stenting and embolic protection may be considered medically necessary in patients with:

  • 50–99% stenosis (NASCET [North American Symptomatic Carotid Endarterectomy Trial] measurement); AND
  • Symptoms of focal cerebral ischemia (transient ischemic attack [TIA] or monocular blindness) in previous 120 days, symptom duration less than 24 hours, or nondisabling stroke; AND
  • Anatomic contraindication for carotid endarterectomy (CEA), such as prior radiation treatment or neck surgery, lesions surgically inaccessible, spinal immobility, or tracheostomy.

Carotid angioplasty with or without associated stenting and embolic protection is considered experimental, investigational and unproven for all other indications, including but not limited to, patients with carotid stenosis who are suitable candidates for CEA and patients with carotid artery dissection.

Rationale

Risk/benefit ratio of invasive carotid procedures

Endovascular carotid angioplasty and stenting (CAS) or surgical endarterectomy (CEA) for carotid artery disease trades procedure-related harms of stroke and death for the benefit of reduced stroke risk over subsequent years—the balance determines whether either intervention will result in a net clinical benefit.  That balance has been scrutinized for CEA although not for CAS; accordingly results from trials of CEA must be extrapolated to CAS.

A series of landmark clinical trials from the late 1980s through the 1990s compared the benefits and harms of CEA to best medical therapies then available in symptomatic and asymptomatic individuals with carotid artery stenosis (North American Symptomatic Carotid Endarterectomy Trial Collaborators, 1991; MRC European Carotid Surgery Trial Collaborators, 1991; Mayberg, 1991; Executive Committee for the Asymptomatic Carotid Athereosclerosis Study, 1995; MRC European Carotid Surgery Trial Collaborators, 1998; Barnett, 1998; Halliday, 2004).  The trial results defined the magnitude of risk reduction for stroke, and periprocedural stroke and death rates that can be traded to achieve a net clinical benefit or benefit outweighing harm—30 day rates less than 3% for asymptomatic (greater than 60% stenosis), and less than 6% for symptomatic patients (50–69% or 70–99% stenosis).  Furthermore, because periprocedural harms are immediate but benefit is accrued over time, a net clinical benefit is obtained only in those patients surviving long enough to counterbalance the immediate harms.  The necessary life expectancy was defined by the trial duration needed to demonstrate benefit—two years for symptomatic patients with 70–99% stenosis, five years for symptomatic patients with 50–69% stenosis or asymptomatic patients with greater than 60% stenosis (summarized in the following Table). 

Symptoms

 

Stenosis (%)

 

Acceptable Periprocedural Death/Stroke Rate, %

 

Anticipated Life Expectancy, yr

 

No

60–99

<3%

 

Yes

 

50–69 

<6%

70–99

<6%

 

As an example of the fine line between benefit and harm, Arazi (2008) performed a decision analysis of benefit for patients with asymptomatic stenosis using a base case derived from the Asymptomatic Carotid Surgery Trial (ACST) (periprocedural death or stroke rate of 1.8%) Halliday, 2004).  As discussed in paper from Halliday et al., over a five year time horizon, CEA provided four days of stroke-free survival and a net harm when periprocedural death/disabling stroke rates exceeded 2.1% (Halliday, 2004).

Since the landmark trials were performed, there have been considerable improvements in medical care and evidence of substantial decline in stroke rates with medical care in asymptomatic carotid disease (Marquardt, 2010; Naylor, 2008).  Current medical therapies including aggressive lipid lowering were inconsistently used in the landmark trials.  While indirect, evidence for impact of improved medical care supports a perspective that guidelines for periprocedural death or stroke rates reflect upper limits needed to obtain a net clinical benefit.  Surgeons in contemporary clinical trials have also achieved CEA periprocedural death and stroke rates lower than those in pivotal trials.  For example, in the Carotid Revascularization Endarterectomy versus Stenting Trial (CREST), (Brott, 2010) the death or stroke rates for symptomatic patients was 3.2% and for asymptomatic patients was 1.4%. Accordingly, benchmarks established decades ago might no longer be appropriate upper bounds.

Excluded from landmark CEA trials were patients with significant comorbidities such as those judged likely to cause death within five years that might also increase periprocedural and anesthetic risk for complications.  Therefore, CAS has appeal as a treatment option for patients with potentially higher periprocedural risk due to medical or anatomic reasons (e.g., medical factors include severe cardiac dysfunction, requirement for combined coronary and carotid revascularization, severe renal or pulmonary dysfunction, and other characteristics associated with increased surgical risk; anatomic factors include surgically inaccessible stenosis, prior radiation, prior neck surgery, spinal immobility, prior laryngeal nerve palsy, contralateral occlusion, prior ipsilateral CEA, restenosis after CEA).

Although general anesthetic risk is considered a potential reason to use CAS, CEA can typically be safely performed under local or regional anesthesia, (Jordan, 1998) as confirmed by Lewis et al. in the 95-center General Anesthesia versus Local Anesthesia (GALA) trial (Lewis, 2008).  Investigators randomized 3,526 patients undergoing CEA to general or local anesthesia and found no difference in 30-day death, stroke or myocardial infarction (MI) rates according to anesthetic approach (risk ratio [RR]: 0.94; 95% confidence interval [CI]: 0.70 to 1.3) (Lewis, 2008).

Randomized controlled trials of CAS versus CEA

SAPPHIRE:  The first major RCT of CAS versus CEA was the Stenting and Angioplasty, with Protection in Patients at High Risk for Endarterectomy (SAPPHIRE) trial (Yadav, 2004).  The relevant conclusions are summarized as follows:

  • SAPPHIRE included few patients with symptomatic stenosis at increased risk for periprocedural complications from CEA (n=96), which resulted in wide confidence intervals; differences between arms in 30-day and one year outcomes were not statistically significant.
  • For patients with asymptomatic stenosis at increased risk for periprocedural complications from CEA, differences in 30-day outcomes also had wide confidence intervals and were not statistically significant.  While there were significant differences in one year outcomes favoring CAS with embolic protection device (EPD) for this indication, the adequacy of one year’s follow-up duration was questionable, since durability of benefits from CAS with EPD was unknown, and since the time to benefit relative to medical management is long when surgical risks are high.  Furthermore, publicly available data reviewed by the FDA but not included in the published trial report suggested more frequent restenosis at two years in the CAS with EPD arm.
  • Early study closure resulted in fewer study patients than planned, which compromised the evaluation of non inferiority.
  • Variance in differential complication rates for the two treatments across sites may have influenced results, since five of 34 sites contributed 64% of randomized patients, and data were unavailable for comparison.
  • Also, direct comparative evidence was lacking for optimal medical management alone as an alternative to adding CAS with EPD or CEA for patients with increased risk of surgical complications.
  • Long-term follow-up of SAPPHIRE was reported in 2008 at three years (Eckstein, 2008; Gurm, 2008; Mas, 2008).  For asymptomatic and symptomatic patients combined, ipsilateral strokes from day 31 to 1,080 days were observed in 4.4% of patients undergoing CAS and 3.6% with CEA (from digitized figure).  Two-year restenosis rates greater than 50% reported to the FDA in SAPPHIRE were 17.3% following CAS and 13.3% after CEA (studies obtained in 75 patients undergoing CAS in 45 CEA cases).

SPACE:  In 2006, the Stent-supported Percutaneous Angioplasty of the Carotid Artery versus Endarterectomy (SPACE) trial was published.  

  • This trial, reported by Ringleb et al., randomized 1,200 patients within 180 days of neurologic symptoms, transient ischemic attack (TIA), or moderate (non-disabling) stroke, and with ≥50% stenosis of the ipsilateral carotid artery, to CAS (N=605) with or without EPD (73% of procedures performed without), or CEA (N=595) (Ringleb, 2006).  The analysis (N=1,183) failed to conclude that CAS was non inferior to CEA by a margin of 2.5% for the primary outcome of ipsilateral ischemic stroke or death by 30 days after randomization.  Periprocedural (30-day) event rates were 6.8% for the CAS group and 6.3% for the CEA group.  The absolute between-group difference favored CEA and was 0.5% (90% CI: -1.9% to 2.9%) by intent-to-treat (ITT) analysis and 1.3% (90% CI: -1.1 to 3.8) in per-protocol analysis. 
  • Editorialists (Naylor, 2006; Furlan, 2006) pointed to some methodologic issues raised with SPACE, including the high rate of rejection for potential participating collaborators (approximately 25%, based on their prior outcomes records, but review criteria were not reported), and the trial did not require use of an EPD with CAS (although 30-day event rates were 7.3% with vs. 6.7% without EPD).
  • Long-term follow-up of the SPACE study was reported in 2008 at two years (Eckstein, 2008; Gurm, 2008; Mas, 2008).  Approximate annual ipsilateral stroke rates from day 31 through longest follow-up for CAS and CEA, respectively, were 0.4% and 0.4%.  These results support a conclusion that following the periprocedural period (i.e., 31 days to longest follow-up), stroke risk reduction in symptomatic patients not selected for medical or anatomic comorbidities is similar with either CAS or CEA.  Recurrent stenosis greater than 70% was more frequent two years following CAS versus CEA (10.7% vs. 4.6%, respectively).

EVA-3S:  The Endarterectomy Versus Stenting in patients with Symptomatic Severe carotid Stenosis (EVA-3S) trial by Mas et al. was a non inferiority comparison of CAS (with EPD in 92%) versus CEA in symptomatic patients at average risk for complications from CEA with ≥60% stenosis of the ipsilateral carotid artery (Mas, 2006). 

  • The trial was terminated prematurely (N=527 enrolled; original target N=872), based on interim analysis of 30-day outcomes.  The incidence of any stroke or death through 30 days was 3.9% (95% CI: 2.0% to 7.2%) after CEA and 9.6% (95% CI: 6.4% to 14%) after CAS (RR: 2.5; 95% CI: 1.2% to 5.1%; p=0.01).
  • Long-term follow-up of EVA-3S was reported in 2008 at four years (Eckstein, 2008; Gurm, 2008; Mas, 2008).  Approximate annual ipsilateral stroke rates from day 31 through longest follow-up for CAS and CEA, respectively, were 1.1% and 0.9%.  These results support a conclusion that following the periprocedural period (i.e., 31 days to longest follow-up) stroke risk reduction in symptomatic patients not selected for medical or anatomic comorbidities is similar with either CAS or CEA.
  • Editorialists (Naylor, 2006; Furlan, 2006) criticized EVA-3S for recommending but not requiring, antiplatelet premedication (three days of aspirin plus either ticlopidine or clopidogrel) and for not requiring interventionalists to be adequately experienced with the specific stent and EPD devices they used to treat trial subjects.  Participating interventionalists were required to have successfully completed 12 or more CAS procedures, compared with 25 or more CEAs for vascular surgeons.  EVA-3S also permitted use of five different stents and seven different EPDs but required only two prior procedures with a new device before an investigator could use that device on a patient randomized to CAS.

ICSS:  The International Carotid Stenting Study (22) (Erdele, 2010) enrolled 1,713 symptomatic patients at 50 academic medical centers across Europe, Australia, New Zealand, and Canada between May 2001 and October 2008.

  • EPDs were recommended but not required (utilized in 72% of procedures), and a number of different stents and EPD types were used.  Based on plausible event rates, a target study sample size of 1,500 was estimated able to define a between-group difference less than 3.3% in disabling stroke or death, but also a 3.0% difference in 30-day stroke, death, or MI.  Only interim 30- and 120-day results were included in the initial report.  From a per-protocol analysis, the 7.1% periprocedural death or stroke death rates accompanying CAS both exceed the rate established to provide a net clinical benefit and was more than twice that following CEA (3.4%).  
  • In the Bonati et al. sub study of 231 ICSS participants, new ischemic brain lesions were approximately three-fold more frequent following CAS—protection devices did not appear to mitigate their occurrence (Bonati, 2010).  While follow-up of the sample for the primary endpoint is ongoing, interim results are consistent with the accompanying editorialist’s (Rothwall) conclusion that “routine stenting in symptomatic patients must now be difficult to justify….”(Rothwall, 2010).

CREST:  The Carotid Revascularization Endarterectomy versus Stenting Trial reported by Brott (2010) was conducted between December 2000 and July 2008, enrolling 2,522 patients at 117 centers across the U.S. and Canada.

  • From Hopkins et al. of 427 interventionalists who applied to participate in CREST, only 224 (52%) were ultimately approved (Hopkins, 2010).  Inclusion was initially restricted to recently symptomatic patients; due to slow enrollment, the protocol was amended to include asymptomatic patients.  A March 2004 protocol amendment excluded further enrollment of patients 80 years and older due to poor outcomes.  Of the 1,271 patients randomized to CAS, 65 underwent CEA and 54 neither procedure; of the 1,251 patients randomized to CEA, 13 underwent CAS and 44 neither procedure.  There were 20 patients excluded from one site due to reported data fabrication.  A sample size of 2,500 was targeted to detect a 46% reduction in the hazard ratio for the primary endpoint of any death, stroke, or MI during the periprocedural period or ipsilateral stroke within four years after randomization.
  • In the entire sample (symptomatic and asymptomatic patients), investigators reported no difference between CAS and CEA for the primary outcome of any periprocedural death, stroke, or MI, or postprocedural ipsilateral stroke.  Stroke was more frequent following CAS, MI after CEA.  The periprocedural MI rate after CEA (2.3%) was considerably higher in CREST than any comparable trial (e.g., in EVA-3S 0.8%, SPACE 0%, ICSS 0.6%).  This may be attributable to a somewhat higher prevalence of coronary artery disease among participants and routine cardiac enzyme assays, but the relative difference was large.  Periprocedural CAS death or stroke rates were the lowest reported in any trial.  Although participating interventionalists performing CAS were highly selected, periprocedural death or stroke rates following CAS exceeded those for CEA: in symptomatic patients 5.6% versus 2.4%, respectively (the lowest rate for CAS reported in any trial); in asymptomatic patients 2.6% versus 1.4%, respectively, as reported by Silver (2011).  The RR for periprocedural death/stroke in the symptomatic group was 1.89 (95% CI: 1.11 to 3.21) in the asymptomatic group 1.85 (95% CI: 0.79 to 4.34).  The trial had limited power to detect a difference between procedures in the asymptomatic group.
  • In a paper from Roffi et al.  interventionalists in CREST were the most carefully selected in any trial, and the lack of similar careful selection has been a critique expressed concerning the other trials (Roffi, 2010).  However, analyses of CAS in Medicare patients between 2005 and 2007 found that few CAS operators had the experience of CREST investigators (Nallamothu, 2011).  Among the 11,846 procedures where operator experience was documented, 68% were performed by operators having performed fewer than 12 procedures.

Conclusions: The available RCTs enroll a mix of symptomatic and asymptomatic patients and have different selection criteria for participating centers.  

  • Results of these RCTs report that early complications of CAS exceed that of CEA.  
  • Following the early perioperative period, the subsequent rate of ipsilateral and/or TIA appear to be similar for the two procedures.
  • The restenosis rate, however, is higher with CAS compared to CEA.
  • The rates of early complications in these trials exceed the threshold that has been set to denote overall benefit.
  • There is some variability in the results of these trials.  For example, results from CREST were more favorable for CAS than those reported from the SPACE, EVA-3S, or ICSS.
  • Periprocedural death or stroke rates with CAS were lower than 6% in symptomatic and 3% in asymptomatic patients.
  • Interventionalists in CREST were the most carefully selected in any trial.
  • There are no randomized controlled trial (RCT)s of CAS versus medical therapy.  
  • Since the pivotal CEA versus medical therapy trials, there have been marked improvements in medical therapy and declining stroke rates in asymptomatic patients with carotid stenosis.  
  • In 1993 the Asymptomatic Carotid Artery Stenosis (ACAS) trial reported that the annual ipsilateral stroke rate was approximately 2.0% with medical therapy (Executive Committee for the Asymptomatic Carotid Atherosclerosis Study, 1995; Naylor, 2008)). 
  • A recent estimate in 2009 by Marquardt et al. described a contemporary annual ipsilateral stroke or TIA  rate of 0.34% among asymptomatic patients with asymptomatic carotid stenosis equal to or greater than 50%; a rate less than the 0.51% estimated by Arazi et al. needed justify the periprocedural risk of death and disabling stroke (Arazi, 2008).  This evidence can be used to argue that medical therapy in asymptomatic patients is preferable to intervention (Rothwell, 2010; Woo, 2010; Barnett, 2010). 
  • Therefore, it is not possible to determine whether CAS is superior to medical therapy.

Systematic Reviews and Meta-analysis of RCTs

A 2004 Blue Cross Blue Shield Association (BCBSA) Technology Evaluation Center (TEC) Assessment and meta-analyses from 2009 through 2011 have been published with similar findings (BCBSA TEC, 2004; Ederle, 2009; Bangalore ,2011; Murad, 2011; Econompoulos, 2011).  In average risk symptomatic patients the body of evidence demonstrates worse periprocedural outcomes with CAS compared to CEA.  While data reported by Silver (2011) and Touze (2009) show secular improvement in periprocedural outcomes following CAS there is evidence of a net harm compared to CEA.  The individual patient data meta-analysis of SPACE, EVA-3S, and ICSS indicates some uncertainty in comparative periprocedural death/stroke rates for younger symptomatic patients.  Still, that subgroup result must be considered carefully given the larger body of evidence, lack of stratified randomization, as well as the evidence on restenosis.  Meta-analyses have generally found that restenosis is more common following CAS than CEA.  In a meta-analysis of 13 trials, among those reporting restenosis rates, Bangalore (2011) reported pooled relative odds for restenosis following CAS compared to CEA of 2.8 (95% CI: 2.0 to 4.0; I2=0%).

Of note was the individual patient data meta-analysis (n=3,433) of SPACE, EVA-3S and ICSS (Bonati, yea2010).  In these symptomatic patients the 30-day death or stroke risk (per-protocol analyses) with CAS was 7.7% versus 4.4% following CEA (RR 1.74; 95% CI: 1.32 to 2.30).  However, in the subgroup younger than 70 years of age, comparative 30-day death or stroke rates were 5.1% (CAS) and 4.5% (CEA) (RR: 1.11; 95% CI: 0.73 to 1.71); for patients 70 years or older 10.5% (CAS) and 4.4% (CEA) (RR: 2.41; 95% CI: 1.65 to 3.51).  However, randomization was not stratified by age in these trials.

In conclusion, the systematic reviews corroborate the results of individual RCTs in reporting that early adverse events are higher with CAS compared to CEA that long-term stroke rates following the perioperative period are similar, and that restenosis is higher with CAS.  These data indicate that for the average risk patient with carotid stenosis, CAS is associated with a net harm compared to CEA.

Periprocedural death or stroke rates following CAS

This question was assessed in the October 2009 BCBSA TEC Assessment (BCBSA TEC 2009).  Noting again that CAS (like CEA) trades procedure-related risk of stroke and death for a reduced risk of stroke over subsequent years, and limits for periprocedural stroke and death rates that can be traded to achieve a net clinical benefit outlined in current guidelines are less than 3% for asymptomatic and less than 6% for symptomatic patients, this Assessment sought evidence to address the following questions:

1.      Is the periprocedural death or stroke rate with CAS less than 3% for asymptomatic and less than 6% for symptomatic patients?  Eighteen multicenter prospective registries collectively enrolling 20,194 patients were identified; 11 enrolled patients in accordance with FDA labeling and with 30 day outcomes available for analysis according to symptomatic status (13,783 asymptomatic and 3,353 symptomatic).  For nine registries 30 day death or stroke rates were either reported or obtained from investigators; in the remaining two, death or stroke rates were estimated from 30 day death, stroke, or MI, and MI rates.  An independent assessment of neurological outcomes was required in all but one registry.  For asymptomatic patients, the pooled periprocedural death or stroke rate was 3.9% (95% CI: 3.3% to 4.4%; I2=57%); for symptomatic patients 7.4% (95% CI: 6.0% to 9.0%; I2=59%).  Additionally, a subsequent systematic review, without consideration to FDA labeling, reported results consistent with the 2004 BCBSA TEC Assessment (pooled periprocedural death or stroke rates in asymptomatic patients of 3.3% [95% CI: 2.6% to 4.1%; 23 studies; 8,504 patients] and in symptomatic patients of 7.6% [95% CI: 6.3% to 9.1%; 42 studies; 4,910 patients]) (Touze, 2009).

2.      For those subgroups defined by a) medical comorbidities or b) unfavorable anatomy, are periprocedural death or stroke rates with CAS less than 3% for asymptomatic and less than 6% for symptomatic patients?  Combined data from two registries reported periprocedural death or stroke rates for patients with unfavorable anatomy (Gray, 2009; White, 2006) but included only 371 asymptomatic (30 day death or stroke rate 2.7% [95% CI: 1.5% to 4.9%]) and 60 symptomatic patients (30 day death or stroke rate 1.7%% [95% CI: 0.3% to 8.9%]).  No other registry reported results by symptomatic status for those subgroups.

Carotid Dissection

Lee (2006) reported that carotid dissection is uncommon (incidence approximately two per 100,000/year) and occurs generally in younger individuals.  With a frequently favorable prognosis, conservative therapy with anticoagulants to restore blood flow is typically employed while surgical intervention reserved for patients whose symptoms fail to respond to conservative care.  Some have described CAS as a potential treatment in those instances, however, there are no clinical trials comparing alternative strategies and interventions (Schirmer, 2011; Ohta, 2011).  Current guidelines, detailed later in the rationale, rate CAS in for this indication as a CLASS IIb (Level of Evidence: C) recommendation.

Clinical Input Received through Physician Specialty Societies and Academic Medical Centers

While the various physician specialty societies and academic medical centers may collaborate with and make recommendations during this process, through the provision of appropriate reviewers, input received does not represent an endorsement or position statement by the physician specialty societies or academic medical centers, unless otherwise noted.  This clinical input strongly supported use of CAS in recently symptomatic patients where CEA cannot be performed due to anatomic reasons, although acknowledging the limited evidence pertaining to this subgroup.  The lack of alternative treatments for recently symptomatic patients and the established increased risk of stroke were factors supporting this opinion.

Guidelines Rating

Most current is the 2011 American Stroke Association (ASA), American College of Cardiology Foundation (ACCF), American Heart Association (AHA), American Association of Neuroscience Nurses (AANN), American Association of Neurological Surgeons (AANS),

American College of Radiology (ACR), American Society of Neuroradiology (ASNR), Congress of Neurological Surgeons (CNS), Society of Atherosclerosis Imaging and Prevention (SAIP), Society for Cardiovascular Angiography and Interventions (SCAI), Society of Interventional Radiology (SIR), Society of Neuro-Interventional Surgery (SNIS), Society for Vascular Medicine (SVM), Society for Vascular Surgery (SVS) Guideline on the Management of Patients with Extracranial Carotid and Vertebral Artery Disease (Brott, JACC, 2011; Brott, JNS, 2011; Brott, Circulation, 2011; Brott, Stroke, 2011).

CLASS Categories

Level of Evidence

CLASS I Benefit >>> Risk

 

CAS is indicated as an alternative to CEA for symptomatic patients at average or low risk of complications associated with endovascular intervention when the diameter of the lumen of the internal carotid artery is reduced by more than 70% as documented by noninvasive imaging or more than 50% as documented by catheter angiography and the anticipated rate of periprocedural stroke or mortality is less than 6%.

B

Selection of asymptomatic patients for carotid revascularization should be guided by an assessment of comorbid conditions, life expectancy, and other individual factors and should include a thorough discussion of the risks and benefits of the procedure with an understanding of patient preferences.

C

CLASS IIa Benefit >> Risk

 

It is reasonable to choose CEA over CAS when revascularization is indicated in older patients, particularly when arterial pathoanatomy is unfavorable for endovascular intervention.

B

It is reasonable to choose CAS over CEA when revascularization is indicated in patients with neck anatomy unfavorable for arterial surgery.

B

When revascularization is indicated for patients with TIA or stroke and there are no contraindications to early revascularization, intervention within two weeks of the index event is reasonable rather than delaying surgery.

B

CLASS IIb Benefit ≥ Risk

 

Prophylactic CAS might be considered in highly selected patients with asymptomatic carotid stenosis (minimum 60% by angiography, 70% by validated Doppler ultrasound), but its effectiveness compared with medical therapy alone in this situation is not well established.

B

In symptomatic or asymptomatic patients at high risk of complications for carotid revascularization by either CEA or CAS because of comorbidities, the effectiveness of revascularization versus medical therapy alone is not well established.

B

Carotid angioplasty and stenting might be considered when ischemic neurological symptoms have not responded to antithrombotic therapy after acute carotid dissection.

C

CLASS III: NO BENEFIT

 

Except in extraordinary circumstances, carotid revascularization by either CEA or CAS is not recommended when atherosclerosis narrows the lumen by less than 50%.

A

Carotid revascularization is not recommended for patients with chronic total occlusion of the targeted carotid artery.

C

Carotid revascularization is not recommended for patients with severe disability caused by cerebral infarction that precludes preservation of useful function.

C

Key to Levels of Evidence:

A—Data derived from multiple randomized controlled trials or meta-analyses; multiple populations evaluated.

B—Data derived from a single randomized controlled trial or non-randomized studies; limited populations evaluated.

C—Only consensus opinion of experts, case studies, or standard of care; very limited populations evaluated.

Major Ongoing Randomized Trials Comparing CAS versus CEA

  • ACT I (Asymptomatic Carotid Trial), enrolling asymptomatic patients at average risk for complications from CEA (NCT00106938), estimated completion date 2017 December;
  • SPACE 2 (Stent-supported Percutaneous Angioplasty of the Carotid Artery versus Endarterectomy), comparing CAS, CEA, and medical therapy in asymptomatic patients (ISRCTN78592017), estimated completion date 2015 January;
  • ACST-2 (Asymptomatic Carotid Surgery Trial), CEA versus CAS in asymptomatic patients (NCT00883402), estimated completion date 2018 January.

There are no ongoing or direct comparisons of CAS versus CEA in patients at increased risk for CEA complications (Hopkins, 2008).  Particularly problematic is the lack of adequate data, from either randomized or non-randomized studies, to separately compare outcomes of the alternatives (CAS versus CEA versus current optimal medical management) in symptomatic and asymptomatic increased-risk subgroups.

Summary

A substantial body of RCT evidence compares outcomes of CAS with CEA for symptomatic and asymptomatic patients with carotid stenosis.  The evidence does not support use of CAS in carotid artery disease for the average risk patient, since early adverse events are higher with CAS and long-term outcomes are not better.  Data from RCTs and large database studies establish that the risk of CAS exceeds the threshold set to indicate overall benefit from the procedure. Therefore, for patients with carotid stenosis who are suitable candidates for CEA, CAS is considered experimental, investigational and unproven.

However, based on limited data, clinical input, an indirect chain of evidence, and unmet medical need, CAS may be considered a reasonable treatment option in recently symptomatic patients when CEA cannot be performed due to anatomic reasons.  For this population, CAS may be considered medically necessary.  It is considered experimental, investigational and unproven for all other indications, including carotid dissection.

Coding

Disclaimer for coding information on Medical Policies         

Procedure and diagnosis codes on Medical Policy documents are included only as a general reference tool for each policy.  They may not be all-inclusive.           

The presence or absence of procedure, service, supply, device or diagnosis codes in a Medical Policy document has no relevance for determination of benefit coverage for members or reimbursement for providers.  Only the written coverage position in a medical policy should be used for such determinations.           

Benefit coverage determinations based on written Medical Policy coverage positions must include review of the member’s benefit contract or Summary Plan Description (SPD) for defined coverage vs. non-coverage, benefit exclusions, and benefit limitations such as dollar or duration caps. 

ICD-9 Codes

00.40, 00.41, 00.42, 00.43, 00.44, 00.45, 00.46, 00.47, 00.48, 00.61, 00.63, 433.10, 433.11, 433.30, 433.31

ICD-10 Codes

I63.031, I63.032, I63.039, I63.131, I63.132, I63.039, I63.231, I63.232, I63.239, I63.59, I65.21, I65.22, I65.23, I65.29, I65.8, 03CH3ZZ, 03CH4ZZ, 03CJ3ZZ, 03CJ4ZZ, 03CK3ZZ, 03CK4ZZ, 03CL3ZZ, 03CL4ZZ, 03CM3ZZ, 03CM4ZZ, 03CN3ZZ, 03CN4ZZ, 03CP3ZZ, 03CP4ZZ, 03CQ3ZZ, 03CQ4ZZ, 037H34Z, 037H3DZ, 037H3ZZ, 037H44Z, 037H4DZ, 037H4ZZ, 037J34Z, 037J3DZ, 037J3ZZ, 037J44Z, 037J4DZ, 037J4ZZ, 037K34Z, 037K3DZ, 037K3ZZ, 037K44Z, 037K4DZ, 037K4ZZ, 037L34Z, 037L3DZ, 037L3ZZ, 037L44Z, 037L4DZ, 037L4ZZ, 037M34Z, 037M3DZ, 037M3ZZ, 037M44Z, 037M4DZ, 037M4ZZ, 037N34Z, 037N3DZ, 037N3ZZ, 037N44Z, 037N4DZ, 037N4ZZ, 037P34Z, 037P3DZ, 037P3ZZ, 037P44Z, 037P4DZ, 037P4ZZ, 037Q34Z, 037Q3DZ, 037Q3ZZ, 037Q44Z, 037Q4DZ, 037Q4ZZ

Procedural Codes: 37215, 37216, 0075T, 0076T
References
  1. MRC European Carotid Surgery Trial: interim results for symptomatic patients with severe (70-99%) or with mild (0-29%) carotid stenosis.  European Carotid Surgery Trialists’ Collaborative Group.  Lancet (1991 May 25) 337(8752):1235-43.
  2. Beneficial effect of carotid endarterectomy in symptomatic patients with high-grade carotid stenosis.  North American Symptomatic Carotid Endarterectomy Trial Collaborators.  New England Journal of Medicine (1991 August 15) 325(7):445-53.
  3. Mayberg, M.R., Wilson, S.E., et al.  Carotid endarterectomy and prevention of cerebral ischemia in symptomatic carotid stenosis.  Veterans Affairs Cooperative Studies Program 309 Trialist Group.  Journal of the America Medical Association (1991 December 18) 266(23):3289-94.
  4. Endarterectomy for asymptomatic carotid artery stenosis.  Executive Committee for the Asymptomatic Carotid Atherosclerosis Study.  Journal of the American Medical Association (1995 May 10) 273(18):1421-8.
  5. Randomized trial of endarterectomy for recently symptomatic carotid stenosis: final results of the MRC European Carotid Surgery Trial (ECST).  Lancet (1998 May 9) 351(9113):1379-87.
  6. Jordan, W.D., Voellinger, D.C., et al.  A comparison of carotid angioplasty with stenting versus endarterectomy with regional anesthesia.  Journal of Vascular Surgery (1998 September) 28(3):397-402; discussion 402-3.
  7. Barnett, H.J., Taylor, D.W., et al.  Benefit of carotid endarterectomy in patients with symptomatic moderate or severe stenosis.  North American Symptomatic Carotid Endarterectomy Trial Collaborations.  New England Journal of Medicine (1998 November 12) 339(20):1415-25.
  8. White, C.J., Iyer, S.S., et al.  Carotid stenting with distal protection in high surgical risk patients: the BEACH trial 30 day results.  Catheterizations and Cardiovascular Interventions (2006 April) 67(4):503-12.
  9. Halliday, A., Mansfield, A., et al.  Prevention of disabling and fatal strokes by successful carotid enterectomy in patients without recent neurological symptoms: randomized controlled trial.  Lancet (2004 May 8) 363(9420):1491-502.
  10. Yadav, J.S., Wholey, M.H., et al.  Protected carotid-artery stenting versus endarterectomy in high-risk patients.  New England Journal of Medicine (2004 October 7) 351(15):1493-501.
  11. Angioplasty and Stenting of the Cervical Carotid Artery with Embolic Protection of the Cerebral Circulation.  Chicago, Illinois: Blue Cross Blue Shield Association Technology Evaluation Center Assessment (2005 February) 19(15):1-29.
  12. Naylor, A.R.  SPACE: no the final frontier.  Lancet (2006 October 7) 368(9543):1215-6.
  13. Ringleb, P.A., Allenberg, J., et al.  30 day results from the SPACE trial of stent-protected angioplasty versus carotid endarterectomy in symptomatic patients: a randomized non-inferiority trial.  Lancet (2006 October 7) 368(9543):1239-47.
  14. Mas, J.L., Chatellier, G., et al. Endarterectomy versus stenting in patients with symptomatic severe carotid stenosis.  New England Journal of Medicine (2006 October 19) 355(16):1660-71.
  15. Furlan, A.J.  Carotid-artery stenting – case open or closed?  New England Journal of Medicine (2006 October 19) 355(16):1726-9.
  16. Lee, V.H., Brown, R.D., et al.  Incidence and outcome of cervical artery dissection: a population-based study.  Neurology (2006 November 28) 67(10):1809-12.
  17. Gurm, H.S., Yadav, J.S., et al.  Long-term results of carotid stenting versus endarterectomy in high-risk patients.  New England Journal of Medicine (2008 April 10) 358(15):1572-9.
  18. Arazi, H.C., Capparelli, F.J., et al.  Carotid endarterectomy in asymptomatic carotid stenosis: a decision analysis.  Clinical Neurology and Neurosurgery (2008 May) 110(5):472-9.
  19. Naylor, A.R., and P.R. Bell.  Treatment of asymptomatic carotid disease with stenting: con.  Seminars in Vascular Surgery (2008 June) 21(2):100-7.
  20. Hopkins, L.N., Myla, S., et al.  Carotid artery vascularization in high surgical risk patients with the NexStent and the Filterwire EX/EZ: 1-year results in the CABERNET trial.  Catheterizations and Cardiovascular Interventions (2008 June 1) 71(7):950-60.
  21. Mas, J.L., Trinquart, L., et al.  Endarterectomy Versus Angioplasty in Patients with Symptomatic Severe Carotid Stenosis (EVA-3S) trial: results up to 4 years from a randomized, multicenter trial.  Lancet Neurology (2008 October) 7(10):885-92.
  22. Eckstein, H.H., Ringleb, P., et al.  Results of the Stent-Protected Angioplasty versus Carotid Endarterectomy (SPACE) study to treat symptomatic stenoses at 2 years: a multinational, prospective, randomized trial.  Lancet Neurology (2008 October) 7(10):893-902.
  23. Lewis, S.C., Warlow, C.P., et al.  General anesthesia versus local anesthesia for carotid surgery (GALA): a multicenter, randomized controlled trial.  Lancet (2008 December 20) 372(9656):2132-45.
  24. Ederle, J., Featherstone, R.L., et al.  Randomized controlled trials comparing endarterectomy and endovascular treatment for carotid artery stenosis: a Cochrane Systematic Review.  Stroke (2009 April) 40(4):1373-80.
  25. Gray, W.A., Chaturvedi, S., et al.  Thirty-day outcomes for carotid artery stenting in 6320 patients from 2 prospective, multicenter, high-surgical-risk registries.  Circulation and Cardiovascular Interventions (2009 June) 2(3):159-66.
  26. Touze, E., Trinquart, L., et al.  Systematic review of the perioperative risks of stroke or death after carotid angioplasty and stenting.  Stroke (2009 December) 40(12):e683-93.
  27. Marquardt, L., Fairhead, J.F., et al.  Lower rates of intervention for symptomatic carotid stenosis in women than in men reflect differences in disease incidence: a population-based study.  Stroke (2010 January) 41(1):16-20.
  28. Marquardt, L., Geraghty, O.C., et al.  Low risk of ipsilateral stroke in patients with asymptomatic carotid stenosis on best medical treatment: a prospective, population-based study.  Stroke (2010 January) 41(1):e11-7.
  29. Hopkins, L.N., Roubin, G.S., et al.  The Carotid Revascularization Endarterectomy versus Stenting Trial: credentialing of interventionalists and final results of lead-in phase.  Journal of Stroke and Cerebrovascular Disease (2010 March) 19(2):153-62.
  30. Rothwell, P.M.  Carotid stenting: more risky than endarterectomy and often no better than medical treatment alone.  Lancet (2010 March 20) 375(9719):957-9.
  31. Ederle, J., Dobson, J., et al.  Carotid artery stenting compared with endarterectomy in patients with symptomatic carotid stenosis (International Carotid Stenting Study): an interim analysis of a randomized controlled trial.  Lancet (2010 March 30) 375(9719):985-97.
  32. Roffi, M., Sievert, H., et al.  Carotid artery stenting versus surgery: adequate comparisons?  Lace Neurology (2010 April) 9(4):339-41; author reply 341-2.
  33. Bonati, L.H., Jongen, L.M., et al.  New ischemic brain lesions on MRI after stenting or endarterectomy for symptomatic carotid stenosis: a sub study of the International Carotid Stenting Study (ICSS).  Lancet Neurology (2010 April) 9(4):353-62.
  34. Woo, K., Garg, J., et al.  Contemporary results of carotid endarterectomy for asymptomatic carotid stenosis.  Stroke (2010 May) 41(5):975-9.
  35. Brott, T.G., Hobson, R.W., et al.  Stenting versus endarterectomy for treatment of carotid-artery stenosis.  New England Journal of Medicine (2010 July 1) 363(1):11-23.
  36. Angioplasty and Stenting of the Cervical Carotid Artery with Embolic Protection of the Cerebral Circulation.  Chicago, Illinois: Blue Cross Blue Shield Association Technology Evaluation Center Assessment (2010 August) 24(12):1-51.
  37. Bonati, L.H., Dobson, J., et al.  Short-term outcome after stenting versus endarterectomy for symptomatic carotid stenosis: a preplanned meta-analysis of individual patient data.  Lancet (2010 September 25) 376(9743):162-73.
  38. Barnett, H.J., Pelz, D.M., et al.  Reflections by contrarians on the post-CREST evaluation of carotid stenting for stroke prevention.  International Journal of Stroke (2010 December) 5(6):455-6.
  39. Bangalore, S., Kumar, S., et al.  Carotid artery stenting vs carotid endarterectomy: meta-analysis and diversity-adjusted trial sequential analysis of randomized trials.  Archives of Neurology (2011 February) 68(2):172-84.
  40. Brott, T.G., Halperin, J.L., et al.  2011 ASA/ACCF/AHA/AANN/AANS/ACR/ASNR/
  41. CNS/SAIP/SCAI/SIR/SNIS/SVM/SVS guideline on the management of patients with extracranial carotid and vertebral artery disease: executive summary.  A report of the American College of Cardiology Foundation/American Heart Association Task Force on Practice Guidelines, and the American Stroke Association, American Association of Neuroscience Nurses, American Association of Neurological Surgeons, American College of Radiology, American Society of Neuroradiology, Congress of Neurological Surgeons, Society of Atherosclerosis Imaging and Prevention, Society of Cardiovascular Angiography and Interventions, Society of Interventional Radiology, Society of NeuroInterventional Surgery, Society for Vascular Medicine, and Society for Vascular Surgery developed in collaboration with the American Academy of Neurology and Society of Cardiovascular Computed Tomography.  Vascular Medicine (2011 February) 16(1):35-77.
  42. Brott, T.G., Halperin, J.L., et al.  2011 ASA/ACCF/AHA/AANN/AANS/ACR/ASNR/
  43. CNS/SAIP/SCAI/SIR/SNIS/SVM/SVS guideline on the management of patients with extracranial carotid and vertebral artery disease: executive summary.  A report of the American College of Cardiology Foundation/American Heart Association Task Force on Practice Guidelines, and the American Stroke Association, American Association of Neuroscience Nurses, American Association of Neurological Surgeons, American College of Radiology, American Society of Neuroradiology, Congress of Neurological Surgeons, Society of Atherosclerosis Imaging and Prevention, Society of Cardiovascular Angiography and Interventions, Society of Interventional Radiology, Society of NeuroInterventional Surgery, Society for Vascular Medicine, and Society for Vascular Surgery developed in collaboration with the American Academy of Neurology and Society of Cardiovascular Computed Tomography.  Journal of the American College of Cardiology (2011 February 22) 57(8):1002-44.
  44. Brott, T.G., Halperin, J.L., et al.  2011 ASA/ACCF/AHA/AANN/AANS/ACR/ASNR/
  45. CNS/SAIP/SCAI/SIR/SNIS/SVM/SVS guideline on the management of patients with extracranial carotid and vertebral artery disease.  A report of the American College of Cardiology Foundation/American Heart Association Task Force on Practice Guidelines, and the American Stroke Association, American Association of Neuroscience Nurses, American Association of Neurological Surgeons, American College of Radiology, American Society of Neuroradiology, Congress of Neurological Surgeons, Society of Atherosclerosis Imaging and Prevention, Society of Cardiovascular Angiography and Interventions, Society of Interventional Radiology, Society of NeuroInterventional Surgery, Society for Vascular Medicine, and Society for Vascular Surgery developed in collaboration with the American Academy of Neurology and Society of Cardiovascular Computed Tomography.  Journal of the American College of Cardiology (2011 February 22) 57(8):e16-94.
  46. Silver, F.L., Mackey, A., et al.  Safety of stenting and endarterectomy by symptomatic status in the Carotid Revascularization Endarterectomy Versus Stenting Trial (CREST).  Stroke (2011 March) 42(3):675-80.
  47. Economopoulos, K.P., Sergentanis, T.N., et al.  Carotid artery stenting versus carotid enterectomy: a comprehensive meta-analysis of short-term and long-term outcomes.  Stroke (2011 March) 42(3):687-92.
  48. Murad, M.H., Shahrour, A., et al.  A systematic review and meta-analysis of randomized trials of carotid endarterectomy vs stenting.  Journal of Vascular Surgery (2011 March) 53(3):792-7.
  49. Brott, T.G., Halperin, J.L., et al.  2011 ASA/ACCF/AHA/AANN/AANS/ACR/ASNR/
  50. CNS/SAIP/SCAI/SIR/SNIS/SVM/SVS guideline on the management of patients with extracranial carotid and vertebral artery disease: executive summary.  A report of the American College of Cardiology Foundation/American Heart Association Task Force on Practice Guidelines, and the American Stroke Association, American Association of Neuroscience Nurses, American Association of Neurological Surgeons, American College of Radiology, American Society of Neuroradiology, Congress of Neurological Surgeons, Society of Atherosclerosis Imaging and Prevention, Society of Cardiovascular Angiography and Interventions, Society of Interventional Radiology, Society of NeuroInterventional Surgery, Society for Vascular Medicine, and Society for Vascular Surgery.  Journal Neurointerventional Surgery (2011 June) 3(2):100-30.
  51. Schirmer, C.M., Atalay, B., et al.  Endovascular recanalization of symptomatic flow-limiting cervical carotid dissection in an isolated hemisphere.  Neurosurgery Focus (2011 June) 30(6):E16.
  52. Ohta, H., Natarajan, S.K., et al.  Endovascular stent therapy for extracranial and intracranial carotid artery dissection: single-center experience.  Journal of Neurosurgery (2011 July) 115(1):91-100.
  53. Brott, T.G., Halperin, J.L., et al.  2011 ASA/ACCF/AHA/AANN/AANS/ACR/ASNR/
  54. CNS/SAIP/SCAI/SIR/SNIS/SVM/SVS guideline on the management of patients with extracranial carotid and vertebral artery disease: executive summary.  A report of the American College of Cardiology Foundation/American Heart Association Task Force on Practice Guidelines, and the American Stroke Association, American Association of Neuroscience Nurses, American Association of Neurological Surgeons, American College of Radiology, American Society of Neuroradiology, Congress of Neurological Surgeons, Society of Atherosclerosis Imaging and Prevention, Society of Cardiovascular Angiography and Interventions, Society of Interventional Radiology, Society of NeuroInterventional Surgery, Society for Vascular Medicine, and Society for Vascular Surgery.  Circulation (2011 July 26) 124(4):489-532.
  55. Brott, T.G., Halperin, J.L., et al.  2011 ASA/ACCF/AHA/AANN/AANS/ACR/ASNR/
  56. CNS/SAIP/SCAI/SIR/SNIS/SVM/SVS guideline on the management of patients with extracranial carotid and vertebral artery disease.  A report of the American College of Cardiology Foundation/American Heart Association Task Force on Practice Guidelines, and the American Stroke Association, American Association of Neuroscience Nurses, American Association of Neurological Surgeons, American College of Radiology, American Society of Neuroradiology, Congress of Neurological Surgeons, Society of Atherosclerosis Imaging and Prevention, Society of Cardiovascular Angiography and Interventions, Society of Interventional Radiology, Society of NeuroInterventional Surgery, Society for Vascular Medicine, and Society for Vascular Surgery.  Circulation (2011 July 26) 124(4):e54-130.
  57. Brott, T.G., Halperin, J.L., et al.  2011 ASA/ACCF/AHA/AANN/AANS/ACR/ASNR/
  58. CNS/SAIP/SCAI/SIR/SNIS/SVM/SVS guideline on the management of patients with extracranial carotid and vertebral artery disease: executive summary.  A report of the American College of Cardiology Foundation/American Heart Association Task Force on Practice Guidelines, and the American Stroke Association, American Association of Neuroscience Nurses, American Association of Neurological Surgeons, American College of Radiology, American Society of Neuroradiology, Congress of Neurological Surgeons, Society of Atherosclerosis Imaging and Prevention, Society of Cardiovascular Angiography and Interventions, Society of Interventional Radiology, Society of NeuroInterventional Surgery, Society for Vascular Medicine, and Society for Vascular Surgery.  Stroke (2011 August) 42(8):e420-63.
  59. Brott, T.G., Halperin, J.L., et al.  2011 ASA/ACCF/AHA/AANN/AANS/ACR/ASNR/
  60. CNS/SAIP/SCAI/SIR/SNIS/SVM/SVS guideline on the management of patients with extracranial carotid and vertebral artery disease.  A report of the American College of Cardiology Foundation/American Heart Association Task Force on Practice Guidelines, and the American Stroke Association, American Association of Neuroscience Nurses, American Association of Neurological Surgeons, American College of Radiology, American Society of Neuroradiology, Congress of Neurological Surgeons, Society of Atherosclerosis Imaging and Prevention, Society of Cardiovascular Angiography and Interventions, Society of Interventional Radiology, Society of NeuroInterventional Surgery, Society for Vascular Medicine, and Society for Vascular Surgery.  Stroke (2011 August) 42(8):e464-540.
  61. Angioplasty and Stenting of the Cervical Carotid Artery with Embolic Protection of the Cerebral Circulation.  Chicago, Illinois: Blue Cross Blue Shield Association Technology Evaluation Center Assessment (2012 February) 24(12):1-51.
  62. Extracranial Carotid Angioplasty/Stenting.  Chicago, Illinois: Blue Cross Blue Shield Association Medica Policy Reference Manual (2012 March) Medicine 7.01.68.
History
July 2011 Policy reviewed: updated description, rationale, and references; revised policy statement from not medically necessary to investigational; no coding changes
July 2012 Policy updated with literature search, references 11, 27, 28, 43-45 added. Carotid dissection added to policy statement as investigational, and policy statement clarified to read that CAS is investigational in patients who are suitable candidates for CEA.
October 2013 Policy formatting and language revised.  Policy statement unchanged.  Title changed from "Extracranial Carotid Artery Stenting/Angioplasty" to "Extracranial Carotid Angioplasty or Stenting".
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Extracranial Carotid Artery Stenting/Angioplasty