| Coverage Policy Manual | |
| Policy #: | 1998150 |
| Category: | Surgery |
| Initiated: | March 1998 |
| Last Review: | May 2023 |
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| Angioplasty/Stenting, Percutaneous, Carotid Artery | |
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| Description: |
Carotid artery angioplasty with stenting is a treatment for carotid stenosis that is intended to prevent a future stroke. It is an alternative to medical therapy and a less-invasive alternative to carotid endarterectomy (CEA).
Combined with optimal medical management, carotid angioplasty with or without stenting has been evaluated as an alternative to carotid endarterectomy (CEA). Carotid artery stenting (CAS) involves the introduction of coaxial systems of catheters, microcatheters, balloons, and other devices. The procedure is most often performed through the femoral artery but a transcervical approach can also be used to avoid traversing the aortic arch. The procedure typically takes 20–40 minutes. Interventionalists almost uniformly use an embolic protection device (EPD) to reduce the risk of stroke caused by thromboembolic material dislodged during CAS. Embolic protection devices can be deployed proximally (with flow reversal) or distally (using a filter). Carotid angioplasty is rarely performed without stent placement.
The proposed advantages of CAS over CEA include the following:
Regulatory Status
A number of carotid artery stents and EPDs have been approved by the U.S. Food and Drug Administration (FDA) through the premarket approval (PMA) or the 510(k) process.
Below is the list of CAS and EPD with premarket approval:
Below is the list of CAS and EPD approved by the U.S. FDA through the 510(k) process:
Each FDA-approved carotid stent system is indicated for combined use with a EPD device to reduce risk of stroke in patients considered at increased risk for periprocedural complications from CEA who are symptomatic with >50% stenosis, or asymptomatic with >80% stenosis with the degree of stenosis assessed by ultrasound or angiogram, with computed tomography angiography also used. Patients are considered at high risk for CEA complications 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 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.
In 2015, the ENROUTE Transcarotid Neuroprotection System was cleared for marketing by the FDA through the 510(k) process.ENROUTE is a flow-reversal device designed to be placed via direct carotid access. In April 2022, the ENROUTE®Transcarotid Stent System received expanded approval for use in the treatment of individuals at standard risk of complications from CEA. For those with neurological symptoms, criteria include 70% or more stenosis by ultrasound or 50% or more stenosis by angiogram. For asymptomatic individuals, criteria include 70% or more stenosis by ultrasound or 60% or more stenosis angiogram. The carotid bifurcation location must be a minimum of 5 cm above the clavicle to allow for the placement of the ENROUTE Transcarotid Neuroprotection System.
FDA product codes: NIM (stents) and NTE (EPDs).
Coding
For 2015, the CPT coding for these procedures were revised to include open and percutaneous transcatheter placement, angioplasty when performed, and all associated radiological supervision and interpretation:
37215: Transcatheter placement of intravascular stent(s), cervical carotid artery, open or percutaneous, including angioplasty, when performed, and radiological supervision and interpretation; with distal embolic protection
37216: without distal embolic protection
Prior to 2015
Beginning in 2014, the following new CPT code is effective:
37217: Transcatheter placement of an intravascular stent(s), intrathoracic common carotid artery or innominate artery by retrograde treatment, via open ipsilateral cervical carotid artery exposure, including angioplasty, when performed, and radiological supervision and interpretation. This code indicates the procedure is performed trancervically or by retrograde approach, but is considered carotid stenting.
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Policy/ Coverage: |
Effective May 2018
Meets Primary Coverage Criteria Or Is Covered For Contracts Without Primary Coverage Criteria
Carotid artery angioplasty with stenting and distal protection device meets primary coverage criteria for effectiveness and is covered for individuals with:
Significant comorbid conditions include but are not limited to congestive heart failure, class III/IV; left ventricular ejection fraction of < 30%; unstable angina; contra lateral carotid occlusion; recent myocardial infarction; previous carotid endarterectomy with recurrent stenosis; and prior radiation treatment to neck.
Does Not Meet Primary Coverage Criteria Or Is Investigational For Contracts Without Primary Coverage Criteria
The following services are not covered based on benefit certificate primary coverage criteria that there be scientific evidence of effectiveness:
For contracts without primary coverage criteria, the following services are considered investigational and not covered:
Investigational services are an exclusion in the member certificate of coverage.
Effective prior to May 2018
Carotid artery angioplasty with stenting and distal protection device meets primary coverage criteria for effectiveness and is covered for patients with:
Significant comorbid conditions include but are not limited to congestive heart failure, class III/IV; left ventricular ejection fraction of < 30%; unstable angina; contra lateral carotid occlusion; recent myocardial infarction; previous carotid endarterectomy with recurrent stenosis; and prior radiation treatment to neck.
The following services are not covered based on benefit certificate primary coverage criteria that there be scientific evidence of effectiveness:
For contracts without primary coverage criteria, the following services are considered investigational and not covered:
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| Rationale: |
The success of coronary artery angioplasty and stenting has prompted interest in other applications of this minimally invasive, catheter-based technique. At the present time, carotid endarterectomy is considered a stroke prevention option in patients with greater than 60% occlusion of the carotid artery. However, in general, randomized trials comparing the outcomes of carotid endarterectomy versus ongoing medical management enrolled a relatively health population of patients. Further, any benefit from endarterectomy may be lost if the procedural risk was greater than 6%. Therefore, there has been interest in carotid angioplasty and stenting (CAS) as a possible minimally invasive treatment option for higher risk patients. (High-risk factors include severe cardiac dysfunction, requirement for combined coronary and carotid vascularization, severe pulmonary dysfunction, contralateral internal carotid artery occlusion, and previous ipsilateral carotid endarterectomy.) In addition, even in average risk patients, the minimally invasive nature of CAS and the lack of a need for general or regional anesthesia may make CAS an attractive treatment option if the short- and long-term outcomes are equivalent to carotid endarterectomy. Outcomes of particular interest include the rates of morbidity and ipsilateral stroke, measured perioperatively and at various points during follow-up.
The literature on carotid angioplasty and stenting (CAS) consists of a variety of single institution case series and results of several randomized studies. Results of case series suggest that CAS is associated with stroke rates that are similar to carotid endarterectomy. For example, Roubin and colleagues have reported the immediate and late clinical outcomes in 528 consecutive patients undergoing CAS and followed up for 5 years. The overall 30-day stroke and death rate was 7.4%. On Kaplan Meier analysis, the 3-year freedom from ipsilateral or fatal stroke was 92%. The authors concluded that these results suggest that CAS has equivalent clinical outcomes compared to carotid endarterectomy. Based on an international survey that reported the outcomes of 5,210 procedures in 4,575 patients, Wholey and colleagues estimated that the combined 30-day minor, major strokes and procedure-related death rate was 5.07%, which the authors concluded was an acceptable complication rate compared to that of carotid endarterectomy. However, without a controlled trial it is not possible to assess how patient selection bias might have affected results.
Various authors have pointed out the need for randomized trials to further investigate the relative safety and effectiveness of the procedures. In 1998, the American Heart Association (AHA) issued a warning regarding the “premature adoption” of these percutaneous techniques. In support of this warning, the AHA remarked on the known overall safety and efficacy of carotid endarterectomy contrasted with the uncertain morbidity and mortality of angioplasty and stenting. In addition, unlike coronary or iliac angioplasty, acute occlusion of the carotid artery associated with angioplasty or stenting may not be amenable to emergency surgical correction. Finally, the morbidity and mortality of treatment of restenosis after angioplasty and stenting are unknown. The statement concluded that at a minimum, the equivalence of percutaneous approaches to surgical carotid endarterectomy must be established in sufficiently powered, prospective randomized trials. In 2001, a consensus of opinion leaders in carotid angioplasty was published. The group concluded that CAS should not currently undergo widespread diffusion, pending results of randomized trials. Further, the group concurred that CAS is not generally appropriate for those patients considered at low risk while it could be considered appropriate treatment of patients at high risk when performed in experienced centers.
Randomized Studies
Several randomized trials have been completed comparing percutaneous angioplasty to endarterectomy. An early trial was stopped early because of significantly worse outcomes in the angioplasty arm. The Wallstent trial was also stopped early because of adverse events in the patients treated with angioplasty. The CAVATAS trial had rates of disabling stroke or death of 6.4% in the angioplasty arm and 5.9% in the endarterectomy group. This 5.9% risk of stroke or death from endarterectomy is significantly higher than the risks found in three large clinical trials of carotid endarterectomy (2.3%).
The SAPPHIRE trial results were reported in October, 2004; of 747 patients, 334 of them underwent randomization. The researchers concluded that carotid artery stenting with the use of an emboli protection device is not inferior to carotid endarterectomy in the prevention of stroke, death or myocardial infarction among patients for whom surgery poses and increased risk.
Brooks and colleagues reported the results of a study that randomized 104 patients with symptomatic carotid artery stenosis to undergo either CAS or carotid endarterectomy. Patients were followed up for 2 years. The outcomes were equivalent in the 2 groups; i.e., morbidity, stroke, and hospital stay. The Carotid and Vertebral Transluminal Angioplasty Study (CAVATS) randomized 504 patients with carotid stenosis to undergo either endovascular treatment or carotid endarterectomy. Those assigned to the endovascular arm underwent either angioplasty alone (74%) or angioplasty plus stenting (26%). The rates of stroke or death within 30 days of first treatment were not different between the 2 groups. After 1 year of treatment, severe ipsilateral carotid stenosis was more usual after endovascular treatment, however, there was no difference in the incidence of ipsilateral stroke between groups.
Two other randomized trials were initiated but stopped prematurely due to an increased incidence of complications in the group undergoing CAS. Naylor and colleagues reported that in their randomized study of CAS and carotid endarterectomy, 5 of the 7 patients who initially underwent CAS experienced a stroke, compared to no incidence of stroke in the first 10 patients undergoing carotid endarterectomy. The trial was terminated. Alberts initiated a randomized trial comparing CAS with endarterectomy that recruited 219 patients of the planning 700 patients before it was prematurely terminated; the rate of any major stroke was 3.7% for those undergoing CAS compared with 0.9% for those undergoing carotid endarterectomy.
Category B Investigational Device Exemption (IDE) Trials
The following studies are being conducted on various stents specifically for their use in carotid arteries.
CREST (Carotid Revascularization Endarterectomy versus Stent Trial)
The CREST trial contrasts the relative efficacy of carotid endarterectomy and CAS in preventing primary outcomes of stroke, myocardial infarction, death during a 30-day periprocedural period, or ipsilateral stroke over the follow-up period extending up to 4 years. A total of 2,500 patients with a history of TIA or mild stroke will be enrolled at 60 centers. The sample size was selected to provide a 90% power to detect absolute annual difference of 1.2% in the event rate. CREST is sponsored by the U.S. National Institute of Neurological Disorders and Stroke (NINDS). The stent being used in the trial is the Acculink™, manufactured by Guidant Corporation, and the data from the CREST trial will be used as part of the FDA-approval process for the Acculink stent. As of February 2002, a total of 79 patients had been enrolled in the trial.
SHELTER (Stenting of High-risk patients Extracranial Lesions Trial with Emboli Removal)
This study is a single-arm prospective multicenter study designed to evaluate the potential advantage of using a carotid stent with a distal protection device as opposed to open surgery for preventing stroke. Trial enrollment was initiated in January 2001 and is expected to include 400 patients at 30 centers. This trial is part of a FDA IDE for a stent manufactured by Boston Scientific.
ARCHER (Acculink for Revascularization of Carotid in High Risk Patients)
This single-arm prospective multicenter study is sponsored by Guidant Corporation and will enroll 400 patients at 30 centers.
MAVERIC (Evaluation of the Medtronic AVE Self-expanding Carotid Stent System with Distal Protection in the Treatment of Carotid Stenosis)
The MAVERIC trial is initiated as a phase I study of 50 patients at 10 centers evaluating the safety and efficacy of both the self-expanding carotid stent and the GuardWire Plus system in patients with carotid stenosis who are also high-risk candidates for carotid endarterectomy. A phase II trial of 350 patients at 40 centers is planned on completion of the phase I trial.
On August 30, 2004, the FDA approved the ACCULINK™ Carotid Stent System and RX ACCULINK™ Carotid Stent System (P040012) by Guidant. The device is indicated for the treatment of patients at high risk for adverse events from carotid endarterectomy who have neurological symptoms with >/= 50% stenosis of the common or internal carotid artery or patients without neurological symptoms who have >/= 80% stenosis of the common or internal carotid artery. Patients must have a reference vessel diameter within the range of 4.0 mm and 9.0 mm at the target lesion.
The Interceptor filter and Exponent stent from Medtronic is in phase III trials in the U.S. but it is available in Europe. The Neurolink System by Guidant has an FDA HDE (H01004) approval.
The SAPPHIRE trial results were reported in October, 2004, 747 patients, and 334 of them underwent randomization. The researchers concluded that carotid artery stenting with the use of an emboli protection device is not inferior to carotid endarterectomy in the prevention of stroke, death or myocardial infarction among patients for whom surgery poses an increased risk.
2007 Update
In February 2007, evidence through January 2007 on angioplasty and stenting of the cervical carotid artery with embolic protection of the cerebral circulation including published registry data was reviewed. No new randomized controlled trials were identified.
Eight prospective published registries reported 30-day outcomes; a single registry reported 1-year outcomes. When reported, conventional stroke/death rates ranged from 2.1% to 6.9%. In 6 of the 7 registries enrolling a substantial majority (69% to 86%) of asymptomatic patients, reported rates of stroke or death with or without myocardial infarction (MI) exceeded 5.7%. It is therefore unlikely that the periprocedural complication rate in the asymptomatic groups was less than the 3% felt needed to accrue benefit. In the 3 registries reporting outcomes according to symptomatic status or calculable, 30-day periprocedural complication rates exceeded 3% in asymptomatic and 6% in symptomatic individuals. Only CaRESS reported 1-year outcomes, including a 10.9% stroke/death/MI rate comparable to that found in SAPPHIRE. A subgroup of patients from the BEACH registry were considered to be at high-risk owing to anatomic features had a 1.8% risk for periprocedural death or major stroke (any stroke, 3.5%). Limited evidence suggests that patients in this subgroup may be appropriate candidates for CAS.
The conclusion was that available evidence does not support concluding that CAS is performed with acceptable periprocedural stroke/death rates for symptomatic or asymptomatic patients, that it provides a net health benefit to patients at high medical risk, or is equally effective as CEA. There is limited evidence and a clinical rationale to suggest that CAS may be beneficial in the group of patients at high anatomic risk, but present evidence has not clearly differentiated outcomes for this subgroup according to symptomatic status.
The current Cochrane Review concludes, “The current evidence does not support a widespread change in clinical practice away from recommending carotid endarterectomy as the treatment of choice for suitable carotid artery stenosis. There is a strong case to continue recruitment in the current randomised trials comparing carotid stenting with endarterectomy.”
An updated guideline on stroke prevention from the American Heart Association/American Stroke Association Council on Stroke includes recommendations on interventional approaches for patients with extracranial carotid artery atherosclerosis. The guideline affirms that CEA is the preferred treatment for patients with recent (i.e., in the past 6 months) transient ischemic attack or non-disabling ischemic stroke and severe ipsilateral carotid stenosis (between 70% and 90% of the lumen diameter), when performed by a surgeon with less than 6% perioperative morbidity and mortality. The guideline also recommends considering CEA for similar patients with moderate carotid stenosis (50% to 69% of the vessel lumen), depending on patient-specific factors age, gender, comorbidities, and severity of initial symptoms). Finally, the guideline recommends that CAS may be considered as a reasonable alternative to CEA for patients with symptomatic severe stenosis (>70%), in whom the stenosis is difficult to access surgically, or with medical conditions that greatly increase the risk for surgery, or when other specific circumstances exist (e.g., radiation-induced stenosis or restenosis after prior CEA), provided it is performed by operators with established periprocedural morbidity and mortality rates of 4% to 6%.
There are no ongoing or direct comparisons of CAS versus CEA in patients at increased risk for CEA complications. There is the lack of adequate data, from either randomized or non-randomized studies, to separately compare outcomes of the alternatives (CAS vs. CEA vs. current optimal medical management) in symptomatic and asymptomatic high-risk subgroups.
Two meta-analyses of carotid artery stenting versus carotid endarterectomy were published in February 2008. A meta-analysis of 8 randomized and 2 nonrandomized trials that involved 3580 patients showed a 30-day rate of stroke or death ranging from 4% to 10% among carotid endarterectomy (CAE) patients and from 2% to 12% among carotid artery stenting (CAS) patients. Thirty-day risk for stroke or death was significantly higher with CAS than with CEA; for stroke alone, the risk ration (1.27) just failed to reach significance. In analysis of the five trials with exclusively symptomatic patients, the 30-day risk for stroke or death was even more unfavorable for CAS patients. Exclusion of the two nonrandomized trials did not affect the findings. Use of embolic protection devices was not associated with better CAS outcomes (Brahmanandam, et al.). A second meta-analysis of 2985 patients (89% of whom were symptomatic) enrolled in 8 randomized trials found a significant increased risk of stroke or death in CAS patients within 30 days after treatment. The authors concluded, “The main result is that surgical treatment still remains the gold standard for treatment of patients with symptomatic carotid artery stenosis, who do not have an increased surgical risk. Carotid artery stenting is neither safer than nor as safe as carotid endarterectomy in large clinical trials when short-term stroke and death rates are taken into account. Further recruitment into ongoing randomized trials is strongly recommended (Ringleb, et al.).
The Sapphire Trial (see above under “Randomized Studies”) which was a trial comparing the safety and effectiveness of carotid artery stenting versus endarterectomy in high-risk patients found no outcome differences at 30 days and a 1 year. A recent update of that trial at 3 years has been reported (Gurm HS, et al. 2008). Data were available for ~ 79% of the patients (85.6 % of the stenting group and 70.1% of the endarterectomy group. No significant difference could be shown in long-term outcomes between patients who underwent carotid artery stenting with an emboli-protection device and those who underwent endarterectomy. The authors did state, “Our results may not be generalizable to the use of stents and emboli-protection devices other than those used in this study, and our findings do not apply to patients at low-to-moderate surgical risk with carotid endarterectomy.
Major ongoing randomized trials comparing CAS versus CEA include:
2011 Update
A search of the MEDLINE database was conducted through February 2011. There was no literature identified that would prompt a change in the coverage statement. Publications were identified from two trials enrolling “conventional” or “average-risk” patients—the Carotid Revascularization Endarterectomy vs. Stenting Trial (CREST) and the International Carotid Stenting Study (ICSS). These publications are discussed below.
Between May 2001 and October 2008, ICSS enrolled 1,713 symptomatic patients at 50 academic medical centers across Europe, Australia, New Zealand, and Canada. 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. Although from a per-protocol analysis, the 7.1% periprocedural death/stroke death rates accompanying CAS both exceeds rates established to provide a net clinical benefit and was more than twice the rate following CEA (3.4%). In a substudy of 231 ICSS participants, new ischemic brain lesions were approximately 3-fold more frequent following CAS—protection devices did not appear 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 conclusion that “routine stenting in symptomatic patients must now be difficult to justify….” (Rothwell, 2010)
CREST was conducted between December 2000 and July 2008, enrolling 2,522 patients at 108 centers across the U.S. and Canada. Of 427 interventionalists who applied to participate in CREST, only 224 were ultimately approved (Hopkins, 2010). Inclusion was initially restricted to recently symptomatic patients; due to slow enrollment the protocol subsequently 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 stroke, MI, or death during the periprocedural period or ipsilateral stroke within 4 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 stroke, MI, or death 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%). While this may be attributable to a somewhat higher prevalence of coronary artery disease among participants, the relative difference was large. Periprocedural CAS death/stroke rates were the lowest reported in any trial. Although participating interventionalists performing CAS were highly selected, periprocedural death/stroke rates following CAS exceeded those for CEA: in symptomatic patients 5.6% versus 2.4%; in asymptomatic patients 2.6% versus 1.5% (Silver, 2011). The relative risk for periprocedural death/stroke in the symptomatic group was 1.89 (95% CI: 1.11 to 3.21) in the asymptomatic group 1.88 (95% CI: 0.79 to 4.42). The trial had limited power in the asymptomatic group—21% power to detect a relative risk of 1.88. Finally, commenting on CREST the principle investigator of NASCET, Barnett expressed a view that by combining dissimilar patient groups (symptomatic and asymptomatic) flawed the trial (Barnett, 2010).
2012 Update
A search of the MEDLINE database was conducted through September 2012. There was no new information identified that would prompt a change in the coverage statement.
2013 Update
A literature search was conducted using MEDLINE database through September 2013. There wss no new information identified that would prompt a change in the coverage statement. The following is a summary of the key identified literature.
A secondary analysis of the CREST study was published in 2012 (Lal, 2012). The authors report 2-year restenosis (>70%) or reocclusion rates were similar following either CEA (6.3%) or CAS (6.0%)—2-year restenosis alone 5.8% with either procedure (Lal, 2012). Female sex, diabetes, and dyslipidaemia were independent predictors of restenosis or occlusion after the two procedures. Smoking predicted an increased rate of restenosis after carotid endarterectomy but not after carotid artery stenting.
Ongoing Clinical Trials
Major ongoing randomized trials comparing CAS versus CEA include:
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 vs. CEA vs. current optimal medical management) in symptomatic and asymptomatic increased-risk subgroups.
Practice Guidelines
ESC Guidelines on the diagnosis and treatment of peripheral artery diseases indicate the following (Tendera, 2011):
Levels of Evidence:
A (Data derived from multiple randomized clinical trials or meta-analyses.)
B (Data derived from a single randomized clinical trial or large non-randomized studies)
C (Consensus of opinion of the experts and/or small studies, retrospective studies, registries)
Updated Society for Vascular Surgery guidelines for management of extracranial carotid disease are as follows (Ricotta, 2011):
Levels of Evidence:
A (high quality)
B (moderate quality)
C (low quality)
NICE (NICE, 2011)
“Current evidence on the safety of CAS placement for asymptomatic extracranial carotid stenosis shows well documented risks, in particular, the risk of stroke. The evidence on efficacy is inadequate in quantity. Therefore, this procedure should only be used with special arrangements for clinical governance, consent, and audit or research” (NICE, 2011).
2014 Update
A literature search conducted through January 2014 did not reveal any new information that would prompt a change in the coverage statement. The key identified literature is summarized below.
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.. 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/stroke exceed those 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 vs Stenting Trial (CREST), the death/stroke rates for symptomatic patients was 3.2% and for asymptomatic patients was 1.4%. Accordingly, the benchmarks established decades ago may no longer be appropriate. A recent consensus document suggests benchmarks of 2.0% for asymptomatic and 4.0% for symptomatic individuals (De Rango, 2013).
Excluded from landmark CEA trials were patients with significant comorbidities such as those judged likely to cause death within 5 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 (eg, 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).
2015 Update
A literature search conducted through February 2015 did not reveal any new information that would prompt a change in the coverage statement. The key identified literature is summarized below.
In 2014, Mas and colleagues published long-term follow up (median 7.2 years) from the EVA-3S trial (Mas, 2014). Complete follow-up until death or the final telephone interview was obtained in 493 patients (94%). At the 5 year follow-up point, the main composite end point (ipsilateral stroke after randomization or procedural stroke or death) occurred in 29/265 subjects in the CAS group and 16/262 subjects in the CEA group (cumulative probability 11% vs 6.3%; 5-year absolute risk reduction 4.7%). The HR for CAS versus CEA was 1.85 (95% CI 1.0 to 3.40; P=0.04). At the 10 year follow-up point, the HR for the main composite endpoint for CAS versus CEA was 1.70 (95% CI 0.95 to 3.06; P=0.07).
In 2014, Bonati and colleagues published longer term follow up results from the ICSS study (Bonati, 2014). The cumulative 5-year risk of fatal or disabling stroke did not differ significantly between the CAS and CEA groups (6.4% for CAS vs 6.5% for CEA; HR 1.06; 95% CI 0.72 to 1.57; P=0.77). The risk of any stroke was higher in the CAS group compared with the CEA group (5-year cumulative risk 15.2% vs 9.45; HR 1.71; 95% Ci 1.28 to 2.3; P<0.001). The authors note that the difference between CEA and CAS groups in stroke risk after the procedural period was mainly attributable to strokes occurring in the contralateral carotid or vertebrobasilar territory in the CAS group. Functional outcomes, measured by modified Rankin scale scores, did not differ significantly between groups.
Also in 2014, Altinbas and colleagues reported that periprocedural rates of hemodynamic instability in the ICSS study differed between CEA and CAS groups (Altinbas, 2014). Hemodynamic depression occurred more commonly in CAS patients (13.8% vs 7.2%; RR 1.9; 95% CI 1.4 to 2.6; P<0.0001), while hypertension requiring treatment occurred less commonly in CAS patients (RR 0.2; 95% CI 0.1 to 0.4; P<0.0001). Hemodynamic instability was not associated with the ICSS study’s primary composite outcome.
In a follow up analysis of the CREST trial data, Gonzalez and colleagues reported no differences in outcomes for subjects treated in high-, medium-, or low-volume centers (Gonzales, 2014).
Additional RCTs
Several additional smaller trials have compared CEA with CAS. In 2014, Li et al published a study that reported to randomize 130 subjects at high risk of stroke due to angiographically confirmed carotid stenosis (≥50%) to CEA (n=65) or CAS (n=65) (Li, 2014). The authors report a 3-month post-operative risk of mortality of 1.5% with CAS, compared with 9.2% with CEA. However, “existence of complete follow-up data” is an inclusion criterion, and insufficient details are provided about enrollment and randomization procedures to allow conclusions to be drawn about the study. In 2015, Kuliha and colleagues published results of an RCT which randomized 150 subjects with at least 70% ICA stenosis to CEA (n=73) or CAS (n=77) (Kuliha, 2015). New infarctions on MRI were found more frequently after CAS
(49% vs 25%; P=0.002).
Paraskavas and colleagues conducted a systematic review of studies comparing cognitive outcomes after CEA with those after CAS (Paraskavas, 2014). Thirteen studies were included, with heterogeneity in the types of cognitive outcome measures reported. In qualitative analysis, the authors report that the majority of studies did not report a significant difference between CEA and CAS in terms of cognitive outcomes, but that the heterogeneity in outcomes reported precluded more definitive conclusions.
Galyfos and colleagues reported results of a systematic review that included 9 trials (n=5959) with a focus on risk of periprocedural symptomatic or asymptomatic myocardial ischemia or infarction (Galyfos, 2014). Four studies did not report their definition used for myocardial ischemia, and other studies varied in their definitions. In pooled analysis, compared with CEA, CAS was associated with decreased risk for cardiac damage (pooled RR 0.37; 95% Ci 0.22 to 0.61; P=0.0001). However, the study provides incomplete information about selection of studies for inclusion, which limits conclusions that can be drawn.
Additional evidence has been published related to rates of periprocedural stroke/death following CAS, particularly related to subgroups defined by medical comorbidities. Spangler and colleagues evaluated patients treated with isolated primary CEA (n=11,336) or primary CAS (n=544) at 29 centers between 2003 and 2013 to assess periprocedural mortality and stroke risks for patients considered medically high risk (Spangler, 2014). A Cox proportional hazards model was used to generate predicted 5-year mortality, and patients in the highest risk score quartile were considered high risk. For asymptomatic patients, there were no significant differences between CEA and CAS for major periprocedural outcomes (major or minor stroke, myocardial infarction, death) for either high- or low-risk patients. Periprocedural death/stroke rates with CAS were 1.1% for low-risk patients and 1.6% for high risk patients. For symptomatic patients, periprocedural death/stroke rates were higher with CAS than CEA for both low- and high-risk groups. For low-risk symptomatic patients, periprocedural death/stroke rates were 6.0% for CAS, compared with 2.2% for CEA (P<0.01). For high-risk symptomatic patients, periprocedural death/stroke rates were 9.3% for CAS, compared with 2.5% for CEA (P<0.01).
Ongoing and Unpublished Clinical Trials
There are 2 large ongoing randomized trials comparing CEA and CAS (ACT I, enrolling asymptomatic patients at average risk for complications from CEA, was terminated), which are summarized below:
SPACE 2: Stent-protected angioplasty in asymptomatic carotid artery stenosis vs endarterectomy: two two-arm clinical trials (ISRCTN78592017); a RCT comparing CAS, CEA, and best medical therapy in asymptomatic patients with carotid stenosis; estimated study completion date of January 2020; planned enrollment 3523 (1636 in CEA vs best medical therapy and 1636 in CAS vs best medical therapy).
ACST-2: Carotid Endarterectomy Versus Carotid Artery Stenting in Asymptomatic Patients (NCT00883402); RCT comparing CEA and CAS in asymptomatic patients; estimated study completion date of January 2019; planned enrollment 5000.
CAS: carotid artery stenting; CEA: carotid endarterectomy; RCT: randomized controlled trial
SPACE 2 was originally planned as a 3-arm clinical trial to compare CAS, CEA, and best medical therapy. In January 2013, due to insufficient enrollment, the study protocol was changed two 2-arm superiority trials. Patients are allocated to one of the two substudies based on the decision of the including physician and the patient's preference: either CEA compared with best medical management (SPACE2a substudy) or CAS compared with best medical management (SPACE2b substudy).
2018 Update
Annual policy review completed with a literature search using the MEDLINE database through April 2018. No new literature was identified that would prompt a change in the coverage statement.The key literature is summarized below.
In 2016, the Carotid Stenting Trialists’ Collaboration published an IPD meta-analysis (N=4754) of SPACE, EVA-3S, and ICSS data, plus data from symptomatic patients in CREST to evaluate the association between age and risk of stroke or death with CEA and CAS (Howard, 2016). The periprocedural period was defined as 120 days, which is considerably longer than the conventional 30-day periprocedural definition. For symptomatic patients assigned to CEA, there was no increase in periprocedural or postprocedural risk of death or stroke for patients older than 65 compared to patients younger than 60. In contrast, for patients assigned to CAS, the risk of periprocedural events increased with age, from a 2.1% risk for patients younger than 60 years, to 11% for patients older than 70 years. These analyses found increased periprocedural stroke risk for CAS versus CEA in patients approximately 65 years of age and older, but not among those younger patients (an age threshold was not defined). Age was not significantly associated with postprocedural stroke risk. The results suggest that the risk-benefit profile for CAS in symptomatic patients enrolled in these trials could be modified by age, but there was considerable imprecision in the age-specific CAS versus CEA comparisons for periprocedural risk. For example, among patients aged 60 to 64 years, the hazard ratio comparing CAS to CEA for the periprocedural risk of stroke or death was 1.07 (95% CI, 0.56 to 2.01).
2019 Update
A literature search was conducted through April 2019. There was no new information identified that would prompt a change in the coverage statement. The key identified literature is summarized below.
Retrospective Analyses
Salzler et al conducted a large retrospective analysis of the increased use of CAS since the Centers for Medicare & Medicaid guidelines recommended CAS for high-risk patients needing carotid revascularization (Salzler, 2017). Data from the Nationwide Inpatient Sample were searched for patients undergoing carotid revascularization. From 2005 (when the guidelines were published) to 2011, 20,079 CEAs and 3447 CASs were performed on high-risk patients. During the study period, CAS utilization increased significantly among all high-risk patients. A subgroup analysis of symptomatic high-risk patients did not show an increase in CAS use, indicating that the increase in CAS was primarily in asymptomatic high-risk patients. The odds of in-hospital mortality (odds ratio, 2.6; 95% CI, 1.2 to 5.6) and postoperative in-hospital stroke (odds ratio, 1.5; 95% CI, 1.1 to 3.7) were independently and significantly higher in patients undergoing CAS compared with CEA in the overall sample of high-risk patients.
2020 Update
A literature search was conducted through April 2020. There was no new information identified that would prompt a change in the coverage statement.
2021 Update
Annual policy review completed with a literature search using the MEDLINE database through April 2021. No new literature was identified that would prompt a change in the coverage statement. The key identified literature is summarized below.
Reiff et al published 1 -year interim results of the Stent-supported Percutaneous Angioplasty of the Carotid Artery versus Endarterectomy 2 (SPACE-2) RCT (Reiff, 2019). The SPACE-2 RCT was originally planned to compare best medical treatment (BMT) to CEA plus BMT or CAS plus BMT in 3,550 patients with high grade asymptomatic extracranial carotid artery stenosis. However, because patient recruitment was slow, the RCT was amended in 2013 to become 2 parallel randomized studies (BMT alone versus CEA plus BMT, and BMT alone versus CAS plus BMT). After recruitment continued to be slow, SPACE-2 was ultimately stopped early in 2016 after only 513 patients were randomized. Although the interim analysis did not find significant differences between CEA and CAS in 1-year rates of stroke or all-cause mortality, SPACE-2 authors noted that it is insufficiently powered to detect such differences.
Several TEC Assessments and meta-analyses have been published, all reporting similar findings (Muller, 2020; BCBSA TEC, 2005; Ederle, 2009; Bangalore, 2011; Murad, 2011; Economopoulos, 2011). In average-risk symptomatic patients, the body of evidence has demonstrated worse periprocedural outcomes with CAS than with CEA. For example, a 2020 Cochrane review found CAS associated with an increased risk of periprocedural death or stroke based on 10 RCTs that included 5,396 patients (odds ratio [OR]=1.70, 95% CI 1.31 to 2.19) (Mueller, 2020). Risk of periprocedural death or stroke remained higher with CAS in subgroup analysis of patients younger than age 70 years (OR=1.11, 95% CI 0.74 to 1.64) and in those patients age 70 years and older (OR 2.23, 95% CI 1.61 to 3.08), although this estimate was not statistically significant. The effect was similar in asymptomatic patients based on 7 trials of 3,378 individuals (OR=1.72, 95% CI 1.00 to 2.97). The review also found CAS associated with a significantly increased risk of at least moderate (≥50%) restenosis (4 RCTs; n=2,115; OR=2.00, 95% CI 1.12 to 3.60) and a nonsignificant risk of severe (≥70%) restenosis (9 RCTs; n=5,744; OR 1.26, 95% CI 0.79 to 2.00) in a pooled group of symptomatic and asymptomatic patients.
The Carotid Stenting Trialists’ Collaboration published an individual patient data meta-analysis (N=4,754 patients) of SPACE, EVA-3S, and ICSS data, plus data from symptomatic patients in CREST to evaluate the association between age and risk of stroke or death with CEA and CAS (Vincent, 2015). The periprocedural period was defined as 120 days, which is considerably longer than the conventional 30-day periprocedural definition. For symptomatic patients assigned to CEA, there was no increase in the periprocedural or postprocedural risk of death or stroke for patients older than 65 compared with those younger than 60. In contrast, for patients assigned to CAS, the risk of periprocedural events increased with age, from a 2.1% risk for patients less than 60 years, to 11% for patients over 70 years. These analyses found increased periprocedural stroke risk for CAS versus CEA in patients approximately 65 years and older, but not among those younger patients (an age threshold was not defined). Age was not significantly associated with postprocedural stroke risk. The results would suggest that the risk-benefit profile for CAS in symptomatic patients enrolled in these trials could be modified by age, but there was considerable imprecision in the age-specific CAS versus CEA comparisons for periprocedural risk. For example, among patients ages 60 to 64 years, the HR comparing CAS with CEA for the periprocedural risk of stroke or death was 1.07 (95% CI, 0.56 to 2.01). These results were consistent with those in the 2020 Cochrane review (Muller, 2020). In 2019, on behalf of the Carotid Stenting Trialists’ Collaboration, Brott et al published another individual patient data meta-analysis of the same symptomatic patient group (N=4775 patients) from SPACE, EVA-3S, ICSS, and CREST to evaluate long-term outcomes (mean follow-up of 4 years) (Brott, 2019). Periprocedural and postprocedural risks continued to favor CEA.
2022 Update
Annual policy review completed with a literature search using the MEDLINE database through April 2022. No new literature was identified that would prompt a change in the coverage statement. The key identified literature is summarized below.
The second asymptomatic carotid surgery trial (ACST-2) was a multicenter RCT comparing CAS and CEA in 3625 asymptomatic patients with severe carotid stenosis (Halliday, 2021). There was no significant difference between groups in the composite of death, MI, or stroke with CAS or CEA (3.9% vs. 3.2%; p=.26) within 30 days of the procedure. Five-year non-procedure related stroke was also similar between groups (5.3% with CAS vs. 4.5% with CEA; RR=1.6; 95% CI, 0.86 to 1.57; p=.33). The authors considered the long-term outcomes of these procedures to be similar with uncommon serious complications.
The American Heart Association and the American Stroke Association (2021) issued guidance for the prevention of stroke in patients with stroke and transient ischemic attack (TIA) (Kleindorfer, 2021). They recommended that for patients with severe extracranial carotid artery stenosis ipsilateral to a nondisabling stroke or TIA, the choice between carotid endarterectomy (CEA) and CAS in patients who are candidates for intervention should be patient specific. Specific recommendations for CAS or CEA are summarized below:
The Society for Vascular Surgery published updated guidelines for management of extracranial cerebrovascular disease in 2022 (AbuRahma, 2022). They recommended CEA over CAS in low-and standard-risk patients with more than 50% symptomatic artery stenosis (strong evidence of high quality).
2023 Update
Annual policy review completed with a literature search using the MEDLINE database through April 2023. No new literature was identified that would prompt a change in the coverage statement. The key identified literature is summarized below.
In 2022, Meschia et al published a post hoc analysis of 826 asymptomatic patients enrolled in CREST with no stroke symptoms at baseline and with at least 1 completed follow-up Questionnaire for Verifying Stroke-free Status (QVSS) (Meschia, 2022). The HR for adjudicated stroke with CAS compared to CEA in this analysis was nonsignificant at 1.02 (95% CI, 0.57 to 1.85). However, significant treatment differences for CAS versus CEA were detected for the outcome of stroke symptoms (HR, 1.54; 95% CI, 1.15to 2.08) and the composite outcome of adjudicated stroke or stroke symptoms (HR, 1.38; 95% CI, 1.04 to 1.83). The authors concluded that inclusion of stroke symptoms to broaden the outcome of stroke prevention trials should be considered to permit sufficiently powered analyses in low-risk populations.
Reiff et al published 5-year outcomes from SPACE-2 (Reiff, 2022). Median follow-up was 59.9 months (interquartile range, 46.6 to 60). The cumulative incidence of any stroke (ischemic or hemorrhagic) or death from any cause within 30 days, or any ipsilateral ischemic stroke within 5 years of follow up was 2.5% (95% CI, 1.0 to 5.8), 4.4% (95% CI, 2.2 to8.6), and 3.1% (95% CI, 1.0 to 9.4) with CEA plus BMT, CAS plus BMT, and BMT alone, respectively. No significant difference in risk for the primary efficacy endpoint was found for CEA plus BMT versus BMT alone (HR, 0.93; 95% CI, 0.22 to 3.91; p=.93) or for CAS plus BMT versus BMT alone (HR, 1.55; 95% CI, 0.41 to 5.85; p=.52). Since superiority of CEA or CAS to BMT was not demonstrated, noninferiority testing was not conducted. In both the CEA and CAS groups, 5 strokes and no deaths occurred in the 30-day periprocedural period. During 5-year follow-up, 3 ipsilateral strokes occurred in both the CAS plus BMT and BMT alone groups compared to none in the CEA plus BMT group.
The ongoing Carotid Revascularization and Medical Management for Asymptomatic Carotid Stenosis Trial (CREST-2; NCT02089217) may elucidate whether CAE or CAS plus contemporary intensive medical management is superior in preventing stroke beyond medical management alone (Howard, 2017). The primary outcome consists of the composite of stroke and death within 44 days of randomization and incidence of ipsilateral stroke through 4 years. Change in cognition and differences in major and minor stroke are planned secondary outcomes.
Wang et al conducted a meta-analysis of 7 RCTs, including ASCT-2, reporting outcomes for 7118 asymptomatic patients (Wang, 2022). No significant difference was observed with CAS compared to CEA in the perioperative composite outcome of stroke, death, or any MI (OR, 1.13; 95% CI, 0.87 to 1.47; p=.37). However, CAS had a higher risk of any stroke (OR, 1.62; 95% CI, 1.16to 2.24; p=.004) and nondisabling stroke (OR, 1.81; 95% CI, 1.23 to 2.65; p=.003). No significant difference in risk of disabling stroke and death was detected between groups (OR, 0.91; 95% CI, 0.50 to 1.65; p=.76).
Naazie et al published a systematic review and meta-analysis of 9 nonrandomized studies including 4012 individuals who underwent transcarotid artery revascularization (TCAR) and smaller comparative analyses of outcomes between TCAR and transfemoral CAS (TF-CAS; 2 studies) or CEA (4 studies) (Naazie, 2020). Periprocedural (30-day) rates of stroke or death, stroke, death, MI, stroke/death/MI, or cranial nerve injury were 1.89% (95% CI, 1.50 to 2.37), 1.34% (95% CI, 1.02 to 1.75), 0.76% (95% CI, 0.56 to1.08), 0.60% (95% CI, 0.23 to 1.59), 2.20% (95% CI, 1.31 to 3.69), and 0.31% (95% CI, 0.12 to 0.83), respectively. The perioperative risks of stroke (1.33% vs. 2.55%; OR, 0.52; 95% CI, 0.36 to 0.74) and death (0.76% vs. 1.46%; OR, 0.52; 95% CI,0.32 to 0.84) were significantly lower with TCAR compared to TF-CAS. When compared against CEA, no statistically significant differences were observed for rates of stroke or death, stroke, or stroke/death/MI with TCAR. However, the risk of death alone was significantly elevated with TCAR (0.81% vs. 0.41%; OR, 1.92; 95% CI, 1.01 to 3.67). Analysis of data based on symptomatic status was not feasible. The authors note that larger, prospective studies comparing TCAR with TF-CAS and CEA are needed, particularly in high-risk patients.
The U.S. Preventive Services Task Force recommends against screening for asymptomatic carotid artery stenosis in the general adult population (Grade D; reaffirmed in 2021) (Krist, 2021).
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Group specific policy will supersede this policy when applicable. This policy does not apply to the Wal-Mart Associates Group Health Plan participants or to the Tyson Group Health Plan participants.
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