MEDICAL POLICY

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Extracranial Carotid Angioplasty/Stenting

Number 7.01.520*

Effective Date May 28, 2013

Revision Date(s) 05/13/13; 05/08/12; 07/12/11; 08/10/10; 08/11/09; 05/13/08; 05/08/07; 05/09/06; 05/10/05; 05/11/04; 08/13/02; 10/06/98

Replaces 7.01.68

*Medicare has a policy.

Policy

Carotid angioplasty with or without associated stenting and distal embolic protection may be considered medically necessary when both of the following criteria are met:

  • The individual has anatomic contraindication for carotid endarterectomy and requires revascularization; and
  • The individual has ONE of the following, as demonstrated on ultrasound or angiogram:
  • neurological symptoms and > 50% stenosis of the common or internal carotid artery; or
  • no neurological symptoms and > 80% stenosis of the common or internal carotid artery.

Related Policies

None

 

Policy Guidelines

N/A

Description

Carotid artery angioplasty with stenting (CAS) is a treatment for carotid stenosis that is intended to prevent 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 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 a placed embolic protection device (EPD) designed 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.

Proposed advantages of CAS as opposed to carotid endarterectomy include:

  • general anesthesia is not used (although CEA can be performed under local/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) has approved carotid artery stents and EPD’s from various manufacturers. Examples include:

  • ACCULINK™ and RX ACCULINK™ carotid stents and ACCUNET™ and RX ACCUNET™ cerebral protection filters, Guidant Corp. (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 Corp. (approved September 2006);
  • ProtegeRX™ and SpideRX™, ev3 Inc. Arterial Evolotuion Technology.(approved January 2007);
  • NexStent® carotid stent over-the-wire and monorail delivery systems, Endotex Interventional Systems; and FilterWire EX™ embolicprotection system, Boston Scientific Corp. (approved October 2006); and
  • Carotid Wallstent®, Boxton Scientific Corp. (approved October 2008);
  • GORE® Flow Reversal System (clearance February 2009); GORE® Embolic Filter (clearance May 2011)
  • Mo.Ma® Ultra Proximal Cerebral Protection Device, Invatec S.P.A. (clearance October 2009).

Each FDA-approved carotid stent system is indicated for combined use with an EPD to reduce stroke risk in patients considered to be at increased risk for periprocedural complications from CEA who are symptomatic with >=50% stenosis, or asymptomatic with >=80% stenosis. Patients are considered at increased risk for complications during CEA if affected by any item from a list of anatomical features and comorbid conditions included in each stent system’s information from 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 EPD’s 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 (the SAPPHAIRE trial; see Rationale section). Other devices were approved based upon uncontrolled, single-arm trials or registries, and comparison to historical controls. The FDA has mandated post-marketing 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.

Scope

Medical policies are systematically developed guidelines that serve as a resource for Company staff when determining coverage for specific medical procedures, drugs or devices. Coverage for medical services is subject to the limits and conditions of the member benefit plan. Members and their providers should consult the member benefit booklet or contact a customer service representative to determine whether there are any benefit limitations applicable to this service or supply.

Benefit Application

N/A

Rationale

This policy was created in 1998 and updated annually with literature review. The last update with literature review covers the period of January 2012 through January 2013.

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 in symptomatic and asymptomatic individuals with carotid artery stenosis. (1-7) 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 <3% for asymptomatic (>60% stenosis), and <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—2 years for symptomatic patients with 70%–99% stenosis, 5 years for symptomatic patients with 50%–69% stenosis or asymptomatic patients with >60% stenosis. (Summarized in the following Table)

Symptoms

 

Stenosis (%)

 

Acceptable Periprocedural Death/Stroke Rate, %

 

Anticipated Life Expectancy, yr

 

No

60–99

<3

5

Yes

50–69

<6

5

70–99

<6

2

As an example of the fine line between benefit and harm, Arazi et al. (8) 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/stroke rate of 1.8%). (7) Over a 5-year time horizon CEA provided 4 days of stroke-free survival and a net harm when periprocedural death/stroke rates exceeded 2.1%.

Since the landmark trials were performed, there have been substantial improvements in medical care and evidence of substantial decline in stroke rates with medical care in asymptomatic carotid disease. (9, 10) Current medical therapies such as 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 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 vs. Stenting Trial (CREST), (11) the death/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 5 years that might also increase periprocedural and anesthetic risk for complications. Therefore, CAS has appeal as a treatment option for potentially higher periprocedural risk patients 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 (12), as confirmed in the 95-center General Anesthesia versus Local Anesthesia (GALA) trial. (13) Investigators randomized 3,526 patients undergoing CEA to general or local anesthesia and found no difference in 30-day death/stroke/myocardial infarction (MI) rates according to anesthetic approach (RR 0.94, 95% CI: 0.70 to 1.3). (13)

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) (14) trial. The relevant conclusion 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 statistically significant differences in one-year outcomes favoring CAS with 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 noninferiority.
  • 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.
  • 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 at 3 years. (15-17) For asymptomatic and symptomatic patients combined, ipsilateral strokes from day 31 to 1,080 days were observed in 4.4.% patients undergoing CAS and 3.6% with CEA (from digitized figure). Cumulative 3-year repeat target vessel revascularization (a proxy for restenosis) was more common after CEA (7.1% vs. 3.0%). (16)

SPACE, In 2006, the Stent-supported Percutaneous Angioplasty of the Carotid Artery versus Endarterectomy (SPACE) trial was published. This trial randomized 1,200 patients within 180 days of neurologic symptoms, transient ischemic attack, or moderate (non-disabling) stroke, and with ≥50% stenosis of the ipsilateral carotid artery, to CAS (N=605), with (27%) or without EPD (73%), or to CEA (N=595).(18) The analysis (N=1183) failed to conclude that CAS was not inferior to CEA by a margin of ≥2.5% for the primary outcome of ipsilateral ischemic stroke or death by 30 days after randomization. Event rates were 6.84% for the CAS group and 6.34% for the CEA group. The absolute between-group difference favored CEA and was 0.51% (90% CI: -1.89%, +2.91%) by intent-to-treat analysis and 1.32% (90% CI: -1.10, 3.76) by per-protocol analysis.

Editorialists (19,20) 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 at 2-years. (15-17) Approximate annual ipsilateral stroke rates from day 31 though 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 2 years following CAS versus CEA (10.7% vs. 4.6%, respectively).

EVA-3S

The endarterectomy versus angioplasty in patients with severe symptomatic stenosis (EVA-3S) trial was a non-inferiority trial 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. (21) 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 by 30 days after treatment 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).

Over a mean follow-up of 2.1 years restenosis (>50%) was more frequent following CAS than CEA (12.5% versus 5.0%). (22) Long-term follow-up of EVA-3S was reported at 4 years. (15-17) 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 (19,20) 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 prior CAS procedures, compared with >25 CEAs for vascular surgeons. EVA-3S also permitted use of five different stents and seven different EPD devices, 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 (23) 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/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 a substudy of 231 ICSS participants, new ischemic brain lesions were approximately 3-fold more frequent following CAS—protection devices did not appear to mitigate their occurrence. (24) 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….” (25)

CREST

The Carotid Revascularization Endarterectomy vs. Stenting Trial (11) was conducted between December 2000 and July 2008, enrolling 2,522 patients at 117 centers across the U.S. and Canada. Of 427 interventionalists who applied to participate in CREST, only 224 (52%) were ultimately approved. (25) 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 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%). 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/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%, respectively (the lowest rate for CAS reported in any trial); in asymptomatic patients 2.6% versus 1.4%, respectively. (27) 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 CREST, 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. (28)

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. (29) However, analyses of CAS in Medicare patients between 2005 and 2007 found that few CAS operators had the experience of CREST investigators. (30) 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 transient ischemic attack (TIA) appears to be similar for the 2 procedures. While some trials found higher restenosis rates after CAS (SAPPHIRE, SPACE, EVA-3S) restenosis in CREST occurred with similar frequency following either procedure. 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/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 and the criteria used to credential in other trials has been a focus criticisms along with the inconsistent use of embolic protection devices.(31)

There are no RCTs 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 trial (32) reported that the annual ipsilateral stroke rate was approximately 2.0% with medical therapy. (10) A recent estimate in 2009 (9) described a contemporary annual ipsilateral stroke or transient ischemic attack (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. (8) needed justify the periprocedural risk of death and disabling stroke. This evidence can be used to argue that medical therapy in asymptomatic patients is preferable to intervention. (25, 33, 34) Therefore, it is not possible to determine whether CAS is superior to medical therapy.

Systematic Reviews and Meta-analysis of RCTs

Several TEC Assessments and meta-analyses have been published with similar findings. (35) (36-39) In average risk symptomatic patients the body of evidence demonstrates worse periprocedural outcomes with CAS compared to CEA. While data show secular improvement in periprocedural outcomes following CAS (27, 40) 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 et al. (41) 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. (42) In these symptomatic patients the 30-day death/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/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.

Conclusions

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/stroke rates following CAS

This question was assessed in the October 2009 TEC Assessment. (43) 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, the Assessment sought evidence to address the following questions:

  1. Is the periprocedural death/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 9 registries 30-day death/stroke rates were either reported or obtained from investigators; in the remaining 2, death/stroke rates were estimated from 30-day death/stroke/MI and MI rates. An independent assessment of neurological outcomes was required in all but one registry. For asymptomatic patients, the pooled periprocedural death/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%).
  • A subsequent systematic review, without consideration to FDA labeling, reported results consistent with the TEC Assessment (pooled periprocedural death/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]). (37)
  1. For those subgroups defined by a) medical comorbidities or b) unfavorable anatomy, are periprocedural death/stroke rates with CAS less than 3% for asymptomatic and less than 6% for symptomatic patients?
  2. Combined data from 2 registries reported periprocedural death/stroke rates for patients with unfavorable anatomy (41, 42) but included only 371 asymptomatic (30-day death/stroke rate 2.7% [95% CI: 1.5% to 4.9%]) and 60 symptomatic patients (30-day death/stroke rate 1.7%% [95% CI: 0.3% to 8.9%]). No other registry reported results by symptomatic status for those subgroups.

Carotid Dissection

Carotid dissection is uncommon (incidence approximately 2 per 100,000/year) and occurs generally in younger individuals. (46) 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 (47, 48) however, there are no clinical trials comparing alternative strategies and interventions. Current guidelines (detailed below) rate CAS in for this indication as a class IIb (Level of Evidence: C) recommendation.

Ongoing Clinical Trials

Major ongoing randomized trials comparing CAS versus CEA include:

  • ACT I, enrolling asymptomatic patients at average risk for complications from CEA (NCT00106938), estimated completion date 12/2017;
  • SPACE 2, comparing CAS, CEA, and medical therapy in asymptomatic patients (ISRCTN78592017), estimated completion date 1/2015;
  • ACST-2, Carotid Endarterectomy Versus Carotid Artery Stenting in Asymptomatic Patients (NCT00883402), estimated completion date 1/2018.

There are no ongoing or direct comparisons of CAS versus CEA in patients at increased risk for CEA complications. (49) 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.

Clinical Input Received through Physician Specialty Societies and Academic Medical Centers

In response to requests, input was received through 4 physician specialty societies (6 reviewers) and 4 academic medical centers while this policy was under review in 2009. (In addition, one unsolicited response from a specialty society was also received.) 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.

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 investigational.

Practice Guidelines and Position Statements

2011 ASA/ACCF/AHA/AANN/AANS/ACR/ASNR/CNS/SAIP/SCAI/SIR/SNIS/SVM/SVS Guideline on the Management of Patients with Extracranial Carotid and Vertebral Artery disease. (50-52)

CLASS I Benefit >>> Risk

Level of Evidence

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% (360).

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 2 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 his 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

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

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.

Updated Society for Vascular Surgery guidelines for management of extracranial carotid disease. (53)

GRADE I "benefit clearly outweighs risk"

Level of Evidence

In most patients with carotid stenosis who are candidates for intervention, CEA is preferred to CAS for reduction of all-cause and periprocedural death

B

GRADE II "benefits and risks are more closely matched and are more dependent on specific clinical scenarios"

CAS is preferred over CEA in symptomatic patients with >50% stenosis and tracheal stoma, situations where local tissues are scarred and fibrotic from prior ipsilateral surgery or external beam radiotherapy, prior cranial nerve injury, and lesions that extend proximal to the clavicle or distal to the C2 vertebral body

B

CAS is preferred over CEA in symptomatic patients with >50% stenosis and severe uncorrectable coronary artery disease, congestive heart failure, or chronic obstructive pulmonary disease

C

There are insufficient data to recommend CAS as primary therapy for neurologically asymptomatic patients with 70% to 99% diameter stenosis. In properly selected asymptomatic patients, CAS is equivalent to CEA in the hands of experienced interventionalists with a combined stroke and death rate <3%

B

Levels of Evidence:

A (high quality)

B (moderate quality)

C (low quality)

ESC Guidelines on the diagnosis and treatment of peripheral artery diseases. (54)

Class IIa "Should be considered"

Level of Evidence

In symptomatic patients at high surgical risk requiring revascularization, CAS should be considered as an alternative to CEA

B

Class IIb "May be considered"

In symptomatic patients requiring carotid revascularization, CAS may be considered as an alternative to CEA in high-volume centers with documented death or stroke rate <6%

B

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)

NICE (55)

“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.”

Australasian (56)

“CAS may be considered as a treatment option for patients with symptomatic severe carotid stenosis who are at high risk of stroke, but are surgically unsuitable for CEA, namely postradiation therapy, block dissection of the neck, in situ tracheostomy, recurrent stenosis following previous CEA, severe cervical spine arthritis, surgically inaccessible carotid stenosis (e.g., obesity, high carotid bifurcation), contralateral recurrent laryngeal nerve injury, and contralateral internal carotid occlusion.”

“The overall results of randomized controlled trials indicate that CAS is not as safe as CEA for treatment of symptomatic carotid stenosis for prevention of ipsilateral stroke.”

“There is currently no evidence to support CAS as a treatment for asymptomatic carotid stenosis.”

Medicare Policy (57)

From March 2001, Medicare’s national coverage policy restricted coverage for carotid angioplasty and stenting to patients participating in a clinical trial with Category B Investigational Device Exemption (IDE) designation from the FDA. PTA of the vertebral and cerebral arteries remained noncovered.

When FDA approved the first (Guidant) devices, Medicare coverage under the IDE trial policy was no longer available for that manufacturer’s devices and was not applicable to FDA-required post-approval studies. Thus, on October 12, 2004, Medicare broadened its national coverage policy and “determined that the evidence is adequate to conclude that percutaneous transluminal angioplasty (PTA) with carotid stent placement is reasonable and necessary when performed consistent with FDA approval of the carotid stent device and in an FDA required post-approval study.” For unapproved stents and EPD devices, the prior policy remained in effect and restricted coverage to patients participating in an FDA-approved Category B IDE trial of stent placement in the cervical carotid artery.

While the Medicare decision differed from the conclusions of this policy, Medicare made a public policy decision “that making available new, effective therapies aimed at addressing treatment and prevention of cerebrovascular disease was important to Medicare beneficiaries.” Medicare also noted that it recognized value in supporting post-approval studies as “the collected data may provide an opportunity for practitioners to determine which patients are most appropriate for carotid artery stenting and to reinforce IDE trial data on health outcomes and adverse events.”

CMS provides a continually updated listing of facilities eligible for Medicare reimbursement that met CMS's minimum facility standards for performing carotid artery stenting for high-risk patients.

On March 17, 2005, CMS determined that CAS with EPD is reasonable and necessary for patients at high risk for CEA who also have symptomatic carotid artery stenosis >70%. CMS limited coverage for these patients to procedures performed using FDA-approved devices. CMS also limited coverage for patients at high risk for CEA with symptomatic carotid artery stenosis between 50% and 70%, and for patients at high risk for CEA with asymptomatic stenosis >80%, to FDA-approved Category B IDE clinical trials for unapproved devices, or to FDA-required post-approval studies for approved devices. CMS defined patients at high risk for CEA as having significant comorbidities and/or anatomic risk factors (i.e., recurrent stenosis and/or previous radical neck dissection) who would be poor candidates for CEA in the opinion of a surgeon. This links proves a list of CMS-certified facilities for CAS with EPD. (Last accessed April 1, 2013.)

The paragraph below provides CMS’ reasoning for this change in coverage policy:

“Considering the evidence and clinical situation, there appears to be sufficient evidence to infer that CAS with embolic protection can improve health outcomes for patients with severe symptomatic stenosis >70% who are also at high risk for CEA, if performed with the same expertise and rate of adverse events as demonstrated in the published clinical trials. Since patients with severe symptomatic stenosis >70% are at high risk for stroke, carotid interventions to reduce the risk of stroke should be considered. Although the published studies on CAS have various potential biases, we feel that the need for an alternative treatment to CEA for patients who are truly at high risk for CEA should be factored into the coverage decision, unlike the BCBS TEC report, which did not consider this circumstance. By not covering this group, symptomatic patients who also are at high risk for surgery may be left with no other treatment options. The risk benefit consideration may be similarly influenced. However, having mentioned this situation, the high risk CAS studies compared CAS to CEA and found that CEA can be performed as well as CAS in a group classified as high risk. Therefore, two comparable options exist for patients with symptomatic stenosis >70% who are at high risk.”

On April 30, 2007, a decision memo reaffirmed CMS’s previous decision following a request to expand coverage while clarifying that “CAS is only covered when used with an embolic protection device and is, therefore, not covered if deployment of the distal embolic protection device is not technically possible.” On October 14, 2008, in the sixth reconsideration, CMS again reaffirmed their prior coverage decision.

On January 25, 2012 CMS convened a MEDCAC panel to consider “management of Carotid Atherosclerosis.” Panel members voted on specific questions using a scale of 1(low confidence) to 5 (high confidence). For symptomatic patients not considered at high-risk, the mean scores to the question of whether CAS is the favored treatment strategy in this population was 1.85 and for CEA 3.6. For asymptomatic patients not considered high-risk the evidence was not judged to reach a level of certainty to provide allow determining a favored treatment.

References

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  27. Silver FL, Mackey A, Clark WM et al. Safety of Stenting and Endarterectomy by Symptomatic Status in the Carotid Revascularization Endarterectomy Versus Stenting Trial (CREST). Stroke 2011; 42(3):675-80.
  28. Lal BK, Beach KW, Roubin GS et al. Restenosis after carotid artery stenting and endarterectomy: a secondary analysis of CREST, a randomised controlled trial. Lancet Neurol 2012; 11(9):755-63.
  29. Roffi M, Sievert H, Gray WA et al. Carotid artery stenting versus surgery: adequate comparisons? Lancet Neurol 2010; 9(4):339-41; author reply 41-2.
  30. Nallamothu BK, Gurm HS, Ting HH et al. Operator experience and carotid stenting outcomes in Medicare beneficiaries. JAMA 2011; 306(12):1338-43.
  31. Gray WA. Carotid stenting or carotid surgery in average surgical-risk patients: interpreting the conflicting clinical trial data. Prog Cardiovasc Dis 2011; 54(1):14-21.
  32. Endarterectomy for asymptomatic carotid artery stenosis. Executive Committee for the Asymptomatic Carotid Atherosclerosis Study. JAMA 1995; 273(18):1421-8.
  33. Woo K, Garg J, Hye RJ et al. Contemporary results of carotid endarterectomy for asymptomatic carotid stenosis. Stroke 2010; 41(5):975-9.
  34. Barnett HJ, Pelz DM, Lownie SP. Reflections by contrarians on the post-CREST evaluation of carotid stenting for stroke prevention. Int J Stroke 2010; 5(6):455-6.
  35. Blue Cross and Blue Shield Association Technology Evaluation Center (TEC). Angioplasty and stenting of the cervical carotid artery with distal embolic protection of the cerebral circulation. TEC Assessments 2004; Volume 19, Tab 15.Ederle J, Featherstone RL, Brown MM. Randomized controlled trials comparing endarterectomy and endovascular treatment for carotid artery stenosis: a Cochrane systematic review. Stroke 2009; 40(4):1373-80.
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  37. Murad MH, Shahrour A, Shah ND et al. A systematic review and meta-analysis of randomized trials of carotid endarterectomy vs stenting. J Vasc Surg 2011; 53(3):792-7.
  38. Economopoulos KP, Sergentanis TN, Tsivgoulis G et al. Carotid artery stenting versus carotid endarterectomy: a comprehensive meta-analysis of short-term and long-term outcomes. Stroke 2011; 42(3):687-92.
  39. Touze E, Trinquart L, Chatellier G et al. Systematic review of the perioperative risks of stroke or death after carotid angioplasty and stenting. Stroke 2009; 40(12):e683-93.
  40. Bangalore S, Kumar S, Wetterslev J et al. Carotid Artery Stenting vs Carotid Endarterectomy: Meta-analysis and Diversity-Adjusted Trial Sequential Analysis of Randomized Trials. Arch Neurol 2011; 68(2):172-84.
  41. Bonati LH, Jongen LM, Haller S et al. New ischaemic brain lesions on MRI after stenting or endarterectomy for symptomatic carotid stenosis: a substudy of the International Carotid Stenting Study (ICSS). Lancet Neurol 2010; 9(4):353-62.
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  43. Gray WA, Chaturvedi K, Verta P. Thirty-day outcomes for carotid artery stenting in 6320 patients from 2 prospective, multicenter, high-surgical-risk registries. Circ Cardiovasc Intervent 2009; 2:159-66.
  44. White CJ, Iyer SS, Hopkins LN et al. Carotid stenting with distal protection in high surgical risk patients: the BEACH trial 30 day results. Catheter Cardiovasc Interv 2006; 67(4):503-12.
  45. Lee VH, Brown RD, Jr., Mandrekar JN et al. Incidence and outcome of cervical artery dissection: a population-based study. Neurology 2006; 67(10):1809-12.
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  51. Brott TG, Halperin JL, Abbara S et al. 2011 ASA/ACCF/AHA/AANN/AANS/ACR/ASNR/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 for Cardiovascular Angiography and Interventions, Society of Interventional Radiology, Society of NeuroInterventional Surgery, Society for Vascular Medicine, and Society for Vascular Surgery. Stroke 2011; [ePub ahead of printRicotta JJ, Aburahma A, Ascher E et al. Updated Society for Vascular Surgery guidelines for management of extracranial carotid disease. J Vasc Surg 2011; 54(3):e1-31.
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  54. Guidelines for patient selection and performance of carotid artery stenting. Intern Med J 2011; 41(4):344-7.
  55. Centers for Medicare and Medicaid Services (CMS). National Coverage Analysis (NCA) for Percutaneous Transluminal Angioplasty (PTA) of the Carotid Artery Concurrent with Stenting (CAG-00085N). Available online at: http://www.cms.gov/medicare-coverage-database/ . Last accessed April 1, 2013.
  56. Blue Cross and Blue Shield Association. Extracranial Carotid Angioplasty/Stenting. Medical Policy Reference Manual, Policy No. 7.01.68. Last reviewed March 2013.

Coding

Codes

Number

Description

CPT

0075T

Transcatheter placement of extracranial vertebral or intrathoracic carotid artery stent(s), including radiologic supervision and interpretation, percutaneous; initial vessel

 

0076T

each additional vessel (List separately in addition to code for primary procedure)

 

37215

Transcatheter placement of intravascular stent(s), cervical carotid artery, percutaneous; with distal embolic protection

 

37216

without distal embolic protection

 

37217

Transcatheter placement of an intravascular stent(s), intrathoracic common carotid artery or innominate artery by retrograde treatment (effective 01/01/14)

ICD-9 Procedure

00.61

Percutaneous angioplasty or atherectomy of precerebral (extracranial) vessel(s)

 

00.63

Percutaneous insertion of carotid artery stent(s)

 

39.50

Angioplasty or atherectomy of other noncoronary vessel(s)

 

39.90

Insertion of non-drug-eluting peripheral vessel stent(s)

ICD-9 Diagnosis

433.1

Occlusion and stenosis of carotid artery

 

433.3

Occlusion and stenosis of precerebral arteries; multiple and bilateral

ICD-10_CM
(effective 10/01/14)

I65.21-I65.29

Occlusion and stenosis of carotid artery code range

 

433.30-433.31

Occlusion and stenosis of precerebral arteries; multiple and bilateral, code range

ICD-10-PCS
(effective 10/01/14)

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

Surgical, upper arteries, dilation, carotid artery, code by body part (common, internal or external, and right or left), approach (percutaneous or percutaneous endoscopic) and device (drug-eluting intraluminal, intraluminal or none)

 

037P34Z, 037P3DZ,
037P3ZZ, 037P44Z,
037P4DZ, 037P4ZZ,
037Q34Z, 037Q3DZ,
037Q3ZZ, 037Q44Z,
037Q4DZ, 037Q4ZZ

Surgical, upper arteries, dilation, vertebral artery, code by body part (right or left), approach (percutaneous or percutaneous endoscopic) and device (drug-eluting intraluminal, intraluminal or none)

 

03CH3ZZ, 03CH4ZZ,
03CJ3ZZ, 03CJ4ZZ,
03CK3ZZ, 03CK4ZZ,
03CL3ZZ, 03CL4ZZ,
03CM3ZZ, 03CM4ZZ,
03CN3ZZ, 03CN4ZZ

Surgical, upper arteries, extirpation, carotid artery, code by body part (common, internal or external, and right or left), and approach (percutaneous or percutaneous endoscopic)

 

03CP3ZZ, 03CP4ZZ,
03CQ3ZZ, 03CQ4ZZ

Surgical, upper arteries, extirpation, vertebral artery, code by body part (right or left), and approach (percutaneous or percutaneous endoscopic)

HCPCS

   

Type of Service

Cardiology

 

Place of Service

Inpatient

 

Appendix

N/A

History

Date

Reason

10/06/98

Add to Medicine Section - New Policy

08/13/02

Replace Policy - Policy reviewed; policy statement unchanged; additional information regarding Medicare coverage policy and ongoing clinical trials added. Policy title changed from Carotid Angioplasty/Stenting.

05/11/04

Replace Policy - Policy reviewed; policy statement unchanged.

05/10/05

Replace with PR Policy - Policy replaces BC.7.01.68; changing policy statement from investigational to medically necessary under specific circumstances. Medicare policy and current clinical trials information added.

05/09/06

Replace Policy - Policy updated with literature search; references added; no change to policy statement.

06/06/09

Disclaimer and Scope update - No other changes.

05/08/07

Replace Policy - Policy updated with literature search; CMS coverage and FDA-approved devices; policy statement unchanged. References added.

05/13/08

Replace Policy - Policy updated with literature search; no change to the policy statement. Reference added.

08/11/09

Replace Policy - Policy updated with literature search; no change to the policy statement.

08/10/10

Replace Policy - Policy updated with literature review; references added. No change in policy statement.

07/12/2011

Replace Policy - Policy updated with literature review; reference list revised and renumbered. No change to policy statement.

05/22/12

Replace Policy. Policy updated with literature and reference list revised and renumbered. No change to policy statement.

05/28/13

Replace policy. Policy updated with literature and reference list revised and renumbers. No change to policy statement. ICD-10 codes added.

01/13/14

Coding Update. Add CPT 37217 effective 01/01/14.

03/17/14

Update Related Policies. Remove 2.01.54 as it was archived.


Disclaimer: This medical policy is a guide in evaluating the medical necessity of a particular service or treatment. The Company adopts policies after careful review of published peer-reviewed scientific literature, national guidelines and local standards of practice. Since medical technology is constantly changing, the Company reserves the right to review and update policies as appropriate. Member contracts differ in their benefits. Always consult the member benefit booklet or contact a member service representative to determine coverage for a specific medical service or supply. CPT codes, descriptions and materials are copyrighted by the American Medical Association (AMA).
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