Part 5/Chapter 32/10-min read

Carotid Stenting and Transcarotid Artery Revascularization

Carotid stenting encompasses distinct procedures. Transfemoral carotid stenting and transcarotid artery revascularization share a stent but differ in access, embolic-protection physics, anatomic vulnerability, and the type of data supporting their use. Patient selection requires matching the individual to the correct comparator: symptomatic trial data when stroke risk is front-loaded, high-surgical-risk data when endarterectomy risk is unusually high, asymptomatic data only when intervention is already justified, and registry data for transcarotid outcomes without treating those registries as randomized equivalence with endarterectomy.

Edited by Tal M. Hörer MD, PhD · David T. McGreevy MD, PhD·Version 2 · Last published ·5 sections · 32 references

Revision history

Definition and clinical presentation

Carotid stenting and transcarotid artery revascularization are endovascular interventions for extracranial carotid artery . Intervention is considered only after an indication is established based on presenting features, life expectancy, medical therapy, and center peri-procedural outcomes .

Clinical presentation dictates the primary goal of intervention:

  • Symptomatic disease: Patients presenting with recent stroke or transient ischemic attack undergo revascularization primarily to prevent early recurrent stroke.
  • Asymptomatic disease: intervention seeks a stroke-prevention benefit sufficient to outweigh procedural harm in a patient likely to survive long enough to benefit; a survival advantage from the procedure is not the required demonstrated endpoint.

Medical management is foundational for all patients. Baseline therapy includes blood-pressure control, statin administration, smoking cessation, and appropriate antiplatelet therapy regardless of the ultimate procedural decision . Stent-based treatment requires an agreed peri-procedural DAPT regimen; the doses, lead-in and minimum duration are described in Chapter 30. Thereafter, long-term single-agent therapy is required, but aspirin is not the only permitted agent: ESVS prefers clopidogrel after symptomatic CAS. The patient’s bleeding risk, other antithrombotic indications and exact device instructions also matter.

Diagnosis and anatomic stratification

For native-carotid atherosclerotic disease, duplex grading should name the validated laboratory scheme and integrate visible plaque/lumen, peak systolic velocity (PSV), end-diastolic velocity (EDV) and PSV ratio. The IAC’s November 2023 recommendations provide a named contemporary example: PSV 180 to 230 cm/s, ratio 2 to 4 and EDV 40 to 100 cm/s support 50 to 69% stenosis with substantial plaque; PSV 125 to 180 cm/s with ratio ≥2 and significant plaque may also represent this category. Severe stenosis short of near-occlusion typically has PSV >230 cm/s, ratio >4 and EDV >100 cm/s with concordant plaque/lumen findings. Normal arteries and <50% disease both usually have PSV <180 cm/s and are distinguished by plaque; near-occlusion can have high, low or undetectable velocities and must be identified separately. These are multiparameter categories, not requirements to satisfy every velocity threshold mechanically; post-CEA and in-stent restenosis require separate interpretation. Before stent planning, obtain appropriate or MRA of the arch and extra- and intracranial circulation and resolve important discordance.

Anatomic stratification defines the procedural hazards for stent-based therapies. Transfemoral access requires navigation through the iliofemoral system, aortic arch, and great-vessel origins. Arch elongation, heavy atheroma, calcification, severe tortuosity, and common-carotid disease increase embolic risk during transfemoral catheter manipulation . Transcarotid access bypasses these proximal structures via direct surgical exposure of the common carotid artery in the neck, establishing dynamic flow reversal before the target lesion is crossed .

Treatment-decision thresholds and modality selection

Establish an indication before choosing a stent or access route. Use Chapter 30 for the guideline-specific stenosis, timing, survival and 30-day quality framework; do not transfer an in-hospital registry endpoint to that 30-day framework. CEA remains the reference treatment for suitable symptomatic patients, and contemporary asymptomatic medical-therapy comparisons require separate interpretation.

When intervention is indicated, modality selection follows a stepwise evaluation of systemic risk and access anatomy:

  1. Decide surveillance versus intervention based on symptoms, stenosis severity, and patient life expectancy.
  2. Establish why a stent-based route is appropriate for this patient. High surgical risk and a hostile neck—prior irradiation, CEA or radical , tracheostomy, high bifurcation or contralateral laryngeal nerve palsy—are relevant, but not the only considerations. Selected younger symptomatic patients may also consider CAS; a hostile neck does not automatically provide safe TCAR access.
  3. Evaluate protection as well as access. A distal filter requires lesion crossing before deployment; transfemoral CAS can instead use proximal balloon protection. TCAR establishes cervical flow reversal before lesion crossing and avoids aortic-arch catheter navigation.
  4. Consider TCAR when a stent is appropriate and arch navigation is hazardous, provided the common-carotid access segment, venous return and flow-reversal tolerance are suitable for the specified device.
  5. Defer intervention in patients with prohibitive overall risk, limited life expectancy, or goals of care prioritizing no intervention.

How protection and stent systems differ

A stent and an embolic-protection system are separate components. In one randomized device study, 104 patients with lipid-rich plaques received single-layer Carotid Wallstent or double-layer Roadsaver stents with either distal FilterWire or proximal Mo.Ma Ultra protection. Differences concerned Doppler microembolic signals; the study does not establish a clinical-stroke advantage for a device class.

The ENROUTE TCAR platform combines a self-expanding carotid stent with a distinct transcarotid neuroprotection system. Direct common-carotid access and proximal control establish flow through an external filter to venous return before the lesion is crossed; the stent is then delivered under protection. Its NPS and NPS PLUS labelling requires a common-carotid diameter ≥6 mm, a bifurcation at least 5 cm above the clavicle and suitable venous access. Assess the target-vessel diameter, cervical disease, antiplatelet suitability and tolerance of flow reversal against the exact model’s instructions. These are technical eligibility requirements, not proof of clinical superiority.

Dated device safety note — 20 September 2026: FDA’s August 2026 Class I notice concerns specific ENROUTE NPS/NPS PLUS lots with possible arterial sheath-tip separation. Check the affected-lot list and do not use recalled units. This is not a withdrawal of every TCAR system.

Carotid intervention modality selection

  • Symptomatic, standard surgical risk

    Key caution
    Strongly preferred in patients aged >= 70 years due to higher stenting stroke risk.
    Route preferenceCitation

  • High systemic surgical risk, favorable arch

    Key caution
    Supported by high-risk trial criteria; dependent on low center stroke and death rates.
    Route preferenceTransfemoral stentingCitation

  • Hostile neck anatomy

    Key caution
    Prior neck irradiation, prior endarterectomy or radical neck dissection, tracheostomy, a high C2 bifurcation, or contralateral laryngeal nerve palsy favours a stent-based approach over open surgery.
    Route preferenceStenting (transfemoral or transcarotid)Citation

  • Hostile transfemoral access path

    Key caution
    TCAR avoids arch traversal but still needs suitable cervical common-carotid access and flow-reversal conditions.
    Route preferenceConsider TCAR or CEA according to the overall indicationCitation

  • Asymptomatic, standard risk

    Key caution
    ACST-2 compares CEA with CAS, not medical therapy alone; CREST-2 comprises separate intervention-versus-medical comparisons and does not establish TCAR equivalence.
    Route preferenceReassess medical therapy versus an appropriate intervention before selecting a routeCitation

  • Prohibitive risk or limited life expectancy

    Key caution
    Continued optimal medical therapy only.
    Route preferenceNo interventionCitation

Evidence and landmark trials

Randomized trial evidence for carotid intervention is cohort-specific. Symptomatic European trials consistently demonstrated early peri-procedural hazards for transfemoral stenting compared with endarterectomy. ICSS’s per-protocol analysis found more stroke, death or procedural MI within 30 days of treatment after CAS; its main interim intention-to-treat window extended to 120 days after randomization. The substudy found more new diffusion-weighted lesions after CAS, an imaging endpoint distinct from clinical stroke. EVA-3S was stopped early for excessive 30-day stroke or death after stenting, and SPACE failed to demonstrate non-inferiority for stenting at 30 days . Similar post-procedural ipsilateral stroke prevention does not imply identical long-term any-stroke outcomes. ICSS retained an excess of any stroke after CAS, so the entire difference cannot be assigned automatically to the procedural period.

In a mixed cohort, CREST reported a similar overall primary composite for stenting and endarterectomy, but the constituent events differed: stenting caused more peri-procedural strokes, whereas endarterectomy caused more myocardial infarctions . Age functions as a treatment-effect modifier; patients aged 70 years and older experience worse peri-procedural stroke outcomes with stenting .

TCAR evidence must be labelled by design. ROADSTER’s 141-patient high-CEA-risk pivotal cohort reported 30-day stroke of 1.4% and stroke or death of 2.8%. ROADSTER 2 was also single-arm: among 692 intention-to-treat patients and 632 per-protocol patients, stroke rates were 1.9% and 0.6%, and stroke/death/MI rates were 3.2% and 1.7%. The per-protocol cohort excludes patients with major protocol violations; the difference between cohort rates does not isolate the causal effects of antiplatelet adherence or flow reversal. Neither study is a randomized comparison with CEA.

ROADSTER 3 extends prospective single-arm evidence to selected standard-risk patients younger than 80. Its 344-patient intention-to-treat cohort and 320-patient per-protocol cohort had 30-day stroke/death/MI rates of 0.9% and 0.6%. Only 49 per-protocol patients were symptomatic, and only 12 were treated within two weeks of the preceding event. These results do not establish randomized equivalence with CEA or settle early symptomatic selection.

Randomized intervention outcomes at 30 days and long term

  • Mixed symptomatic and asymptomatic (CREST)

    Key trial finding
    Similar primary composite; more stroke after stenting, more myocardial infarction after endarterectomy.
    Limitation or context
    Ten-year follow-up did not establish a significant composite difference; this is not formal equivalence of every outcome.
    Citation

  • Symptomatic (ICSS)

    Key trial finding
    Higher treatment-to-30-day stroke, death or procedural MI after CAS in the per-protocol analysis.
    Limitation or context
    Distinguish 120-day ITT, procedural events, later ipsilateral stroke and any stroke.
    Citation

  • Symptomatic severe stenosis (EVA-3S)

    Key trial finding
    Stopped early for excess 30-day stroke or death after stenting.
    Limitation or context
    Operator experience and protection-device use varied between centers.
    Citation

  • Symptomatic severe stenosis (SPACE)

    Key trial finding
    Failed to demonstrate non-inferiority of stenting at 30 days.
    Limitation or context
    The failure to establish non-inferiority is not proof that the procedures are equivalent.
    Citation

  • High surgical risk (SAPPHIRE)

    Key trial finding
    CAS met noninferiority for the one-year composite including 30-day death/stroke/MI and subsequent death or ipsilateral stroke.
    Limitation or context
    Symptomatic ≥50% or asymptomatic ≥80%, high-CEA-risk selection; not proof for every standard-risk symptomatic patient.
    Citation

  • Selected asymptomatic (ACST-2)

    Key trial finding
    Similar five-year non-procedural fatal/disabling stroke; more procedural non-disabling strokes after CAS.
    Limitation or context
    Selected patients already considered for intervention; no medical-only or TCAR arm.
    Citation

Areas of controversy

TCAR comparisons with TF-CAS and CEA remain chiefly observational. The 2019 VQI matched analysis reported in-hospital stroke/death of 1.6% after TCAR versus 3.1% after TF-CAS; this is not a 30-day estimate. VQI is a clinical quality registry, although later studies link it to administrative claims. A 2025 VQI–Medicare analysis supports an association with lower subsequent stroke after TCAR than TF-CAS, not randomized superiority.

A 2026 report of 57,843 contemporary VQI procedures further shows why risk stratum and adjustment matter: weighted standard-risk symptomatic comparisons did not establish significant differences between either stenting route and CEA. These studies do not establish randomized TCAR–CEA equivalence. Chapter 30’s CREST-2 and ECST-2 results should not be relabelled as TCAR evidence.

Asymptomatic-specific evidence is also unsettled. A 2026 retrospective TriNetX electronic-health-record analysis matched 2,207 patients per group and found no statistically significant difference in ischemic stroke between TCAR and code-defined CAS during follow-up extending to four years (HR 0.68, 95% CI 0.44–1.06). Missing stenosis severity and anatomic data, possible stroke under-ascertainment and residual confounding limit interpretation; nonsignificance does not establish equivalence. An asymptomatic-focused meta-analysis reported favorable perioperative associations for TCAR versus TF-CAS, but its observational studies had potentially overlapping registry cohorts and nonuniform outcome definitions and follow-up. Neither analysis establishes TCAR benefit over medical therapy alone.

Further reading

  • Trans-Carotid Artery Revascularization Versus Carotid Endarterectomy in Patients With Carotid Artery Disease: Systematic Review and Meta-analysis of 30-day Outcomes. (2025). TCAR-versus-CEA short-term comparative evidence; does not prove randomized equivalence or replace device-specific current notices.

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