A Prospective Registry of Carotid Stenting With the Nexstent and Distal Protection With the FilterWire EX in High Risk Patients - CABERNET

Nov 08, 2004
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Date Presented:
01/01/2004
Date Updated:
11/08/2004
Original Posted Date:
11/08/2004
References

Description:

This was a registry evaluating the safety and efficacy of the self-expanding Endotex NexStent and distal protection using the Filterwire EZ/EX device for treatment of carotid stenosis in patients who were poor candidates for sugical revascularization.

Hypothesis:

Carotid stenting using the self-expanding Endotex NexStent and distal protection using the Filterwire EZ/EX device would be associated with a low rate of adverse events.

Study Design

Study Design:

Patients Enrolled: 488
Mean Follow Up: 30-days

Patient Populations:

Symptomatic carotid stenosis 50% or greater by ultrasound or angiography OR asymptomatic carotid stenosis 80% or greater by ultrasound or 60% by angiography. To be enrolled, patients also required anatomic and/or clinical exclusions to surgical revascularization as defined below:

Anatomic Contraindication to Surgery (one criteria)

  • Restenosis post endarterectomy
  • Contralateral occlusion
  • Previous neck radiation or surgery
  • Surgically inaccesible lesion (above C2/below clavicle)
  • Neck immobility
  • Tracheostomy
  • Contralateral laryngeal palsy<\li>
  • Bilateral stenosis requiring treatment<\li>

    AND/OR

    Clinical Exclusion to surgery (One required)

  • Unstable Angina
  • LVEF 30% or less
  • CHF (NYHA III or IV)
  • Dialysis dependent renal failure
  • Severe COPD
  • Planned CABG or valve replacement<\li>

    AND/OR

    Clinical Exclusion to surgery (Two required)

  • Age 75 or greater year
  • MI within 6 weeks
  • Planned peripheral vascular surgery
  • 2 or more diseased coronary arteries with 70% or greater stenosis

    Exclusions:

    Candidate for carotid endarterectomy without exclusion criteria above.

    Primary Endpoints:

    Major adverse events (death, stroke, MI)

    Drug/Procedures Used:

    Carotid stent placement using the self-expanding Endotex NexStent and distal protection using the Filterwire EZ/EX device.

    • Principal Findings:

    Major adverse events (Death, stroke or MI) were 3.8% at 30-days. The death rate was 0.5% (n=2). The MI rate was 0.2% (n=2). The overall stroke rate was 3.4% (n=15) and 1.4% (n=6) were major and 2.0% (n=9) were minor. Procedureal success rates were high. Successful stent placement occurred in 96.9% of patients and the Filterwire was successfully placed in 99.1% of patients.

    Interpretation:

    This registry reports the lowest 30-day adverse event rates to date in a large prospective trial of carotid stenting. Though these data were obtained in high-risk patients the procedures were performed by highly skilled operators in selected patients. Further randomized data comparing carotid endarterectomy to carotid stenting in patients without contraindication to surgery and with challenging lesion morphologies are forthcoming.

    References:

    Hopkins, LN. Carotid Artery Revascularization Using the Boston Scientific FiltERwire EX/EZ aNd th EndoTex Nexstent- 30 Day Results. Presented at Transcatheter Therapeutics 2004, Sept. 29, Washington, D.C.

    Keywords: Stroke, Endarterectomy, Carotid, Tracheostomy, Constriction, Pathologic, Peripheral Vascular Diseases, Stents, Renal Dialysis, Pulmonary Disease, Chronic Obstructive, Renal Insufficiency, Cerebrovascular Disorders, Coronary Vessels, Carotid Stenosis


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