Carotid challenges: updates and device characteristics

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The two European carotid trials, the Endarterectomy vs. Angioplasty in Patients with Symptomatic Severe Carotid Stenosis (EVA-3S) and the Stent-Supported Percutaneous Angioplasty of the Carotid Artery vs. Endarterectomy (SPACE) trials, will be presented at this year’s Charing Cross International Symposium, by Jean-Pierre Becquemin, Paris, France and Professor Hans-Henning Eckstein, Munich, Germany, respectively.

At the time of publication both trials received much criticism and, following the presentations, delegates will have the opportunity to hear the views of both surgeons (Sir Peter Bell) and interventionalists (Professor Peter Gains) and assess whether the trials were ‘a setback for carotid stenting’ or their conclusions were defined by the trial design as both EVA-3S and SPACE are investigator driven, neurologically controlled randomised trials.

CREST

Also to be presented at this year’s meeting will be the Carotid Revascularization Endarterectomy vs. Stent Trial (CREST), presented by Dr Robert Hobson, NJ, the principal investigator for the trial. CREST is a randomised clinical trial to evaluate patients who are at normal risk for surgery, the efficacy of stenting as compared to surgery in preventing stroke, myocardial infarction and death in the 30-day period immediately following the procedures, and ipsilateral stroke during a multi-year follow-up period.

ACST-2

There will also be the opportunity to hear update from ACST-2 that will compare stenting to surgery as ‘gold standard’. Patient eligibility will be based in unilateral or bilateral carotid artery stenosis appropriate for surgery or stenting (only one side allowed in trial). In addition, only patients fit for and willing to have surgery or stenting and accessible for follow-up to five-years (mostly by telephone) will be included, where both the doctor and patient are ‘substantially uncertain’ whether the patient should have carotid endarterectomy or carotid stenting.

TACIT

In addition, Dr Barry Katzen, Miami, FL, will present an update from the Transatlantic Asymptomatic Carotid Intervention Trial (TACIT). TACIT will study all-risk patients, assigning these patients to one of three treatment arms. The first arm will provide optimal medical therapy alone, consisting of antiplatelet, antilipidemic and antihypertensive therapy, as well as tight glycemic control and tobacco cessation efforts. The second arm will provide optimal medical therapy plus carotid endarterectomy. The third arm will provide optimal medical therapy plus carotid artery stenting, with embolic protection using commercially available devices at the time of trial initiation. TACIT will comprise 100 sites, equally divided between the US and Europe, and will enrol at least 2,400 patients: 850 patients in each of the revascularisation arms and 700 patients in the medical treatment arm alone. The primary endpoint is the three-year rate of all strokes and death. Secondary endpoints include transient ischaemic attack, myocardial infarction, economic cost and quality-of-life analysis, neurocognitive function, and duplex stenosis progression.

Carotid stenting: do device characteristics matter?

Another topical issue surrounding carotid stenting is whether the type of device utilised affects outcomes. This question will be addressed in two presentations by Dr Marc Bosiers, Dendermonde, Belgium and Dr Barry Katzen, Miami, FL.

Previously, it has been suggested that closed cell design of the carotid artery stents provides superior clinical outcomes compared to open cell stents.

The investigators wanted to assess how different carotid stents impact patient outcomes, and therefore studied the theoretical difference in closed vs. open-cell stents as well as eccentric vs. concentric embolic protection devices (EPDs). The researchers reviewed an existing single-centre database of 701 consecutively performed carotid artery stenting procedures in an effort to identify factors that negatively impacted patient outcome and compared the clinical results of open vs. closed cell carotid stents.

Moreover, Katzen will discuss whether patient outcomes are affected by device characteristics, such as significantly lower incidence of hypotension. “As carotid artery stenting becomes a mature technique, it is important to look at the subtle differences between technologies that could affect patient care,” commented Katzen.

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