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Debate: Flawed Carotid Stenting Trials Results Have Minimal Impact
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Added: 11/16/2006
Type: Summary
Viewed: 806 time(s)
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Debate: Flawed Carotid Stenting Trials Results Have Minimal Impact
On-going CAS data from several trials, such as the Stenting Angioplasty Protection Patients High Risk Endarterectomy (SAPPHIRE) and capture trials were debated in New York today at the 33rd annual VEITHsymposium™.
Investigators behind these trials continue to suggest that these trials offer enough scientific proof to show that CAS should be offered to all high-risk patients to prevent a stroke. Others have a different point of view. Peter R.B. Bell, M.D., Professor of Surgery, University of Leicester, (Leicester, UK), "Attempts to show that CAS is equivalent or better than carotid endarterectomy (CEA) have repeatedly failed. The only trial, which has shown a benefit for CAS, is the Sapphire trial which is deeply flawed and has now largely been discredited." Bell went on to say that the Sapphire trial used the wrong endpoints with involvement of industry in the design of the trial.
More than 400 patients were not considered for randomization for reasons, which have never been made clear. Bell continued to say that the experience of the surgeons carrying out the CEA in this trial remains in doubt and the stroke rate for both CAS and CEA in largely asymptomatic patients is higher even than the historical levels suggested 20 years ago. Bell said, "For such patients the risk of stroke is less than 2% per annum, and in the Sapphire trial the rate of 5.8% at 30 days is unacceptable." Clarifying this point Bell said, "Basically what this means is that the so-called experts in angioplasty involved in this trial caused more strokes in their patients than doing nothing at all. This can only mean that when the procedure is used more widely by less experienced operators the stroke rate will increase to a level which is completely unacceptable."
The capture trial: Bell said the Capture trial is not a trial but a registry again sponsored by industry, which clearly shows no benefit from CAS in patients with carotid artery stenosis. Most of the patients in this registry (90%) were again asymptomatic and had a stroke and death rate of 4.9% "As far as symptomatic patients are concerned, two recent trials, the EVA 3S and SPACE trials have shown no benefit for CAS in patients with symptoms who need treatment. The EVAS/3S trial showed a big difference between CEA and CAS with a stroke and death rate of 3.9% for CEA and 9.6% for CAS. The German SPACE trial showed a stroke and death rate of 6.84% for CAS and 6.34% for CEA. The CAPTURE data for symptomatic patients had a stroke and death rate of 14% for these patients. If all these data are put together, it shows a very clear superiority for CEA and provides no evidence that CAS should be expanded and used more widely. Bell concluded, "On the contrary, these trials show that the procedure is dangerous even in the hands of experts and should not be used more widely otherwise, a potential disaster will occur."
About VEITHsymposium™: Now entering its fourth decade, VEITHsymposium™ provides vascular surgeons, interventional radiologists, interventional cardiologists and other vascular specialists with a unique and exciting format to learn the most current information about what is new and important in the treatment of vascular disease. The 5-day event features 300 rapid-fire presentations from the world's most renowned vascular specialists with emphasis on the latest advances, changing concepts in diagnosis and management, pressing controversies and new techniques.
What is Carotid Stenting (CAS)?
CAS is a less invasive procedure that is fast becoming the choice method of treatment for carotid artery disease (CAD).
Procedure: Diagnostic tests allow the specialist to snake a thin wire through an artery in the leg up
into the neck.
What is Carotid Artery Disease? Narrowing of arteries in the neck that blocks the flow of blood to the brain; Build up of plaque in the walls of the arteries that can cause atherosclerosis (a/k/a) hardening of the arteries
Risk Factors: Elevated cholesterol levels, Stroke, Diabetes, Weight gain, Family history, Smoking, Poor diet Lack of exercise
Treatment Options: Medications, Vascular laboratory diagnostic follow up, Vitamin supplements Exercise, Carotid Endarterectomy -- open surgery, Carotid Stenting/Angioplasty - minimally invasive
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