There is a consensus emerging that carotid angioplasty and stenting (CAS) has its place, particularly for high-risk surgical patients. As technologies and techniques are refined and results from expert centres improve, the question is whether CAS can replace carotid endarterectomy as the gold standard treatment. Is CAS ready for primetime?

European randomised clinical trials of carotid stenting are now gathering steam. The Stent-protected Percutaneous Angioplasty of the Carotid artery with Endarterectomy (SPACE) trial, which is being conducted in Germany and Austria, so far has 16 centres active, according to Peter Ringleb of the University of Heidelberg. In total, 223 patients have been included into the SPACE trial (112 stent-protected percutaneous angioplasty of the carotid artery, and 111 carotid endarterectomy). Recruitment is ongoing, with an expected enrolment of 1,900 patients at 30 centres. Meanwhile, the International Carotid Stenting Study (ICSS), or CAVATAS II as it is also known, by September 2002 had enrolled 12 centres, with another three in the process of joining, and randomised 54 patients. ICSS aims to compare the risks and benefits of primary carotid stenting with conventional carotid endarterectomy in the prevention of stroke. The European Union has now favourably reviewed a grant application to set up a European carotid stenting network under the Framework Programme 5 and this should lead to further support for ICSS following completion of contract negotiations. Although only well-designed, randomised clinical trials will be able to establish the safety and efficacy of carotid stenting compared to carotid endarterectomy, there is concern. Some quarters are asking whether it is too early for such trials. With the current knowledge and understanding of the new procedures, is it ethically justifiable to randomise patients for standard operation or balloon angioplasty and stenting? In addition, technological advancements may make any of the trials currently underway redundant.

Carotid stenting under debate
In the south of France two different meetings covered the topic of carotid stenting. The first was the International Workshop on Endovascular Surgery held in Ajaccio, Corsica. This debate pitted two vascular surgeons, Jacques Watelet and Sir Peter Bell, against the interventional cardiologist Max Amor and the interventional radiologist Derek Gould. The topic of the debate was controversial in itself: “Carotid Angioplasty benefits Industry and Physicians but not Patients”. Watelet opened the debate by saying that the fact that 120,000 carotid endarterectomies are performed in the US shows how attractive this procedure is. He also stated that carotid angioplasty and stenting was more expensive despite requiring a shorter hospital stay. He pointed out that carotid endarterectomy has excellent results where teams have sufficient experience, achieving a 1.5% to 2% stroke and death rate, and highlighted results from the SCV, the famous French vascular surgical meeting, where a series by the interventionalists showed a 1% stoke and death rate but the surgeons, who had audited the same series of patients, showed that this was 9%. He concluded by saying that the commercial interest in carotid stenting was far greater than the interests of the patients.

Max Amor, in ebullient form, defended carotid stenting by reminding the audience that it took 40 years to prove that carotid endarterectomy was a procedure with good results, from 1952 to 1992, and all this time the procedure was reimbursed. “Cardiologists and radiologists have come to improve your surgery and make you more intelligent,” he said. He then claimed that those defending carotid endarterectomy where like the crypto-communists of the 1950s. Cerebral protection is bringing better results into line and certainly often better than surgery. However, he pointed out that it would be wrong to perform carotid stenting on patients less than 60 years of age because there hasn’t been any long-term follow up.

Benefits but not for the patient
Sir Peter Bell attacked carotid stenting with a simple statistic that symptomatic carotid stenoses required 100 operations to save 30 stokes but asymptomatic carotid stenoses required 40 operations to do one stoke and that many of the patients selected for carotid stenting were asymptomatic. He stated that equipoise does not exist, and that it had not been proven that cerebral protection would provide a benefit. He concluded that stenting does benefit the physicians, because they can make a name for themselves. Physicians can be on the front page of a magazine companies can sponsor them – there is financial gain to performing carotid stenting. There is also benefit for neurologists, and with the results of the European Carotid Surgery Trial (ECST) they lost the only patients that they could treat, which were transient ischaemic attacks (TIAs) with aspirin and they almost cried! And it benefits the companies who want to sell more disposable products, £1,000 for a catheter, all to make more profits. Ever since doctors stuffed a balloon up an artery this has been what they have wanted and they are against randomised controlled trials. And therefore stenting benefits the physicians and the companies but not the patients.

Derek Gould countered by saying that there is no evidence of no benefit, that there is equipoise around the fact that carotid stenting has not been properly trialed and that the ICSS and CREST (Carotid Revascularisation Endarterectomy vs Stent Trial) are needed and that there has been considerable technological evolution in carotid stenting. He remarked that the Veith consensus highlighted that a panel of experts had shown that there was benefit to patients who had high risks and he also said that industry has had a hard time in terms of the investment needed to establish this procedure. None the less the result of the debate was an overwhelming majority in favour of the motion that carotid angioplasty benefits industry and physicians but not the patients.

There was, however, an altogether different environment in the Multidisciplinary European Endovascular Therapy (MEET) meeting in Marseille.

A different audience, a different opinion
The MEET meeting covered all kinds of aspects to do with carotid stenting and a number of the debate results were far more favourable towards stenting. However, this meeting had a more interventionalist audience with many interventional cardiologists present opposed to the more surgical environment in Ajaccio. This may have been the reason for the difference in the results of the debates. André Nevelsteen spoke about recurrent stenosis after endarterectomy and he said that this was an unusual event and that it is not clear that restenosis leads to stroke. He also said that surgery is not an easy procedure and pointed to an incidence of cranial nerve injury of up to 20%. The consensus of the audience was for carotid stenting for early restenosis but its use remains unclear for late restenosis. Frank Veith commented that many restenosis should be left alone and that they were benign lesions. In the discussion on age being a factor for carotid stenting, Veith commented that age is one of the factors but judgement is what counts. However he agreed with Amor that carotid stenting should not be carried out on the young as there has not been any long-term follow-up.

What was also interesting was the number of people that are not convinced by cerebral protection. One of the presentations given by J. M. Bartoli, who does not use cerebral protection but drug therapy. Bartoli works closely with Philippe Piquet, who has earlier said to Vascular News that they rely exclusively on pharmacological protection because the efficacy and safety of mechanical protection had not been demonstrated, secondly because “it is a complication of a procedure that is meant to be simple” and finally because of the cost.