Jonathan D. Beard, MD, is a consultant vascular surgeon working at the Sheffield Vascular Institute in Sheffield, United Kingdom. He was a co-applicant, participating physician and member of the Steering Committee of the International Carotid Stenting Study (ICSS), a randomized comparison of stenting vs endarterectomy to determine long-term efficacy for treatment of carotid artery stenosis. At the 2015 VEITH Symposium in New York, Vascular Disease Management spoke with Dr. Beard about details of the results.
VDM: Can you highlight some of the important data points from the ICSS trial?
Beard: The ICSS trial is the largest trial of patients with symptomatic carotid disease in the world. The principal investigator is Dr. Martin Brown from London. It randomized patients with symptomatic severe stenosis with either carotid stenting or carotid surgery. Recently, we published the long-term results of the trial, which are a median of over 4 years of follow-up for all patients. They’ve shown that the long-term results are essentially equivalent for carotid surgery and carotid stenting.
However, we can’t get away from the fact that while the long-term results are equivalent, the short-term periprocedural outcomes are very different. Carotid stenting has twice the risk of periprocedural stroke and death as surgery, and that’s mainly due to embolic stroke, which happens at the time of the stent procedure or shortly afterwards. Surgery has a risk of cranial nerve injury and bleeding relating to the operation. Whilst the majority of cranial nerve injuries are temporary, there are some cranial nerve injuries that can be devastating and just disabling for the patient as a stroke. My own view is that cranial nerve injury must be regarded as the equivalent a stroke, whether it’s temporary or permanent because that’s the patient’s viewpoint. The family doesn’t care whether the patient can’t swallow because of a stroke or because of cranial nerve injury. They only care that they can’t swallow or can’t speak as well as they could. Those risks need to be explained to patients.
The two techniques are complementary, and patients need to be offered the choice. If you don’t offer patients the choice and explain in an honest way the benefits and risks of both, you are failing in your duty of care to the patient. If you can’t offer both options, you should say so rather than advise toward the one you can offer. If you only have a hammer but the best treatment for the patient is not a nail, then maybe you should send them elsewhere. That’s easier to do in the UK because we have a national service and, apart from pride, I have nothing to lose from referring a patient elsewhere. In the United States, of course, it’s a matter of physician and hospital income, which is more problematic in many ways.
VDM: Do the long-term data from ICSS fly in the face of any previously held beliefs or standards?
Beard: I don’t think there was much doubt that the long-term data were going to be pretty equivalent. Once you are over that periprocedural risk period, whether you have a stent or operation, the effect is probably going to be very similar. What we have now is the numbers to show that this is actually the case. One of the early studies of carotid intervention randomized trials was the CAVATAS trial. That was criticized for two reasons: one is most of the endovascular interventions were angioplasty rather than stenting and we now know that angioplasty is a pretty dangerous thing to do in the carotid artery because it increases the risk of embolization. Because of that, most underwent stenting. However, that trial did show that there was a risk for restenosis after endovascular treatment and so one of the valid long-term questions to ask was whether carotid stenting would have a significantly higher restenosis rate than carotid surgery. The ICSS trial shows that although there is a slightly higher restenosis with stenting, it’s not significant out as far as we’ve measured so far. If you look at symptomatic restenosis, it’s even less of an issue. I think patients can be reassured that once they’re out of the periprocedural danger zone, stroke and restenosis risks are similar for stenting and surgery, and both methods are probably pretty equivalent in terms of cost effectiveness as well.
VDM: Anything else for a peripheral vascular clinician to keep in mind when either making a choice between the two or describing risk and benefit to patients?
Beard: There is probably at least a day of carotid talks here at VEITH, and every meeting you go to, there’s going to be a day of these talks where facts and figures are bandied about between carotid surgeons and carotid interventionalists, as well as the physicians who don’t think we should be treating anyone! Essentially, it boils down to some very simple things. Patients deserve to be apprised of the facts. You don’t need to go into huge detail, but physicians first must inform the patient of the procedures they can offer someone who has had a recent stroke that is thought to be carotid stenosis. Can you offer surgery? Can you offer stenting? Can you offer both? Next, physicians must know what their unit’s procedural risk rates and complication rates are for these two procedures. If the interventionalist, surgeon, or cardiologist can’t answer that question, the patient should walk away. Find somebody who can answer that question. You wouldn’t buy a car from a person who couldn’t answer your questions, why would you allow that person to treat you?
The next step is to run through the pros and cons of the two procedures in terms of their risks. Which risk is more important to the patient? One option has a slightly higher risk of stroke, the other one has a risk of cranial nerve injury and bleeding. Many of the trials in carotid stenting talk about high-risk patients who are not suitable for surgery, but very few patients are not suitable for surgery: possibly those with unstable angina, and very few others. There are more patients who can’t have a stent because the aortic arch anatomy has to be suitable for a stent. So, you can’t ask the question of whether someone is suitable for a stent until you’ve done appropriate imaging and you need to do that imaging first to avoid finding out in the middle of a procedure that it isn’t going to work. The risk of a stroke increases significantly if you have adverse arch anatomy. But, all things being equal, it’s the patient’s choice.
As an example, a patient referred to me was an opera singer. He had a recent stroke, fully recovered, a high-grade carotid stenosis and I recommended to him that he should have a carotid endarterectomy because the risk of stroke was lower than with a stent. He opted for a stent because his voice was his profession and he was very worried that during the operation, I could not guarantee that I would not damage his superior or recurrent laryngeal nerve, which would affect his voice. He opted for a stent in full knowledge of the fact that he was running a slightly higher risk of stroke. That was his choice based on his profession and what was important to him. We should remember that Julie Andrews never sang again after her neck operation.
What I am making a plea for here is a less paternalistic and financially orientated practice when it comes to symptomatic carotid artery disease. Do what is best for the patient, not your pocket. It is your responsibility to provide all the facts so that the patient, and their relatives, can come to an informed decision.
Editor’s note: Dr. Beard has completed and returned the ICMJE Form for Disclosure of Potential Conflicts of Interest. He reports royalties from Elsevier for Current Therapy in Vascular and Endovascular Surgery, 5th Edition.