Belgium authorities deny reimbursement for carotid stenting.
The Belgian government has opted against reimbursement for carotid artery stenting based on outcomes from the Endarterectomy Versus Angioplasty in Patients With Severe Symptomatic Carotid Stenosis (EVA3S) trial, which showed that carotid artery stenting has higher rates of death and stroke at one and six months compared with carotid endarterectomy. According to Dr Patrick Peeters, Chief of the Department Cardio-Vascular and Thoracic Surgery of the Imelda Hospital, Bonheiden, Belgium, the future possibility of carotid artery stenting reimbursement looks doubtful without definite proof from randomised controlled trials that carotid artery stenting is equal to carotid endarterectomy: “In a healthcare system based on a solidarity principle, the government is responsible for each Euro spent. From this point of view, it makes sense there is no reimbursement for carotid artery stenting in Belgium until the moment that level-one evidence is released showing that carotid artery stenting and surgery yield equal results. It is of utter importance that these controlled, randomised trials are conducted by highly trained physicians, as many problems occur when accessing the supra-aortic arteries, potentially causing brain infarcts,” To date, randomized trials have failed to show equality, and the SPACE (Stent-protected Percutaneous Angioplasty of the Carotid vs. Endarterectomy) study failed to prove a significant difference between 30-day complication rates for surgery and carotid artery stenting. Carotid artery stenting, even with embolic protection devices (EPD), was also associated with silent cerebral ischaemia. “The introduction of embolic protection devices has led to a situation in which we do not have major embolic events in the cath lab anymore. What we see now are minor embolic events a few hours after the intervention itself. This is probably caused by debris dislodged from the surface of the plaque that is not covered by the struts of the stent,” added Peeters. Numerous registries and the randomised SAPPHIRE (Stenting and Angioplasty with Protection in Patients at High Risk for Endarterectomy) trial have reported a lower rate of combined strokes, death, and myocardial infarction (MI) in stented patients. The difference may be due to a large number of patients with recurrent stenosis compared with the EVA3S and SPACE trials, which excluded restenosis. In asymptomatic patient, nearly three-quarters of those with extracranial internal carotid artery stenosis, there are currently two trials comparing stenting with surgery. However, neither trial is evaluating targeted medical therapy with defined risk management reduction strategies. A third multinational randomized trial, TACIT (Transatlantic Asymptomatic Carotid Intervention Trial), will compare optimal medical therapy alone, optimal medical therapy with stenting, and optimal medical therapy and surgery in asymptomatic patients. However, TACIT has yet to get underway. “There is a big difference between asymptomatic and symptomatic patients presenting with a carotid stenosis or occlusion. In this respect, the TACIT trial, albeit a well-conducted and useful trial, is running a bit ahead of the facts. Our first point of interest should be providing evidence that carotid artery stenting has a use in symptomatic patients. As long as there is no proof in favour of carotid artery stenting from evidence based medicine, the Belgian government will remain reluctant to introduce CAS in general health care,” concluded Peeters.