Guideliner for stenting trial#

High cervical ICA lesion or CCA lesions below the clavicle and severe tandem lesion are also included in the high risk group for CEA. In SAPPHIRE trial, clinically significant cardiac disease, severe pulmonary disease, contralateral carotid occlusion, contralateral laryngeal nerve palsy, previous radiation therapy or radical surgery of neck, recurrent stenosis after endarterectomy, and older than 80 years are categorized as high risk group of CEA. In endarterectomy trials, patients at high risk for complications from the treatment have been identified. In this document, we followed the HIRA guideline in asymptomatic stenosis. HIRA allowed the insurance coverage for patients with more than 80% narrowing for CAS and all cases for CEA in asymptomatic stenosis. ACC/AHA reported that CAS might be considered for highly selected patients with asymptomatic stenosis of more than 60% by angiography. In the SAPPHIRE and CREST, some enrolled patients were asymptomatic patients.

Guideliner for stenting trial#

In contrast to CEA, there is no randomized controlled trial between CAS versus medical therapy. ACAS reported that the patients with more than 60% stenosis have absolute risk reduction of 5.9% for CEA as compared to medical therapy over a 5-year period. The only large, well-constructed, randomized, controlled trial published to date comparing surgical endarterectomy with medical therapy in asymptomatic carotid stenosis is the Asymptomatic Carotid Atherosclerosis Study (ACAS). In the asymptomatic carotid stenosis, the evidence does not show either CEA or CAS having a clear benefit compared with treatment by medication alone. In the cases of flow disturbance due to dissection, arterio-venous fistula, and pseudoaneurysm, CAS is included in the insurance coverage by HIRA regardless of stenosis degree. The Korean HIRA also allowed the insurance coverage as more than 50% narrowing in the special cases of ulcerative plaque, restenosis after CEA, tandem lesion, dissection, fibromuscular dysplasia, Takayasu's arteritis, and stenosis after radiotherapy. Therefore, the indication for CAS in Korea needs to be broadened to the patients without surgically high risk.

However in 2008 the Health Insurance Review & Assessment Service (HIRA) in Korea announced the indication of insurance coverage for CAS as more than 70% narrowing and 50% narrowing with surgically high risk or unsuitable patients. The '2013 Clinical Practice Guideline for Stroke' in Korea recommended the same guideline as ACC/AHA in terms of stenosis degree. ACC and AHA reported in their guidelines that CAS is indicated as an alternative to CEA for a patient with symptomatic carotid stenosis of more than 50% as documented by catheter angiography. On pooling data from the ECST, NASCET and Veterans Affairs trial, endarterectomy was of marginal benefit in those with 50-69% stenosis (in this document, all reporting of the degree of stenosis follows the NASCET criteria) and was highly beneficial in those with 70% stenosis or greater without near occlusion. For purpose of consistency, it is recommended that symptomatic patients be defined as those with neurological or ocular symptoms within 6 months (180 days). Various endarterectomy and stent trials have defined symptomatic patients as those with symptoms of acute ischemic stroke or transient ischemic stroke within 90 to 180 days of trial entry. Patients can be selected according to multiple factors such as degree of stenosis, presence of symptoms, patient age, and presence of factors related with high risk of complications from CAS.