Uncertainty--the building block of hope?
Since the unveiling of the 2010 CREST trial results, a great deal of research has materialized outlining the possible benefits of carotid artery stenting (CAS) vs. carotid endarterectomy (CEA) to treat carotid stenosis. In CREST, the new kid on the block (CAS) was found to be roughly equivalent to the gold standard treatment (CEA). However, the researchers did find that there were more MIs in the CEA arm compared with the stenting arm: 2.3 percent vs. 1.1 percent; and more strokes in the stenting arm compared with the surgery group: 4.1 percent vs. 2.3 percent. Additionally, patients aged 69 and younger fared better with stenting, while those older than 70 fared better with surgery.
Since this marathon trial, CAS has hit many milestones, particularly when the FDA expanding CAS indications in May 2011 to include patients who are at a standard risk of surgery. In January of last year, FDA’s Circulatory System Devices Advisory Panel recommended that CAS be expanded to patients at a standard risk of stroke when undergoing surgery based on 10-year CREST trial results.
Yet, even with these expanded indications, data has come forth questioning whether CAS is all it’s cracked up to be, especially in certain patient populations. For example, a study in Lancet Neurology last May showed that women may have a higher risk of peri-procedural risk with CAS compared with CEA; however, this difference in men was minute. Additionally, a study in Stroke found that elderly patients treated with CAS saw higher rates of stroke with increasing age compared with those who underwent CEA. The researchers cautioned physicians and urged them to take age into account when performing the procedure. Lastly, a study published in AIM questioned the use of CAS, because of the "inconclusive data." Researchers said that CAS should get a "less is more" designation for asymptomatic patients because of its "definite harms and unclear benefits."
The best treatment approach remains uncertain, thus should be handled on a case by case basis. This week, the Centers of Medicare & Medicaid Services said more data are needed to outline the most beneficial strategies for atherosclerosis management to prevent stroke, especially those surrounding CAS and CEA.
Despite the headway made with CAS, its future still remains uncertain.
On these topics of others, please feel free to email me.
Cardiovascular Business, associate editor