Safety of Stenting and Endarterectomy by Symptomatic Status in the Carotid Revascularization Endarterectomy Versus Stenting Trial (CREST)

Abstract

Background and Purpose The safety of carotid artery stenting (CAS) and carotid endarterectomy (CEA) has varied by symptomatic status in previous trials. The Carotid Revascularization Endarterectomy versus Stenting Trial (CREST) data were analyzed to determine safety in symptomatic and asymptomatic patients. Methods CREST is a randomized trial comparing safety and efficacy of CAS versus CEA in patients with high-grade carotid stenoses. Patients were defined as symptomatic if they had relevant symptoms within 180 days of randomization. The primary endpoint was stroke, myocardial infarction, or death within the periprocedural period or ipsilateral stroke up to 4 years. Results For 1321 symptomatic and 1181 asymptomatic patients, the periprocedural aggregate of stroke, myocardial infarction, and death did not differ between CAS and CEA (5.2% versus 4.5%; hazard ratio, 1.18; 95% CI, 0.82 to 1.68; P=0.38). The stroke and death rate was higher for CAS versus CEA (4.4% versus 2.3%; hazard ratio, 1.90; 95% CI, 1.21 to 2.98; P=0.005). For symptomatic patients, the periprocedural stroke and death rates were 6.0%±0.9% for CAS and 3.2%±0.7% for CEA (hazard ratio, 1.89; 95% CI, 1.11 to 3.21; P=0.02). For asymptomatic patients, the stroke and death rates were 2.5%±0.6% for CAS and 1.4%±0.5% for CEA (hazard ratio, 1.88; 95% CI, 0.79 to 4.42; P=0.15). Rates were lower for those aged <80 years. Conclusions There were no significant differences between CAS versus CEA by symptomatic status for the primary CREST endpoint. Periprocedural stroke and death rates were significantly lower for CEA in symptomatic patients. However, for both CAS and CEA stroke and death rates were below or comparable to those of previous randomized trials and were within the complication thresholds suggested in current guidelines for both symptomatic and asymptomatic patients.

Stroke Caused by Extracranial Disease

“…16 In CREST (Carotid Revascularization Endarterectomy Versus Stenting Trial), rates of stroke and death for patients <80 years old were 1.5% for CEA and 2.4% for carotid artery stenting (CAS). 21 Current guidelines recommend the consideration of CEA in asymptomatic patients with >70% stenosis if the risk of perioperative stroke, myocardial infarction (MI), and death is <3%. 4 The guidelines acknowledge that the effectiveness of CEA in this population compared with best medical management is not well established.…”

What number of you can read but still not see? A comment on a recent survey of carotid guidelines

“…Current rules frequently underutilize and underestimate quality, freely approved, non-randomized observational information. Such information, for instance, have demonstrated enhanced patient results with restorative treatment alone [6][7][8][9] and with CEA, [10][11][12] and a determination of significantly higher dangers from CAS [2,3].…”

The impact of regulatory approval and Medicare coverage on outcomes of carotid stenting

“…It is noteworthy that in the aforementioned studies and in others from Europe [10,11], the longterm stroke prevention efficacy and durability of revascularization by CAS have repeatedly been demonstrated to be equivalent to results achieved by CEA [10][11][12], such that the primary comparative measure for CAS is now largely focused on the safety outcomes of death, stroke, and myocardial infarction (DSMI) rates in the periprocedural period (i.e., 30 days following revascularization).…”