Tailored Approach to Stenting, Surgery Comparable for Stroke Prevention

Physician-guided selection of carotid artery stenting or endarterectomy for stroke prevention in appropriate patients provided comparable periprocedural and long-term outcomes, according to a review of data from a high-volume vascular center published Jan. 31 in the Journal of the American College of Cardiology.

After assigning patients to the procedure that best suited their clinical characteristics and carotid artery morphology, Dr. Paola De Rango from the University of Perugia (Italy) and colleagues found that the primary end point of stroke or death within 30 days of the procedure and any ipsilateral stroke after the procedure occurred in 2.8% of patients treated with carotid artery stenting (CAS) and 2.0% of those treated with carotid endarterectomy (CEA).

These outcomes confirm the overall results of the CREST (Carotid Revascularization Endarterectomy vs. Stenting Trial) study, the most recent and largest randomized trial to include symptomatic and asymptomatic patients and to require well-trained operators for both procedures. But they also "offer the opportunity to analyze outcomes in a large number of consecutive patients treated for carotid stenosis with CAS and CEA reflecting the modern ‘real-world’ scenario outside the selected within-trial population," the investigators wrote (J. Am. Coll. Cardiol. 2011;57:664-71).

Indeed, the results show that in appropriately selected patients, CAS does not lead to higher rates of recurrent stenosis or stroke over the long term than does CEA, and that the procedures might not be associated with differences in outcomes because of age, gender, or symptom status.

The investigators included interventions performed at one center from January 2001 through March 2009 for symptomatic patients with greater than 60% stenosis of the carotid artery or asymptomatic patients with greater than 70% stenosis. They excluded the first 195 CAS procedures (during 2001-2003) to avoid bias from training, because it was after this period that the rate of disabling strokes during CAS significantly decreased and remained stable at less than 2% per year. Because CEA was reserved more often for the most complex cases during 2008-2009, the investigators excluded CEA procedures performed during that period to avoid possible major selection bias. The percentage of carotid revascularization procedures that used CEA declined from 50% in 2004 to 20% in 2007.

The choice of the revascularization procedure was left to the discretion of the treating surgeon. Relative contraindications for CAS included unfavorable aortic arch anatomy, severe peripheral vascular disease precluding femoral access, extremely tortuous carotid anatomy, renal insufficiency, or allergies to aspirin, clopidogrel, or contrast media, whereas those for CEA included high-neck carotid bifurcation, long carotid lesions, obesity, and ongoing dual antiplatelet therapy.

Among 1,084 CAS and 1,118 CEA procedures, the investigators reported similar rates of periprocedural MI (3.1% vs. 2.7%, respectively). However, in the 30-day period following procedures there was a significantly higher rate of transient ischemic attack with CAS (3.6% vs. 1.1%) and a significantly higher rate of cranial nerve injury with CEA (4.4% vs. 0%).

Long-term follow-up of patients averaged 33 months and ranged from 6 to 108 months. By 5 years, ipsilateral stroke had occurred in 0.9% of CAS patients and 2.7% of CEA patients, while estimates of recurrent stenosis of 50% or more were similar between CAS (3.4%) and CEA (5.8%) patients. This finding is important, the investigators wrote, "because some investigators had anticipated that an increased rate of late stroke after CAS could be expected because of a most likely higher probability of restenosis."

At 5 years, the investigators estimated the rates of the composite primary end point to be 3.7% in CAS patients and 4.7% in CEA patients. Estimates of survival from any cause mortality at 5 years also were similar for CAS (88%) and CEA (82%).

The periprocedural stroke and death rates for CAS and CEA did not differ significantly between symptomatic (4.5% vs. 2.9%, respectively) or asymptomatic patients (2.3% vs. 1.6%); between those aged 70 years or older (3.6% vs. 2%); or between men (3.1% vs. 1.6%) and women (2.2% vs. 3.1%).

Probability analyses showed that there was a propensity for patients to undergo CAS if they had a history of coronary artery disease, hypertension, diabetes, hyperlipidemia, statin therapy, or if they were of older age. Patients were less likely to undergo CAS if they had a history of neurologic symptoms or peripheral artery disease or if they had complex carotid plaque.

"Based on this study, patients with unfavorable aortic arch anatomy, extreme tortuous carotid anatomy, or severe peripheral vascular disease precluding femoral access, as well as known allergies to aspirin or clopidogrel should be considered preferentially for CEA. Patients with severe coronary disease, high-neck carotid bifurcation, and obesity should be considered at increased risk during CEA and might be best suited for CAS," the investigators concluded.

They also noted that their findings "might not be reproducible under less ideal conditions (and might not reflect the management of patients treated at many community hospitals)."

The investigators had no relevant financial disclosures.

Physician-guided selection of carotid artery stenting or endarterectomy for stroke prevention in appropriate patients provided comparable periprocedural and long-term outcomes, according to a review of data from a high-volume vascular center published Jan. 31 in the Journal of the American College of Cardiology.

After assigning patients to the procedure that best suited their clinical characteristics and carotid artery morphology, Dr. Paola De Rango from the University of Perugia (Italy) and colleagues found that the primary end point of stroke or death within 30 days of the procedure and any ipsilateral stroke after the procedure occurred in 2.8% of patients treated with carotid artery stenting (CAS) and 2.0% of those treated with carotid endarterectomy (CEA).

These outcomes confirm the overall results of the CREST (Carotid Revascularization Endarterectomy vs. Stenting Trial) study, the most recent and largest randomized trial to include symptomatic and asymptomatic patients and to require well-trained operators for both procedures. But they also "offer the opportunity to analyze outcomes in a large number of consecutive patients treated for carotid stenosis with CAS and CEA reflecting the modern ‘real-world’ scenario outside the selected within-trial population," the investigators wrote (J. Am. Coll. Cardiol. 2011;57:664-71).

Indeed, the results show that in appropriately selected patients, CAS does not lead to higher rates of recurrent stenosis or stroke over the long term than does CEA, and that the procedures might not be associated with differences in outcomes because of age, gender, or symptom status.

The investigators included interventions performed at one center from January 2001 through March 2009 for symptomatic patients with greater than 60% stenosis of the carotid artery or asymptomatic patients with greater than 70% stenosis. They excluded the first 195 CAS procedures (during 2001-2003) to avoid bias from training, because it was after this period that the rate of disabling strokes during CAS significantly decreased and remained stable at less than 2% per year. Because CEA was reserved more often for the most complex cases during 2008-2009, the investigators excluded CEA procedures performed during that period to avoid possible major selection bias. The percentage of carotid revascularization procedures that used CEA declined from 50% in 2004 to 20% in 2007.

The choice of the revascularization procedure was left to the discretion of the treating surgeon. Relative contraindications for CAS included unfavorable aortic arch anatomy, severe peripheral vascular disease precluding femoral access, extremely tortuous carotid anatomy, renal insufficiency, or allergies to aspirin, clopidogrel, or contrast media, whereas those for CEA included high-neck carotid bifurcation, long carotid lesions, obesity, and ongoing dual antiplatelet therapy.

Among 1,084 CAS and 1,118 CEA procedures, the investigators reported similar rates of periprocedural MI (3.1% vs. 2.7%, respectively). However, in the 30-day period following procedures there was a significantly higher rate of transient ischemic attack with CAS (3.6% vs. 1.1%) and a significantly higher rate of cranial nerve injury with CEA (4.4% vs. 0%).

Long-term follow-up of patients averaged 33 months and ranged from 6 to 108 months. By 5 years, ipsilateral stroke had occurred in 0.9% of CAS patients and 2.7% of CEA patients, while estimates of recurrent stenosis of 50% or more were similar between CAS (3.4%) and CEA (5.8%) patients. This finding is important, the investigators wrote, "because some investigators had anticipated that an increased rate of late stroke after CAS could be expected because of a most likely higher probability of restenosis."

At 5 years, the investigators estimated the rates of the composite primary end point to be 3.7% in CAS patients and 4.7% in CEA patients. Estimates of survival from any cause mortality at 5 years also were similar for CAS (88%) and CEA (82%).

The periprocedural stroke and death rates for CAS and CEA did not differ significantly between symptomatic (4.5% vs. 2.9%, respectively) or asymptomatic patients (2.3% vs. 1.6%); between those aged 70 years or older (3.6% vs. 2%); or between men (3.1% vs. 1.6%) and women (2.2% vs. 3.1%).

Probability analyses showed that there was a propensity for patients to undergo CAS if they had a history of coronary artery disease, hypertension, diabetes, hyperlipidemia, statin therapy, or if they were of older age. Patients were less likely to undergo CAS if they had a history of neurologic symptoms or peripheral artery disease or if they had complex carotid plaque.

"Based on this study, patients with unfavorable aortic arch anatomy, extreme tortuous carotid anatomy, or severe peripheral vascular disease precluding femoral access, as well as known allergies to aspirin or clopidogrel should be considered preferentially for CEA. Patients with severe coronary disease, high-neck carotid bifurcation, and obesity should be considered at increased risk during CEA and might be best suited for CAS," the investigators concluded.

They also noted that their findings "might not be reproducible under less ideal conditions (and might not reflect the management of patients treated at many community hospitals)."

The investigators had no relevant financial disclosures.

Physician-guided selection of carotid artery stenting or endarterectomy for stroke prevention in appropriate patients provided comparable periprocedural and long-term outcomes, according to a review of data from a high-volume vascular center published Jan. 31 in the Journal of the American College of Cardiology.

After assigning patients to the procedure that best suited their clinical characteristics and carotid artery morphology, Dr. Paola De Rango from the University of Perugia (Italy) and colleagues found that the primary end point of stroke or death within 30 days of the procedure and any ipsilateral stroke after the procedure occurred in 2.8% of patients treated with carotid artery stenting (CAS) and 2.0% of those treated with carotid endarterectomy (CEA).

These outcomes confirm the overall results of the CREST (Carotid Revascularization Endarterectomy vs. Stenting Trial) study, the most recent and largest randomized trial to include symptomatic and asymptomatic patients and to require well-trained operators for both procedures. But they also "offer the opportunity to analyze outcomes in a large number of consecutive patients treated for carotid stenosis with CAS and CEA reflecting the modern ‘real-world’ scenario outside the selected within-trial population," the investigators wrote (J. Am. Coll. Cardiol. 2011;57:664-71).

Indeed, the results show that in appropriately selected patients, CAS does not lead to higher rates of recurrent stenosis or stroke over the long term than does CEA, and that the procedures might not be associated with differences in outcomes because of age, gender, or symptom status.

The investigators included interventions performed at one center from January 2001 through March 2009 for symptomatic patients with greater than 60% stenosis of the carotid artery or asymptomatic patients with greater than 70% stenosis. They excluded the first 195 CAS procedures (during 2001-2003) to avoid bias from training, because it was after this period that the rate of disabling strokes during CAS significantly decreased and remained stable at less than 2% per year. Because CEA was reserved more often for the most complex cases during 2008-2009, the investigators excluded CEA procedures performed during that period to avoid possible major selection bias. The percentage of carotid revascularization procedures that used CEA declined from 50% in 2004 to 20% in 2007.

The choice of the revascularization procedure was left to the discretion of the treating surgeon. Relative contraindications for CAS included unfavorable aortic arch anatomy, severe peripheral vascular disease precluding femoral access, extremely tortuous carotid anatomy, renal insufficiency, or allergies to aspirin, clopidogrel, or contrast media, whereas those for CEA included high-neck carotid bifurcation, long carotid lesions, obesity, and ongoing dual antiplatelet therapy.

Among 1,084 CAS and 1,118 CEA procedures, the investigators reported similar rates of periprocedural MI (3.1% vs. 2.7%, respectively). However, in the 30-day period following procedures there was a significantly higher rate of transient ischemic attack with CAS (3.6% vs. 1.1%) and a significantly higher rate of cranial nerve injury with CEA (4.4% vs. 0%).

Long-term follow-up of patients averaged 33 months and ranged from 6 to 108 months. By 5 years, ipsilateral stroke had occurred in 0.9% of CAS patients and 2.7% of CEA patients, while estimates of recurrent stenosis of 50% or more were similar between CAS (3.4%) and CEA (5.8%) patients. This finding is important, the investigators wrote, "because some investigators had anticipated that an increased rate of late stroke after CAS could be expected because of a most likely higher probability of restenosis."

At 5 years, the investigators estimated the rates of the composite primary end point to be 3.7% in CAS patients and 4.7% in CEA patients. Estimates of survival from any cause mortality at 5 years also were similar for CAS (88%) and CEA (82%).

The periprocedural stroke and death rates for CAS and CEA did not differ significantly between symptomatic (4.5% vs. 2.9%, respectively) or asymptomatic patients (2.3% vs. 1.6%); between those aged 70 years or older (3.6% vs. 2%); or between men (3.1% vs. 1.6%) and women (2.2% vs. 3.1%).

Probability analyses showed that there was a propensity for patients to undergo CAS if they had a history of coronary artery disease, hypertension, diabetes, hyperlipidemia, statin therapy, or if they were of older age. Patients were less likely to undergo CAS if they had a history of neurologic symptoms or peripheral artery disease or if they had complex carotid plaque.

"Based on this study, patients with unfavorable aortic arch anatomy, extreme tortuous carotid anatomy, or severe peripheral vascular disease precluding femoral access, as well as known allergies to aspirin or clopidogrel should be considered preferentially for CEA. Patients with severe coronary disease, high-neck carotid bifurcation, and obesity should be considered at increased risk during CEA and might be best suited for CAS," the investigators concluded.

They also noted that their findings "might not be reproducible under less ideal conditions (and might not reflect the management of patients treated at many community hospitals)."

The investigators had no relevant financial disclosures.