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Carotid Stents: Excess Strokes in Elderly, Women

LOS ANGELES - Women, as well as all patients aged 65 years or older who have substantial carotid artery stenosis that needs revascularization, may prefer endarterectomy, and would want to steer clear of carotid stenting, according to new data from CREST, the largest randomized trial to compare these two carotid interventions.

All patients aged 65 or older who were randomized to treatment by carotid artery stenting had a statistically significant excess of strokes, compared with similar subgroups who were treated with CEA during the periprocedural period and 4-year follow-up, George Howard, Dr.P.H., said at the conference. “Patient age should be an important factor in selecting the treatment option for carotid stenosis," said Dr. Howard, professor and chairman of biostatistics at the University of Alabama at Birmingham.

Analysis of the patients enrolled in CREST (Carotid Revascularization Endarterectomy vs. Stenting Trial) by sex showed that the treatment of carotid stenosis by stenting led to an excess rate of periprocedural strokes among women, but not in men, Virginia J. Howard, Ph.D., said in a separate talk at the conference. Women who underwent an endarterectomy also had no excess risk for myocardial infarctions, compared with women who received a carotid stent, unlike men who had a significantly increased rate of MIs following open surgery, compared with those who got stented, said Dr. Howard, an epidemiologist at the University of Alabama at Birmingham.

The primary results from CREST, first reported last year, showed that all patients who were enrolled in the study had similar rates of stroke, MI, or death regardless of whether they underwent carotid CEA or stenting (N. Engl. J. Med. 2010;363:11-23).

But these new details, which show an excess rate of periprocedural strokes in women undergoing stenting as well as the excess of all strokes in patients aged 65 or older undergoing stenting, may tip the balance away from stenting in these patients.

Going into CREST, which began in 2000, “we thought the results would be the opposite. [At that time,] we preferred to take older patients to stenting," commented Dr. Thomas G. Brott, lead investigator for CREST and a professor of neurology and director or research at the Mayo Clinic in Jacksonville, Fla. “Our interventionalists believe that age is a surrogate marker for patients with calcified and tortuous vessels that might not be suitable for stenting." Regarding the sex-related finding, the implications “depend on how a woman would value [the risk of having] a stroke or a MI. If the woman is more concerned about a periprocedural stroke, then the results suggest there could be a preference for endarterectomy," Dr. Brott said in an interview.

In the sex-based analysis, the rate of periprocedural stroke was 5.5% in stented women and 2.2% in those who underwent CEA, a statistically significant 2.6-fold increased rate with stenting, Dr. Virginia Howard reported.

During the entire follow-up, which added the rate of ipsilateral strokes during 4 years following the intervention, stroke rates were 7.8% in stented women and 5.0% in those who had endarterectomy, a nonsignificant difference. The two treatment options produced no difference in stroke rates in men, either periprocedurally or after 4 years. MI rates were similar in women following either intervention, both periprocedurally and after 4 years. The periprocedural and 4-year MI rates in men were significantly higher with CEA.

In the age-based analyses, a calculation that used age as a continuous variable showed that the number of strokes occurring with either CEA or stenting was similar for patients aged 64 years. For those aged 65 or older, fewer strokes occurred with CEA, a relationship that grew stronger with increasing age. For patients aged 63 or younger, stenting produced fewer strokes, and the relationship grew stronger with decreasing age.

The age analysis also divided patients into three prespecified age groups: younger than 65, 65-74 years, and 75 and older. (See box.) The most striking age effect occurred in patients aged 75 or older: In this subgroup, treatment with stenting more than doubled the total stroke risk, both periprocedural and long-term strokes, compared with patients who were treated with CEA.

The incidence of MI showed a much weaker age effect, and patients who underwent stenting had a reduced rate of MI at all ages, compared with those who had CEA. In addition, in the CEA arm, age had no significant effect on the MI rate, Dr. George Howard said.

Commenting on the study, Christopher J. Moran, M.D., is a professor of radiology and neurological surgery at Washington University in St. Louis, who performs carotid artery stenting but did not participate in CREST, stated, “If you are trying to prevent strokes in patients with carotid artery disease, you would have to think long and hard before treating a woman with carotid stenting. In some cases, CEA may not be an option: The woman may be a poor operative candidate because she has a large neck, or the lesion may be high above the mandible and hard to get above."

In addition, some patients have pulmonary disease and are not good candidates for anesthesia. But if a woman is a good operative candidate, she should be treated with endarterectomy.

Conventional angiography or CT angiography lets an operator assess the size of a woman's arteries, he said.

“The smallest self-expanding stents available for treating carotid disease are 5 mm in diameter, and because these are ideally oversized to the artery, the smallest diameter carotid that should be stented is 4 mm. Many women have carotids that are smaller than 4 mm, and in those cases you should definitely think twice about stenting.

“The same considerations apply to patients who are 70-80 years old. If they are good operative candidates, they should undergo CEA," he concluded.

Body

Recently, carotid angioplasty/stenting (CAS) has been recommended as an alternative to carotid endarterectomy (CEA). Several randomized and non-randomized prospective trials have been conducted over the past several years to evaluate the efficacy of CAS, in comparison to CEA, for the prevention of stroke for both symptomatic and asymptomatic patients. While EVA-3S and the International Carotid Stenting Study showed that CEA was superior to CAS for symptomatic patients, the SPACE trial showed that CAS was not inferior to CEA. However, the CREST trial showed that CAS significantly increased the risk of stroke and decreased the risk of myocardial infarction in comparison to CEA, but the combined stroke, myocardial infarction, and death rates were similar for both. A recent meta-analysis of all randomized trials (including CREST) comparing CEA versus CAS by Murad and published in the Journal of Vascular Surgery showed that CAS significantly increases the risk of stroke, but decreases the risk of MI. This study added another twist of CREST, this time favoring CEA, particularly for women and men who are above 65-70 years of age. The readers must also remember that the real world data as found by the Society for Vascular Surgery registry showed that CEA is safer than CAS in both strokes and strokes/deaths. Therefore, at present, most authorities believe that CAS is a better alternative to CEA in high-risk patients, but its role in normal surgical patients is still unclear

Ali AbuRahma, M.D., is professor and chief of vascular and endovascular surgery and the medical director, Vascular Laboratory, at the Robert C. Byrd Health Sciences Center, West Virginia University, Charleston, Charleston Area Medical Center. He is an associate medical editor for Vascular Specialist.

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Recently, carotid angioplasty/stenting (CAS) has been recommended as an alternative to carotid endarterectomy (CEA). Several randomized and non-randomized prospective trials have been conducted over the past several years to evaluate the efficacy of CAS, in comparison to CEA, for the prevention of stroke for both symptomatic and asymptomatic patients. While EVA-3S and the International Carotid Stenting Study showed that CEA was superior to CAS for symptomatic patients, the SPACE trial showed that CAS was not inferior to CEA. However, the CREST trial showed that CAS significantly increased the risk of stroke and decreased the risk of myocardial infarction in comparison to CEA, but the combined stroke, myocardial infarction, and death rates were similar for both. A recent meta-analysis of all randomized trials (including CREST) comparing CEA versus CAS by Murad and published in the Journal of Vascular Surgery showed that CAS significantly increases the risk of stroke, but decreases the risk of MI. This study added another twist of CREST, this time favoring CEA, particularly for women and men who are above 65-70 years of age. The readers must also remember that the real world data as found by the Society for Vascular Surgery registry showed that CEA is safer than CAS in both strokes and strokes/deaths. Therefore, at present, most authorities believe that CAS is a better alternative to CEA in high-risk patients, but its role in normal surgical patients is still unclear

Ali AbuRahma, M.D., is professor and chief of vascular and endovascular surgery and the medical director, Vascular Laboratory, at the Robert C. Byrd Health Sciences Center, West Virginia University, Charleston, Charleston Area Medical Center. He is an associate medical editor for Vascular Specialist.

Body

Recently, carotid angioplasty/stenting (CAS) has been recommended as an alternative to carotid endarterectomy (CEA). Several randomized and non-randomized prospective trials have been conducted over the past several years to evaluate the efficacy of CAS, in comparison to CEA, for the prevention of stroke for both symptomatic and asymptomatic patients. While EVA-3S and the International Carotid Stenting Study showed that CEA was superior to CAS for symptomatic patients, the SPACE trial showed that CAS was not inferior to CEA. However, the CREST trial showed that CAS significantly increased the risk of stroke and decreased the risk of myocardial infarction in comparison to CEA, but the combined stroke, myocardial infarction, and death rates were similar for both. A recent meta-analysis of all randomized trials (including CREST) comparing CEA versus CAS by Murad and published in the Journal of Vascular Surgery showed that CAS significantly increases the risk of stroke, but decreases the risk of MI. This study added another twist of CREST, this time favoring CEA, particularly for women and men who are above 65-70 years of age. The readers must also remember that the real world data as found by the Society for Vascular Surgery registry showed that CEA is safer than CAS in both strokes and strokes/deaths. Therefore, at present, most authorities believe that CAS is a better alternative to CEA in high-risk patients, but its role in normal surgical patients is still unclear

Ali AbuRahma, M.D., is professor and chief of vascular and endovascular surgery and the medical director, Vascular Laboratory, at the Robert C. Byrd Health Sciences Center, West Virginia University, Charleston, Charleston Area Medical Center. He is an associate medical editor for Vascular Specialist.

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LOS ANGELES - Women, as well as all patients aged 65 years or older who have substantial carotid artery stenosis that needs revascularization, may prefer endarterectomy, and would want to steer clear of carotid stenting, according to new data from CREST, the largest randomized trial to compare these two carotid interventions.

All patients aged 65 or older who were randomized to treatment by carotid artery stenting had a statistically significant excess of strokes, compared with similar subgroups who were treated with CEA during the periprocedural period and 4-year follow-up, George Howard, Dr.P.H., said at the conference. “Patient age should be an important factor in selecting the treatment option for carotid stenosis," said Dr. Howard, professor and chairman of biostatistics at the University of Alabama at Birmingham.

Analysis of the patients enrolled in CREST (Carotid Revascularization Endarterectomy vs. Stenting Trial) by sex showed that the treatment of carotid stenosis by stenting led to an excess rate of periprocedural strokes among women, but not in men, Virginia J. Howard, Ph.D., said in a separate talk at the conference. Women who underwent an endarterectomy also had no excess risk for myocardial infarctions, compared with women who received a carotid stent, unlike men who had a significantly increased rate of MIs following open surgery, compared with those who got stented, said Dr. Howard, an epidemiologist at the University of Alabama at Birmingham.

The primary results from CREST, first reported last year, showed that all patients who were enrolled in the study had similar rates of stroke, MI, or death regardless of whether they underwent carotid CEA or stenting (N. Engl. J. Med. 2010;363:11-23).

But these new details, which show an excess rate of periprocedural strokes in women undergoing stenting as well as the excess of all strokes in patients aged 65 or older undergoing stenting, may tip the balance away from stenting in these patients.

Going into CREST, which began in 2000, “we thought the results would be the opposite. [At that time,] we preferred to take older patients to stenting," commented Dr. Thomas G. Brott, lead investigator for CREST and a professor of neurology and director or research at the Mayo Clinic in Jacksonville, Fla. “Our interventionalists believe that age is a surrogate marker for patients with calcified and tortuous vessels that might not be suitable for stenting." Regarding the sex-related finding, the implications “depend on how a woman would value [the risk of having] a stroke or a MI. If the woman is more concerned about a periprocedural stroke, then the results suggest there could be a preference for endarterectomy," Dr. Brott said in an interview.

In the sex-based analysis, the rate of periprocedural stroke was 5.5% in stented women and 2.2% in those who underwent CEA, a statistically significant 2.6-fold increased rate with stenting, Dr. Virginia Howard reported.

During the entire follow-up, which added the rate of ipsilateral strokes during 4 years following the intervention, stroke rates were 7.8% in stented women and 5.0% in those who had endarterectomy, a nonsignificant difference. The two treatment options produced no difference in stroke rates in men, either periprocedurally or after 4 years. MI rates were similar in women following either intervention, both periprocedurally and after 4 years. The periprocedural and 4-year MI rates in men were significantly higher with CEA.

In the age-based analyses, a calculation that used age as a continuous variable showed that the number of strokes occurring with either CEA or stenting was similar for patients aged 64 years. For those aged 65 or older, fewer strokes occurred with CEA, a relationship that grew stronger with increasing age. For patients aged 63 or younger, stenting produced fewer strokes, and the relationship grew stronger with decreasing age.

The age analysis also divided patients into three prespecified age groups: younger than 65, 65-74 years, and 75 and older. (See box.) The most striking age effect occurred in patients aged 75 or older: In this subgroup, treatment with stenting more than doubled the total stroke risk, both periprocedural and long-term strokes, compared with patients who were treated with CEA.

The incidence of MI showed a much weaker age effect, and patients who underwent stenting had a reduced rate of MI at all ages, compared with those who had CEA. In addition, in the CEA arm, age had no significant effect on the MI rate, Dr. George Howard said.

Commenting on the study, Christopher J. Moran, M.D., is a professor of radiology and neurological surgery at Washington University in St. Louis, who performs carotid artery stenting but did not participate in CREST, stated, “If you are trying to prevent strokes in patients with carotid artery disease, you would have to think long and hard before treating a woman with carotid stenting. In some cases, CEA may not be an option: The woman may be a poor operative candidate because she has a large neck, or the lesion may be high above the mandible and hard to get above."

In addition, some patients have pulmonary disease and are not good candidates for anesthesia. But if a woman is a good operative candidate, she should be treated with endarterectomy.

Conventional angiography or CT angiography lets an operator assess the size of a woman's arteries, he said.

“The smallest self-expanding stents available for treating carotid disease are 5 mm in diameter, and because these are ideally oversized to the artery, the smallest diameter carotid that should be stented is 4 mm. Many women have carotids that are smaller than 4 mm, and in those cases you should definitely think twice about stenting.

“The same considerations apply to patients who are 70-80 years old. If they are good operative candidates, they should undergo CEA," he concluded.

LOS ANGELES - Women, as well as all patients aged 65 years or older who have substantial carotid artery stenosis that needs revascularization, may prefer endarterectomy, and would want to steer clear of carotid stenting, according to new data from CREST, the largest randomized trial to compare these two carotid interventions.

All patients aged 65 or older who were randomized to treatment by carotid artery stenting had a statistically significant excess of strokes, compared with similar subgroups who were treated with CEA during the periprocedural period and 4-year follow-up, George Howard, Dr.P.H., said at the conference. “Patient age should be an important factor in selecting the treatment option for carotid stenosis," said Dr. Howard, professor and chairman of biostatistics at the University of Alabama at Birmingham.

Analysis of the patients enrolled in CREST (Carotid Revascularization Endarterectomy vs. Stenting Trial) by sex showed that the treatment of carotid stenosis by stenting led to an excess rate of periprocedural strokes among women, but not in men, Virginia J. Howard, Ph.D., said in a separate talk at the conference. Women who underwent an endarterectomy also had no excess risk for myocardial infarctions, compared with women who received a carotid stent, unlike men who had a significantly increased rate of MIs following open surgery, compared with those who got stented, said Dr. Howard, an epidemiologist at the University of Alabama at Birmingham.

The primary results from CREST, first reported last year, showed that all patients who were enrolled in the study had similar rates of stroke, MI, or death regardless of whether they underwent carotid CEA or stenting (N. Engl. J. Med. 2010;363:11-23).

But these new details, which show an excess rate of periprocedural strokes in women undergoing stenting as well as the excess of all strokes in patients aged 65 or older undergoing stenting, may tip the balance away from stenting in these patients.

Going into CREST, which began in 2000, “we thought the results would be the opposite. [At that time,] we preferred to take older patients to stenting," commented Dr. Thomas G. Brott, lead investigator for CREST and a professor of neurology and director or research at the Mayo Clinic in Jacksonville, Fla. “Our interventionalists believe that age is a surrogate marker for patients with calcified and tortuous vessels that might not be suitable for stenting." Regarding the sex-related finding, the implications “depend on how a woman would value [the risk of having] a stroke or a MI. If the woman is more concerned about a periprocedural stroke, then the results suggest there could be a preference for endarterectomy," Dr. Brott said in an interview.

In the sex-based analysis, the rate of periprocedural stroke was 5.5% in stented women and 2.2% in those who underwent CEA, a statistically significant 2.6-fold increased rate with stenting, Dr. Virginia Howard reported.

During the entire follow-up, which added the rate of ipsilateral strokes during 4 years following the intervention, stroke rates were 7.8% in stented women and 5.0% in those who had endarterectomy, a nonsignificant difference. The two treatment options produced no difference in stroke rates in men, either periprocedurally or after 4 years. MI rates were similar in women following either intervention, both periprocedurally and after 4 years. The periprocedural and 4-year MI rates in men were significantly higher with CEA.

In the age-based analyses, a calculation that used age as a continuous variable showed that the number of strokes occurring with either CEA or stenting was similar for patients aged 64 years. For those aged 65 or older, fewer strokes occurred with CEA, a relationship that grew stronger with increasing age. For patients aged 63 or younger, stenting produced fewer strokes, and the relationship grew stronger with decreasing age.

The age analysis also divided patients into three prespecified age groups: younger than 65, 65-74 years, and 75 and older. (See box.) The most striking age effect occurred in patients aged 75 or older: In this subgroup, treatment with stenting more than doubled the total stroke risk, both periprocedural and long-term strokes, compared with patients who were treated with CEA.

The incidence of MI showed a much weaker age effect, and patients who underwent stenting had a reduced rate of MI at all ages, compared with those who had CEA. In addition, in the CEA arm, age had no significant effect on the MI rate, Dr. George Howard said.

Commenting on the study, Christopher J. Moran, M.D., is a professor of radiology and neurological surgery at Washington University in St. Louis, who performs carotid artery stenting but did not participate in CREST, stated, “If you are trying to prevent strokes in patients with carotid artery disease, you would have to think long and hard before treating a woman with carotid stenting. In some cases, CEA may not be an option: The woman may be a poor operative candidate because she has a large neck, or the lesion may be high above the mandible and hard to get above."

In addition, some patients have pulmonary disease and are not good candidates for anesthesia. But if a woman is a good operative candidate, she should be treated with endarterectomy.

Conventional angiography or CT angiography lets an operator assess the size of a woman's arteries, he said.

“The smallest self-expanding stents available for treating carotid disease are 5 mm in diameter, and because these are ideally oversized to the artery, the smallest diameter carotid that should be stented is 4 mm. Many women have carotids that are smaller than 4 mm, and in those cases you should definitely think twice about stenting.

“The same considerations apply to patients who are 70-80 years old. If they are good operative candidates, they should undergo CEA," he concluded.

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