User login
HONOLULU – , according to a pooled analysis presented at the International Stroke Conference sponsored by the American Heart Association. The treatments have similar rates of procedural complications and 4-year ipsilateral stroke, said Jon S. Matsumura, MD, chairman of the division of vascular surgery at the University of Wisconsin in Madison.
Asymptomatic severe carotid stenosis is the most common indication for carotid operations in the United States. Data support carotid endarterectomy in selected asymptomatic patients. Carotid artery stenting with embolic protection is a newer treatment option. Two of the five most recent large, randomized trials – CREST and ACT I – compared carotid stenting with endarterectomy in asymptomatic patients. Dr. Matsumura and his colleagues conducted a pooled analysis of these two trials to help inform the choice of treatment.
The investigators analyzed data from the CREST and ACT I studies, which had many similarities. The researchers in these trials carefully selected the surgeons and the interventionalists who participated in them. Each trial used single carotid stent systems, and both trials used routine, distally placed embolic protection. The trials had independent neurologic assessment, routine cardiac enzyme screening, and central clinical and adjudication committees.
Dr. Matsumura and his colleagues decided to conduct a patient-level pooled analysis and defined the primary endpoint as a composite of death, stroke, and myocardial infarction in the periprocedural period and any ipsilateral stroke within 4 years of randomization. They included in their analysis all randomized, asymptomatic patients who were younger than 80 years.
The analysis comprised 2,544 patients, 1,637 of whom were randomized to stenting, and 907 of whom were randomized to endarterectomy. The population included more than 1,000 patients with 3-year follow-up and more than 500 with 4-year follow-up. Patients randomized to stenting were slightly younger, but the percentage of patients older than age 65 was similar between groups. Current cigarette smoking was slightly more common among patients randomized to stenting. The groups were well balanced by sex, race, and risk factors such as hypertension, hyperlipidemia, and diabetes.
The rate of primary endpoint events was 5.3% in the stenting arm and 5.1% in the endarterectomy arm (hazard ratio with stenting, 1.02; 95% confidence interval, 0.7-1.5; P = .91). The rate of periprocedural stroke was 2.7% in the stenting arm and 1.5% in the endarterectomy arm (P = .07). The rate of periprocedural myocardial infarction was 0.6% in the stenting arm and 1.7% in the endarterectomy arm (P = .01). The rate of periprocedural stroke and death was 2.7% in the stenting arm and 1.6% in the endarterectomy arm (P = .07). The rate of 4-year ipsilateral stroke was 2.3% in the stenting arm and 2.2% in the endarterectomy arm (P = .97).
A secondary analysis indicated that the cumulative, 4-year rate of stroke-free survival was 93.2% in the stenting arm and 95.1% in the endarterectomy arm (P = .10). “Almost all this difference is the initial periprocedural hazard difference,” said Dr. Matsumura. The rate of cumulative 4-year survival was 91% in the stenting arm and 90.2% in the endarterectomy arm.
The results of the pooled analysis do not support the perception that stenting entails an increased risk of periprocedural stroke. “The majority of trials have been in symptomatic patients,” said Dr. Matsumura. “We’re studying asymptomatic patients. We’re also studying them in the context of second-generation devices.” The results may reflect the amount of device-related training that the researchers undertook, as well as the decision to use single-stent dedicated carotid systems, he added.
Sponsors of the analysis included the University of Wisconsin, Massachusetts General Hospital, the Medical University of South Carolina, the University of Alabama at Birmingham, Cardiovascular Associates, and Mayo Clinic Jacksonville.
HONOLULU – , according to a pooled analysis presented at the International Stroke Conference sponsored by the American Heart Association. The treatments have similar rates of procedural complications and 4-year ipsilateral stroke, said Jon S. Matsumura, MD, chairman of the division of vascular surgery at the University of Wisconsin in Madison.
Asymptomatic severe carotid stenosis is the most common indication for carotid operations in the United States. Data support carotid endarterectomy in selected asymptomatic patients. Carotid artery stenting with embolic protection is a newer treatment option. Two of the five most recent large, randomized trials – CREST and ACT I – compared carotid stenting with endarterectomy in asymptomatic patients. Dr. Matsumura and his colleagues conducted a pooled analysis of these two trials to help inform the choice of treatment.
The investigators analyzed data from the CREST and ACT I studies, which had many similarities. The researchers in these trials carefully selected the surgeons and the interventionalists who participated in them. Each trial used single carotid stent systems, and both trials used routine, distally placed embolic protection. The trials had independent neurologic assessment, routine cardiac enzyme screening, and central clinical and adjudication committees.
Dr. Matsumura and his colleagues decided to conduct a patient-level pooled analysis and defined the primary endpoint as a composite of death, stroke, and myocardial infarction in the periprocedural period and any ipsilateral stroke within 4 years of randomization. They included in their analysis all randomized, asymptomatic patients who were younger than 80 years.
The analysis comprised 2,544 patients, 1,637 of whom were randomized to stenting, and 907 of whom were randomized to endarterectomy. The population included more than 1,000 patients with 3-year follow-up and more than 500 with 4-year follow-up. Patients randomized to stenting were slightly younger, but the percentage of patients older than age 65 was similar between groups. Current cigarette smoking was slightly more common among patients randomized to stenting. The groups were well balanced by sex, race, and risk factors such as hypertension, hyperlipidemia, and diabetes.
The rate of primary endpoint events was 5.3% in the stenting arm and 5.1% in the endarterectomy arm (hazard ratio with stenting, 1.02; 95% confidence interval, 0.7-1.5; P = .91). The rate of periprocedural stroke was 2.7% in the stenting arm and 1.5% in the endarterectomy arm (P = .07). The rate of periprocedural myocardial infarction was 0.6% in the stenting arm and 1.7% in the endarterectomy arm (P = .01). The rate of periprocedural stroke and death was 2.7% in the stenting arm and 1.6% in the endarterectomy arm (P = .07). The rate of 4-year ipsilateral stroke was 2.3% in the stenting arm and 2.2% in the endarterectomy arm (P = .97).
A secondary analysis indicated that the cumulative, 4-year rate of stroke-free survival was 93.2% in the stenting arm and 95.1% in the endarterectomy arm (P = .10). “Almost all this difference is the initial periprocedural hazard difference,” said Dr. Matsumura. The rate of cumulative 4-year survival was 91% in the stenting arm and 90.2% in the endarterectomy arm.
The results of the pooled analysis do not support the perception that stenting entails an increased risk of periprocedural stroke. “The majority of trials have been in symptomatic patients,” said Dr. Matsumura. “We’re studying asymptomatic patients. We’re also studying them in the context of second-generation devices.” The results may reflect the amount of device-related training that the researchers undertook, as well as the decision to use single-stent dedicated carotid systems, he added.
Sponsors of the analysis included the University of Wisconsin, Massachusetts General Hospital, the Medical University of South Carolina, the University of Alabama at Birmingham, Cardiovascular Associates, and Mayo Clinic Jacksonville.
HONOLULU – , according to a pooled analysis presented at the International Stroke Conference sponsored by the American Heart Association. The treatments have similar rates of procedural complications and 4-year ipsilateral stroke, said Jon S. Matsumura, MD, chairman of the division of vascular surgery at the University of Wisconsin in Madison.
Asymptomatic severe carotid stenosis is the most common indication for carotid operations in the United States. Data support carotid endarterectomy in selected asymptomatic patients. Carotid artery stenting with embolic protection is a newer treatment option. Two of the five most recent large, randomized trials – CREST and ACT I – compared carotid stenting with endarterectomy in asymptomatic patients. Dr. Matsumura and his colleagues conducted a pooled analysis of these two trials to help inform the choice of treatment.
The investigators analyzed data from the CREST and ACT I studies, which had many similarities. The researchers in these trials carefully selected the surgeons and the interventionalists who participated in them. Each trial used single carotid stent systems, and both trials used routine, distally placed embolic protection. The trials had independent neurologic assessment, routine cardiac enzyme screening, and central clinical and adjudication committees.
Dr. Matsumura and his colleagues decided to conduct a patient-level pooled analysis and defined the primary endpoint as a composite of death, stroke, and myocardial infarction in the periprocedural period and any ipsilateral stroke within 4 years of randomization. They included in their analysis all randomized, asymptomatic patients who were younger than 80 years.
The analysis comprised 2,544 patients, 1,637 of whom were randomized to stenting, and 907 of whom were randomized to endarterectomy. The population included more than 1,000 patients with 3-year follow-up and more than 500 with 4-year follow-up. Patients randomized to stenting were slightly younger, but the percentage of patients older than age 65 was similar between groups. Current cigarette smoking was slightly more common among patients randomized to stenting. The groups were well balanced by sex, race, and risk factors such as hypertension, hyperlipidemia, and diabetes.
The rate of primary endpoint events was 5.3% in the stenting arm and 5.1% in the endarterectomy arm (hazard ratio with stenting, 1.02; 95% confidence interval, 0.7-1.5; P = .91). The rate of periprocedural stroke was 2.7% in the stenting arm and 1.5% in the endarterectomy arm (P = .07). The rate of periprocedural myocardial infarction was 0.6% in the stenting arm and 1.7% in the endarterectomy arm (P = .01). The rate of periprocedural stroke and death was 2.7% in the stenting arm and 1.6% in the endarterectomy arm (P = .07). The rate of 4-year ipsilateral stroke was 2.3% in the stenting arm and 2.2% in the endarterectomy arm (P = .97).
A secondary analysis indicated that the cumulative, 4-year rate of stroke-free survival was 93.2% in the stenting arm and 95.1% in the endarterectomy arm (P = .10). “Almost all this difference is the initial periprocedural hazard difference,” said Dr. Matsumura. The rate of cumulative 4-year survival was 91% in the stenting arm and 90.2% in the endarterectomy arm.
The results of the pooled analysis do not support the perception that stenting entails an increased risk of periprocedural stroke. “The majority of trials have been in symptomatic patients,” said Dr. Matsumura. “We’re studying asymptomatic patients. We’re also studying them in the context of second-generation devices.” The results may reflect the amount of device-related training that the researchers undertook, as well as the decision to use single-stent dedicated carotid systems, he added.
Sponsors of the analysis included the University of Wisconsin, Massachusetts General Hospital, the Medical University of South Carolina, the University of Alabama at Birmingham, Cardiovascular Associates, and Mayo Clinic Jacksonville.
REPORTING FROM ISC 2019