PTAS vs Medical Therapy for Prevention of Recurrent Stroke
PTAS vs Medical Therapy for Prevention of Recurrent Stroke
Chimowitz MI, Lynn MJ, Derdeyn CP, et al; SAMMPRIS Trial Investigators
N Engl J Med. 2011;365:993-1003
Is percutaneous transluminal angioplasty and stenting (PTAS) with aggressive medical therapy superior to aggressive medical therapy alone in patients with a recent transient ischemic attack or stroke? The authors conducted a randomized trial comparing these 2 alternative therapeutic approaches in patients at risk for a subsequent stroke. The primary endpoints were stroke in the area of the afflicted artery or death within 30 days. After enrollment of 451 patients, the trial was terminated because of an unexpectedly large number of deaths in the PTAS group: 14.7% of PTAS patients died or had a stroke, compared with only 5.8% in the medically managed group (P = .002).
The initial hypothesis of this randomized trial was that surgery would improve results for these high-risk patients. The results turned out to be entirely opposite: After an ischemic attack or stroke in patients with high-grade stenosis of vessels that lead to the brain, aggressive medical therapy is superior. The high mortality rate in surgical patients appeared soon after the onset of the trial. After 1 month, the rates of occurrence of stroke or death were similar in the 2 groups. Medical therapy consisted of aspirin and clopidogrel, along with management of major risk factors such as hypertension, cholesterol levels, control of diabetes, and smoking. An accompanying editorial pointed out that careful clinical trials are the best way to judge the effectiveness of new treatment pathways for the management of patients at high risk for stroke.
Abstract
Stenting Versus Aggressive Medical Therapy for Intracranial Arterial Stenosis.
Chimowitz MI, Lynn MJ, Derdeyn CP, et al; SAMMPRIS Trial Investigators
N Engl J Med. 2011;365:993-1003
Summary
Is percutaneous transluminal angioplasty and stenting (PTAS) with aggressive medical therapy superior to aggressive medical therapy alone in patients with a recent transient ischemic attack or stroke? The authors conducted a randomized trial comparing these 2 alternative therapeutic approaches in patients at risk for a subsequent stroke. The primary endpoints were stroke in the area of the afflicted artery or death within 30 days. After enrollment of 451 patients, the trial was terminated because of an unexpectedly large number of deaths in the PTAS group: 14.7% of PTAS patients died or had a stroke, compared with only 5.8% in the medically managed group (P = .002).
Viewpoint
The initial hypothesis of this randomized trial was that surgery would improve results for these high-risk patients. The results turned out to be entirely opposite: After an ischemic attack or stroke in patients with high-grade stenosis of vessels that lead to the brain, aggressive medical therapy is superior. The high mortality rate in surgical patients appeared soon after the onset of the trial. After 1 month, the rates of occurrence of stroke or death were similar in the 2 groups. Medical therapy consisted of aspirin and clopidogrel, along with management of major risk factors such as hypertension, cholesterol levels, control of diabetes, and smoking. An accompanying editorial pointed out that careful clinical trials are the best way to judge the effectiveness of new treatment pathways for the management of patients at high risk for stroke.
Abstract
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