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ABSTRACT BACKGROUND Atherosclerotic intracranial arterial stenosis is an important cause of stroke that is increasingly being treated with percutaneous transluminal angioplasty and stenting (PTAS) to
ABSTRACT BACKGROUND Atherosclerotic intracranial arterial stenosis is an important cause of stroke that is increasingly being treated with percutaneous transluminal angioplasty and stenting (PTAS) to prevent recurrent stroke. However, PTAS has not been compared with medi- cal management in a randomized trial. METHODS We randomly assigned patients who had a recent transient ischemic attack or stroke attributed to stenosis of 70 to 99% of the diameter of a major intracranial artery to aggressive medical management alone or aggressive medical management plus PTAS with the use of the Wingspan stent system. The primary end point was stroke or death within 30 days after enrollment or after a revascularization procedure for the qualifying lesion during the follow-up period or stroke in the territory of the quali- fying artery beyond 30 days. RESULTS Enrollment was stopped after 451 patients underwent randomization, because the 30-day rate of stroke or death was 14.7% in the PTAS group (nonfatal stroke, 12.5%; fatal stroke, 2.2%) and 5.8% in the medical-management group (nonfatal stroke, 5.3%; non-stroke-related death, 0.4%) (P=0.002). Beyond 30 days, stroke in the same ter- ritory occurred in 13 patients in each group. Currently, the mean duration of follow- up, which is ongoing, is 11.9 months. The probability of the occurrence of a primary end-point event over time differed significantly between the two treatment groups (P=0.009), with 1-year rates of the primary end point of 20.0% in the PTAS group and 12.2% in the medical-management group. CONCLUSIONS In patients with intracranial arterial stenosis, aggressive medical management was superior to PTAS with the use of the Wingspan stent system, both because the risk of early stroke after PTAS was high and because the risk of stroke with aggressive medical therapy alone was lower than expected. (Funded by the National Institute of Neurological Disorders and Stroke and others; SAMMPRIS ClinicalTrials.gov num- ber, NCT00576693.)Table 1. Baseline Characteristics of the Patients.# Medical-Management Group PTAS Group Characteristic (N=227) (N=224) Age - yr 59.5+11.8 61.0+10.7 Male sex - no. (%) 145 (63.9) 127 (56.7) Race - no. (%)+ Black 50 (22.0) 55 (24.6) White 161 (70.9) 160 (71.4) Other 16 (7.0) 9 (4.0) Hypertension - no. (%) 203 (89.4) 201 (89.7) Diabetes - no. (%) 103 (45.4) 106 (47.3) Lipid disorder - no. (%) 203 (89.4) 194 (86.6) Smoking history - no./total no. (%) Never 78/227 (34.4) 90/223 (40.4) Former 80/227 (35.2) 79/223 (35.4) Current 69/227 (30.4) 54/223 (24.2) History of coronary artery disease - no. (%) 59 (26.0) 47 (21.0) History of stroke other than qualifying event - no. (%) 58 (25.6) 60 (26.8) Qualifying event - no. (%) Stroke 152 (67.0) 142 (63.4) TIA 75 (33.0) 82 (36.6) Already receiving antithrombotic therapy at time of qualifying event - 141 (62.1) 145 (64.7) no. (%) Time from qualifying event to randomization - days 7 7 Median 4-19 4-16 Interquartile range Symptomatic qualifying artery - no. (%) Internal carotid 49 (21.6) 45 (20.1) Middle cerebral 105 (46.3) 92 (41.1) Vertebral 22 (9.7) 38 (17.0) Basilar 51 (22.5) 49 (21.9) Stenosis of symptomatic qualifying artery$ 80+7 Mean percentage stenosis 81+7 Distribution - no./total no. (%) 70-79% stenosis 102/227 (44.9) 107/223 (48.0) 80-89% stenosis 97/227 (42.7) 92/223 (41.3) 90-99% stenosis 28/227 (12.3) 24/223 (10.8)Table 2. Measures of Risk Factors at Baseline and 4 Months.* Medical-Management Group PTAS Group Variable (N=227) (N=224) Baseline 4 Mo Baseline 4 Mo Clinical factor Blood pressure No. of patients evaluated 227 179 220 173 Systolic - mm Hg 146.8+21.8 134.8+17.0 143.9+20.6 133.1+15.9 Diastolic - mm Hgt 82.3+12.0 77.3+10.0 77.9+10.7 76.2+9.7 Lipids No. of patients evaluated 226 175 219 174 LDL cholesterol - mg/dl 97.7+36.6 72.8+26.0 96.3+38.5 75.9140.9 HDL cholesterol - mg/dl 38.8+10.1 41.9+11.4 37.8+10.6 43.2+13.3 Non-HDL cholesterol - mg/dl 116.6+40.3 90.9+30.8 116.6+43.9 94.3+50.2 Glycated hemoglobin in patients with diabetes No. of patients evaluated 98 47 102 50 Level of glycated hemoglobin -% 8.3+2.3 7.5+2.0 7.9+2.1 7.8+2.4 Body-mass index 1 No. of patients evaluated 227 180 224 170 Value 30.7+6.3 30.4+6.4 30.3+6.2 30.0+6.2 Lifestyle factor No. of patients evaluated 227 181 223 173 Current smoker -% 30.4 20.4 24.2 17.3 Moderate or vigorous exercise - %| 29.1 56.6 34.2 56.1Read the information on page 1 of the article that was provided with this quiz and also take a look at Tables 1 and 2 from that article. Find a 99% confidence interval for the true mean body mass index (BMI), at 4 months, of patients in the medical- management group
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