Abstract 2: Tolerability and Medication Requirements of Aggressive Medical Management in SAMMPRIS

Stroke ◽  
2017 ◽  
Vol 48 (suppl_1) ◽  
Author(s):  
Sami Al Kasab ◽  
Chirantan Banerjee ◽  
Michael Lynn ◽  
George A Cotsonis ◽  
Azhar Nizam ◽  
...  
Keyword(s):  
Risk Factor ◽  
Medical Management ◽  
Postural Hypotension ◽  
Descriptive Statistics ◽  
Lipid Lowering ◽  
Multiple Risk Factor ◽  
Secondary Stroke Prevention ◽  
Aggressive Medical Management ◽  
Event Rates

Introduction: SAMMPRIS was the first secondary stroke prevention trial to employ multi-modal protocol-driven aggressive medical management (AMM). Achievement of target SBP, LDL and physical activity were predictors of lower vascular event rates. We sought to determine the tolerability and medication requirements related to AMM. Methods: Medications and adverse events (AEs) in all 451 SAMMPRIS patients were recorded by sites at baseline, 30 days, 4 monthly visits, and closeout. Start and stop dates were recorded for each medication and AE, with AEs classified by the site as possibly, probably, definitely, or unrelated to risk factor treatment. AEs were adjudicated centrally by consensus of 3 neurologists after the trial ended. Standard descriptive statistics were used. Results: As Table 1 shows, most subjects were on statins and BP medications at baseline. The use of rosuvastatin, which was donated for the trial, increased during follow-up. ACE inhibitors were the most commonly used BP medication. AEs related to BP medications (e.g. standing BP drop > 15mm Hg or postural hypotension) occurred in 240 (53.2%) patients at any point in the trial (including baseline), of which 123 (27.3%) were symptomatic. Syncope occurred in 11 patients, with 3 considered probably or definitely related to study treatment. AEs related to lipid lowering medications occurred in 18.8% patients, 16.6% of which were myopathy symptoms and 1.3% were AST/ALT > 3 times normal, and there were no reported cases of rhabdomyolysis. AEs related to other risk factor treatments occurred in 17.5% patients (e.g. hypoglycemia secondary to glipizide). Conclusion: In the SAMMPRIS trial, AMM required the use of multiple risk factor medications and was well tolerated by most patients, with AE rates similar to SPS3 and SPARCL.

Abstract 141: Impact of an Aggressive Medical Management Protocol on Early Risk Factor Measures in the Stenting and Aggressive Medical Management for Preventing Recurrent stroke in Intracranial Stenosis (SAMMPRIS) Trial

Stroke ◽  
2012 ◽  
Vol 43 (suppl_1) ◽  
Author(s):  
Tanya N Turan ◽  
Azhar Nizam ◽  
Michael J Lynn ◽  
Colin P Derdeyn ◽  
David Fiorella ◽  
...  
Keyword(s):  
Risk Factors ◽  
Risk Factor ◽  
Medical Management ◽  
Intracranial Stenosis ◽  
Patient Specific ◽  
Early Risk ◽  
Aggressive Medical Management ◽  
The Impact ◽  
Early Risk Factor

Purpose: SAMMPRIS is the first stroke prevention trial to include protocol-driven aggressive management of multiple vascular risk factors. We sought to determine the impact of this protocol on early risk factor control in the trial. Materials and Methods: SAMMPRIS randomized 451 patients with symptomatic 70%-99% intracranial stenosis to aggressive medical management or stenting plus aggressive medical management at 50 USA sites. For the primary risk factor targets (SBP < 140 mm/Hg (<130 if diabetic) and LDL < 70 mg/dL), the study neurologists follow medication titration algorithms and risk factor medications are provided to the patients. Secondary risk factors (diabetes, non-HDL, weight, exercise, and smoking cessation) are managed with assistance from the patient’s primary care physician and a lifestyle modification program (provided). Sites receive patient-specific recommendations and feedback to improve performance. Follow-up continues, but the 30-day data are final. We compared baseline to 30-day risk factor measures using paired t-tests for means and McNemar tests for percentages. Results: The differences in risk factor measures between baseline and 30 days are shown in Table 1. Conclusions: The SAMMPRIS protocol resulted in major improvements in controlling most risk factors within 30 days of enrollment, which may have contributed to the lower than expected 30 day stroke rate in the medical group (5.8%). However, the durability of this approach over time will be determined by additional follow-up.

Impact of Baseline Features and Risk Factor Control on Cognitive Function in the Stenting and Aggressive Medical Management for Preventing Recurrent Stroke in Intracranial Stenosis Trial

2019 ◽  
Vol 47 (1-2) ◽  
pp. 24-31 ◽  
Author(s):  
Tanya N. Turan ◽  
Sami Al Kasab ◽  
Alison Smock ◽  
George Cotsonis ◽  
David Bachman ◽  
...  
Keyword(s):  
Risk Factors ◽  
Risk Factor ◽  
Cognitive Impairment ◽  
Cognitive Function ◽  
Medical Management ◽  
Physical Inactivity ◽  
Recurrent Stroke ◽  
Older Age ◽  
Aggressive Medical Management

Background: Cerebrovascular disease is an important cause of cognitive impairment. The aim of this study is to report the relationship between cognitive function and risk factors at baseline and during follow-up in the Stenting and Aggressive Medical Management for Preventing Recurrent stroke in Intracranial Stenosis (SAMMPRIS) trial. Methods: Subjects in the SAMMPRIS trial were included in this study. In order to have an assessment of cognitive function independent of stroke, patients with a stroke as a qualifying event whose deficits included aphasia or neglect were excluded from these analyses as were those with a cerebrovascular event during follow-up. The Montreal Cognitive Assessment (MoCA) score was used to assess cognitive impairment at baseline, 4 months, 12 months and closeout. Cognitive impairment was defined as MoCA < 26. A multivariate analysis was performed to determine what risk factors were independent predictors of cognitive function at baseline, 12 months and closeout. Among patients randomized to aggressive medical management only, the percentage of patients with cognitive impairment was compared between patients in versus out of target for each risk factor at 12 months and closeout. Results: Of the 451 patients in SAMMPRIS, 371 patients met the inclusion criteria. MoCA < 26 was present in 55% at baseline. Older age and physical inactivity were associated with cognitive impairment at baseline. Older age, non-white race, lower baseline body mass index, and baseline cognitive impairment were associated with cognitive impairment at 12 months. In the aggressive medical management group, at 12 months, physical inactivity during follow-up was the strongest risk factor associated with cognitive impairment. Conclusion: Cognitive impairment is common in patients with severe symptomatic intracranial atherosclerosis. Physical inactivity at baseline and during follow-up is a strong predictor of cognitive impairment.

Abstract W P130: Relationship Between Risk Factor Control and Vascular Events in the Stenting and Aggressive Medical Management for Preventing Recurrent Stroke in Intracranial Stenosis (SAMMPRIS) Trial

Stroke ◽  
2014 ◽  
Vol 45 (suppl_1) ◽  
Author(s):  
Tanya N Turan ◽  
Azhar Nizam ◽  
Michael J Lynn ◽  
Jean Montgomery ◽  
Colin P Derdeyn ◽  
...  
Keyword(s):  
Risk Factors ◽  
Risk Factor ◽  
Medical Management ◽  
Lower Risk ◽  
Intracranial Stenosis ◽  
Vascular Events ◽  
Risk Factor Control ◽  
Increased Risk ◽  
Aggressive Medical Management

Background and Purpose: Symptomatic intracranial stenosis patients with poorly controlled cholesterol and blood pressure had an increased risk of vascular events in WASID. Therefore, SAMMPRIS aggressive medical management protocols targeted these risk factors. We sought to determine if intensive risk factor control in SAMMPRIS resulted in lower risk of vascular events during follow-up. Methods: Data on 227 SAMMPRIS patients randomized to aggressive medical management alone were used for these analyses. Vascular risk factors were recorded at baseline, 30 days, and every 4 months. Additional follow-up and close-out visit data were also included. For each patient, values for all risk factor measures (from baseline until the time of an event) were averaged and dichotomized based on the risk factor target. Time to event curves for a vascular event (stroke, MI, and vascular death) were compared between subjects with and without risk factor control using the log-rank test and hazard ratios were calculated with Cox proportional hazards regression. Results: The univariate analyses are shown in the table. Subjects with mean follow-up SBP < 140 mm Hg (< 130 for diabetics), LDL < 70 mg/dL, and at least moderate exercise had lower risk of vascular events compared to those who did not achieve those targets. Control of other risk factors (HgA1c, smoking, non-HDL, and Body Mass Index) did not have a significant impact on outcome. Conclusions: Well controlled SBP and LDL during follow-up were predictors of lower vascular events in SAMMPRIS, confirming that SBP and LDL should be aggressively treated in patients with intracranial stenosis to prevent future vascular events. Exercise participation was also associated with fewer vascular events and should be strongly encouraged.

Abstract T MP105: Relationship Between Compliance With the Lifestyle Modification Program and Risk Factor Control in the Stenting and Aggressive Medical Management for Preventing Recurrent Stroke in Intracranial Stenosis (SAMMPRIS) Trial

Stroke ◽  
2014 ◽  
Vol 45 (suppl_1) ◽  
Author(s):  
Tanya N Turan ◽  
Azhar Nizam ◽  
Michael J Lynn ◽  
Jean Montgomery ◽  
Colin P Derdeyn ◽  
...  
Keyword(s):  
Risk Factors ◽  
Risk Factor ◽  
Medical Management ◽  
Lifestyle Modification ◽  
Recurrent Stroke ◽  
Risk Factor Control ◽  
Chi Square ◽  
Lifestyle Modification Program ◽  
Aggressive Medical Management

Background and Purpose: SAMMPRIS was the first vascular disease prevention trial to provide a commercially available lifestyle modification program to subjects to enhance risk factor control. We sought to determine the relationship between compliance with the lifestyle modification program and risk factor control in SAMMPRIS. Methods: SAMMPRIS aggressive medical management included a telephonic lifestyle modification program provided free of charge to all subjects (n=451) during their participation in the study. Subjects with < 3 expected lifestyle coaching calls were excluded from these analyses. Subjects with ≥ 78.5% of calls (median % of completed/expected calls) were considered Compliant (n=201). Subjects with < 78.5% and those who refused to participate were considered Noncompliant (n=200). Mean risk factor values or % in-target for each risk factor were compared between Compliant vs. Noncompliant subjects, using t-tests and chi-square tests. Risk factor changes from baseline to follow-up were compared between the groups to account for baseline differences between the groups. Results: As shown in the figure, Compliant subjects had better risk factor control throughout follow-up for LDL, SBP, HgA1c, non-HDL, non-smoking, and exercise than Noncompliant subjects, but there was no difference for BMI. Compliant subjects also had better control of LDL, non-HDL, and HgA1c at baseline. Both groups had some improvement in risk factors throughout the study (except for BMI), but after adjusting for baseline differences between the groups, Compliant subjects had a greater change from baseline than Noncompliant subjects for SBP at 24 months and HgA1c at 6 months. Conclusions: SAMMPRIS subjects who were compliant with the lifestyle modification program had better risk factor control during the study for almost all risk factors.

Abstract 4985: Are All Patients Considered “Low Risk” for Coronary Heart Disease Really Low Risk? An Analysis from the Atherosclerosis Risk in Communities (ARIC) Study

Circulation ◽  
2008 ◽  
Vol 118 (suppl_18) ◽  
Author(s):  
Vijay Nambi ◽  
Lloyd Chambless ◽  
Aaron R Folsom ◽  
Yijuan Hu ◽  
Tom Mosley ◽  
...  
Keyword(s):  
Coronary Heart Disease ◽  
Heart Disease ◽  
Risk Group ◽  
Low Risk ◽  
Lipid Lowering ◽  
Chd Risk ◽  
The Absolute ◽  
Event Rates ◽  
Aric Study

Low risk for coronary heart disease (CHD) is defined by ATP III as a 10 year risk of <10%. There have been suggestions, however, that a 10 year CHD risk of 5–10% be considered as intermediate risk. The addition of carotid intima media thickness (CIMT) has been shown to improve CHD risk prediction when added to traditional risk factors (TRF) (age, gender, high density lipoprotein cholesterol, total cholesterol, diabetes, hypertension and cigarette smoking) in the ARIC study. We investigated the absolute event rates with and without the addition of CIMT to TRF in the ARIC study and determined the impact in the 0–10% risk group. Participants in the ARIC study (n=13145) without baseline CHD or stroke and with CIMT measurements available were included for this analysis. Using Cox proportional hazards models the participants were classified into various risk categories using TRF and further classified by sex specific CIMT (categorized as <25 th , 25 th to 75 th and >75 th percentile). The absolute event rates were then described in each group (table ). Over a mean follow up of 13.8 years, 1601 (12.2%) individuals had incident CHD events. Approximately 31% of these incident CHD events were in the 5–10% risk group which made up 28% of the study while only 16% of the incident CHD events occurred in the 0–5% risk group which made up 47% of the study population. The 5–10% group had event rates (13.7%) greater than the study average (12.2%), especially in those with thicker CIMT (>75 th percentile, event rate 17%), and greater event rates than those in the 0–5% risk group (4.1%) (table ). Given the notably higher observed CHD risk in the 5–10% group (especially in those with thicker CIMT) relative to the 0–5% group, the availability of safe, low cost lipid lowering medications and low risk tests such as ultrasound that may improve risk stratification, it may be time to evaluate the low risk group more carefully for cardiovascular preventive therapies. Table. Incident CHD in the various risk groups over a mean follow up of 13.8 years in the ARIC study

Abstract 15934: Higher Midlife Serum Levels of Kidney-injury Molecule-1 (KIM-1) are Associated With Incident Fatal CHD Over Very Long-term Follow-up Among Men

Circulation ◽  
2015 ◽  
Vol 132 (suppl_3) ◽  
Author(s):  
Rachel H Mackey ◽  
Greg G Grandits ◽  
Lewis H Kuller ◽  
Joel Estis ◽  
John A Todd ◽  
...  
Keyword(s):  
Risk Factor ◽  
Limit Of Detection ◽  
Kidney Injury ◽  
Multiple Risk Factor ◽  
Serum Samples ◽  
Increased Risk ◽  
Long Term Follow Up ◽  
Kidney Injury Molecule 1

Introduction: Higher levels of kidney-injury molecule-1 (KIM-1) measured in urine are associated with presence and progression of acute renal disease. A recent study reported similar results for KIM-1 measured in blood. Hypothesis: We hypothesized that KIM-1 measured in stored serum from middle-aged men who participated in the Multiple Risk Factor Intervention Trial (MRFIT) would differentiate very long-term risk of fatal CHD vs. survival to a mean age of 80 over approximately 30 year follow-up. Methods: We conducted a nested case-control study within MRFIT, which in 1973-76 randomized 12,866 high risk but CVD free men ages 35-57 to risk factor intervention vs. usual care. Serum samples were collected at baseline and stored for future use. The trial concluded in 1982 but long-term mortality follow-up was ascertained through 2005 using the National Death Index. From MRFIT participants with stored serum from baseline, we sampled 100 men who died of CHD (mean age 47.3 at baseline and 73.9 at death), and 100 men who survived to 2005 (mean age =48.4 at baseline and 80.1 in 2005.) KIM-1 was assayed from stored serum samples using high sensitivity single-molecule counting technology (Erenna ® Immunoassay System, Singulex), with limit of detection (LoD)=0.5 pg/ml, and lower limit of quantification (LLoQ)=2.0 pg/ml. Results were compared between cases and controls using Wilcoxon rank tests and logistic regression. Results: Inter-assay %CVs were 8%. Median KIM-1 was higher for smokers vs. non-smokers and for men with vs. without hypertension, but was not associated with high cholesterol. KIM-1 was significantly higher in cases (183 pg/ml (IQR: 137-239) versus controls, (161 pg/ml (IQR:109-212), p=0.03; OR (95%CI)for Q4 versus Q1 was 2.26 (1.02 - 5.02) Adjusted for age and smoking the OR(95%CI) of fatal CHD for Q4 vs. Q1 was 2.34 (1.02- 5.37), and further adjusted for diastolic BP and serum cholesterol at baseline, was 2.0 (95% CI: 0.8-4.7). Conclusions: Higher serum KIM-1 levels at midlife were associated with a ∼2-fold increased risk of fatal CHD vs. survival over ∼30 years of follow-up. This is the first report of a longitudinal association of circulating KIM-1 levels with fatal CHD in long-term follow-up.

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