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.

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 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.

scholarly journals Relationship between risk factor control and vascular events in the SAMMPRIS trial

Neurology ◽  
2016 ◽  
Vol 88 (4) ◽  
pp. 379-385 ◽  
Author(s):  
Tanya N. Turan ◽  
Azhar Nizam ◽  
Michael J. Lynn ◽  
Brent M. Egan ◽  
Ngoc-Anh Le ◽  
...  
Keyword(s):  
Physical Activity ◽  
Risk Factors ◽  
Myocardial Infarction ◽  
Blood Pressure ◽  
Risk Factor ◽  
Recurrent Stroke ◽  
Density Lipoprotein ◽  
Vascular Events ◽  
Risk Factor Control

Objective:The Stenting and Aggressive Medical Management for Preventing Recurrent Stroke in Intracranial Stenosis (SAMMPRIS) study is the first stroke prevention trial to include protocol-driven intensive management of multiple risk factors. In this prespecified analysis, we aimed to investigate the relationship between risk factor control during follow-up and outcome of patients in the medical arm of SAMMPRIS.Methods:Data from SAMMPRIS participants in the medical arm (n = 227) were analyzed. Risk factors were recorded at baseline, 30 days, 4 months, and then every 4 months for a mean follow-up of 32 months. For each patient, values for all risk factor measures were averaged and dichotomized as in or out of target.Results:Participants who were out of target for systolic blood pressure and physical activity, as well as those with higher mean low-density lipoprotein cholesterol and non–high-density lipoprotein, were more likely to have a recurrent vascular event (stroke, myocardial infarction, or vascular death) at 3 years compared to those who had good risk factor control. In the multivariable analysis, greater physical activity decreased the likelihood of a recurrent stroke, myocardial infarction, or vascular death (odds ratio 0.6, confidence interval 0.4–0.8).Conclusions:Raised blood pressure, cholesterol, and physical inactivity should be aggressively treated in patients with intracranial atherosclerosis to prevent future vascular events. Physical activity, which has not received attention in stroke prevention trials, was the strongest predictor of a good outcome in the medical arm in SAMMPRIS.ClinicalTrials.gov identifier:NCT00576693.

Long-term effects of an intensive prevention program (IPP) after acute myocardial infarction – the IPP Follow-up and Prevention Boost Trial

2020 ◽  
Vol 41 (Supplement_2) ◽  
Author(s):  
H Wienbergen ◽  
A Fach ◽  
S Meyer ◽  
J Schmucker ◽  
R Osteresch ◽  
...  
Keyword(s):  
Risk Factors ◽  
Myocardial Infarction ◽  
Risk Factor ◽  
Prevention Program ◽  
Study Endpoint ◽  
Funding Source ◽  
Risk Factor Control ◽  
One Year

Abstract Background The effects of an intensive prevention program (IPP) for 12 months following 3-week rehabilitation after myocardial infarction (MI) have been proven by the randomized IPP trial. The present study investigates if the effects of IPP persist one year after termination of the program and if a reintervention after &gt;24 months (“prevention boost”) is effective. Methods In the IPP trial patients were recruited during hospitalization for acute MI and randomly assigned to IPP versus usual care (UC) one month after discharge (after 3-week rehabilitation). IPP was coordinated by non-physician prevention assistants and included intensive group education sessions, telephone calls, telemetric and clinical control of risk factors. Primary study endpoint was the IPP Prevention Score, a sum score evaluating six major risk factors. The score ranges from 0 to 15 points, with a score of 15 points indicating best risk factor control. In the present study the effects of IPP were investigated after 24 months – one year after termination of the program. Thereafter, patients of the IPP study arm with at least one insufficiently controlled risk factor were randomly assigned to a 2-months reintervention (“prevention boost”) vs. no reintervention. Results At long-term follow-up after 24 months, 129 patients of the IPP study arm were compared to 136 patients of the UC study arm. IPP was associated with a significantly better risk factor control compared to UC at 24 months (IPP Prevention Score 10.9±2.3 points in the IPP group vs. 9.4±2.3 points in the UC group, p&lt;0.01). However, in the IPP group a decrease of risk factor control was observed at the 24-months visit compared to the 12-months visit at the end of the prevention program (IPP Prevention Score 10.9±2.3 points at 24 months vs. 11.6±2.2 points at 12 months, p&lt;0.05, Figure 1). A 2-months reintervention (“prevention boost”) was effective to improve risk factor control during long-term course: IPP Prevention Score increased from 10.5±2.1 points to 10.7±1.9 points in the reintervention group, while it decreased from 10.5±2.1 points to 9.7±2.1 points in the group without reintervention (p&lt;0.05 between the groups, Figure 1). Conclusions IPP was associated with a better risk factor control compared to UC during 24 months; however, a deterioration of risk factors after termination of IPP suggests that even a 12-months prevention program is not long enough. The effects of a short reintervention after &gt;24 months (“prevention boost”) indicate the need for prevention concepts that are based on repetitive personal contacts during long-term course after coronary events. Figure 1 Funding Acknowledgement Type of funding source: Foundation. Main funding source(s): Stiftung Bremer Herzen (Bremen Heart Foundation)

Relationship between country income, socioeconomic factors and control of cardiovascular disease risk factors in patients with type 2 Diabetes: insights from the global DISCOVER registry

2020 ◽  
Vol 41 (Supplement_2) ◽  
Author(s):  
A Malik ◽  
H Chen ◽  
A Cooper ◽  
M Gomes ◽  
V Hejjaji ◽  
...  
Keyword(s):  
Risk Factors ◽  
Type 2 Diabetes ◽  
Optimal Control ◽  
Risk Factor ◽  
Socioeconomic Factors ◽  
Funding Source ◽  
Risk Factor Control ◽  
Cv Disease

Abstract Background In patients with type 2 diabetes (T2D), optimal management of cardiovascular (CV) risk factors is critical for primary prevention of CV disease. Purpose To describe the association of country income and patient socioeconomic factors with risk factor control in patients with T2D. Methods DISCOVER is a 37-country, prospective, observational study of 15,983 patients with T2D enrolled between January 2016 and December 2018 at initiation of 2nd-line glucose-lowering therapy and followed for 3 years. In patients without known CV disease with sub-optimally controlled risk factors at baseline, we examined achievement of risk factor control (HbA1c &lt;7%, BP &lt;140/90 mmHg, appropriate statin) at the 3 year follow-up. Countries were stratified by gross national income (GNI)/capita, per World Bank report. We explored variability across countries in risk factor control achievement using hierarchical logistic regression models and examined the association of country- and patient-level economic factors with risk factor control. Results Among 9,613 patients with T2D but without CV disease (mean age 57.2 years, 47.9% women), 83.1%, 37.5%, and 66.3% did not have optimal control of glucose, BP, and statins, respectively, at baseline. Of these, 40.8%, 55.5%, and 28.6% achieved optimal control at 3 years of follow-up. There was substantial variability in achievement of risk factor control across countries (Figure) but no association of country GNI/capita on achievement of risk factor control (Table). Insurance status, which differed substantially by GNI group, was strongly associated with glycemic control, with no insurance and public insurance associated with lower odds of patients achieving HbA1c &lt;7%. Conclusions In a global cohort of patients with T2D, a substantial proportion do not achieve risk factor control even after 3 years of follow-up. The variability across countries in risk factor control is not explained by the GNI/capita of the country. Proportion of patients at goal Funding Acknowledgement Type of funding source: Private company. Main funding source(s): The DISCOVER study is funded by AstraZeneca

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 TP184: Did Race Impact Risk Factor Control in the SAMMPRIS Trial?

Stroke ◽  
2016 ◽  
Vol 47 (suppl_1) ◽  
Author(s):  
Lidia B Yamada ◽  
Tanya N Turan ◽  
George A Cotsonis ◽  
Michael Lynn ◽  
Oscar Benavente ◽  
...  
Keyword(s):  
Risk Factor ◽  
Primary Endpoint ◽  
Proportional Hazards ◽  
Recurrent Stroke ◽  
Vascular Risk Factor ◽  
Cox Proportional Hazards ◽  
Rank Test ◽  
Risk Factor Control ◽  
Chi Square ◽  
Significant Difference

Background: WASID showed that Blacks with symptomatic intracranial atherosclerosis are at higher risk of recurrent stroke and have a greater vascular risk factor burden than whites. We sought to determine if aggressive medical management (AMM) in SAMMPRIS resulted in equal control of risk factors in Blacks vs. other races and eliminated the racial disparity in outcome. Methods: Data on all 451 SAMMPRIS patients receiving AMM were used to determine risk factor control in Blacks vs. Others. SBP, LDL, and exercise were recorded throughout the trial, averaged (from baseline until primary endpoint), and dichotomized as in/out of target. Chi-square and t-tests were used to compare risk factor control in Blacks vs. Others. For outcome analyses, data from 227 patients randomized to AMM only were used. Time to event curves for the primary endpoint were compared between Blacks vs. Others using the log-rank test and hazard ratios were calculated with Cox proportional hazards regression. Results: There were no differences between the percentage of Blacks (n=104) vs. Others (n=347) that were in-target for SBP (57.1% vs 62.3%, p=0.36), LDL (40.4% vs 48.5%, p=0.14), or exercise (40.4% vs 43.2%, p=0.61) and no difference in mean SBP (135.2 vs 133.3 mm Hg, p=0.19), LDL (80.7 vs 76.3 mg/dL, p=0.19), or PACE exercise score (3.6 vs 3.8, p=0.27). There was a numerically higher primary endpoint rate among Blacks, but no statistically significant difference in outcome (Figure). However, power to detect a HR of 1.5 for Black race (the HR for the primary endpoint in WASID) was only 20%. Conclusions: Control of SBP and LDL, and exercise, which were highly associated with a good outcome in SAMMPRIS, were not different between Blacks and other races. However, the study lacked sufficient power to detect a difference in outcome between blacks and other races and therefore we cannot conclude that reducing racial disparities in risk factor control will lead to reducing disparities in outcome.

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