Baseline Risk Factor Profiles Research Articles

Risk of recurrent venous thromboembolism and major bleeding according to risk factor profiles in Asian patients: a subgroup analysis EINSTEIN-Extension and EINSTEIN-CHOICE

BackgroundRisks of recurrence and major bleeding with extended anticoagulation in Asian patients with venous thromboembolism (VTE) are similar to those in non-Asian patients but risks according to baseline risk factor profiles is not well documented.MethodsSubgroup analysis of two randomized trials, which compared once-daily rivaroxaban (20 mg or 10 mg) with placebo or aspirin (100 mg) for extended treatment in Asian patients with VTE who had completed 6–12 months of anticoagulation. Index events were classified as unprovoked, provoked by major persistent risk factors, minor persistent risk factors, minor transient risk factors, or major transient risk factors. One-year cumulative risks of recurrent VTE were calculated for these risk factor profiles.Results367 patients received rivaroxaban, 159 aspirin, and 48 placebo. For patients with unprovoked VTE, one-year cumulative incidences of recurrence in the 202 patients given rivaroxaban, the 89 given aspirin and the 28 given placebo were 1.6%, 5.8%, and 14.8%, respectively. For patients with VTE provoked by minor persistent risk factors, these incidences were 0% in the 74 patients given rivaroxaban, 9.3% in the 36 given aspirin, and 0% in the 12 given placebo. No recurrent VTE occurred in patients with VTE provoked by major persistent or transient risk factors or minor transient risk factors. Rivaroxaban was not associated with a significant increase in major bleeding.ConclusionsRivaroxaban seems to be an effective and safe option for extended treatment in Asian patients, especially those presenting with unprovoked VTE. Subgroups of patients with provoked risk factors were too small to draw meaningful conclusions.Trial registrationNCT00439725 and NCT02064439.

TRACK_9: Testosterone replacement assessment: Classical vs. functional hypogonadism-knowledge from a 9-year study.

The longitudinal efficacy and clinical utility of Testosterone Therapy (TTh) in ameliorating functional hypogonadism (FH) remain contentious, with long-term data being scarce. To address this lacuna, a comprehensive long-term registry study, stratifying patients across a spectrum of hypogonadal etiologies, offers a robust investigative paradigm. This 9-year registry, encompassing 650 patients (equivalent to 4,362 cumulative years of treatment), included 188 patients diagnosed with FH (mean age 42.3±11.3 years) and 462 individuals with classical hypogonadism (CH). The cohort segregated into 266 men with primary hypogonadism (PH, mean age 34.0±11.7 years) and 196 with secondary hypogonadism (SH, mean age 31.9±12.0 years). Uniform treatment across the cohort involved intramuscular administration of testosterone undecanoate (1,000mg). A comparative analysis was conducted focusing on anthropometric, metabolic, and safety parameters. Serum testosterone levels increased from 6.6±2.4 to 19.3±2.9nmol/L (p<0.001). TTh was linked with weight reduction and decreased waist circumference (WC) in both CH and FH cohorts (both p<0.001). Cox regression and Kaplan-Meier analyses delineated disparities: men with FH demonstrated a higher propensity for losing>10% body weight and>5% WC compared to CH (hazard ratio [HR] 1.3 [1.1-1.4], p=0.008 and HR 1.4 [1.3-1.5], p=0.001). Increases in hematocrit>50% were uniform across groups, albeit amelioration of anemia was more pronounced in FH versus CH (p=0.002). Increments of prostate-specific antigen (PSA) levels were more likely to occur in FH (HR 1.3 [1.1-1.6], p=0.003). FH patients exhibited pronounced improvements in metabolic parameters and in aging male symptom score (AMS) and IIEF-EF questionnaire scores. These effects were markedly modulated by age and initial weight. Subgroup analysis of age-matched obese patients revealed an accentuated impact of TTh in CH compared to FH. The therapeutic outcomes of TTh across distinct hypogonadal populations demonstrate heterogeneous responses, significantly influenced by diagnostic categorization, age, and baseline risk factor profiles.

Integrative analysis of clinicopathological features defines novel prognostic models for mantle cell lymphoma in the immunochemotherapy era: a report from The North American Mantle Cell Lymphoma Consortium

BackgroundPatients with mantle cell lymphoma (MCL) exhibit a wide variation in clinical presentation and outcome. However, the commonly used prognostic models are outdated and inadequate to address the needs of the current multidisciplinary management of this disease. This study aims to investigate the clinical and pathological features of MCL in the immunochemotherapy era and improve the prognostic models for a more accurate prediction of patient outcomes.MethodsThe North American Mantle Cell Lymphoma Project is a multi-institutional collaboration of 23 institutions across North America to evaluate and refine prognosticators for front-line therapy. A total of 586 MCL cases diagnosed between 2000 and 2012 are included in this study. A comprehensive retrospective analysis was performed on the clinicopathological features, treatment approaches, and outcomes of these cases. The establishment of novel prognostic models was based on in-depth examination of baseline parameters, and subsequent validation in an independent cohort of MCL cases.ResultsIn front-line strategies, the use of hematopoietic stem cell transplantation was the most significant parameter affecting outcomes, for both overall survival (OS, p < 0.0001) and progression-free survival (PFS, p < 0.0001). P53 positive expression was the most significant pathological parameter correlating with inferior outcomes (p < 0.0001 for OS and p = 0.0021 for PFS). Based on the baseline risk factor profile, we developed a set of prognostic models incorporating clinical, laboratory, and pathological parameters that are specifically tailored for various applications. These models, when tested in the validation cohort, exhibited strong predictive power for survival and showed a stratification resembling the training cohort.ConclusionsThe outcome of patients with MCL has markedly improved over the past two decades, and further enhancement is anticipated with the evolution of clinical management. The innovative prognostic models developed in this study would serve as a valuable tool to guide the selection of more suitable treatment strategies for patients with MCL.

Risk of recurrent thromboembolic events according to treatment duration in patients with superficial vein thrombosis treated with intermediate dose of tinzaparin.

To evaluate the risk of symptomatic venous thromboembolism (VTE) recurrence at 3months in relation to treatment duration, according to baseline risk factor profiles, in patients with superficial vein thrombosis (SVT) treated with intermediate dose of tinzaparin. We performed a pooled analysis on individual data from two prospective studies designed to assess the efficacy and safety of tinzaparin in intermediate dose (131IU/kg) in patients with SVT. Treatment duration was at the treating physician's discretion. All patients were followed up for at least 3months. A total of 956 patients (65% female, mean age 58.7 ± 13.7years) were included. The median treatment duration was 30days (range, 3-200days). History of deep vein thrombosis (DVT), location of SVT above the knee, and palpable induration were the only independent factors associated with prolonged treatment duration. During follow-up, 95.9% of patients were event free. Outcomes-related adverse events occurred in 39 (4.1%) patients and their median duration of treatment was 33days (range, 7-200days). Recurrent VTE events occurred in 33 patients, including 22 cases of SVT recurrence, 8 cases of DVT, and 1 case of pulmonary embolism. The median time to the event was 29 (6-113) days. Recurrent thromboembolic events were not related to treatment duration as occurred in 17 patients (51.5%) treated up to 30days and in 16 patients (48.8%) received prolong treatment (p = .46). Length of thrombus at the index event was significantly associated with higher risk for VTE recurrence. Intermediate dose of tinzaparin for 30days is an effective and safe treatment for SVT. The risk of recurrent VTE events may be higher in patients with greater amount of thrombus at index event.

416-P: Mortality, Major Adverse Cardiovascular Events (MACE) and Diabetic Complications in Men with Hypogonadism and Type 2 Diabetes on Long-Term Testosterone Treatment: An Update from a Urological Registry Study

Background: Men with hypogonadism are at increased risk of MACE and mortality. Studies in men with T2DM show that testosterone therapy reduces both MACE and mortality. Methods: In a registry of 883 men with hypogonadism, 370 men (41.9%) have T2DM. 190 received TU 1000 mg/12 weeks (T-group) , 180 opted against treatment (CTRL) . All patients received standard diabetes treatment including lifestyle courses at a diabetes center. MACE, mortality, and diabetic complications were recorded and compared between groups. Results: Mean baseline age in the T-group and CTRL was 61.0±5.3 and 63.0±4.9 years. Mean follow-up in T-group and CTRL was 9.0 and 9.7 years. 71 patients (37.4%) in the T-group and 74 (41.1%) in CTRL had a history of cardiovascular disease (myocardial infarction MI, stroke, or coronary artery disease diagnosis) (p&amp;lt;0.05) . Baseline smoking prevalence was 41.6% (79 men) in the T-group and 37.4% (67 men) in CTRL (p=0.415) . The T-group had a worse baseline risk factor profile than CTRL: BMI (36.5±4.4 vs. 32.8±4.7 kg/m²) , systolic blood pressure (163.0±13.3 vs. 145.5±14.5 mmHg) , LDL (4.7±0.8 vs. 4.1±1.4 mmol/L) , HbA1c 9.5±1.4 vs. 7.8±0.7% (p&amp;lt;0.00for all) . Mortality: during the entire observation period, 21 patients (11.1%) died in the T-group vs. 62 (34.4%) in CTRL (p&amp;lt;0.0001) . Major adverse cardiovascular events (MACE) : in the T-group, there were no cases of MI or stroke. In CTRL, there were 62 cases of MI (34.4%) and 51 cases of stroke (28.3%) . Diabetic complications: in the T-group and CTRL, the incidence of retinopathy was 4 (2.1%) vs. 30 (16.7%) (p&amp;lt;0.0001) , nephropathy 1 (0.01%) vs. 7 (0.4%) (p=0.05) , polyneuropathy (5.3%) vs. 97 (53.9%) (p&amp;lt;0.0001) , diabetic foot syndrome 0 (0%) vs. 17 (9.4%) (p&amp;lt;0.0001) . Conclusions: Long-term treatment with TU in men with hypogonadism and T2DM reduces mortality, MACE, and diabetic complications, compared to untreated controls. Disclosure K.S.Haider: Other Relationship; Bayer AG. A.Haider: Other Relationship; Bayer AG. F.Saad: Consultant; Bayer AG, Stock/Shareholder; AbbVie Inc., Bayer AG, GlaxoSmithKline plc. Funding Bayer AG

Improved glycaemic control and reduced incidence of myocardial infarctions, strokes, and mortality in men with hypogonadism and type 2 diabetes, with and without long-term testosterone therapy

Abstract Introduction Guidelines by the ESC and EASD state that patients with diabetes have a two-fold excess risk of vascular outcomes. An increasing number of studies suggests that testosterone therapy (TTh) has cardiometabolic benefits in men with hypogonadism and type 2 diabetes (T2DM). Methods In a registry of men with hypogonadism in a urological office, 361 men had T2DM and received standard diabetes treatment including lifestyle recommendations and coaching in a diabetes center. 183 men received TTh with testosterone undecanoate injections 1000 mg/12 weeks following an initial 6-week interval (T-group). 178 men opted against TTh and served as controls (CTRL). Changes over time between groups were compared and adjusted for age, weight, waist circumference, fasting glucose, blood pressure, lipids and quality of life to account for baseline differences between the two groups. 12-year analyses of 3149 patient-years are reported. Results Mean (median) follow-up 8.2±3.2 (8) years in the T-group, 9.2±2.8 (10) years in CTRL, baseline age: 60.6±5.4 (T-group) and 63.5±5.0 (CTRL) years (p&amp;lt;0.0001). All but 7 patients were overweight or obese. 70 patients (38.3%) in the T-group and 70 (39.3%) in CTRL had a history of cardiovascular disease (myocardial infarction MI, stroke, or coronary artery disease diagnosis) (p=0.8341). Baseline smoking prevalence was 41.0% (75 men) in the T-group and 38.2% (68 men) in CTRL (p=0.5161). The T-group had significantly worse baseline risk factor profile than CTRL: BMI (36.5±4.5 vs. 33.4±5.3 kg/m2), systolic blood pressure (163.0±13.5 vs. 145.6±14.6 mmHg), LDL (4.7±0.9 vs. 4.1±1.4 mmol/L), HbA1c 9.4±1.4 vs. 7.8±0.7% (p&amp;lt;0.0001 for all). HbA1c progressively decreased by 3.7±0.2% at 12 years in the T-group and increased in CTRL by 3.2±0.2%, estimated adjusted difference between groups: −6.9% [95% CI: −7.4; −6.4] (p&amp;lt;0.0001 for all). Fasting glucose decreased in the T-group by 1.9±0.1 and increased in CTRL by 1.8±0.1 mmol/L, estimated adjusted difference: −3.6 mmol/L [95% CI: −4.0; −3.3] (p&amp;lt;0.0001 for all). Men in the T-group lost 19.7±0.4% weight, men in CTRL gained 9.1±0.4%, estimated adjusted difference: −28.8% [95% CI: −30.2; −27.4] (p&amp;lt;0.0001 for all). During the observation period, 15 patients (8.2%) died in the T-group vs. 61 (34.3%) in CTRL (p&amp;lt;0.0001). In the T-group, there were no cases of MI or stroke. In CTRL, there were 56 cases of MI (31.5%) and 56 cases of stroke (31.5%). 35 patients (19.7%) suffered a MI and a stroke. Medication adherence to testosterone was 100% as all injections were administered in the medical office and documented. Conclusions Long-term treatment with TU in men with hypogonadism and T2DM significantly reduces mortality, compared to untreated controls. Improved glycaemic control and weight loss may have contributed to these outcomes. Funding Acknowledgement Type of funding sources: Private company. Main funding source(s): Bayer AG, Berlin, Germany

240-OR: Mortality, MACE, and Diabetic Complications in Men with Hypogonadism and Type 2 Diabetes (T2DM) Receiving Long-Term Treatment with Testosterone Undecanoate Injections (TU): An Update of 12-Year Real-World Data

Background: Men with hypogonadism are at increased risk of MACE and mortality. Studies in men with T2DM show that testosterone therapy (TTh) reduces both MACE and mortality. Methods: Of 361 men with hypogonadism and T2DM, 183 received testosterone undecanoate injections (TU) 1000 mg/12 weeks (T-group), 178 opted against treatment (CTRL). MACE, mortality, and diabetic complications were recorded and compared between groups. Results: Mean baseline age in the T-group and CTRL was 60.7±5.5 and 63.0±4.9 years. Mean follow-up in T-group vs. CTRL was 8.2 and 9.2 years. 70 patients (38.3%) in the T-group and 70 (39.3%) in CTRL had a history of cardiovascular disease (myocardial infarction MI, stroke, or coronary artery disease diagnosis) (p=0.8341). Baseline smoking prevalence was 41.0% (75 men) in the T-group and 38.2% (68 men) in CTRL (p=0.5161). The T-group had significantly worse baseline risk factor profile than CTRL: BMI (36.5±4.5 vs. 33.4±5.3 kg/m2), systolic blood pressure (163.0±13.5 vs. 145.6±14.6 mmHg), LDL (4.7±0.9 vs. 4.1±1.4 mmol/L), HbA1c 9.4±1.4 vs. 7.8±0.7% (p&amp;lt;0.0001 for all). Mortality: during the entire observation period, 15 patients (8.2%) died in the T-group vs. 61 (34.3%) in CTRL (p&amp;lt;0.0001). Major adverse cardiovascular events (MACE): in the T-group, there were no cases of MI or stroke. In CTRL, there were 56 cases of MI (31.5%) and 56 cases of stroke (31.5%). 35 patients (19.7%) suffered a MI and a stroke. Diabetic complications: in the T-group vs. CTRL, the incidence of retinopathy was 6 (3.3%) vs. 30 (16.9%) (p&amp;lt;0.0001), nephropathy 1 (0.01%) vs. 5 (2.8%) (p&amp;lt;0.05), polyneuropathy 11 (6.0%) vs. 97 (54.5%) (p&amp;lt;0.0001), diabetic foot syndrome 0 (0%) vs. 10.1% (p&amp;lt;0.0001). Conclusions: Long-term treatment with TU in men with hypogonadism and T2DM significantly reduces mortality, compared to untreated controls. Disclosure K. S. Haider: Other Relationship; Self; Bayer AG. A. Haider: Other Relationship; Self; Bayer AG. F. Saad: Consultant; Self; Bayer AG, Stock/Shareholder; Self; AbbVie Inc., Bayer AG, Novo Nordisk. Funding Bayer AG

Racial disparities among Asian Americans with atrial fibrillation: An analysis from the NCDR® PINNACLE Registry

BackgroundThere is paucity of data on Atrial Fibrillation (AF) management and associated clinical outcomes among Asian Americans. This study sought to investigate baseline risk factor profiles, racial disparities in clinical management and adverse clinical outcomes among White and Asian Americans. MethodsWe used National Cardiovascular Data Registry (NCDR®) Practice Innovation and Clinical Excellence (PINNACLE) registry and linked Centers of Medicare and Medicaid Services data to identify Asian and White patients with AF between January 1, 2013–June 30, 2018. We compared rates of baseline risk factors, management strategies (rate versus rhythm control), anticoagulation use and rates of adverse events between racial groups. The two race groups were compared using hierarchical multivariable adjusted regression models to account for site and confounders. ResultsIn total, 1,359,827 patients (18,793 Asians and 1,341,034 Whites) were included in our analysis. Compared to White Americans, Asian Americans were more likely to use a rate control strategy (Odds Ratio [OR]: 1.20, 95% Confidence Interval [CI]: 1.15–1.25) and lower odds of rhythm control strategy (atrial ablations, cardioversions, or use of antiarrhythmic drugs) (OR: 0.83, 95% CI: 0.80–0.87) in adjusted analysis. Use of oral anticoagulants and direct oral anticoagulants were similar. There were no significant race-based differences in likelihood of all-cause mortality, stroke, and bleeding requiring hospitalization. Analyses performed using propensity score matching were consistent with the main results. ConclusionsAsian Americans with AF have a lower likelihood of being managed with rhythm control strategies. Overall use of OAC and AF related adverse events remain similar between the two racial groups.

Venous Thromboembolism in COVID-19: Are Women Different?

AbstractThe epidemiological data suggests predominant male prevalence, morbidity and mortality with SARS COVID-2. Similarly, venous thromboembolic (VTE) events have a male sex predilection with variant mechanisms involving angiotensin-converting enzyme 2 (ACE-2) expression and pathways in women. COVID-19 could directly affect or it could be an indirect action of the disease via critical ailment hypoxemia, or hemostatic abnormalities might be the underlying mechanisms of VTE in a COVID-19 patient with baseline risk factor profile. VTE diagnosis in a COVID scenario has issues of a prone positioned patient, exposure of health workers and minimal therapeutic benefits in a critically ill patient with acute respiratory distress syndrome (ARDS). Anticoagulation with low-molecular weight heparin (LMWH) can be chosen over unfractionated heparin (UFH) with less monitoring requirements and thereby low exposure to healthcare workers. Variant guidelines for thromboprophylaxis (in hospital/extended postdischarge) have come up, stating anticoagulant administration, according to baseline risk profile and hemostatic biomarkers. Catheter-directed interventions should be reserved only for life-threatening situations. In women, hormonal milieu (for e.g., 17 β-estradiol) might influence occurrence of favorable ACE 2 polymorphisms with less VTE events. The management strategies in a female patient with VTE would be more or less similar to males. Combined oral contraceptives (COC) and estrogen replacement therapies (ERT) may be curtailed in COVID-19 positive patients, given their thrombogenic potential. Pregnancy and postpartum state in COVID-19 positive patient need VTE prophylaxis all the more in the presence of risk profile favoring VTE. Also, VTE prophylaxis when indicated should be continued in women in a normal menstrual cycle. Bleeding risks specific to women (menorrhagia secondary to dysfunctional uterine bleeding [DUB], fibroids, adnexal malignancies and masses, hypothyroidism, etc.) need to be weighed while taking a decision for indicated anticoagulation regimen.

401-P: Mortality, Major Adverse Cardiovascular Events (MACDE), and Diabetic Complications in Men with Hypogonadism and Type 2 Diabetes (T2DM) Receiving Long-Term Treatment with Testosterone Undecanoate Injections (TU): 11-Year Real-World Data

Background: Men with hypogonadism are at increased risk of MACE and mortality. Studies in men with T2DM show that testosterone therapy (TTh) reduces both MACE and mortality. Methods: In a registry of 858 men with hypogonadism, 356 men (41.5%) had T2DM. 178 received testosterone undecanoate injections (TU) 1000 mg/12 weeks (T-group) and 178 opted against treatment (CTRL). MACE, mortality, and diabetic complications were recorded and compared between groups. Results: Mean baseline age in the T-group and CTRL was 61.8±5.1 and 63.6±4.9 years, respectively. Mean follow-up in T-group vs. CTRL was 7.4 and 8.3 years, respectively. 69 patients (38.8%) in the T-group and 70 (39.3%) in CTRL had a history of cardiovascular disease (myocardial infarction, stroke, or coronary artery disease diagnosis) (p=0.9135). Baseline smoking prevalence was 41.6% (74 men) in the T-group and 38.2% (68 men) in CTRL (p=0.5161). The T-group had significantly worse baseline risk factor profile than CTRL: BMI (36.5±4.5 vs. 33.4±5.3 kg/m²), systolic blood pressure (163.0±13.3 vs. 145.6±14.6 mmHg), LDL (4.7±0.9 vs. 4.1±1.4 mmol/L), HbA1c 9.4±1.4 vs. 7.8±0.7% (p&amp;lt;0.0001 for all). Mortality: during the entire observation period, 13 patients (7.3%) died in the T-group vs. 48 (27.0%) in CTRL (p&amp;lt;0.0001). MACE: in the T-group, there were no cases of myocardial infarction or stroke. In CTRL, there were 55 cases of myocardial infarction (30.9%) and 45 cases of stroke (25.3%). Diabetic complications: in the T-group vs. CTRL, the incidence of retinopathy was 3.4% and 16.9% (p&amp;lt;0.0001), nephropathy 0.6% and 4% (p&amp;lt;0.05), polyneuropathy 6.2% and 54.8% (p&amp;lt;0.0001), diabetic foot syndrome 0% and 9.6% (p&amp;lt;0.0001). Conclusions: Long-term treatment with TU in men with hypogonadism and T2DM significantly reduces MACE and mortality, as well as diabetic complications compared to untreated controls. Disclosure A. Haider: None. K.S. Haider: None. F. Saad: Consultant; Self; Bayer AG. Stock/Shareholder; Self; AbbVie Inc., Bayer AG. Funding Bayer AG

Abstract TP123: Baseline Differences in Risk Factor Control Between CREST-2 and SAMMPRIS

Baseline Differences in Risk Factor Control and Medication Use Between 2 Trials Employing Intensive Medical Management (SAMMPRIS &amp; CREST2) Background: The CREST2 trial Intensive Medical Management (IMM) protocol was adapted from the SAMMPRIS trial. However, since the 2011 publication of initial results of SAMMPRIS, there has been a greater appreciation for the importance of risk factor control in patients at risk of stroke associated with atherosclerosis. Therefore, we sought to determine differences in baseline risk factor control and medication use between SAMMPRIS and CREST2. Methods: Baseline risk factor and medication use data from 451 patients enrolled in SAMMPRIS (2008-2011) with severe symptomatic intracranial atherosclerosis and 1473 patients enrolled in CREST2 (2014-2019) with severe asymptomatic carotid stenosis were compared using the Chi-square test and t-test. Results: The Table shows baseline risk factor values and medications. SAMMPRIS patients were younger but had significantly worse risk factor control than CREST2 patients for all measures. There was no significant difference in statin use at baseline, but the mean SAMMPRIS subjects’ LDL was 16.1 mg/dL higher than in CREST2. CREST2 patients had higher rates of use of angiotensin receptor blockers (ARB), calcium channel blockers (CCB), and thiazides, but lower rates of use of angiotensin converting enzyme (ACE) inhibitors. Conclusions: Despite being older, CREST2 patients have significantly better baseline risk factor profiles than SAMMPRIS patients. This could be due to greater appreciation of the importance of risk factor control and healthy lifestyle habits for stroke prevention or more aggressive treatment targets in guideline recommendations. Although risk factor control appears to be improving since SAMMPRIS, many CREST2 patients are still not meeting recommended risk factor goals at baseline and may benefit from IMM protocols.

Risk of recurrent venous thromboembolism according to baseline risk factor profiles

AbstractThe optimal duration of anticoagulation for venous thromboembolism (VTE) is uncertain. In this prespecified analysis, we used data from 2 randomized trials, which compared once-daily rivaroxaban (20 mg or 10 mg) with aspirin (100 mg) or placebo for extended VTE treatment to estimate the risk of recurrence according to baseline risk factor profiles. Index VTE events were centrally classified as unprovoked, or provoked by major transient or persistent, or minor transient or persistent risk factors, and rates of recurrence at 1 year were calculated. A total of 2832 patients received rivaroxaban; 1131 received aspirin, and 590 received placebo. With unprovoked VTE, rates of recurrence in the 1173 patients given rivaroxaban, the 468 given aspirin, and the 243 given placebo were 2.0%, 5.9%, and 10.0%, respectively. There were no recurrences in patients with VTE provoked by major transient risk factors. With VTE provoked by minor persistent risk factors, recurrence rates in the 1184 patients given rivaroxaban, the 466 given aspirin, and the 248 given placebo were 2.4%, 4.5%, and 10.7%, respectively. For patients with minor transient risk factors, recurrence rates were 0.4% in the 268 patients given rivaroxaban, 4.2% in the 121 given aspirin, and 7.1% in the 56 given placebo. Recurrence rates in patients with VTE provoked by minor persistent or minor transient risk factors were not significantly lower than that with unprovoked VTE (hazard ratio [HR], 0.81; 95% confidence interval [CI], 0.56-1.16; and HR, 0.68; 95% CI, 0.32-1.30, respectively). Therefore, such patients may also benefit from extended anticoagulation therapy.

Abstract 12044: Absence of Coronary Artery Disease by Coronary Computed Tomographic Angiography and the Warranty Period Associated With All-Cause Mortality: Findings From the CONFIRM Long-Term Follow-Up Registry

Introduction: Coronary computed tomographic angiography (CCTA) is widely utilized for the detection of coronary artery disease (CAD). Foremost, the very low risk associated with normal CCTA is an important component for the purpose of cardiovascular risk stratification. To date, however, data that accounts for long-term prognosis of normal CCTA is sparse. Purpose: Using data from a multi-center, global observational CCTA registry, we sought to determine the potential warranty period of normal CCTA. Methods: Among 12,086 patients who underwent CCTA, 7,651 patients without history of previous CAD, aged between 30-74 years, were included in the current analysis and followed consecutively over 5 years. Normal CCTA was defined as the absence of any plaque in the coronary arteries. Annual mortality was calculated and compared with overall patients. The primary event in this study was all-cause mortality (ACM). Results: During a median follow-up of 5.8 years (IQR, 5.3-6.3 years), 120 of all-cause deaths occurred among 3,051 patients with normal CAD. Mean age of the study population was 52±11 years, and 45% were men. Annual mortality rate was 0.68% (95% confidence interval (CI), 0.57~0.82), while annual mortality of overall patients was 1.31% (95% CI, 1.20~1.42) ( p &lt;0.001). When we defined warranty period as a follow-up duration until the estimated mortality reached the threshold of 5% using a Kaplan Meier curve, the warranty period of normal CCTA for ACM was 7.2 years. In subgroup analysis, according to a baseline risk factor profile using Framingham risk scores (FRS), annual mortality rate was 1.31% (95% CI, 0.85~2.03) among patients with high FRS and 0.62% (95% CI, 0.51~0.76) among those with low to intermediate FRS. Conclusion: Absence of CAD by CCTA demonstrates a favorable survival rate with a minimum warranty period of at least 7 years. Persons presenting with a high cardiovascular risk profile displayed a relatively higher mortality, which is similar to overall population. Therefore, they should be considered a distinct group of individuals at-risk by physicians and researchers alike.

Effects of Age on Outcome in the SENTIS Trial: Better Outcomes in Elderly Patients

Background: Increasing age is associated with poor outcome after stroke. The Safety and Efficacy of NeuroFlo Technology in Ischemic Stroke (SENTIS) trial explored the augmentation of collateral circulation to the ischemic penumbra as a novel approach to stroke treatment. The aim of this post hoc analysis was to examine the effect of age on outcomes in the SENTIS trial. Methods: Using data from the randomized controlled SENTIS trial, we explored outcomes of cerebral blood flow augmentation using the NeuroFlo™ device in patients categorized by age strata at 70 and 80 years. We evaluated outcomes of overall serious adverse event (SAE) and intracerebral hemorrhage (ICH) rates, freedom from all-cause and stroke-related mortality, and independent functional outcome as defined by the modified Rankin Scale score (mRS ≤2). Results: The SENTIS as-treated cohort included 251 patients ≥70 years and 107 patients ≥80 years. Elderly SENTIS patients included a higher percentage of women and Caucasians than the younger group. Patients in the older group more frequently had vascular risk factors including hypertension, previous stroke, transient ischemic attacks and atrial fibrillation. However, baseline risk-factor profile, stroke severity, and time to randomization did not differ between the treated and nontreated elderly patients. The older patients treated with NeuroFlo had significantly higher chances for survival and for obtaining an independent functional state (mRS ≤2) compared with those who were not treated. Rates of SAEs and ICHs did not differ between the treatment groups. Conclusions: NeuroFlo treatment is safe and results in better outcomes for elderly patients. This may be the result of recruitment and support of already existing collateral systems in these patients.

An evidence-based score to detect prevalent peripheral artery disease (PAD)

Detection of peripheral artery disease (PAD) typically entails collection of medical history, physical examination, and noninvasive imaging, but whether a risk factor-based model has clinical utility in population screening is unclear. Our objective was to derive and validate a new score for estimating PAD probability in individuals or populations. PAD presence was determined by a history of previous or current intermittent claudication associated with an ankle-brachial index (ABI) of < 0.9 or previous lower extremity arterial intervention. Multivariable stepwise logistic regression identified cross-sectional correlates of PAD from demographic, clinical, and laboratory variables. Analyses were derived from 18,049 US REACH (REduction of Atherothrombosis for Continued Health) Registry outpatients with a complete baseline risk factor profile (enrolled from December 2003 to June 2004). Model performance was assessed internally using 10-fold cross validation, and effect estimates were used to generate the score. The model was externally validated using the Framingham Offspring Study. Age, sex, smoking, diabetes mellitus, body mass index, hypertension stage, and history of heart failure, coronary artery disease, and cerebrovascular disease were predictive of PAD prevalence. The model had reasonable discrimination on derivation and internal validation (c-statistic = 0.61 and 0.60, respectively) and external validation (c-statistic = 0.63 [ABI < 0.9] or 0.64 [clinical PAD]). The model-estimated PAD prevalence varied more than threefold from lowest to highest decile (range, 4.5-16.7) and corresponded closely with actual PAD prevalence in each population. In conclusion, this new tool uses clinical variables to estimate PAD prevalence. While predictive power may be limited, it may improve PAD detection in vulnerable, at-risk populations.

Abstract 5791: A New Score to Improve the Detection of Peripheral Artery Disease

Background: Detection of peripheral artery disease (PAD) typically entails noninvasive imaging or population screening, but whether a risk factor-based model has clinical utility is unclear. Our objective was to derive and internally validate a new score for estimating the probability of PAD utilizing the large US REACH Registry dataset. Methods: Analyses were conducted on 23,395 US REACH Registry outpatients with a complete baseline risk factor profile. PAD presence was determined by previous or current intermittent claudication associated with an ankle-brachial index &lt;0.9 or previous lower extremity intervention. Multivariable stepwise logistic regression identified cross-sectional correlates of PAD from demographic, clinical, and laboratory variables. Model performance was assessed internally using 10-fold cross validation, and effect estimates were used to generate the PAD score. Results: Overall PAD prevalence was 9.1% (n=2135), with a mean age of 70 years. Age, smoking, history of congestive heart failure, diabetes, coronary artery disease (CAD), cerebrovascular disease (CVD), BMI, sex, and hypertension stage were predictive of PAD (Table 1 ). The model had reasonable discrimination on derivation and internal validation (c-index = 0.61 and 0.60, respectively). The model-estimated PAD prevalence varied more than 3-fold from lowest to highest decile (range 4.8% to 16.4%) and corresponded closely with the actual PAD prevalence observed in each. Conclusions: This new PAD detection score uses easily available clinical variables to estimate the probability of disease prevalence. While the predictive power of the model may be limited, its use should nevertheless improve PAD detection in vulnerable, at-risk populations. These data should provide clinicians and patients with a simple risk-based tool to estimate the probability of PAD prevalence across a wide range of patients with atherothrombosis. Table 1: Factors related to PAD

Adverse Baseline Physiological and Psychosocial Profiles of Women Enrolled in a Cardiac Rehabilitation Clinical Trial

Coronary heart disease (CHD) remains the leading cause of death in women. Despite positive outcomes associated with cardiac rehabilitation (CR), investigations of women are sparse. This article presents the baseline physiological and psychosocial profiles of 182 women in the Women's-Only Cardiac Rehabilitation study. Women were randomized to a women's-only motivational interviewing or traditional CR group. Physiological measures included lipid profiles, body mass index, functional capacity, and anthropomorphic measures. Psychosocial measures included optimism, hope, social support, anxiety, depression, quality of life, and health perceptions. The median age was used to split the sample to examine data on 92 younger (< or = 64 years) and 90 older (>64 years) women. With a mean age of 63 years, 66.5% were white, 47% were retired, and 54% were married. Most women were physically inactive (83%), hypertensive (76%), and overweight (56%). Most women (71.4%) met the criteria for metabolic syndrome. Younger women demonstrated significantly worse psychosocial profiles than older women. More of the younger women (64%) had depressive symptoms than older women (37%). Younger women demonstrated a mean Center for Epidemiological Studies Depression Scale score of 20.8 +/- 12.4, whereas older women had a substantially lower mean score of 14.9 +/- 9.5 (P < .001). Younger participants also reported significantly more anxiety than older participants (38.8 +/- 13.4 vs 32.8 +/- 10.6, P < .001). Younger women enrolled in a CR clinical trial had adverse baseline risk factor profiles placing them at high risk for disease progression.

Clinical features, risk factors, and prognosis in transient global amnesia: a follow‐up study

We previously observed a high frequency of psychopathological features in transient global amnesia (TGA). We aimed at assessing differences in risk factor profile and prognosis between TGA and transient ischemic attack (TIA) patients with a focus on aspects with possible psychopathological relevance. We studied 51 TGA patients (mean age +/- SD, 62.7 +/- 6.7 years; M/F = 24/27) and 51 control patients with TIA (mean age +/- SD, 63.8 +/- 6.7 years; M/F = 41/10) and followed them up for about 7 years. Compared with TIA controls, TGA patients more frequently had a history of psychiatric diseases (age and sex-corrected OR = 2.86, 95% CI: 1.01-8.05) and alcohol use (OR = 3.26, 95% CI: 1.10-9.66) and less frequently a history of cardiac (OR = 0.29, 95% CI: 0.11-0.76) or peripheral artery disease (OR = 0.11, 95% CI: 0.01-0.96). A family history of psychiatric diseases was reported more frequently by TGA than TIA patients (OR = 2.99, 95% CI: 1.04-8.59). On follow-up, in comparison with TIA patients, TGA patients had a significantly lower risk of combined stroke, myocardial infarct, and death (log-rank test, P = 0.0059). In the multivariate analysis, the dissimilar baseline risk factor profile explained most of the difference in prognosis between the two groups. In comparison with TIA patients, patients with TGA have more frequently a personal or family history of psychiatric diseases and a more favorable vascular risk factor profile and prognosis. These results have therapeutic implications and reinforce the hypothesis that TGA is a benign disorder.