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Abstract: Background: Lower extremity peripheral arterial disease (PAD) is a coronary heart disease (CHD) risk equivalent. Selected studies have demonstrated less intense risk factor management and diminished mobility in individuals with PAD as compared to individuals with clinical recognized CHD. However, comparable data have not been reported from a nationally representative population. Objectives: To assess the prevalence, treatment, and control of cardiovascular risk factors among individuals with PAD as defined by an ankle-brachial index (ABI) <0.90 (but without recognized CHD) as compared with individuals with recognized CHD (but without PAD). A second objective was to evaluate the diagnostic accuracy of measures of walking dysfunction to identify individuals with PAD. Design, setting, and participants: We analyzed data from 7571 participants aged 40 or older who participated in the National Health and Nutrition Examination Survey (NHANES) 1999–2004, a nationally representative cross-sectional survey of the U.S. population. Results: The prevalence of PAD without CHD was 4.1% (95% CI 3.6–4.5) compared to 7.9% (7.1, 8.9) for CHD (without PAD). Hypertension prevalence was similar, but treatment and control rates were lower among individuals with PAD compared to CHD (treatment: 69% vs. 84%, p <0.001; control: 50% vs. 63%, p =0.01). Treatment of hypercholesterolemia was lower among individuals with PAD (54% vs. 79%, p <0.001) but control was similar (83% vs. 85%, p =0.78). Diabetes awareness, treatment, and control did not differ between the two groups. Walking mobility limitations were specific, but insensitive, for the identification of individuals with PAD. Conclusion: PAD in the absence of clinically recognized CHD is under-treated and poorly controlled in the general U.S. population. Leg symptoms are not adequate to identify individuals with PAD, who are at high risk of ischemic events. [Copyright &y& Elsevier]

Objectives: The purpose of this study is to determine if an ankle-brachial index (ABI) ≥1.40 is associated with reduced quality of life (QoL). Background: Ankle-brachial index values ≥1.40 have been associated with some cardiovascular disease (CVD) risk factors and increased mortality, but the relationship to other disease morbidity such as reduced QoL has not been previously evaluated. Methods: The PARTNERS (PAD Awareness, Risk and Treatment: New Resources for Survival) program was a national cross-sectional study of 7,155 patients age >50 years recruited from 350 primary care sites. All sites performed the ABI using a Doppler device and a standardized technique. Results: A total of 296 subjects had an ABI ≥1.40 in at least 1 leg, and 4,420 had an ABI between 0.90 and 1.40. Diabetes, male gender, and waist circumference were positively associated with a high ABI, and smoking and dyslipidemia were inversely associated with a high ABI. After adjustment for age, gender, and the traditional CVD risk factors, and accounting for multiple comparisons, the high ABI group had significantly higher odds for foot ulcers (p < 0.005) and borderline associations with heart failure, stroke, and neuropathy. After the same adjustments and adjusting for patients with other CVD, the high ABI group scored 2.0 points lower on the physical component scale on the Medical Outcomes Study Standard Form–36 and 5.5 points lower on the Walking Impairment Questionnaire walking distance domain (p < 0.05 for both). Conclusion: Individuals with a high ABI have higher odds for foot ulcers and neuropathy, as well as lower scores on some physical functioning QoL domains. [Copyright &y& Elsevier]

Background and aims Traditional glycemic markers, fasting glucose and hemoglobin A1c (HbA1c), predict incident peripheral artery disease (PAD). However, it is unknown whether nontraditional glycemic markers, fructosamine, glycated albumin, and 1,5-anhydroglucitol, are associated with PAD and whether these glycemic markers demonstrate particularly strong associations with severe PAD, critical limb ischemia (CLI). Methods We quantified the associations of these five glycemic markers with incident PAD (hospitalizations with PAD diagnosis or leg revascularization) in 11,634 ARIC participants using Cox regression models. Participants were categorized according to diabetes diagnosis and clinical cut-points of glycemic markers (nontraditional glycemic markers were categorized according to percentiles corresponding to the HbA1c cut-points). Results Over a median follow-up of 20.7 years, there were 392 cases of PAD (133 were CLI with tissue loss). HbA1c was more strongly associated with incident PAD than fasting glucose, with adjusted hazard ratios (HR) 6.00 (95% CI, 3.73–9.66) for diagnosed diabetes with HbA1c ≥ 7% and 3.53 (2.39–5.22) for no diagnosed diabetes with HbA1c ≥ 6.5% compared to no diagnosed diabetes with HbA1c <5.7%. Three nontraditional glycemic markers demonstrated risk gradients intermediate between HbA1c and fasting glucose and their risk gradients were substantially attenuated after adjusting for HbA1c. All glycemic markers consistently demonstrated stronger associations with CLI than PAD without CLI ( p for difference <0.02 for all glycemic markers). Conclusions Nontraditional glycemic markers were associated with incident PAD independent of fasting glucose but not necessarily HbA1c. Our results also support the importance of glucose metabolism in the progression to CLI. [ABSTRACT FROM AUTHOR]

Background and aims Most prior studies investigating the association of lower extremity peripheral artery disease (PAD) with physical function were small or analyzed selected populations (e.g., patients at vascular clinics or persons with reduced function), leaving particular uncertainty regarding the association in the general community. Methods Among 5262 ARIC participants (age 71–90 years during 2011–2013), we assessed the cross-sectional association of ankle-brachial index (ABI) with the Short Physical Performance Battery (SPPB) score (0–12), its individual components (chair stands, standing balance, and gait speed) (0–4 points each), and grip strength after accounting for potential confounders, including a history of coronary disease, stroke, or heart failure. Results There were 411 participants (7.8%) with low ABI ≤0.90 and 469 (8.9%) participants with borderline low ABI 0.91–1.00. Both ABI ≤0.90 and 0.91–1.00 were independently associated with poor physical function (SPPB score ≤6) compared to ABI 1.11–1.20 (adjusted odds ratio 2.10 [95% CI 1.55–2.84] and 1.86 [1.38–2.51], respectively). The patterns were largely consistent across subgroups by clinical conditions (e.g., leg pain or other cardiovascular diseases), in every SPPB component, and for grip strength. ABI >1.3 (472 participants [9.0%]), indicative of non-compressible pedal arteries, was related to lower physical function as well but did not necessarily reach significance. Conclusions In community-dwelling older adults, low and borderline low ABI suggestive of PAD were independently associated with poorer systemic physical function compared to those with normal ABI. Clinical attention to PAD as a potential contributor to poor physical function is warranted in community-dwelling older adults. [ABSTRACT FROM AUTHOR]

Background and aims Low 25-hydroxyvitamin D [25(OH)D] concentrations have been associated with peripheral artery disease (PAD). Prevalence of low 25(OH)D and PAD differ between whites and blacks. However, these associations have not been studied prospectively or in a population based cohort. We tested the hypothesis that low 25(OH)D is associated with greater risk of incident PAD in white and black adults. Methods 25(OH)D was measured in serum collected at ARIC visit 2 (1990–1992). We followed 11,789 ARIC participants free of PAD at visit 2 through 2011 for incident PAD events. 25(OH)D (ng/mL) was categorized as deficient (<20), insufficient (20 to <30) or sufficient (≥30). PAD was defined by an ankle brachial index (ABI) of <0.9 at ARIC visits 3 or 4 or a hospital diagnosis with an ICD-9 code indicating PAD during follow-up. Analysis used multivariable-adjusted Cox proportional hazards regressions. Results Over a mean follow-up of 17.1 years, 1250 incident PAD events were identified. 22% of whites and 61% of blacks were 25(OH)D deficient. After adjustment for demographic characteristics, the hazard ratio (95% CI) of PAD in participants with deficient versus sufficient 25(OH)D was 1.49 (1.26, 1.76). Inclusion of BMI, physical activity, and smoking status attenuated the association [1.25 (1.06, 1.48)]. The association between 25(OH)D and PAD was qualitatively stronger in blacks ( p for interaction = 0.20). Conclusions Deficient 25(OH)D was associated with increased risk of PAD in black and white participants. Whether treatment of low vitamin D through supplementation or modest sunlight exposure prevents PAD is unknown. [ABSTRACT FROM AUTHOR]

Objective: To explore the relationship between gender, native artery diameters, and outcomes of stent revascularization (ST) in the "Claudication: Exercise versus Endoluminal Revascularization" trial. Methods: A comparative analysis was performed of the impact of gender, age, weight, height, body mass index, and body surface area on revascularization outcomes at baseline and 6 months in 55 arterial segments of aorta, common iliac artery, and external iliac artery (EIA). Results: Women demonstrated smaller diameter of the EIA. However, the clinical outcomes of revascularization were not negatively affected by the gender-based differences. Conclusion: Gender-based differences are unlikely to significantly impact outcome of ST. [ABSTRACT FROM AUTHOR]

Background: Tobacco use is an important preventable cause of peripheral artery disease (PAD) and a major determinant of adverse clinical outcomes.Objectives: This study hypothesized that tobacco use by PAD patients would be associated with higher health care utilization and associated costs.Methods: We conducted a retrospective, cross-sectional study using 2011 claims data from the largest Minnesota health plan. The total cohort included individuals with 12 months of continuous enrollment and ≥ 1 PAD-related claim. Tobacco cessation pharmacotherapy billing codes were queried in a subgroup with pharmacy benefits. Outcomes were total costs, annual proportion of members hospitalized, and primary discharge diagnoses.Results: A PAD cohort of 22,203 was identified, comprising 1,995 (9.0%) tobacco users. A subgroup of 9,027 with pharmacy benefits included 1,158 (12.8%) tobacco users. The total cohort experienced 22,220 admissions. The pharmacy benefits subgroup experienced 8,152 admissions. Within 1 year, nearly one-half the PAD tobacco users were hospitalized, 35% higher than nonusers in the total cohort (p < 0.001) and 30% higher in the subgroup (p < 0.001). In both cohorts, users were more frequently admitted for peripheral or visceral atherosclerosis (p < 0.001), acute myocardial infarction (p < 0.001), and coronary heart disease (p < 0.05). Observed costs in the total cohort were $64,041 for tobacco users versus $45,918 for nonusers. Costs for tobacco users also were consistently higher for professional and facility-based care, persisting after adjustment for age, sex, comorbidities, and insurance type.Conclusions: Tobacco use in PAD is associated with substantial increases in PAD-related hospitalizations, coronary heart disease and PAD procedures, and significantly greater costs. The results suggest that immediate provision of tobacco cessation programs may be especially cost effective. [ABSTRACT FROM AUTHOR]

Background: Treatment for claudication that is due to aortoiliac peripheral artery disease (PAD) often relies on stent revascularization (ST). However, supervised exercise (SE) is known to provide comparable short-term (6-month) improvements in functional status and quality of life. Longer-term outcomes are not known.Objectives: The goal of this study was to report the longer-term (18-month) efficacy of SE compared with ST and optimal medical care (OMC).Methods: Of 111 patients with aortoiliac PAD randomly assigned to receive OMC, OMC plus SE, or OMC plus ST, 79 completed the 18-month clinical and treadmill follow-up assessment. SE consisted of 6 months of SE and an additional year of telephone-based exercise counseling. Primary clinical outcomes included objective treadmill-based walking performance and subjective quality of life.Results: Peak walking time improved from baseline to 18 months for both SE (5.0 ± 5.4 min) and ST (3.2 ± 4.7 min) significantly more than for OMC (0.2 ± 2.1 min; p < 0.001 and p = 0.04, respectively). The difference between SE and ST was not significant (p = 0.16). Improvement in claudication onset time was greater for SE compared with OMC, but not for ST compared with OMC. Many disease-specific quality-of-life scales demonstrated durable improvements that were greater for ST compared with SE or OMC.Conclusions: Both SE and ST had better 18-month outcomes than OMC. SE and ST provided comparable durable improvement in functional status and in quality of life up to 18 months. The durability of claudication exercise interventions merits its consideration as a primary PAD claudication treatment. [ABSTRACT FROM AUTHOR]

Comparative effectiveness research (CER) aims to provide decision makers with the evidence needed to evaluate the benefits and harms of alternative clinical management strategies. CER has become a national priority, with considerable new research funding allocated. Cardiovascular disease is a priority area for CER. This workshop report provides an overview of CER methods, with an emphasis on practical clinical trials and observational treatment comparisons. The report also details recommendations to the National Heart, Lung, and Blood Institute for a new framework for evidence development to foster cardiovascular CER, and specific studies to address 8 clinical issues identified by the Institute of Medicine as high priorities for cardiovascular CER. [Copyright &y& Elsevier]

Abstract: Objective: To evaluate systemic and limb ischemic event rates of PAD patients with prior leg amputation and determine predictors of adverse outcomes. Methods: The REduction of Atherothrombosis for Continued Health (REACH) Registry provided a prospective multinational cohort of 7996 outpatients with PAD enrolled from primary medical clinics in 44 countries in 2003–2004. 1160 patients (14.5%) had a prior leg amputation at any level. Systemic (myocardial infarction [MI], stroke, cardiovascular death) and limb (angioplasty, surgery, amputation) ischemic event rates were determined in a 3-year follow-up. Results: PAD patients with leg amputations on entry had a 5-fold higher rate of a subsequent amputation (12.4% vs. 2.4%, P <.001), lower rate of peripheral angioplasty (8.3% vs. 10.7%, P =.005), and similar rates of surgical revascularization procedures compared with PAD patients without amputation. A nearly 2-fold increase in rates of cardiovascular death (14.5% vs. 7.7%, P <.001) and all-cause mortality (21.8% vs. 12.6%, P <.001) and an increase in the composite outcome of MI, stroke, cardiovascular death, or hospitalization (48.7% vs. 40.0%, P <.001) were noted. Recent (≤1 year) amputation was associated with higher rates of worsening PAD, subsequent lower extremity surgical revascularization procedures, re-amputation, non-fatal MI, and the composite outcome, including hospitalization. Adverse systemic and limb ischemic outcomes were similar regardless of amputation level. Conclusions: Individuals with a history of leg amputations have markedly elevated rates of systemic and limb-related outcomes. PAD patients with recent ischemic amputation have the highest risk of adverse events. A history of “minor” ischemic amputation may confer an identical systemic risk as “major” leg amputation. [Copyright &y& Elsevier]

Objectives: This study tested the effectiveness of a smoking cessation program designed for patients with peripheral artery disease (PAD). Background: Tobacco use is the leading risk factor for PAD incidence and progression and for ischemic events. Tobacco cessation reduces PAD-related morbidity and mortality, yet few prospective clinical trials have evaluated smoking cessation interventions in PAD patients. Methods: We recruited outpatients with lower extremity PAD identified from medical records as cigarette smokers. Participants were randomly assigned to an intensive tailored PAD-specific counseling intervention or a minimal intervention. Participants completed surveys at baseline and at 3- and 6-month follow-up. Reported 7-day point prevalent smoking abstinence was confirmed by cotinine or carbon monoxide assessment. Results: In all, 687 outpatients were identified as probable smokers with lower extremity PAD; 232 met study eligibility requirements; and 124 (53% of eligible) enrolled. Participants were receptive to counselor contact: the median number of sessions was 8.5 (range 0 to 18). Participants randomly assigned to the intensive intervention group were significantly more likely to be confirmed abstinent at 6-month follow-up: 21.3% versus 6.8% in the minimal intervention group (chi-square = 5.21, p = 0.023). Conclusions: Many long-term smokers with PAD are willing to initiate a serious quit attempt and to engage in an intensive smoking cessation program. Intensive intervention for tobacco dependence is a more effective smoking cessation intervention than minimal care. Studies should be conducted to examine the long-term effectiveness of intensive smoking cessation programs in this population to examine the effect of this intervention on clinical outcomes related to PAD. [ABSTRACT FROM AUTHOR]

Despite its proven efficacy, low cost, and wide availability, aspirin remains underused. We examined current aspirin use and determined factors that influence its use among outpatients in the United States (US). The REduction of Atherothrombosis for Continued Health (REACH) Registry is an international, prospective, longitudinal study of >68,000 outpatients with established atherothrombosis or ≥3 atherothrombotic risk factors. The rates of aspirin use were compared in various patient subgroups. Multivariate logistic regression models were constructed to determine the factors influencing the baseline use of aspirin and other antithrombotic agents in the US population. Approximately 70% of 25,686 US outpatients were treated with aspirin, with greater use in the Midwest and among men, whites, and those aged <65 years. Among aspirin users, 18% took other antiplatelet agents and 6% took oral anticoagulants. Low-dose aspirin (≤100 mg/day) was used in approximately 2/3 of aspirin users. Of patients not taking aspirin, 1/2 were receiving oral anticoagulants or other antiplatelet agents. However, 15% of patients used no antithrombotic agent at all. Female gender, current smoking, or having diabetes mellitus were predictors of a lack of antithrombotic use; white race, atrial fibrillation or vascular disease, the use of other risk-reducing medications, or treatment by a cardiologist were associated with a greater likelihood of receiving antithrombotic therapy. In conclusion, approximately 1/4 of US patients with vascular disease are not treated with aspirin for secondary prevention, and 15% are not treated with any antithrombotic agent. [Copyright &y& Elsevier]

Severe mitral regurgitation (MR), whether isolated or with coronary disease, was associated with adverse clinical outcomes. However, clinician practice is characterized by different thresholds for treatment. No data exist that described current practice patterns, factors that affected these patterns, or whether physicians followed American College of Cardiology/American Heart Association guidelines in clinical practice for patients with MR. Cardiovascular specialists were surveyed using e-mail, and 1,076 physicians completed the survey (71% response rate), including adult cardiologists (94%) and cardiac surgeons (5%) who practiced in the United States (78%), Canada (5%), and other nations (17%). Wide variations were noted regarding rates of referral of asymptomatic patients with severe MR for mitral valve repair. There was geographic and specialty-dependent heterogeneity in practice. Most physicians (65%) used medications to delay the progression of MR in the absence of guideline recommendations. A minority (28%) of respondents routinely quantitated MR by calculating the effective regurgitant orifice area. In patients undergoing percutaneous coronary intervention, MR severity was not assessed before the procedure by 1 in 4 providers, and the presence of MR frequently did not affect clinical care decisions. In conclusion, considerable variability existed in the clinical management of MR, particularly regarding referral of asymptomatic patients for mitral valve reparative surgery. Medications were frequently used to treat asymptomatic patients with MR in the absence of evidence of pharmacologic efficacy. MR was frequently not considered a relevant factor before treatment of patients with coexistent coronary artery disease. [Copyright &y& Elsevier]

In patients with symptomatic coronary heart disease, skin cholesterol (SC) content is associated with the presence and extent of coronary artery disease; however, its relation to subclinical arterial disease in asymptomatic patients is unknown. The purpose of this study was to determine the relations between SC and carotid intima–media thickness (CIMT) in asymptomatic subjects across a wide range of cardiovascular risk. SC was measured using a noninvasive assay. CIMT and carotid plaque presence were determined by high-resolution B-mode ultrasound. Associations among SC, CIMT, carotid plaque presence, and cardiovascular risk factors were evaluated by multivariable logistic regression analyses. SC and CIMT were measured in 565 asymptomatic subjects (57 ± 10 years of age, 38% women) from 6 sites in North America. The mean Framingham 10-year cardiovascular risk was 8.4 ± 7.2%. A 10-U increase in SC was associated with a 12% increase in the odds of having increased CIMT (p = 0.006) and a 15% increase in carotid plaque presence (p = 0.002). Odds ratios (95% confidence intervals) associated with SC >110 U were 2.19 (1.25 to 3.85, p = 0.006) for increased CIMT and 2.89 (1.61 to 5.19, p <0.001) for carotid plaque presence. In conclusion, SC identified the presence of advanced subclinical atherosclerosis. The relations among increasing SC, increasing CIMT, and carotid plaque presence were consistent across all levels of cardiovascular risk and were independent of cardiovascular risk factors. SC may be a useful test for cardiovascular risk prediction. [Copyright &y& Elsevier]

Abstract: Background: The clinical significance of a high ankle-brachial index (ABI), defined by the associated risk factor burden and ischemic risk, is largely unknown. Methods: Using data from the Atherosclerosis Risk in Communities Study, we categorized 14,777 participants into normal (ABI between 0.9 and 1.3) and high ABI groups (ABI>1.3, >1.4, and >1.5) and compared the risk factor profile and CVD event rates of the normal ABI group to each high ABI group. Results: The prevalence of high ABI was 5.5% for ABI>1.3, 1.2% for ABI>1.4, and 0.37% for ABI>1.5. Compared with participants with a normal ABI, those with ABI>1.3 had a lower prevalence of hypertension and current smoking. The ABI>1.3 group had a greater mean body mass index, but was characterized by fewer pack years of smoking and lower systolic and diastolic blood pressures than the normal ABI group. The prevalence of diabetes, left ventricular hypertrophy, claudication, and coronary heart disease and mean values of fibrinogen, factor VIII activity, von Willebrand factor, lipoprotein (a), and carotid and popliteal intimal-medial thickness were similar between the two ABI groups. The risk factor profiles of the ABI>1.4 and >1.5 groups were also not statistically significantly different from that of the normal ABI group. Over a mean follow-up time of 12.2 years, the age, sex, and race-adjusted CVD event rates per 1000 person years were 8.1 in the normal ABI group, 7.6 in the ABI>1.3 group, 7.6 in the ABI>1.4 group, and 7.4 in the ABI>1.5 group. The CVD event rates of the high ABI groups were similar to that of the normal ABI group. Conclusion: Individuals with a high ABI are not characterized by a more adverse atherosclerosis risk factor profile and do not suffer greater CVD event rates than those with a normal ABI. [Copyright &y& Elsevier]

Abstract: Background:: Some risk factors for peripheral arterial disease (PAD) have been identified, but little information is available on PAD risk factors in individuals with diabetes. Methods:: Using data from the Atherosclerosis Risk in Communities (ARIC) Study, we assessed the relation of traditional and non-traditional risk factors with the risk of PAD in 1651 participants with diabetes, but not PAD, at baseline. Incident PAD was defined as an ankle–brachial index (ABI)&#60;0.9 assessed at regular examinations; hospital discharge codes for PAD, amputation, or leg revascularization; or claudication assessed by annual questionnaire. Results:: Over a mean of 10.3 years of follow-up, 238 persons developed incident PAD identified, yielding a PAD event rate of 13.9 per 1000 person years. Adjusted for sex, age, race, and center, the risk of developing PAD was increased 1.87-fold (95% confidence interval (95% CI): 1.36–2.57) in persons who were current smokers versus non-smokers, 2.27-fold (95% CI: 1.57–3.26) for baseline coronary heart disease (CHD) versus no baseline CHD, and 1.75-fold (95% CI: 1.18–2.60) for the highest quartile versus lowest quartile of triglycerides. We found no evidence of an association with other blood lipids or hypertension. Compared with the lowest quartiles, comparably-adjusted relative risks for the highest quartiles were 1.60 (95% CI: 1.10–2.33) for waist-to-hip ratio, 2.52 (95% CI: 1.70–3.73) for fibrinogen, 1.70 (95% CI: 1.17–2.47) for factor VIII, 1.73 (95% CI: 1.18–2.54) for von Willebrand factor, 2.15 (95% CI: 1.43–3.24) for white blood cell count, 1.81 (95% CI: 1.19–2.74) for serum creatinine, 0.55 (95% CI: 0.37–0.83) for serum albumin, and 2.73 (95% CI: 1.77–4.22) for carotid intima-media thickness. Persons who had a prior history of diabetes and were taking insulin had a relative risk of 1.97 (95% CI: 1.35–2.87) for future PAD events, compared with those with newly identified diabetes at baseline. In our final multivariable model, current smoking, prevalent CHD, elevated fibrinogen and carotid IMT, and a prior history of diabetes with insulin treatment were independently associated with greater PAD incidence. Conclusion:: These markers might be useful to identify individuals with diabetes at particular risk for PAD. [Copyright &y& Elsevier]

Objectives: In the current study, we hypothesized that beraprost would: 1) improve treadmill exercise performance and quality of life; and 2) decrease rates of ischemic events in patients with intermittent claudication.Background: Previous trials with beraprost sodium, an orally active prostaglandin I(2) analogue, in the treatment of claudication in patients with peripheral arterial disease (PAD) have been inconsistent.Methods: Patients with intermittent claudication (n = 897) were randomized to receive either 40 microg three times a day of beraprost with meals (n = 385) or placebo (n = 377) in a double-blinded manner for one year. The primary efficacy parameter was treadmill-measured maximum walking distance, as assessed at three and six months after randomization. Secondary efficacy parameters included treadmill-measured pain-free walking distance and change in quality of life.Results: There was no significant improvement in maximum walking distance in the beraprost group (16.7%) as compared with the placebo group (14.6%, p = NS). Administration of beraprost did not improve the pain-free walking distance (p = NS between treatment groups), and there was no improvement in the quality-of-life measures between the treatment groups. The incidence of critical cardiovascular events was 7.3% in the beraprost group and 11.4% in the placebo group (p = NS). There was a significant reduction in the combination of cardiovascular death and myocardial infarction in the beraprost group (p = 0.01).Conclusions: Despite previous investigations suggesting efficacy, these results indicate that beraprost is not an effective treatment to improve symptoms of intermittent claudication in patients with PAD. The potential benefit of beraprost on critical cardiovascular events would require confirmation in a larger prospective investigation. [ABSTRACT FROM AUTHOR]

: ObjectivesIn the current study, we hypothesized that beraprost would: 1) improve treadmill exercise performance and quality of life; and 2) decrease rates of ischemic events in patients with intermittent claudication.: BackgroundPrevious trials with beraprost sodium, an orally active prostaglandin I2 analogue, in the treatment of claudication in patients with peripheral arterial disease (PAD) have been inconsistent.: MethodsPatients with intermittent claudication (n = 897) were randomized to receive either 40 μg three times a day of beraprost with meals (n = 385) or placebo (n = 377) in a double-blinded manner for one year. The primary efficacy parameter was treadmill-measured maximum walking distance, as assessed at three and six months after randomization. Secondary efficacy parameters included treadmill-measured pain-free walking distance and change in quality of life.: ResultsThere was no significant improvement in maximum walking distance in the beraprost group (16.7%) as compared with the placebo group (14.6%, p = NS). Administration of beraprost did not improve the pain-free walking distance (p = NS between treatment groups), and there was no improvement in the quality-of-life measures between the treatment groups. The incidence of critical cardiovascular events was 7.3% in the beraprost group and 11.4% in the placebo group (p = NS). There was a significant reduction in the combination of cardiovascular death and myocardial infarction in the beraprost group (p = 0.01).: ConclusionsDespite previous investigations suggesting efficacy, these results indicate that beraprost is not an effective treatment to improve symptoms of intermittent claudication in patients with PAD. The potential benefit of beraprost on critical cardiovascular events would require confirmation in a larger prospective investigation. [Copyright &y& Elsevier]

Abstract: Objectives: To examine differences in risk factor (RF) management between peripheral artery disease (PAD) and coronary artery (CAD) or cerebrovascular disease (CVD), as well as the impact of RF control on major 1-year cardiovascular (CV) event rates. Methods: The REACH Registry recruited >68000 outpatients aged ≥45 years with established atherothrombotic disease or ≥3 RFs for atherothrombosis. The predictors of RF control that were evaluated included: (1) patient demographics, (2) mode of PAD diagnosis, and (3) concomitant CAD and/or CVD. Results: RF control was less frequent in patients with PAD (n =8322), compared with those with CAD or CVD (but no PAD, n =47492) [blood pressure; glycemia; total cholesterol; smoking cessation (each P <0.001)]. Factors independently associated with optimal RF control in patients with PAD were male gender (OR=1.9); residence in North America (OR=3.5), Japan (OR=2.5) or Latin America (OR=1.5); previous coronary revascularization (OR=1.3); and statin use (OR=1.4); whereas prior leg amputation was a negative predictor (OR=0.7) (P <0.001). Optimal RF control was associated with fewer 1-year CV ischemic symptoms or events. Conclusions: Patients with PAD do not achieve RF control as frequently as individuals with CAD or CVD. Improved RF control is associated with a positive impact on 1-year CV event rates. [Copyright &y& Elsevier]