Objectives The purpose of this study was to quantitatively examine the association of patient- and trial-specific factors with participation in cardiovascular randomized clinical trials. Background ...Randomized clinical trials are central to evidenced-based medicine, but low patient participation rates and potentially modifiable barriers are not well understood. Methods At a large U.S. academic health system, we examined screening logs from December 1, 2005, to February 28, 2011, from 15 cardiovascular randomized clinical trials. We identified 655 patients who were screened and potentially eligible for participation in at least 1 trial. We used multivariable Poisson regression to quantify the risk of not participating in a trial associated with patient- and trial-specific factors. Results The median age was 63 years (interquartile range: 54 to 72), 35% were women, and the median Charlson Index was 2 (interquartile range: 1 to 5). Forty-two percent of patients did not participate in a trial. In multivariable regression (C-Index 0.85), trial-specific factors strongly associated with not participating included intensive trial-related testing (relative risk RR: 1.89; 95% confidence interval CI: 1.63 to 2.20) and anticipated trial participation >6 months (RR: 4.10; 95% CI: 2.30 to 7.29). Patient-specific factors associated with not participating included older age (RR: 1.23; 95% CI: 1.11 to 1.36, per 10-year increase if age ≥65 years), out-of-state residence (RR: 1.26; 95% CI: 1.04 to 1.54), and female sex (RR: 1.17; 95% CI: 1.01 to 1.35). Race was not associated with participation. Conclusions While patient-specific factors were associated with not participating in cardiovascular trials, longer trial duration and intensive trial-related testing were most strongly associated with risk for patients not participating. Innovative trial designs fostering convenience may most enhance trial participation.
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GEOZS, IJS, IMTLJ, KILJ, KISLJ, NLZOH, NUK, OILJ, PNG, SAZU, SBCE, SBJE, UILJ, UL, UM, UPCLJ, UPUK, ZAGLJ, ZRSKP
Abstract Background Coffee and tea are two of the most commonly consumed beverages in the world. The association of coffee and tea intake with coronary artery calcium and major adverse cardiovascular ...events remains uncertain. Methods We examined 6,508 ethnically-diverse participants with available coffee and tea data from the Multi-Ethnic Study of Atherosclerosis. Intake for each was classified as never, occasional (<1 cup/day), and regular (≥1 cup/day). A coronary artery calcium progression ratio was derived from mixed effect regression models using loge(calcium score+1) as the outcome with coefficients exponentiated to reflect coronary artery calcium progression ratio vs. the reference. Cox proportional hazards analyses were used to evaluate the association between beverage intake and incident cardiovascular events. Results Over a median follow-up of 5.3 years for coronary artery calcium and 11.1 years for cardiovascular events, participants who regularly drank tea (≥1 cup/day) had a slower progression of coronary artery calcium compared with never drinkers after multivariable adjustment. This correlated with a statistically significant lower incidence of cardiovascular events for ≥1 cup/day tea drinkers (adjusted HR 0.71; 95% CI 0.53-0.95). Compared to never coffee drinkers, regular coffee intake (≥1 cup/day) was not statistically associated with coronary artery calcium progression or cardiovascular events (adjusted HR 0.97 0.78, 1.20). Caffeine intake was marginally inversely associated with coronary artery calcium progression. Conclusions Moderate tea drinkers had slower progression of coronary artery calcium and reduced risk for cardiovascular events. Future research is needed to understand the potentially protective nature of moderate tea intake.
The newly released 2013 ACC/AHA Guidelines for Assessing Cardiovascular Risk makes progress compared with previous cardiovascular risk assessment algorithms. For example, the new focus on total ...atherosclerotic cardiovascular diseases (ASCVD) is now inclusive of stroke in addition to hard coronary events, and there are now separate equations to facilitate estimation of risk in non-Hispanic white and black individuals and separate equations for women. Physicians may now estimate lifetime risk in addition to 10-year risk. Despite this progress, the new risk equations do not appear to lead to significantly better discrimination than older models. Because the exact same risk factors are incorporated, using the new risk estimators may lead to inaccurate assessment of atherosclerotic cardiovascular risk in special groups such as younger individuals with unique ASCVD risk factors. In general, there appears to be an overestimation of risk when applied to modern populations with greater use of preventive therapy, although the magnitude of overestimation remains unclear. Because absolute risk estimates are directly used for treatment decisions in the new cholesterol guidelines, these issues could result in overuse of pharmacologic management. The guidelines could provide clearer direction on which individuals would benefit from additional testing, such as coronary calcium scores, for more personalized preventive therapies. We applaud the advances of these new guidelines, and we aim to critically appraise the applicability of the risk assessment tools so that future iterations of the estimators can be improved to more accurately assess risk in individual patients.
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GEOZS, IJS, IMTLJ, KILJ, KISLJ, NLZOH, NUK, OILJ, PNG, SAZU, SBCE, SBJE, UILJ, UL, UM, UPCLJ, UPUK, ZAGLJ, ZRSKP
Background Cross-sectional studies have found an association between deficiencies in serum vitamin D, as measured by 25-hydroxyvitamin D (25OHD), and an atherogenic lipid profile. These studies have ...focused on a limited panel of lipid values including low-density lipoprotein cholesterol (LDL-C), high-density lipoprotein cholesterol (HDL-C), and triglycerides (TG). Objective Our study examines the relationship between serum 25(OH)D and an extended lipid panel (Vertical Auto Profile) while controlling for age, gender, glycemic status, and kidney function. Methods We used the Very Large Database of Lipids, which includes US adults clinically referred for analysis of their lipid profile from 2009 to 2011. Our study focused on 20,360 subjects who had data for lipids, 25(OH)D, age, gender, hemoglobin A1c, insulin, creatinine, and blood urea nitrogen. Subjects were split into groups based on serum 25(OH)D: deficient (<20 ng/mL), intermediate (≥20–30 ng/mL), and optimal (≥30 ng/mL). The deficient group was compared to the optimal group using multivariable linear regression. Results In multivariable-adjusted linear regression, deficient serum 25(OH)D was associated with significantly lower serum HDL-C (−5.1%) and higher total cholesterol (+9.4%), non–HDL-C (+15.4%), directly measured LDL-C (+13.5%), intermediate-density lipoprotein cholesterol (+23.7%), very low–density lipoprotein cholesterol (+19.0%), remnant lipoprotein cholesterol (+18.4%), and TG (+26.4%) when compared with the optimal group. Conclusion Deficient serum 25(OH)D is associated with significantly lower HDL-C and higher directly measured LDL-C, intermediate-density lipoprotein cholesterol, very low–density lipoproteins cholesterol, remnant lipoprotein cholesterol, and TG. Future trials examining vitamin D supplementation and cardiovascular disease risk should consider using changes in an extended lipid panel as an additional outcome measurement.
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GEOZS, IJS, IMTLJ, KILJ, KISLJ, NUK, OILJ, PNG, SAZU, SBCE, SBJE, UL, UM, UPCLJ, UPUK
The Remnants of Residual Risk Joshi, Parag H., MD, MHS; Martin, Seth S., MD, MHS; Blumenthal, Roger S., MD
Journal of the American College of Cardiology,
06/2015, Volume:
65, Issue:
21
Journal Article
Peer reviewed
Open access
The investigators performed post-hoc analyses of 1,501 participants from the short-term MIRACL (Myocardial Ischemia Reduction with Aggressive Cholesterol Lowering) trial, performed in the late 1990s, ...and 15,871 participants from the recent longer-term dal-OUTCOMES (A Study of RO4607381 in Stable Coronary Heart Disease Patients With Recent Acute Coronary Syndrome) trial (4,5). ...2 studies showed that a loss of function of apoC3, a key inhibitor of remnant metabolism, led to a lifetime of low remnant levels (as marked by TGs) and markedly reduced ASCVD (8,9).
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GEOZS, IJS, IMTLJ, KILJ, KISLJ, NLZOH, NUK, OILJ, PNG, SAZU, SBCE, SBJE, UILJ, UL, UM, UPCLJ, UPUK, ZAGLJ, ZRSKP
Abstract In December 2014, the US Department of Veterans Affairs and the US Department of Defense (VA/DoD) published an independent clinical practice guideline for the management of dyslipidemia and ...cardiovascular disease risk, adding to the myriad of recently published guidelines on this topic. The VA/DoD guidelines differ from major U.S. guidelines published by the ACC/AHA in 2013 in the following ways: recommending moderate intensity statins for the majority or patients with statin indications, regardless of ACSVD risk; advocating for limited on-treatment lipid monitoring; and de-emphasizing ancillary data such as coronary artery calcium testing to improve atherosclerotic cardiovascular disease risk estimation. In the context of manifold treatment recommendations from numerous guideline committees, the VA/DoD recommendations may generate further confusion and mixed messages among healthcare providers about the optimal treatment of dyslipidemia. In this review, we critically appraise the VA/DoD recommendations with a focus on the evidence base for each area where the VA/DoD differ from the ACC/AHA guidelines. We also call for harmonization of lipid treatment guidelines to ensure high quality and consistent care for patients with, and at risk for, atherosclerotic cardiovascular disease.
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GEOZS, IJS, IMTLJ, KILJ, KISLJ, NLZOH, NUK, OILJ, PNG, SAZU, SBCE, SBJE, UILJ, UL, UM, UPCLJ, UPUK, ZAGLJ, ZRSKP
Abstract Background 25-hydroxyvitamin D 25(OH)D deficiency is associated with increased cardiovascular disease risk, perhaps mediated through dyslipidemia. Deficient 25(OH)D is cross-sectionally ...associated with dyslipidemia, but little is known about longitudinal lipid changes. Our objective was to determine the association of 25(OH)D deficiency with longitudinal lipid changes and risk of incident dyslipidemia. Research Methods This is a longitudinal community-based study of 13,039 ARIC participants who had 25(OH)D and lipids measured at baseline (1990-1992) and lipids re-measured in 1993-1994 and 1996-1998. Mixed-effect models were used to assess associations of 25(OH)D with lipid trends after adjusting for clinical characteristics and for baseline or incident use of lipid-lowering therapy. Risk of incident dyslipidemia was determined for those without baseline dyslipidemia. Results Baseline mean±SD age was 57±6 years and 25(OH)D was 24±9 ng/ml. Participants were 57% women, 24% black. Over a mean follow-up of 5.2 years, the fully-adjusted average differences (95% CI) comparing deficient (<20 ng/ml) to optimal (≥30 ng/ml) 25(OH)D were: total cholesterol (TC) -2.40 mg/dl (-4.21, -0.60), HDL-cholesterol -3.02 mg/dl (-3.73, -2.32) and TC/HDL-C ratio 0.18 (0.11, 0.26). Those with deficient 25(OH)D compared to optimal had modestly increased risk of incident dyslipidemia in demographic-adjusted models RR 1.19 (1.02-1.39), which was attenuated in fully-adjusted models 1.12 (0.95-1.32). Conclusions Deficient 25(OH)D was prospectively associated with lower TC and HDL-C and greater TC/HDL-C ratio after considering factors such as diabetes and adiposity. Further work including randomized controlled trials is needed to better assess how 25(OH)D may impact lipids and cardiovascular risk.
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GEOZS, IJS, IMTLJ, KILJ, KISLJ, NUK, OILJ, PNG, SAZU, SBCE, SBJE, UL, UM, UPCLJ, UPUK, ZRSKP
Abstract Classically, the 3 pillars of atrial fibrillation (AF) management have included anticoagulation for prevention of thromboembolism, rhythm control, and rate control. In both prevention and ...management of AF, a growing body of evidence supports an increased role for comprehensive cardiac risk factor modification (RFM), herein defined as management of traditional modifiable cardiac risk factors, weight loss, and exercise. In this narrative review, we summarize the evidence demonstrating the importance of each facet of RFM in AF prevention and therapy. Additionally, we review emerging data on the importance of weight loss and cardiovascular exercise in prevention and management of AF.
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GEOZS, IJS, IMTLJ, KILJ, KISLJ, NLZOH, NUK, OILJ, PNG, SAZU, SBCE, SBJE, UILJ, UL, UM, UPCLJ, UPUK, ZAGLJ, ZRSKP
Abstract Successful implementation of the 2013 American College of Cardiology/American Heart Association cholesterol guidelines hinges on a clear understanding of the clinician-patient risk ...discussion (CPRD). This is a dialogue between the clinician and patient about potential for atherosclerotic cardiovascular disease risk reduction benefits, adverse effects, drug-drug interactions, and patient preferences. Designed especially for primary prevention patients, this process of shared decision making establishes the appropriateness of a statin for a specific patient. CPRD respects the autonomy of an individual striving to make an informed choice aligned with personal values and preferences. Dedicating sufficient time to high-quality CPRD offers an opportunity to strengthen clinician-patient relationships, patient engagement, and medication adherence. We review the guideline-recommended CPRD, the general concept of shared decision making and decision aids, the American College of Cardiology/American Heart Association Risk Estimator application as an implementation tool, and address potential barriers to implementation.
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GEOZS, IJS, IMTLJ, KILJ, KISLJ, NLZOH, NUK, OILJ, PNG, SAZU, SBCE, SBJE, UILJ, UL, UM, UPCLJ, UPUK, ZAGLJ, ZRSKP
Background Low serum levels of high-density lipoprotein cholesterol (HDL-C) are an important risk factor for atherosclerotic disease. To date, therapeutically raising HDL-C has not been shown to ...impact risk for cardiovascular events. Objective We aim to characterize lipid parameters at the extremes of HDL-C. Methods We examined cholesterol profiles from 1,350,908 US adults and children from the Very Large Database of Lipids who were clinically referred for advanced lipoprotein testing from 2009 to 2011. We categorized patients into HDL-C percentile categories (<0.1th, 0.1th–<1st, 1st–5th, 25th–75th, 95th–99th, >99th–99.9th, and >99.9th). Within these groups, we examined HDL-C subclasses, low-density lipoprotein cholesterol (LDL-C), LDL and very–low density lipoprotein densities, non–HDL-C, triglycerides (TG), very–low density lipoprotein cholesterol, and remnant lipoprotein cholesterol (RLP-C), as well as prevalence of Fredrickson–Levy dyslipidemias. Results Extremely low HDL-C percentiles were associated with increased LDL density, TG, and especially RLP-C. Very high HDL-C levels (≥92 mg/dL) showed increasing HDL2 -C/HDL3 -C ratio and very low levels of RLP-C and triglyceride-rich lipoproteins. Type IV dyslipidemia had the highest prevalence among classical dyslipidemia and was the most frequent at extremely low HDL-C percentiles. Conclusions These findings demonstrate a high prevalence of elevated triglyceride-rich lipoprotein levels and increased LDL density in patients with extremely low HDL-C levels. The relative contributions of these various changes in lipid profiles of patients with low HDL-C to cardiovascular risk need to be further scrutinized to more fully establish if low HDL-C is truly an independent risk factor for coronary heart disease or simply reflects detrimental shifts in the levels of atherogenic lipoproteins.
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