Superior safety of direct oral anticoagulants compared to Warfarin in patients with atrial fibrillation and underlying cancer: a national veterans affairs database study.

BACKGROUND: Studies evaluating safety of warfarin and direct oral anticoagulants (DOACs) for prevention of stroke in patients with atrial fibrillation (AF) are lacking. METHODS & RESULTS: All patients (n = 196,521) receiving care at veteran's affairs with active cancer and AF from 2010-2015 were included. One-year mortality was significantly higher in unadjusted analysis with warfarin (44.9%) compared to dabigatran (25%, P < 0.001), rivaroxaban (24.4%, P < 0.001) and apixaban (30%, P < 0.001) and after adjusting for age, sex and type of cancer mortality (OR = 2.66, 95% CI: 2.52-2.82, P < 0.001). Risk of ischemic stroke (13.5% vs. 11.1%, 12.0%, 14.0%) was similar, however risk of hemorrhagic stroke was significantly higher among patients receiving warfarin (1.2%) compared to patients receiving dabigatran (0.5%), rivaroxaban (0.7%) and apixaban (0.8%) respectively, P = 0.04. CONCLUSIONS: We demonstrated the superior safety profile of DOACs compared to warfarin among patients with underlying cancer and AF. Warfarin was associated with higher mortality, similar ischemic stroke risk but higher risk of hemorrhagic stroke.

Evaluation of YouTube as a reliable source for patient education on aortic valve stenosis.

BACKGROUND: Aortic stenosis (AS) is a prevalent disease in the elderly population and has been a public health concern for decades. YouTube is currently being used for obtaining healthcare related information. We evaluated the quality of information about AS on YouTube for patient education. METHODS: YouTube was queried for the search phrases "aortic valve stenosis", "aortic valve replacement", "transcatheter aortic valve replacement" and "TAVR". Videos were assessed for their reliability and content with two five-point scales. They were categorized into groups according to usefulness and uploader source. All videos were assessed for audience interaction. Videos were viewed and analyzed by 2 independent investigators. Conflicts were resolved by a third investigator. RESULTS: Search phrases yielded 69,300 videos, among which, 120 videos were evaluated and 85 videos were included in the final analysis. Of the 85 videos, only 45 videos (53%) were found to be useful while 40 videos (47%) were found to be non-useful. The majority (98%) of the useful videos were uploaded by professional sources. Overall, videos uploaded by non-professional sources had higher number of views (23,553 vs. 11,110, P≤0.001) despite of being less useful (14% vs. 67%, P<0.001) when compared to videos uploaded by professional sources. CONCLUSIONS: There is a potential to increase public awareness about aortic valve stenosis and the available treatment options by utilizing YouTube. Professional societies are encouraged to provide more useful material that can deliver comprehensive and reliable information in an entertaining and intuitive manner to the public.

Mesalamine-induced Myocarditis in a Young Athlete: Can He Run Again?

Mesalamine is often used in the treatment of inflammatory bowel disease (IBD). Mesalamine-induced cardiotoxicity has been reported in the literature and is a rare entity. The mechanism of cardiotoxicity remains unclear, however, it is believed to be due to a humoral-mediated hypersensitivity reaction. Patients with mesalamine-induced cardiotoxicity could present with a wide range of cardiovascular symptoms ranging from mild chest pain and shortness of breath (SOB) to cardiogenic shock secondary to left ventricular systolic dysfunction. Symptoms could be associated with elevation in cardiac biomarkers and electrocardiogram (EKG) changes including ST-segment or T-wave abnormalities. We report a case of mesalamine-induced myocarditis in a young athlete presenting with chest pain 10 days after mesalamine therapy was initiated for recently diagnosed Crohn's disease. Workup was significant for elevated cardiac biomarkers. The diagnosis was confirmed with cardiovascular magnetic resonance imaging (CMR). Immediate cessation of the medication resulted in resolution of symptomatology and normalization of cardiac biomarkers over a 48-hour period. Mesalamine-induced cardiotoxicity is a rare, yet serious side effect that necessitates medical community awareness. CMR is the confirmatory diagnostic modality of choice.

A Partial Anomalous Pulmonary Venous Connection in a Severely Symptomatic Patient, Is Surgery Always Recommended?

Partial anomalous pulmonary venous connection (PAPVC) is a rare cardiac anomaly occurring when a pulmonary vein drains into the right atrium, coronary sinus or a systemic vein creating a left-to-right shunt. Symptoms develop from right-sided fluid overload and pulmonary vascular disease. We report a rare case of a severely symptomatic patient with an incidentally discovered PAPVC in the setting of underlying severe pulmonary hypertension from multifactorial severe restrictive lung disease. Despite his worsening symptoms, a multi-disciplinary meeting decided against surgical intervention. Nine months after the decision was made, the patient showed no signs or symptoms of clinical deterioration. Prior studies recommend surgery for PAPVCs with evidence of right ventricular dilation, mild-to-moderate tricuspid regurgitation, or early stages of pulmonary vascular disease. However, our case demonstrates how decision making should consider the shunt's contribution to the overall clinical picture and underlying comorbidities. If a decision is made to defer surgical intervention, strict follow up and repeat re-evaluations for possible risk re-stratification and surgery reconsideration are warranted.

Quality of life outcomes in transcatheter aortic valve replacement patients requiring pacemaker implantation.

BACKGROUND: Permanent pacemaker implantation is the most common complication after Transcatheter aortic valve replacement (TAVR) and is associated with worse outcomes and mortality. However, its impact on quality-of-life (QoL) outcomes remains unknown. METHODS: We included 383 consecutive patients undergoing TAVR from January 2012 to 2016 who completed a baseline Kansas City Cardiomyopathy Questionnaire (KCCQ-12) health survey. The clinical, laboratory, angiographic, QoL, mortality, and occurrence of poor outcomes (KCCQ-12 score < 45 or KCCQ decrease of ≥10 points) were obtained. RESULTS: The mean age was 83 ± 8 years, 51% were men, and majority were Caucasians (n = 364, 95%). Permanent pacemaker (PPM) was implanted in 11.5% of patients post-TAVR. PPM patients were more likely to have prior conduction disease including RBBB (25% vs 12%, P = .02) and PQ interval >250 ms (11% vs 5%, P = .07). One-month median KCCQ-12 scores were significantly lower among PPM patients (84.7 vs 68.8, P = .04), but did not differ significantly at 1-year (86.5 vs 90.6, P = .5) post-TAVR. Occurrence of poor outcomes did not differ significantly among those with or without PPM at 1 month (11% vs 7%, P = .39) and 1 year (13% vs 9%, P = .45), respectively. However, patients with poor QoL outcomes at 1 month post-TAVR also had significantly worse mortality during follow-up in unadjusted (31.3% vs 4.5%, P < .001) and adjusted (HR = 5.30, 95% [CI: 1.85-15.22, P = .002])analyses, respectively. CONCLUSION: Permanent pacemaker implantation is associated with short-term reduction in QoL without long-term implications post-TAVR. Patients with poor QoL post-TAVR also have significantly higher mortality.

Fractional flow reserve guided percutaneous coronary intervention results in reduced ischemic myocardium and improved outcomes.

OBJECTIVES: To determine if fractional flow reserve guided percutaneous coronary intervention (FFR-guided PCI) is associated with reduced ischemic myocardium compared with angiography-guided PCI. BACKGROUND: Although FFR-guided PCI has been shown to improve outcomes, it remains unclear if it reduces the extent of ischemic myocardium at risk compared with angiography-guided PCI. METHODS: We evaluated 380 patients (190 FFR-guided PCI cases and 190 propensity-matched controls) who underwent PCI from 2009 to 2014. Clinical, laboratory, angiographic, stress testing, and major adverse cardiac events [MACE] (all-cause mortality, recurrence of MI requiring PCI, stroke) data were collected. RESULTS: Mean age was 63 ± 11 years; the majority of patients were males (76%) and Caucasian (77%). Median duration of follow up was 3.4 [Range: 1.9, 5.0] years. Procedural complications including coronary dissection (2% vs. 0%, P = .12) and perforation (0% vs. 0%, P = 1.00) were similar between FFR-guided and angiography-guided PCI patients. FFR-guided PCI patients had lower unadjusted (14.7% vs. 23.2%, P = .04) and adjusted [OR = 0.58 (95% CI: 0.34-0.98)] risk of repeat revascularization at one year. FFR-guided PCI patients were less likely (23% vs. 32%, P = .02) to have ischemia and had lower (5.9% vs. 21.1%, P < .001) ischemic burden (moderate-severe ischemia) on post-PCI stress testing. Presence of ischemia post-PCI remained a strong predictor of MACE [OR = 2.14 (95%CI: 1.28-3.60)] with worse survival compared to those without ischemia (HR = 1.63 (95% CI: 1.06-2.51). CONCLUSION: Compared with angiography-guided PCI, FFR-guided PCI results in less repeat revascularization and a lower incidence of post PCI ischemia translating into improved survival, without an increase in complications.

Temporal Trends, Complications, and Predictors of Outcomes Among Nonagenarians Undergoing Percutaneous Coronary Intervention: Insights From the Veterans Affairs Clinical Assessment, Reporting, and Tracking Program.

OBJECTIVES: The aim of this study was to determine temporal trends, in-laboratory complications, mortality, and predictors of mortality among nonagenarians undergoing percutaneous coronary intervention (PCI). BACKGROUND: Nonagenarians (patients 90 years of age or older) undergoing PCI are often underrepresented in clinical trials, and their management remains challenging and controversial. METHODS: All veterans undergoing PCI with data recorded in the Veterans Affairs Clinical Assessment, Reporting, and Tracking program from 2005 to 2014 were evaluated. Temporal trends in the use of PCI, occurrence of in-laboratory complications, and 30-day and 1-year mortality were assessed. Using a frailty model, predictors of 30-day and 1-year mortality in nonagenarians were evaluated. RESULTS: Among all veterans undergoing PCI (n = 67,148) between 2005 and 2014, 274 (0.4%) were nonagenarians. The proportion of nonagenarians increased from 0.25% in 2008 to 0.58% in 2014. Compared with younger patients, nonagenarians had a greater risk for acute cardiogenic shock post-procedure (0.73% vs. 0.12%; p = 0.04) and no reflow (2.9% vs. 1.0%; p = 0.02). Unadjusted (10.6% vs. 1.4%; p < 0.0001) and adjusted 30-day mortality (odds ratio: 2.14; 95% confidence interval [CI]: 1.42 to 3.22) and unadjusted (16.3% vs. 4.2%; p < 0.0001) and adjusted 1-year mortality (odds ratio: 1.82; 95% CI: 1.27 to 2.62) were higher among PCI patients who were nonagenarians. The National Cardiovascular Data Registry risk score was highly predictive of both 30-day (hazard ratio: 2.29; 95% CI: 1.86 to 2.82) and 1-year (hazard ratio: 1.43; 95% CI: 1.07 to 1.90) mortality among nonagenarians. CONCLUSIONS: Nonagenarians were a small but growing population with worse 30-day and 1-year mortality. The National Cardiovascular Data Registry risk score was a strong predictor of mortality in these patients.

Prevalence of stroke/transient ischemic attack among patients with acute coronary syndromes in a real-world setting.

BACKGROUND: Atherothrombosis is a systemic disease that may manifest as acute ischemic events in multiple vascular beds. Patients who have experienced an atherothrombosis-related ischemic event in 1 vascular bed are at risk for developing ischemic events in other vascular beds. Antiplatelet therapy demands an understanding of the balance between arterial thrombosis benefit and adverse event risk. Clinical trials indicate that dual antiplatelet therapy with aspirin and the newer thienopyridines increases the risk of bleeding in patients with acute coronary syndromes (ACS) with prior cerebrovascular events. Informed clinical decision making requires a better understanding of the real-world prevalence of cerebrovascular events. OBJECTIVE AND PURPOSE: To estimate the prevalence of stroke and/or transient ischemic attack (TIA) among patients with ACS within US health plan populations. METHODS: A retrospective, observational cohort study was conducted of patients with ACS in 5 health care claims databases. The index event was defined as the first documented inpatient health care claim for myocardial infarction or unstable angina. Patients with ≥12 months of pre-index medical care encounter information were included. Stroke/TIA was identified by the first health care claim for these conditions any time prior to or within 90 days following the index ACS event. RESULTS: Across all databases, between 3.8% and 15.7% of patients with ACS had prior stroke/TIA and between 3.4% and 11.7% of patients with ACS with no history of cerebrovascular events had documented stroke/TIA following the index ACS hospitalization. CONCLUSION: Despite important differences between the various database populations, there is a high prevalence of documented stroke/TIA in patients with ACS both prior to and following the ACS event. These real-world findings, set within the context of the increased bleeding risk observed with the newer thienopyridines, are important considerations when selecting antiplatelet therapy for patients with ACS.

Economic consequences of severe bleeding in patients with acute coronary syndrome in the USA.

INTRODUCTION: Previous studies have demonstrated increased costs associated with bleeding in clinical trials, but none have yet examined the association of bleeding with costs/charges in a real-world setting. This study examines the association between health care charges and severe bleeding events among patients with acute coronary syndrome (ACS) in a real-world US setting. METHODS: This retrospective study of ACS patients enrolled in a regional, 570,000-member commercial health plan evaluated resource utilization for patients with and without severe bleeding using medical encounter data in health care administrative records. Inclusion criteria were continuous health plan enrollment in the 6 months before initial ACS-related hospitalization, age of at least 18 years, and an inpatient ACS claim between January 1995 and May 2007. Severe bleeding events were defined as having an in-hospital record for: (a) bleeding plus blood transfusion, (b) intracranial hemorrhage, or (c) blood transfusion followed by death. Hospitalizations in which the patient had a nonsevere bleeding event, defined as having an International Classification of Diseases, Ninth Revision, Clinical Modification (ICD-9-CM) code for bleeding without transfusion or death, were removed from analysis. Resource utilization was assessed using hospital charges. Multiple linear regression analyses controlling for key covariates were used to assess the association of severe bleeding during initial hospitalization with an ACS diagnosis/procedure with charges and length of stay (LOS). RESULTS: There were 11,266 ACS patients identified: 928 patients (8.2%) had severe bleeding during initial hospitalization. Severe bleeding events were associated with significantly higher hospital charges and increased LOS than hospitalizations without severe bleeding events. After adjusting for patient characteristics, in-hospital ACS-related procedures, and LOS, patients with severe bleeding incurred initial hospitalization charges that were $48,114 higher than those of patients without bleeding (P<0.001). CONCLUSION: In a real-world setting, hospitalizations with both severe bleeding and an ACS diagnosis or procedure are associated with significantly higher hospitalization charges and resource use compared with ACS-related hospitalizations without bleeding events. However, due to the limitations of retrospective analyses, no causal relationship can be determined as patient comorbidities represent a possible source of confounding.

Economic consequences of ACS-related rehospitalizations in the US.

OBJECTIVE: To examine economic consequences related to rehospitalization following initial acute coronary syndrome (ACS) treatment in United States managed care settings. STUDY DESIGN: Retrospective observational studies. RESEARCH DESIGN AND METHODS: Retrospective observational studies were conducted on two managed care populations to examine medical encounter insurance claims and charges for ACS-related rehospitalizations following an index hospitalization for new onset ACS (2002-2007). All charges were adjusted to year 2007 United States Dollars (USDs). MAIN OUTCOME MEASURES: The main outcomes for this study were the direct charges related to ACS rehospitalizations as captured in two separate medical encounter claims databases. RESULTS: Of the 11,266 ACS patients identified for analysis in the health system plan, 3588 (32%) had at least one ACS rehospitalization. Of the 97,177 ACS patients enrolled in the nationally representative managed care database, 32,578 (34%) had at least one ACS-related rehospitalization. Multivariate analyses demonstrated that coronary artery bypass graft (CABG) was the strongest predictor of increased charges during the recurrence in both populations (p < 0.0001). When controlling for length of stay (LOS) in the model, CABG remained a significant predictor of increased charges, while percutaneous coronary intervention (PCI) and stent insertion became even stronger predictors of increased charges. CONCLUSIONS: The costs associated with ACS-related rehospitalizations in a real-world setting are high, even when controlling for known cost drivers such as length of stay.

Clinical impact of early clopidogrel discontinuation following acute myocardial infarction hospitalization or stent implantation: analysis in a single integrated health network.

OBJECTIVE: To determine the association between the discontinuation of clopidogrel therapy prior to 1 year and the risk of acute myocardial infarction (AMI) hospitalization, coronary intervention or all-cause mortality in a cohort of managed-care patients following AMI hospitalization or stent insertion. RESEARCH DESIGN AND METHODS: This observational cohort study included 1152 patients enrolled in the Health Alliance Plan who were hospitalized for AMI, or who underwent coronary stent placement. Clopidogrel use was assessed using pharmacy claims data. The association between discontinuation of clopidogrel prior to 1 year following the initial ACS event and the primary outcome of AMI hospitalization/procedure was assessed using Cox proportional hazards models. Additionally, an analysis was conducted to determine the association of discontinuation prior to 1 year with a secondary composite outcome of AMI hospitalization/coronary stent procedure or all-cause mortality. MAIN OUTCOME MEASURES: The primary outcome was AMI hospitalization or procedure. The secondary outcome was a composite of AMI hospitalization/ procedure, or all-cause mortality. RESULTS: Discontinuation of clopidogrel in the total cohort of patients was associated with a significantly higher risk of the primary outcome of AMI hospitalization/ coronary intervention (HR 2.712, 95% CI 1.634-4.502). Consistent with this finding, discontinuation of clopidogrel was also associated with a significantly higher risk of the secondary composite endpoint (HR 1.844, 95% CI 1.281-2.653). CONCLUSIONS: In patients enrolled in an integrated health network, clopidogrel discontinuation prior to 1 year following AMI hospitalization or stent placement is associated with adverse outcomes including greater risk of death, AMI hospitalization or coronary intervention. These results should be interpreted within the context and limitations of observational research, which cannot attribute causality.

Clinical impact of early clopidogrel discontinuation following acute myocardial infarction hospitalization or stent implantation: analysis in a nationally representative managed-care population.

OBJECTIVES: To evaluate the association between discontinuation of clopidogrel therapy and risk of acute myocardial infarction (AMI) hospitalization or cardiac revascularization in a nationally-representative patient population following hospitalization for an AMI or coronary stent insertion. RESEARCH DESIGN AND METHODS: This observational cohort study was performed using data on patients from the PharMetrics Anonymous Patient-Centric Database who were hospitalized for an AMI or coronary stent insertion and subsequently treated with clopidogrel. Cox proportional hazard modeling was used to evaluate the association between clopidogrel discontinuation prior to 1 year post-initial AMI hospitalization and the primary endpoint of repeat AMI hospitalization or coronary intervention defined as percutaneous coronary intervention (PCI) with or without stent, or coronary artery bypass graft (CABG). MAIN OUTCOME MEASURES: The main outcome for this study was AMI hospitalization or coronary intervention defined as PCI with or without stent placement or CABG. RESULTS: A total of 31 835 patients were included in the analyses. Patients were predominantly male and the average patient age was approximately 60 years. After controlling for baseline patient characteristics and follow-up time, discontinuation of clopidogrel was associated with a significantly higher rate of hospitalization for AMI or coronary intervention (HR 1.34, 95% CI 1.22-1.44). CONCLUSION: Within a population of ACS patients drawn from a database of 85 US health plans, clopidogrel discontinuation within 1 year following hospitalization for AMI or stent placement is associated with an increased risk of AMI hospitalization or coronary intervention. The results of this study should be interpreted within the context of observational research, which does not address cause and effect relationships.

Acute coronary syndrome emergency treatment strategies: Improved treatment and reduced mortality in patients with acute coronary syndrome using guideline-based critical care pathways.

BACKGROUND: An acute coronary syndrome (ACS) emergency treatment strategies (ACSETS) critical care pathway (CCP), embedding guideline-based treatment, was evaluated in a 4-hospital system in Buffalo, NY, for its impact on ACS drug utilization, length of stay, and mortality. METHODS: The study used an observational design comparing pre- (n = 1,240) and post- (n = 1,709) ACSETS implementation cohorts followed over 1 year. Both myocardial infarction (MI) (59%) and unstable angina (UA) (41%) patients were studied. Multivariate regression analysis was used to analyze possible differences in major end points. RESULTS: Appropriate ACS medication use was significantly higher in the ACSETS group in the first 24 hours and at discharge. In a subgroup of managed care health insurance patients (n = 884 ), prescription refills for statins, beta-blockers, angiotensin-converting enzyme inhibitors, and clopidogrel were significantly greater in the ACSETS group up to and including 7 months after discharge, although at 7 months, actual refill rate was poor (30%-50%) for both groups. Length of stay was significantly reduced (HR 0.82 [0.72-0.90]). Inpatient mortality was not significantly reduced. One-year adjusted mortality was reduced significantly compared to non-ACSETS in the MI group (by 19%) (HR 0.81 [0.66-0.99]) but not in the UA group (HR 1.13 [0.71-1.79]). CONCLUSIONS: ACSETS contributes to the proof of concept of critical care pathway (CCP) improvement of ACS care, as revealed by increased acute and chronic evidence-based use of medication, decreased length of stay, and, in the case of MI patients, decreased adjusted 1-year mortality. One-year mortality benefit was observed in MI but not UA patients.

Peroxisome proliferator-activated receptor gamma agonists for the Prevention of Adverse events following percutaneous coronary Revascularization--results of the PPAR study.

BACKGROUND: Patients with metabolic syndrome are at increased risk for cardiovascular complications. We sought to determine whether peroxisome proliferator-activated receptor gamma agonists had any beneficial effect on patients with metabolic syndrome undergoing percutaneous coronary intervention (PCI). METHODS: A total of 200 patients with metabolic syndrome undergoing PCI were randomized to rosiglitazone or placebo and followed for 1 year. Carotid intima-medial thickness (CIMT), inflammatory markers, lipid levels, brain natriuretic peptide, and clinical events were measured at baseline, 6 months, and 12 months. RESULTS: There was no significant difference in CIMT between the 2 groups. There was no difference in the 12-month composite end point of death, myocardial infarction (MI), stroke, or any recurrent ischemia (31.4% vs 30.2%, P = .99). The rate of death, MI, or stroke at 12 months was numerically lower in the rosiglitazone group (11.9% vs 6.4%, P = .19). There was a trend toward a greater decrease over time in high-sensitivity C-reactive protein values compared with baseline in the group randomized to rosiglitazone versus placebo both at 6 months (-35.4% vs -15.8%, P = .059) and 12 months (-40.0% vs -20.9%, P = .089) and higher change in high-density lipoprotein (+15.5% vs +4.1%, P = .05) and lower triglycerides (-13.9% vs +14.9%, P = .004) in the rosiglitazone arm. There was a trend toward less new onset diabetes in the rosiglitazone group (0% vs 3.3%, P = .081) and no episodes of symptomatic hypoglycemia. There was no excess of new onset of clinical heart failure in the rosiglitazone group, nor was there a significant change in brain natriuretic peptide levels. CONCLUSIONS: Patients with metabolic syndrome presenting for PCI are at increased risk for subsequent cardiovascular events. Rosiglitazone for 12 months did not appear to affect CIMT in this population, although it did have beneficial effects on high-sensitivity C-reactive protein, high-density lipoprotein, and triglycerides. Further study of peroxisome proliferator-activated receptor agonism in patients with metabolic syndrome undergoing PCI may be warranted.

Achievement of optimal combined lipid values in a managed care setting: is a new treatment paradigm needed?

BACKGROUND: Published guidelines suggest the management of high-density lipoprotein cholesterol (HDL-C) and triglyceride (TG) values after the low-density lipoprotein cholesterol (LDL-C) goal is achieved. OBJECTIVE: This study evaluated the attainment of optimal combined lipid values (LDL-C, HDL-C, and TGs) and associated therapy over time. METHODS: This retrospective cohort analysis was conducted among managed-care patients who had a baseline lipid panel taken between October 1, 1999, and September 30, 2000; were naive to lipid therapy; and had plan eligibility for at least 12 months before and 12 to 36 months after the baseline lipid values. Patients were categorized as elevated-risk primary prevention (ERP) or as coronary heart disease (CHD) and CHD risk equivalents (CHD-RE). The attainment of optimal combined lipid values was assessed at baseline and quarterly thereafter. Associations between lipid values and the use of lipid-altering therapy were assessed using multivariate logistic regression. RESULTS: A total of 30,348 patients were monitored for a mean (SD) duration of 27 (8) months. Mean (SD) age was 66 (12) years and 55% (16,549/30,348) were men; 43% (13,059/30,348) were categorized as ERP and 57% (17,289/30,348) as CHD-RE. Combined lipid values were optimal in 14% (4167/30,348),18% (5508/30,348), and 22% (2936/13,100) of patients at baseline, 12 months, and 36 months, respectively. After 36 months, 78% (10,164/13,100) of patients did not attain optimal combined lipid values. Lipid therapy, primarily statin monotherapy (87% [7992/ 92251), was prescribed in 30% (9225/30,348) of patients. After 36 months, 34% (4492/13,100) of patients had isolated elevated LDL-C and 20% (2588/13,100) had non-optimal HDL-C and/or TGs. Lipid therapy was associated with the attainment of optimal combined values for LDL-C and TGs (both, P < 0.05), but not for HDL-C. Because the study was retrospective, causality cannot be determined. CONCLUSIONS: Based on the results of this study, use of combination lipid therapy and targeted therapy aimed at the specific lipid abnormalities may increase the attainment of optimal lipid parameters.

Efficacy of extended-release niacin with lovastatin for hypercholesterolemia: assessing all reasonable doses with innovative surface graph analysis.

BACKGROUND: Combination therapy to improve the total lipid profile may achieve greater coronary risk reductions than lowering low-density lipoprotein cholesterol (LDL-C) alone. A new extended-release niacin (niacin ER)/lovastatin tablet substantially lowers LDL-C, triglyceride, and lipoprotein(a) levels and raises high-density lipoprotein cholesterol (HDL-C) level. We evaluated these serum lipid responses to niacin ER/lovastatin at all clinically reasonable doses. METHODS: Men (n = 85) and women (n = 79) with type IIa or IIb primary hyperlipidemia after diet were randomized among 5 parallel treatment arms. Each arm had 5 sequential 4-week treatment periods: niacin ER (starting at 500 mg/d, increasing in 500-mg increments to 2500 mg/d); lovastatin (starting at 10 mg, increasing to 20 mg, then 40 mg/d); and 3 combinations arms, each with a constant lovastatin dose and escalating niacin ER doses. RESULTS: For primary comparisons, mean LDL-C level reductions from baseline were greater with niacin ER/lovastatin (1500/20 mg) than with lovastatin (20 mg) (35% vs 22%, P<.001) and with niacin ER/lovastatin (2000/40 mg) than with lovastatin (40 mg) (46% vs 24%, P<.001). Each 500-mg increase in niacin ER, on average, decreased LDL-C levels an additional 4% and increased HDL-C levels 8%. The maximum recommended dose (2000/40 mg/d) increased HDL-C levels 29% and decreased LDL-C levels 46%, triglyceride levels 38%, and lipoprotein(a) levels 14%. All lipid responses were dose dependent and generally additive. Graphs of the dose-response relationships as 3-dimensional surfaces documented the strength and consistency of these responses. CONCLUSIONS: Niacin ER/lovastatin combination therapy substantially improves 4 major lipoprotein levels associated with atherosclerotic disease. Dose-response surfaces provide a practical guide for dose selection.

Gender bias in lipid assessment and treatment following percutaneous coronary intervention.

OBJECTIVE: To identify a possible gender bias in lipid assessment and treatment of patients following percutaneous coronary intervention (PCI). METHODS: Following PCI, patients were identified from a cardiology practice database, with retrospective follow-up achieved through medical record review in a private cardiology practice and in primary care physician practices. Patients were assessed for lipid measurement of total cholesterol, low-density lipoprotein cholesterol (LDL-C), high-density lipoprotein cholesterol (HDL-C), and triglycerides, and for changes in these measures. RESULTS: A total of 356 patients were identified for analysis: 221 men (62%) and 135 women (38%). Mean post-PCI follow-up was 2.2 +/- 1.6 years. Among females, 80% had lipids measured, as compared with 87% of males (P = 0.07). At pre- and post-PCI, all fractions were significantly higher (P < 0.05) in women, except pre-PCI triglycerides, which were significantly lower in women. From pre- to post-PCI, HDL-C and triglycerides improved significantly more in males, while LDL-C improved significantly more in females. Target LDL-C levels (< 100 mg/dL) were achieved in 46.4% of the overall group. There were no significant gender-related differences in the number of patients treated with dyslipidemic medications or in patients achieving an LDL-C of < 100 mg/dL (P = 0.081). CONCLUSION: Following PCI, a gender bias did not exist for lipid assessment, number of patients treated with pharmacotherapy, or achievement of target LDL-C (< 100 mg/dL). However, in terms of absolute levels achieved, women were treated less aggressively than men for all lipid fractions.

Efficacy and safety of ezetimibe coadministered with lovastatin in primary hypercholesterolemia.

This multicenter, randomized, double-blind, placebo-controlled clinical study assessed the efficacy and safety of ezetimibe administered with lovastatin in primary hypercholesterolemia. After dietary stabilization, a 2- to 12-week washout period, and a 4-week single-blind placebo lead-in period, 548 patients with low-density lipoprotein (LDL) cholesterol > or =145 mg/dl (3.75 mmol/L) and < or =250 mg/dl (6.47 mmol/L) and triglycerides < or =350 mg/dl (3.99 mmol/L) were randomized to one of the following, administered daily for 12 weeks: ezetimibe 10 mg; lovastatin 10, 20, or 40 mg; ezetimibe 10 mg plus lovastatin 10, 20, or 40 mg; or placebo. The primary efficacy variable was percentage decrease in direct LDL cholesterol from baseline to end point for pooled ezetimibe plus lovastatin versus pooled lovastatin alone. Ezetimibe plus lovastatin significantly improved concentrations of LDL cholesterol, high-density lipoprotein (HDL) cholesterol, and triglycerides compared with lovastatin alone (p <0.01). The coadministration of ezetimibe provided an incremental 14% LDL cholesterol decrease, a 5% HDL cholesterol increase, and a 10% decrease in triglycerides compared with pooled lovastatin alone. Ezetimibe plus lovastatin provided mean LDL cholesterol decreases of 33% to 45%, median triglyceride decreases of 19% to 27%, and mean HDL cholesterol increases of 8% to 9%, depending on the statin dose. The coadministration of ezetimibe 10 mg plus the starting dose of lovastatin (10 mg) provided comparable efficacy to high-dose lovastatin (40 mg) across the lipid profile (LDL cholesterol, HDL cholesterol, and triglycerides). Ezetimibe plus lovastatin was well tolerated, with a safety profile similar to both lovastatin alone and placebo. The coadministration of ezetimibe and lovastatin may offer a new treatment option in lipid management of patients with hypercholesterolemia.

Acute coronary syndrome emergency treatment strategies: a rationale and road map for critical pathway implementation.

Clinical guidelines have been established to improve the effectiveness of treatment of patients seeking treatment for acute coronary syndromes and to address the variability in physician approaches to these risks. In patients with established coronary heart disease, clinical trials have consistently demonstrated reduction in morbidity and mortality with secondary prevention therapies. Both ends of this spectrum of therapy can be underused in patients receiving conventional care. Because implementation of evidence-based guideline recommendations into clinical care is limited, presented here is a rationale and process that have been successful in guideline implementation for patients with acute coronary syndromes.