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2.
Int J Cardiol ; 302: 53-58, 2020 Mar 01.
Artigo em Inglês | MEDLINE | ID: mdl-31932116

RESUMO

BACKGROUND: Variation in patient characteristics and practice patterns may influence outcomes at a regional level. METHODS: We assessed differences in demographics, practice patterns, outcomes, and the effect of apixaban compared with warfarin in ARISTOTLE (n = 18,201) by prespecified regions: North America, Latin America, Europe, and Asia Pacific. The primary outcomes were stroke/systemic embolism and major bleeding. RESULTS: Compared with other regions, patients from Asia Pacific were younger, more women were enrolled in Latin America. Coronary artery disease was more prevalent in Europe and Asia Pacific had the highest rate of prior stroke and renal impairment. Over 50% of patients in North America were taking ≥9 drugs at randomization, compared with 10% in Latin America. North America had the highest rates of temporary study drug discontinuation and procedures. Time in therapeutic range (INR 2.0-3.0) on warfarin was highest in North America and lowest in Asia Pacific. After adjustment and compared with Europe, patients in Asia Pacific had 2-fold higher risk of stroke/systemic embolism and 3-fold higher risk of intracranial hemorrhage. Patients in Latin America had 2-fold increased risk of all-cause death compared with Europe. The benefits of apixaban compared with warfarin were consistent across regions; there was a pronounced reduction in major bleeding in patients from Asia Pacific compared with other regions (p-interaction = 0.03). CONCLUSIONS: Patients with AF enrolled in prespecified regions in ARISTOTLE had differences in clinical baseline characteristics and practice patterns. After adjustment, patients in Asia Pacific and Latin America had worse outcomes than patients from other regions. The relative benefits of apixaban compared with warfarin were consistent across regions with an even greater treatment effect in the reduction of bleeding in patients from Asia Pacific.

3.
Am Heart J ; 221: 1-8, 2020 Mar.
Artigo em Inglês | MEDLINE | ID: mdl-31896036

RESUMO

OBJECTIVES: A history of gastrointestinal bleeding (GIB) in patients with atrial fibrillation (AF) may impact decisions about anticoagulation treatment. We sought to determine whether prior GIB in patients with AF taking anticoagulants was associated with an increased risk of stroke or major hemorrhage. METHODS: We analyzed key efficacy and safety outcomes in patients with prior GIB in ARISTOTLE. Centrally adjudicated outcomes according to GIB history were analyzed using Cox proportional hazards models adjusted for randomized treatment and established risk factors. RESULTS: A total of 784 (4.3%) patients had prior GIB events (321 [41%] lower, 463 [59%] upper); 215 (27%) occurred <1 year before study enrollment. Patients with prior GIB were older, had more comorbidities, and higher CHADS2 and HAS-BLED scores than those with no GIB. Major GIB occurred more frequently in those with prior GIB (lower: aHR 1.72, 95% CI 0.86-3.42; upper: aHR 3.13, 95% CI 1.97-4.96). This association with major GIB was more pronounced in patients with GIB <1 year before randomization versus no recent GIB (recent lower: aHR 2.58, 95% CI 0.95-7.01; recent upper: aHR 5.16, 95% CI 2.66-10.0). There was no association between prior GIB and risk of stroke/systemic embolism or all-cause death. In those with prior GIB, the apixaban versus warfarin relative risks for stroke/systemic embolism, hemorrhagic stroke, death, or major bleeding were consistent with the results of the overall trial. CONCLUSIONS: In patients with AF on oral anticoagulants, prior GIB was associated with an increased risk of subsequent major GIB but not stroke, intracranial bleeding, or all-cause mortality. For the key outcomes of stroke, hemorrhagic stroke, death, and major bleeding, we found no evidence that the treatment effect (apixaban vs. warfarin) was modified by a history of GIB.

4.
Circulation ; 141(1): 10-20, 2020 Jan 07.
Artigo em Inglês | MEDLINE | ID: mdl-31747786

RESUMO

BACKGROUND: The use of nonsteroidal anti-inflammatory drugs (NSAIDs) with oral anticoagulants has been associated with an increased risk of bleeding. We investigated the risk of bleeding and major cardiovascular outcomes in patients with atrial fibrillation taking NSAIDs and apixaban or warfarin. METHODS: The ARISTOTLE trial (Apixaban for Reduction in Stroke and Other Thromboembolic Events in Atrial Fibrillation; n=18 201) compared apixaban with warfarin in patients with atrial fibrillation at an increased risk of stroke. Patients in ARISTOTLE without severe renal (creatine clearance ≤30 mL/min) or liver disease were included in this analysis (n=17 423). NSAID use at baseline, NSAID use during the trial (incident NSAID use), and never users were described. The primary outcome was major bleeding. Secondary outcomes included clinically relevant nonmajor bleeding, gastrointestinal bleeding, heart failure hospitalization, stroke or systemic embolism, and all-cause mortality. NSAID use during the trial, and the interaction between randomized treatment, was analyzed using time-dependent Cox proportional hazards models. RESULTS: Those with baseline NSAID use (n=832 [4.8%]), incident NSAID use (n=2185 [13.2%]), and never users were similar in median age (age [25th, 75th]; 70 [64, 77] versus 70 [63, 75] versus 70 [62, 76]). Those with NSAID use at baseline and incident NSAID use were more likely to have a history of bleeding than never users (24.5% versus 21.0% versus 15.6%, respectively). During a median follow-up (25th, 75th) of 1.8 (1.4, 2.3) years and when excluding those taking NSAID at baseline, we found that incident NSAID use was associated with an increased risk of major bleeding (hazard ratio [HR], 1.61 [95% CI, 1.11-2.33]) and clinically relevant nonmajor bleeding (HR, 1.70 [95% CI, 1.16-2.48]), but not gastrointestinal bleeding. No significant interaction was observed between NSAID use and randomized treatment for any outcome. CONCLUSIONS: A substantial number of patients in the ARISTOTLE trial took NSAIDs. Incident NSAID use was associated with major and clinically relevant nonmajor bleeding, but not with gastrointestinal bleeding. The safety and efficacy of apixaban versus warfarin appeared not significantly to be altered by NSAID use. This study warrants more investigation of the effect of NSAIDs on the outcomes of patients treated with apixaban. CLINICAL TRIAL REGISTRATION: URL: https://www.clinicaltrials.gov. Unique identifier: NCT00412984.

5.
J Am Heart Assoc ; 8(23): e014240, 2019 Dec 03.
Artigo em Inglês | MEDLINE | ID: mdl-31771438

RESUMO

Background The New York Heart Association (NYHA) classification has served as a fundamental tool for risk stratification of heart failure (HF) and determines clinical trial eligibility and candidacy for drugs and devices. However, its ability to adequately stratify risk is unclear. Methods and Results To compare NYHA class with objective assessments and survival in patients with HF, we performed secondary analyses of 4 multicenter National Institutes of Health-funded HF clinical trials that included patients classified as NYHA class II or III: TOPCAT (Treatment of Preserved Cardiac Function Heart Failure with an Aldosterone Antagonist), DIG (The Effect of Digoxin on Mortality and Morbidity in Patients With Heart Failure), HF-ACTION (Efficacy and Safety of Exercise Training in Patients With Chronic Heart Failure), and GUIDE-IT (Guiding Evidence-Based Therapy Using Biomarker Intensified Treatment in Heart Failure). Twenty-month cumulative survival was compared between classes using Kaplan-Meier curves and the log rank test. NT-proBNP (N-terminal pro-B-type natriuretic peptide), Kansas City Cardiomyopathy Questionnaire (KCCQ) scores, 6-minute walk distances, left ventricular ejection fraction, and cardiopulmonary test parameters were compared using Wilcoxon rank sum tests and percentage overlap using kernel density estimations. Cumulative mortality varied significantly across NYHA classes and HF clinical trials (likelihood ratio, P<0.001). Mortality at 20 months for NYHA class II ranged from 7% for patients in HF-ACTION to 15% in GUIDE-IT, whereas mortality for NYHA class III ranged from 12% in TOPCAT to 26% in GUIDE-IT. There was substantial percentage overlap in values for NT-proBNP levels (79% and 69%), KCCQ scores (63% and 54%), 6-minute walk distances (63% and 54%), and left ventricular ejection fraction (88% and 83%). Similarly, there was substantial overall in values for minute ventilation-carbon dioxide production relationship (71%), maximal oxygen uptake (54%), and exercise duration (53%). Conclusions The NYHA system poorly discriminates HF patients across the spectrum of functional impairment. These findings raise important questions about the need for improved phenotyping of these patients to facilitate risk stratification and response to interventions.

6.
J Am Coll Cardiol ; 74(9): 1205-1217, 2019 Sep 03.
Artigo em Inglês | MEDLINE | ID: mdl-31466618

RESUMO

BACKGROUND: The GUIDE-IT (GUIDing Evidence Based Therapy Using Biomarker Intensified Treatment in Heart Failure) trial demonstrated that a strategy to "guide" application of guideline-directed medical therapy (GDMT) by reducing amino-terminal pro-B-type natriuretic peptide (NT-proBNP) was not superior to GDMT alone. OBJECTIVES: The purpose of this study was to examine the prognostic meaning of NT-proBNP changes following heart failure (HF) therapy intensification relative to the goal NT-proBNP value of 1,000 pg/ml explored in the GUIDE-IT trial. METHODS: A total of 638 study participants were included who were alive and had available NT-proBNP results 90 days after randomization. Rates of subsequent cardiovascular (CV) death/HF hospitalization or all-cause mortality during follow-up and Kansas City Cardiomyopathy Questionnaire (KCCQ) overall scores were analyzed. RESULTS: A total of 198 (31.0%) subjects had an NT-proBNP ≤1,000 pg/ml at 90 days with no difference in achievement of NT-proBNP goal between the biomarker-guided and usual care arms. NT-proBNP ≤1,000 pg/ml by 90 days was associated with longer freedom from CV/HF hospitalization or all-cause mortality (p < 0.001 for both) and lower adjusted hazard of subsequent HF hospitalization/CV death (hazard ratio: 0.26; 95% confidence interval: 0.15 to 0.46; p < 0.001) and all-cause mortality (hazard ratio: 0.34; 95% confidence interval: 0.15 to 0.77; p = 0.009). Regardless of elevated baseline concentration, an NT-proBNP ≤1,000 pg/ml at 90 days was associated with better outcomes and significantly better KCCQ overall scores (p = 0.02). CONCLUSIONS: Patients with heart failure with reduced ejection fraction whose NT-proBNP levels decreased to ≤1,000 pg/ml during GDMT had better outcomes. These findings may help to understand the results of the GUIDE-IT trial. (Guiding Evidence Based Therapy Using Biomarker Intensified Treatment [GUIDE-IT]; NCT01685840).

7.
Am Heart J ; 214: 46-53, 2019 Aug.
Artigo em Inglês | MEDLINE | ID: mdl-31154196

RESUMO

BACKGROUND: Some studies suggest that black patients may have worse outcomes after drug-eluting stent (DES) placement. There are limited data characterizing long-term outcomes by race. The objective was to compare long-term outcomes between black and white patients after percutaneous coronary intervention (PCI) with DES implantation. METHODS: We analyzed 915 black and 3,559 white (n = 4,474) consecutive patients who underwent DES placement at Duke University Medical Center from 2005 through 2013. Over 6-year follow up, we compared rates of myocardial infarction (MI), all-cause mortality, revascularization, and major bleeding between black and white patients. A multivariable Cox regression model was fit to adjust for potentially confounding variables. Dual-antiplatelet therapy use over time was determined by patient follow-up surveys and compared by race. RESULTS: Black patients were younger; were more often female; had higher body mass indexes; had more diabetes mellitus, hypertension, and renal disease; and had lower median household incomes than white patients (P < .001). At 6 years after DES placement, black relative to white patients had higher unadjusted rates of MI (12.1% vs 10.1%, hazard ratio 1.25, 95% CI 1.00-1.57, P = .05) and major bleeding (17.8% vs 14.3%, hazard ratio 1.28, 95% CI 1.07-1.54, P = .01), but there were no significant differences in other outcomes. After multivariable adjustment, there were no statistically significant racial differences in any of these outcomes at 6 years. Similarly, dual-antiplatelet therapy use was comparable between racial groups. CONCLUSIONS: Unadjusted rates of MI and major bleeding over long-term follow up were higher among black patients compared to white patients, but these differences may be explained by racial differences in comorbid disease.

8.
Eur J Heart Fail ; 21(6): 770-778, 2019 Jun.
Artigo em Inglês | MEDLINE | ID: mdl-30919549

RESUMO

BACKGROUND: Most heart failure (HF) risk scores have been derived from cohorts of stable HF patients and may not incorporate up to date treatment regimens or deep phenotype characterization that change baseline risk over the short- and long-term follow-up period. We undertook the current analysis of participants in the GUIDE-IT (Guiding Evidence-Based Therapy Using Biomarker Intensified Treatment) trial to address these limitations. METHODS AND RESULTS: The GUIDE-IT study randomized 894 high-risk patients with HF and reduced ejection fraction (≤ 40%) to biomarker-guided treatment strategy vs. usual care. We performed risk modelling using Cox proportional hazards models and analysed the relationship between 35 baseline clinical factors and the primary composite endpoint of cardiovascular (CV) death or HF hospitalization, the secondary endpoint of all-cause mortality, and the exploratory endpoint of 90-day HF hospitalization or death. Prognostic relationships for continuous variables were examined and key predictors were identified using a backward variable selection process. Predictive models and risk scores were developed. Over a median follow-up of 15 months, the cumulative number of HF hospitalizations and CV deaths was 328 out of 894 patients (Kaplan-Meier event rate 34.5% at 12 months). Frequency of all-cause deaths was 143 out of 894 patients (Kaplan-Meier event rate 12.2% at 12 months). Outcomes for the primary and secondary endpoints between strategy arms of the study were similar. The most important predictor that was present in all three models was the baseline natriuretic peptide level. Hispanic ethnicity, low sodium and high heart rate were present in two of the three models. Other important predictors included the presence or absence of a device, New York Heart Association class, HF duration, black race, co-morbidities (sleep apnoea, elevated creatinine, ischaemic heart disease), low blood pressure, and a high congestion score. CONCLUSION: Risk models using readily available clinical information are able to accurately predict short- and long-term CV events and may be useful in optimizing care and enriching patients for clinical trials. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov ID number NCT01685840.

9.
J Nutr Gerontol Geriatr ; 38(1): 33-49, 2019.
Artigo em Inglês | MEDLINE | ID: mdl-30810500

RESUMO

Both aging and obesity are associated with increased levels of pro-inflammatory metabolites, while weight reduction is associated with improvements in inflammatory status. However, few studies have explored the response of key inflammatory markers to the combined settings of weight reduction in an aging population. There are also few studies that have investigated the potential impact of diet composition on inflammatory marker responses. In the MEASUR-UP trial, we evaluated changes in baseline levels of inflammatory markers with post-study levels for a traditional weight loss control group versus a group with generous, balanced protein intake. In this 6-month randomized controlled trial (RCT), older (≥60 years) adults with obesity (BMI ≥30 kg/m2) and Short Physical Performance Battery (SPPB) score of 4-10 were randomly assigned to either a traditional weight loss regimen, (Control, n = 14) or one with higher protein intake (≥30 g) at each meal (Protein, n = 25). All participants were prescribed a hypo-caloric diet and attended weekly support and education groups and weigh-ins. Protein participants consumed ≥30 g of high-quality protein/meal, including lean and extra lean beef provided to them for two of the three meals per day. Protein intakes were 0.8 and 1.2 g/kg/day for Control and Protein, respectively. Adiponectin, leptin, C-reactive protein (hs-CRP), tumor necrosis factor-α (TNF-α), interleukin-1 (IL-1), IL-6, IL-8, serum amyloid A (SAA), vascular cell adhesion molecule-1 (VCAM-1), intercellular adhesion molecule-1 (ICAM-1), and glycated serum protein (GSP) levels were measured at 0 and 6-month time points. At the 6-month endpoint, there was significant weight loss and decrease in BMI in both the Control (-4.8 ± 8.2 kg; -2.3 ± 2.4 kg/m2; p = 0.05) and Protein (-8.7 ± 7.4 kg; -2.9 ± 2.3 kg/m2; p < 0.0001) groups. SPPB scores improved in both arms, with a superior functional response in Protein (p < 0.05). Body fat (%) at baseline was positively correlated with leptin, hs-CRP, VCAM-1, ICAM-1, and GSP. Several markers of inflammation responded to the Protein group: leptin (p < 0.001), hs-CRP (p < 0.01), and ICAM-1 (p < 0.01) were decreased and adiponectin increased (p < 0.01). There were no significant changes in any inflammatory markers in the Control arm. In the between group comparison, only adiponectin trended towards a group difference (more improvement in Protein; p < 0.07). Our findings in the MEASUR-UP trial show that a weight loss diet with enhanced protein intake is comparable to an adequate protein diet in terms of weight loss success and that it can lead to improvements in inflammatory status, specifically for adiponectin, leptin, hs-CRP, and ICAM-1. These findings are important given current recommendations for higher protein intakes in older adults and justify the additional study of the inflammatory impact of an enhanced protein diet. (ClinicalTrials.gov identifier: NCT01715753).

10.
Otolaryngol Head Neck Surg ; 160(6): 1071-1080, 2019 06.
Artigo em Inglês | MEDLINE | ID: mdl-30721112

RESUMO

OBJECTIVE: Eustachian tube dysfunction (ETD) prompts >2 million adult visits in the United States annually. While disease prevalence and health care utilization are established for children, practice patterns for adults remain unknown. Our objective was to determine national resource utilization for adult ETD. STUDY DESIGN: Cross-sectional study. SETTING: National database sample. SUBJECTS AND METHODS: The Truven Health MarketScan Databases (2010-2014) analytic cohort included health care encounters of patients ≥18 years of age with a diagnosis of ETD, otitis media with effusion, or tympanic membrane retraction. Visits associated with recent diagnoses of acute upper respiratory infection, head and neck cancer, or radiation therapy were excluded. Acute ETD (<3 months) and chronic ETD (≥3 months) were subgroups. Medication usage was quantified by class. RESULTS: ETD was diagnosed for 1,298,987 patients, 11% of which was chronic. Over 92% of patients were seen in outpatient clinics, most often by otolaryngology (57%) for chronic ETD and by general medicine (49%) for acute ETD. Medications were frequently utilized, as 530,146 (53.7%) patients received ≥1 prescription. Top prescriptions for chronic ETD included intranasal corticosteroids (22%), antibiotics (22%), oral corticosteroids (13%), and analgesics (6%). The overall annual cost of prescribed medications associated with visits in which either acute or chronic ETD was diagnosed exceeded $8.5 million for a mean of $80.78 per patient who filled a prescription. CONCLUSION: Adult ETD is frequently treated with several medication classes by a variety of provider types. Understanding the potential adverse effects and cost associated with these practices should be a priority.


Assuntos
Tuba Auditiva , Custos de Cuidados de Saúde , Otite Média com Derrame/terapia , Aceitação pelo Paciente de Cuidados de Saúde , Padrões de Prática Médica/economia , Adulto , Estudos Transversais , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Otite Média com Derrame/economia , Estados Unidos
11.
JAMA Cardiol ; 4(1): 7-15, 2019 01 01.
Artigo em Inglês | MEDLINE | ID: mdl-30540355

RESUMO

Importance: Patients with peripheral artery disease (PAD) are at high risk for myocardial infarction (MI). Objective: To characterize the incidence and types of MI in a PAD population, identify factors associated with MI, and determine the association of MI with cardiovascular mortality and acute limb ischemia. Design, Setting, and Participants: The Study Comparing Cardiovascular Effects of Ticagrelor and Clopidogrel in Patients With Peripheral Artery Disease (EUCLID) was a double-blind randomized clinical trial conducted at 811 sites in 28 countries that randomized 13 885 patients with symptomatic PAD to monotherapy with ticagrelor or clopidogrel. Participants had an ankle-brachial index (ABI) of 0.80 or less or previous lower extremity revascularization. Median follow-up was 30 months. For these analyses, patients were evaluated for MI occurrence during follow-up irrespective of treatment. Data were analyzed from June 2017 to September 2018. Main Outcomes and Measures: An adjudication clinical events committee classified MI as type 1 (spontaneous), type 2 (secondary), type 3 (sudden cardiac death), type 4a (less than 48 hours after percutaneous coronary intervention), type 4b (definite stent thrombosis), or type 5 (less than 72 hours after coronary artery bypass graft). A multivariate regression model was developed by stepwise selection to identify factors associated with MI, and a time-dependent multivariate Cox regression analysis was performed to determine the association of MI with cardiovascular death and acute limb ischemia requiring hospitalization. Results: Of the 13 885 patients included in this analysis, 9997 (72.0%) were male, and the median (interquartile range) age was 66 (60-73) years. Myocardial infarction occurred in 683 patients (4.9%; 2.4 events per 100 patient-years) during a median follow-up of 30 months. Patients experiencing MI were older (median [interquartile range] age, 69 [62-75] vs 66 [60-72] years), more likely to have diabetes (349 of 683 [51.1%] vs 4996 of 13 202 [37.8%]) or a previous lower extremity revascularization (466 of 683 [68.2%] vs 7409 of 13 202 [56.1%]), and had a lower ABI (if included by ABI) compared with censored patients. Of the 683 patients with MI during follow-up, the most common MI type was type 1 (405 [59.3%]), followed by type 2 (236 [34.6%]), type 4a (14 [2.0%]), type 3 (12 [1.8%]), type 4b (11 [1.6%]), and type 5 (5 [0.7%]). Postrandomization MI was independently associated with cardiovascular death (adjusted hazard ratio, 9.0; 95% CI, 7.3-11.2; P < .001) and acute limb ischemia requiring hospitalization (adjusted hazard ratio, 2.5; 95% CI, 1.3-5.0; P = .008). Conclusions and Relevance: Approximately 5% of patients with symptomatic PAD had an MI during a median follow-up of 30 months. Type 1 MI (spontaneous) was the most common MI type; however, one-third of MIs were type 2 MI (secondary). More research is needed to identify therapies to reduce the risk of MI in patients with PAD and to improve management of type 2 MI. Trial Registration: ClinicalTrials.gov Identifier: NCT01732822.

12.
Am J Cardiol ; 123(4): 571-575, 2019 02 15.
Artigo em Inglês | MEDLINE | ID: mdl-30538035

RESUMO

Although in situ internal mammary artery (is-IMA) grafting remains the most frequent conduit in coronary artery bypass grafting (CABG), circumstances may necessitate free grafting of the IMA (f-IMA), though differences in outcomes have not been fully characterized. The purpose of this study was to compare clinical and angiographic outcomes of is-IMA versus f-IMA coronary bypass grafts in patients who underwent elective CABG surgery. In 1,829 patients in the angiographic cohort of PREVENT IV, 1,572 (85.9%) had at least 1 IMA graft; of these, 34 (2.2%) patients had at least 1 f-IMA graft and 1,538 (97.8%) had at least 1 is-IMA graft without additional f-IMA grafts. Characteristics of patients, procedure, and grafts/targets were compared between cohorts. Primary endpoints included death, myocardial infarction, and revascularization, as well as incidence of graft failure (stenosis >75%) on angiography at 12-18 months postoperatively. Patients receiving is-IMA grafts were more often of white race and higher weight. Aortic cross-clamp time was shorter in the f-IMA cohort (39.5 vs 57.0 min, p = 0.04), but duration of bypass was similar (93.5 vs 100.0 minutes, p = 0.793). Of the in situ grafts, 97.3% were via the left internal mammary artery (LIMA), 86.6% were of good quality, and the left anterior descending (LAD) was bypassed in 88.2%. This compares with free grafts, which were via the LIMA in 68.0%, of good quality in 96.1%, and bypassed the LAD in 58.8% and first obtuse marginal (OM1) in 23.5%. Rates of death, myocardial infarction, and revascularization were similar between groups. The rate of graft failure was higher in f-IMA grafts (23.3%) compared with is-IMA grafts (8.5%; p < 0.01). Although clinical outcomes were similar with use of free versus in situ IMA grafts, higher rates of graft failure were encountered with use of the f-IMA graft. In conclusion, in situ grafts should be the preferred conduit for patients who undergo CABG surgery.


Assuntos
Doença da Artéria Coronariana/mortalidade , Doença da Artéria Coronariana/cirurgia , Oclusão de Enxerto Vascular/epidemiologia , Anastomose de Artéria Torácica Interna-Coronária/efeitos adversos , Infarto do Miocárdio/epidemiologia , Reoperação , Idoso , Estudos de Coortes , Feminino , Humanos , Incidência , Anastomose de Artéria Torácica Interna-Coronária/métodos , Masculino , Pessoa de Meia-Idade , Falha de Tratamento
13.
Am Heart J ; 208: 123-131, 2019 02.
Artigo em Inglês | MEDLINE | ID: mdl-30579505

RESUMO

BACKGROUND: Patients with atrial fibrillation (AF) often have multi-morbidity, defined as ≥3 comorbid conditions. Multi-morbidity is associated with polypharmacy, adverse events, and frailty potentially altering response to anticoagulation. We sought to describe the prevalence of multi-morbidity among older patients with AF and determine the association between multi-morbidity, clinical outcomes, and the efficacy and safety of apixaban compared with warfarin. METHODS: In this post-hoc subgroup analysis of the ARISTOTLE trial, we studied enrolled patients age ≥ 55 years (n = 16,800). Patients were categorized by the number of comorbid conditions at baseline: no multi-morbidity (0-2 comorbid conditions), moderate multi-morbidity (3-5 comorbid conditions), and high multi-morbidity (≥6 comorbid conditions). Association between multi-morbidity and clinical outcomes were analyzed by treatment with a median follow-up of 1.8 (1.3-2.3) years. RESULTS: Multi-morbidity was present in 64% (n = 10,713) of patients; 51% (n = 8491) had moderate multi-morbidity, 13% (n = 2222) had high multi-morbidity, and 36% (n = 6087) had no multi-morbidity. Compared with the no multi-morbidity group, the high multi-morbidity group was older (74 vs 69 years), took twice as many medications (10 vs 5), and had higher CHA2DS2-VASc scores (4.9 vs 2.7) (all P < .001). Adjusted rates per 100 patient-years for stroke/systemic embolism, death, and major bleeding increased with multi-morbidity (Reference no multi-morbidity; moderate multi-morbidity 1.42 [1.24-1.64] and high multi-morbidity 1.92 [1.59-2.31]), with no interaction in relation to efficacy or safety of apixaban. CONCLUSIONS: Multi-morbidity is prevalent among the population with AF; efficacy and safety of apixaban is preserved in this subgroup supporting extension of trial results to the most complex AF patients.


Assuntos
Anticoagulantes/uso terapêutico , Fibrilação Atrial/epidemiologia , Embolia/epidemiologia , Inibidores do Fator Xa/uso terapêutico , Hemorragia/epidemiologia , Multimorbidade , Pirazóis/uso terapêutico , Piridonas/uso terapêutico , Acidente Vascular Cerebral/epidemiologia , Varfarina/uso terapêutico , Fibrilação Atrial/complicações , Método Duplo-Cego , Embolia/etiologia , Embolia/prevenção & controle , Feminino , Hemorragia/induzido quimicamente , Hemorragia/prevenção & controle , Humanos , Masculino , Pessoa de Meia-Idade , Polimedicação , Acidente Vascular Cerebral/etiologia , Acidente Vascular Cerebral/prevenção & controle
14.
Am J Cardiol ; 122(6): 999-1007, 2018 09 15.
Artigo em Inglês | MEDLINE | ID: mdl-30269900

RESUMO

Patients with chronic kidney disease (CKD) and/or end-stage renal disease are less active and experience significant functional limitations. The impact of a structured aerobic exercise intervention on outcomes in ambulatory heart failure (HF) patients with comorbid CKD is unknown. HF-ACTION enrolled 2,331 outpatients with HF and a reduced ejection fraction (i.e., ≤35%) from April 2003 to February 2007 and randomized them to aerobic exercise training versus usual care. Patients were grouped according to the presence of CKD, defined as an estimated glomerular filtration rate <60 ml/min/1.73 m2. A total of 2,091 patients (90%) had serum creatinine measured and were included in the final analytical cohort. The prevalence of CKD was 41% at baseline. In patients with and without CKD, respectively, the incidence of all-cause death and hospitalization was 75% and 63% over a median follow-up of 30 months. After adjusting for potential confounders, CKD was associated with increased risk of the composite of all-cause mortality and hospitalization (hazard ratio 1.18, 95% confidence interval 1.04 to 1.33; p value ≤0.01). With the exception of a marginally greater improvement in exercise duration in response to aerobic exercise training (estimate ± standard error: 0.9 ± 0.2 minutes vs 1.4 ± 0.1 minutes; p value = 0.01), there was no interaction between treatment arm and CKD on functional status, health-related quality of life, or clinical outcomes (p value ≥0.05 for all interactions). In conclusion, the prevalence of CKD was high in ambulatory reduced ejection fraction patients and was associated with a poorer overall prognosis but not a differential response to aerobic exercise training.


Assuntos
Exercício , Insuficiência Cardíaca/complicações , Insuficiência Cardíaca/reabilitação , Falência Renal Crônica/complicações , Idoso , Biomarcadores/sangue , Causas de Morte , Creatinina/sangue , Feminino , Taxa de Filtração Glomerular , Humanos , Falência Renal Crônica/epidemiologia , Masculino , Pessoa de Meia-Idade , Prevalência , Prognóstico , Qualidade de Vida , Volume Sistólico , Resultado do Tratamento
15.
J Am Coll Cardiol ; 72(14): 1563-1572, 2018 10 02.
Artigo em Inglês | MEDLINE | ID: mdl-30261955

RESUMO

BACKGROUND: Lower extremity revascularization (LER) is a common treatment in patients with peripheral artery disease (PAD), but long-term outcomes are poorly defined. OBJECTIVES: The aim was to analyze LER in the EUCLID (Examining Use of tiCagreLor In paD) trial to determine predictors and cardiovascular outcomes. METHODS: Patients were grouped according to whether they received a post-randomization LER (n = 1,738) or not (n = 12,147). All variables were assessed for significance in univariable and parsimonious multivariable models. The primary endpoint was myocardial infarction, ischemic stroke, or cardiovascular death; major adverse limb events (MALE) included acute limb ischemia or major amputation. RESULTS: A post-randomization LER occurred in 12.5% of patients and was an endovascular LER in 74.7%. Endovascular LERs were performed more often in North America, whereas surgical procedures occurred more frequently in Europe. Independent factors predicting LER were prior and type of prior LER, geographic region, limb symptoms, diabetes, and smoking. A post-randomization LER was associated with an increased risk for the primary endpoint (hazard ratio: 1.60; 95% confidence interval: 1.35 to 1.90; p < 0.0001) and MALE (hazard ratio: 12.0; 95% confidence interval: 9.47 to 15.30; p < 0.0001). Event rates for the primary endpoint after LER were numerically higher in the surgical subgroup, but MALE were similar between surgical and endovascular LER. CONCLUSIONS: In the EUCLID trial, LER was most often endovascular. Following LER, there was an increased hazard for the primary endpoint (with higher event rates in the surgical group) and a markedly increased risk for MALE events (with similar event rates between surgical and endovascular LER procedures). (A Study Comparing Cardiovascular Effects of Ticagrelor and Clopidogrel in Patients With Peripheral Artery Disease [EUCLID]; NCT01732822).


Assuntos
Procedimentos Endovasculares , Extremidade Inferior/irrigação sanguínea , Extremidade Inferior/cirurgia , Doença Arterial Periférica/cirurgia , Idoso , Amputação/estatística & dados numéricos , Implante de Prótese Vascular , Endarterectomia , Feminino , Artéria Femoral/cirurgia , Hemorragia/epidemiologia , Humanos , Isquemia/epidemiologia , Masculino , Infarto do Miocárdio/epidemiologia , Artéria Poplítea/cirurgia , Acidente Vascular Cerebral/epidemiologia
16.
Otolaryngol Head Neck Surg ; 159(5): 895-899, 2018 11.
Artigo em Inglês | MEDLINE | ID: mdl-30084293

RESUMO

OBJECTIVE: The objective of this study was to describe patterns of corticosteroid treatment for sudden sensorineural hearing loss and to evaluate effectiveness based on delivery mode (oral vs intratympanic vs both). STUDY DESIGN: Cross-sectional repeated measures. SETTING: Patients were recruited from practices within the Creating Healthcare Excellence through Education and Research (CHEER) Network. CHEER is a National Institutes of Health-funded nationwide network of 30 community and academic otolaryngology practice sites. SUBJECTS AND METHODS: A subset of 117 patients who had been treated with steroids for sudden sensorineural hearing loss were recruited from within a larger initial CHEER Network study on clinical practice guideline compliance. Outcomes included audiometric and speech scores and patient-perceived improvement. Descriptive analyses, Wilcoxon rank-sum tests, and Fisher exact tests were run. RESULTS: Two categories (oral and simultaneous oral + intratympanic) had adequate sample sizes to support statistical comparison of treatment results. Improvements were seen in both audiometry and speech testing scores; 57% of patients self-reported improvement perceived as either minor or major. There were no significant differences in degree of improvement between these treatment groups. CONCLUSIONS: We observed that a majority of steroid-treated patients demonstrated hearing improvement, but this improvement did not meet criteria for statistical significance. As in other studies on this topic, the relatively small sample size may have prevented differentiation of effectiveness among steroid treatments. We propose that the use of alternative approaches, such as pragmatic clinical trials and multidisciplinary electronic health record systems and megadatabases, may hold the most promise for an approach to best practice development.


Assuntos
Glucocorticoides/administração & dosagem , Perda Auditiva Neurossensorial/diagnóstico , Perda Auditiva Neurossensorial/tratamento farmacológico , Perda Auditiva Súbita/diagnóstico , Perda Auditiva Súbita/tratamento farmacológico , Centros Médicos Acadêmicos , Administração Oral , Administração Tópica , Adulto , Audiometria de Tons Puros/métodos , Serviços de Saúde Comunitária/métodos , Estudos Transversais , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Prognóstico , Estudos Retrospectivos , Medição de Risco , Resultado do Tratamento , Membrana Timpânica/efeitos dos fármacos
17.
Am Heart J ; 205: 133-141, 2018 11.
Artigo em Inglês | MEDLINE | ID: mdl-30158057

RESUMO

BACKGROUND: The relationship between diuretic use or change in diuretic use and outcomes in chronic heart failure (HF) remains poorly defined. We evaluated the association between diuretic use and changes in health status, exercise capacity, and clinical events in a large randomized trial of subjects with HF. METHODS: HF-ACTION randomized 2,331 outpatients with HF and ejection fraction ≤35% to aerobic exercise training versus usual care. We grouped patients according to loop diuretic use from baseline through 6 months: continued use, never use, initiated, and discontinued. The association between diuretic use and changes in health status, exercise capacity, and clinical outcomes (all-cause mortality/hospitalization, cardiovascular mortality, and HF hospitalization) through 12 months was assessed using Cox proportional hazards models and generalized linear regression models, respectively. RESULTS: A total of 2,004 (86%) patients had complete data on diuretic use. There was no association between diuretic status and Kansas City Cardiomyopathy Questionnaire, 6-minute walk distance, or peak Vo2 in adjusted analyses (all P > .05). A dose increase was associated with decrease in 6-minute walk distance (-4.25 m, SE 1.12 m, P < .001) and change in Kansas City Cardiomyopathy Questionnaire overall score (-0.56 m, SE 0.24 m, P = .02). There were no between-group differences for all-cause death or hospitalization comparing continuous use versus never use (adjusted HR 0.91; 95% CI 0.72-1.15; P = .432). CONCLUSIONS: The initiation or discontinuation of diuretics over a 6-month time frame was not associated with a difference in mortality, hospitalizations, exercise, or health status outcomes, but a dose increase in HF patients was associated with worse exercise and health status outcomes.


Assuntos
Tolerância ao Exercício/fisiologia , Nível de Saúde , Insuficiência Cardíaca/tratamento farmacológico , Inibidores de Simportadores de Cloreto de Sódio e Potássio/administração & dosagem , Volume Sistólico/fisiologia , Idoso , Causas de Morte/tendências , Relação Dose-Resposta a Droga , Europa (Continente)/epidemiologia , Feminino , Seguimentos , Insuficiência Cardíaca/mortalidade , Insuficiência Cardíaca/fisiopatologia , Humanos , Masculino , Pessoa de Meia-Idade , América do Norte/epidemiologia , Estudos Retrospectivos , Taxa de Sobrevida/tendências , Fatores de Tempo , Resultado do Tratamento
18.
Otol Neurotol ; 39(7): e518-e523, 2018 08.
Artigo em Inglês | MEDLINE | ID: mdl-29912831

RESUMO

OBJECTIVE: Given ongoing debate about the suggested association, the primary objective was to determine if idiopathic sudden sensorineural hearing loss (ISSNHL) was a sentinel event for acute myocardial infarction (AMI) in adults. STUDY DESIGN: Case-control study. SETTING: United States MarketScan administrative health claims database. PATIENTS: Aged 18 years or older, had a diagnosis of ISSNHL on or after January 1st, 2011 and had sufficient follow-up data available to assess for AMI occurrence. INTERVENTION: N/A. MAIN OUTCOME MEASURES: Incidence rates (per 1,000 patient years) of AMI for cases and controls were computed. Adjusted and unadjusted Cox proportional hazards models were created to explore possible associations between ISSNHL and initial AMI. RESULTS: A total of 10,749 ISSNHL cases and 10,749 matched controls were included. There were no significant differences in the incidence rate of AMI between ISSNHL cases (8.29 events/1,000 person-years) and controls (9.25 events/1,000 person-years), nor were there differences within age groups, sex, or comorbidity status (overall incidence rate ratio 0.90; 95% confidence interval [CI] 0.70-1.15 p = 0.39). The unadjusted and adjusted Cox proportional hazards models did not demonstrate an association between ISSNHL and initial AMI (hazard ratio [HR]: 0.90, 95% CI: 0.70-1.15; HR: 0.86, 95% CI: 0.67-1.10, respectively). CONCLUSIONS: ISSNHL is not a predictor of an initial AMI in adult patients from the United States. Considerable inconsistencies in associations between cardiovascular risk factors and ISSNHL exist in the literature. Further work is needed to confirm or refute direct associations between cardiovascular disease risk factors and ISSNHL before definitive mechanistic conclusions can be made.


Assuntos
Perda Auditiva Neurossensorial/epidemiologia , Perda Auditiva Súbita/epidemiologia , Infarto do Miocárdio/epidemiologia , Adolescente , Adulto , Idoso , Estudos de Casos e Controles , Comorbidade , Bases de Dados Factuais , Feminino , Humanos , Incidência , Masculino , Pessoa de Meia-Idade , Modelos de Riscos Proporcionais
19.
Am Heart J ; 198: 18-24, 2018 04.
Artigo em Inglês | MEDLINE | ID: mdl-29653642

RESUMO

BACKGROUND: Current cholesterol guidelines recommend using 10-year risk of atherosclerotic cardiovascular disease (ASCVD) to guide informed decisions regarding statin therapy, yet patients may have difficulty conceptualizing absolute risk estimates. Peer comparisons may provide an improved tool for patient risk comprehension. METHODS: Using data from the 2009-2014 National Health and Nutrition Examination Survey (NHANES), we estimated standardized risk percentiles for various age-, sex-, and race-specific subgroups based on their 10-year ASCVD risks using the Pooled Cohort Equations. RESULTS: We examined 9160 adults in NHANES who were free of cardiovascular disease and had complete clinical data. Among specific age, sex, and race groups, we estimated the distribution of 10-year risk, calculating the 10-year risk corresponding to each percentile in order to generate standardized cardiovascular risk percentiles. Estimated 10-year ASCVD absolute risk varied markedly by age, sex, and race subgroups. A 10-year risk of 7.0% would put a 55 year-old black male in the 20th percentile relative to his peers (ie, at lower risk than 80% of his peers), whereas a 10-year risk of 7.0% would put a 55 year-old white female in the 95th percentile (i.e., only 5% of her peers would have higher risk). Standardized cardiovascular risk percentiles by age, race, and sex are available online at populationrelativerisk.dcri.org. CONCLUSION: Cardiovascular risk varies substantially by age, sex, and race. These data allow for 10-year absolute risks of ASCVD to be translated into a standardized cardiovascular risk percentile, providing patients with information that is easy to understanding regarding how their personal risk of cardiovascular disease compares with their age-, sex-, and race-matched peers.


Assuntos
Aterosclerose/tratamento farmacológico , Doenças Cardiovasculares/diagnóstico , Doenças Cardiovasculares/epidemiologia , Comunicação , Grupos Étnicos/estatística & dados numéricos , Inibidores de Hidroximetilglutaril-CoA Redutases/uso terapêutico , Adulto , Fatores Etários , Idoso , Aterosclerose/complicações , Aterosclerose/diagnóstico , Doenças Cardiovasculares/etiologia , Estudos de Coortes , Tomada de Decisões , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Inquéritos Nutricionais/métodos , Padrões de Referência , Estudos Retrospectivos , Medição de Risco , Fatores Sexuais , Estados Unidos
20.
J Am Soc Echocardiogr ; 31(6): 721-732.e5, 2018 06.
Artigo em Inglês | MEDLINE | ID: mdl-29525250

RESUMO

BACKGROUND: Right ventricular peak systolic longitudinal strain (RVLS) has emerged as an approach for quantifying right ventricular function in diseases such as pulmonary hypertension and congenital heart disease. A major limitation in applying RVLS is that strain imaging and analysis are proprietary, which may result in systematic differences from vendor to vendor. The goal of this study was to test the reproducibility of right ventricular strain analysis among selected vendor-specific software (VSS) and vendor-independent software (VIS) on images obtained from different ultrasound scanners, as would be common in clinical practice or in a multicenter clinical trial. METHODS: In this prospective, single-center study, 35 patients (5 healthy subjects and 30 with pulmonary hypertension) each underwent two echocardiographic scans, one using GE (Vivid E9) and the other using Philips (iE33) ultrasound systems. Images were analyzed using both VSS and VIS (TomTec) software for determination of RVLS. A repeated-measures analysis of variance was used to assess for any systematic differences among methods, as well as effects of scanner and software and a possible interaction between scanner and software for each strain measurement. RESULTS: Differences for global strains were not statistically significant among VSS packages (P ≥ .05), but some differences were noted between VSS and VIS. Wide variability between regional peak strain measurements was noted, but no systematic differences were found. CONCLUSIONS: Global RVLS values between VSS systems are not significantly different but may differ slightly from VIS. When comparing regional strain between VSS and VIS analyses, there is widespread variability without clear systematic differences.


Assuntos
Ecocardiografia/métodos , Ventrículos do Coração/diagnóstico por imagem , Hipertensão Pulmonar/fisiopatologia , Interpretação de Imagem Assistida por Computador/métodos , Software , Função Ventricular Direita/fisiologia , Adulto , Idoso , Feminino , Seguimentos , Ventrículos do Coração/fisiopatologia , Humanos , Hipertensão Pulmonar/diagnóstico , Masculino , Pessoa de Meia-Idade , Estudos Prospectivos , Reprodutibilidade dos Testes
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