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1.
Am Heart J ; 2021 Feb 08.
Artigo em Inglês | MEDLINE | ID: mdl-33571477

RESUMO

BACKGROUND: ROCKET AF demonstrated the efficacy and safety of rivaroxaban compared with warfarin for the prevention of stroke and systemic embolism (SE) in patients with atrial fibrillation (AF). We examined baseline characteristics and outcomes in patients enrolled in Latin America compared with the rest of the world (ROW). METHODS: ROCKET AF enrolled 14,264 patients from 45 countries. Of these, 1878 (13.2%) were from 7 Latin American countries. The clinical characteristics and outcomes (adjusted by baseline characteristics) of these patients were compared with 12,293 patients from the ROW. Treatment outcomes of rivaroxaban compared with warfarin were also stratified by region. RESULTS: The annual rate of stroke/SE was similar in those from Latin American and ROW (p=0.63), but all-cause and vascular death were significantly higher than in ROW (HR 1.40, 95% CI 1.20-1.64; HR 1.38, 95% CI 1.14-1.68; p<0.001). Rates of major or non-major clinically relevant bleeding tended to be lower in Latin America (HR 0.89, 95% CI 0.80-1.0; p=0.05). Rates of stroke/SE were similar with rivaroxaban and warfarin in patients from Latin America and ROW (HR 0.83, 95% CI 0.54-1.29 vs. HR 0.89, 95% CI 0.75-1.07; interaction p=0.77). CONCLUSIONS: Patients with AF in Latin America had similar rates of stroke/SE, higher rates of vascular death, and lower rates of bleeding compared with patients in the ROW. The effect of rivaroxaban compared with warfarin in Latin America was similar to the ROW. Further studies analyzing patient- and country-specific determinants of these regional differences in Latin America are warranted.

2.
JACC Heart Fail ; 9(1): 28-38, 2021 Jan.
Artigo em Inglês | MEDLINE | ID: mdl-33309579

RESUMO

OBJECTIVES: The authors sought to evaluate the association of heart failure hospitalization (HFH) with guideline-directed medical therapy (GDMT) prescribing patterns among patients with heart failure with reduced ejection fraction (HFrEF). BACKGROUND: HFH represents an important opportunity to titrate GDMT among patients with HFrEF. METHODS: The CHAMP-HF (Change the Management of Patients With Heart Failure) registry is a prospective registry of adults with HFrEF (ejection fraction ≤40%). Using data from the CHAMP-HF registry (N = 4,365), adjusted time-to-event models were created to study the association of HFH with GDMT prescribing patterns. RESULTS: HFH (compared with no HFH) was positively associated with initiation of angiotensin-converting enzyme (ACE) inhibitor/angiotensin receptor blocker (ARB), angiotensin receptor-neprilysin inhibitor, beta-blocker, and mineralocorticoid receptor antagonist (MRA). HFH positively associated with dose escalation of ACE inhibitor/ARB (probability ratio: 1.71, 95% confidence interval [CI]: 1.36 to 2.16) and MRA (probability ratio: 8.71, 95% CI: 4.19 to 18.10). In those on prior therapy, HFH was associated with discontinuation and de-escalation of all classes of GDMT. ACE inhibitor/ARB, angiotensin receptor-neprilysin inhibitor, beta-blocker, and MRA de-escalation/discontinuation after HFH was associated with increased risk of all-cause mortality with hazard ratios of 3.82 (95% CI: 2.42 to 6.03), 4.76 (95% CI: 2.06 to 11.03), 2.94 (95% CI: 2.04 to 4.25), and 4.81 (95% CI: 2.61 to 8.87), respectively. CONCLUSIONS: HFH positively associated with changes in GDMT, including initiation, dose escalation, discontinuation, and dose de-escalation. De-escalation/discontinuation of GDMT after HFH associated with increased risk of all-cause mortality. Educational endeavors are needed to ensure GDMT is not inappropriately held in the setting of HFH. For those in whom GDMT must be held/decreased, improvement tools at discharge and post-discharge titration clinics may help ensure lifesaving GDMT regimens remain optimized.

3.
J Stroke Cerebrovasc Dis ; 29(12): 105399, 2020 Dec.
Artigo em Inglês | MEDLINE | ID: mdl-33254370

RESUMO

BACKGROUND: Limited real-world data are available on outcomes following non-cardioembolic minor ischemic stroke (IS) or high-risk transient ischemic attack (TIA), particularly in the United States (US). We examined outcomes and Medicare payments following any severity IS or TIA as well as the subgroup with minor IS or high-risk TIA. METHODS: Medicare beneficiaries >65 years were identified using US nationwide Get with the Guidelines (GWTG)-Stroke Registry linked to Medicare claims data. The cohort consisted of patients enrolled in Medicare fee-for-service plan, hospitalized with non-cardioembolic IS or TIA between 2011 and 2014, segmenting a subgroup with minor IS (National Institute of Health Stroke Scale [NIHSS] ≤5) or high-risk TIA (ABCD2-score ≥6) compatible with the THALES clinical trial population. Outcomes included functional status at discharge, clinical outcomes (all-cause mortality, ischemic stroke, and hemorrhagic stroke, individually and as a composite), hospitalizations, and population average inpatient Medicare payments following non-cardioembolic IS or TIA. RESULTS: The THALES-compatible cohort included 62,518 patients from 1471 hospitals. At discharge, 37.0% were unable to ambulate without assistance, and 96.2% were prescribed antiplatelet therapy. Cumulative incidences at 30 days, 90 days, and 1 year for the composite outcome were 3.7%, 7.6%, and 17.2% and 2.4%, 4.0%, and 7.3% for subsequent stroke. The mean Medicare payment for the index hospitalization was $7951. The cumulative all-cause inpatient Medicare spending per patient (with or without any subsequent admission) at 30 days and 1 year from discharge was $1451 and $8105, respectively. CONCLUSIONS: The burden of illness for minor IS/high-risk TIA patients indicates an important unmet need. Improved therapeutic options may offer a significant impact on both patient outcomes and Medicare spending.

4.
Artigo em Inglês | MEDLINE | ID: mdl-33085123

RESUMO

BACKGROUND: Leadless pacemakers (LPs) provide ventricular pacing without the risks associated with transvenous leads and device pockets. LPs are appealing for patients who need pacing, but do not need defibrillator or cardiac resynchronization therapy. Most implanted LPs provide right ventricular pacing without atrioventricular synchrony (VVIR mode). The Mode Selection Trial in Sinus Node Dysfunction (MOST) showed similar outcomes in patients randomized to dual-chamber (DDDR) versus ventricular pacing (VVIR). We compared outcomes by pacing mode in LP-eligible patients from MOST. METHODS: Patients enrolled in the MOST study with an left ventricular ejection fraction (LVEF) >35%, QRS duration (QRSd) <120 ms and no history of ventricular arrhythmias or prior implantable cardioverter defibrillators were included (LP-eligible population). Cox proportional hazards models were used to test the association between pacing mode and death, stroke or heart failure (HF) hospitalization and atrial fibrillation (AF). RESULTS: Of the 2010 patients enrolled in MOST, 1284 patients (64%) met inclusion criteria. Baseline characteristics were well balanced across included patients randomized to DDDR (N = 630) and VVIR (N = 654). Over 4 years of follow-up, there was no association between pacing mode and death, stroke or HF hospitalization (VVIR HR 1.28 [0.92-1.75]). VVIR pacing was associated with higher risk of AF (HR 1.32 [1.08-1.61], P = .007), particularly in patients with no history of AF (HR 2.38 [1.52-3.85], P < .001). CONCLUSION: In patients without reduced LVEF or prolonged QRSd who would be eligible for LP, DDDR, and VVIR pacing demonstrated similar rates of death, stroke or HF hospitalization; however, VVIR pacing significantly increased the risk of AF development.

5.
J Am Coll Cardiol ; 76(4): 405-415, 2020 Jul 28.
Artigo em Inglês | MEDLINE | ID: mdl-32703511

RESUMO

BACKGROUND: The SCD-HeFT (Sudden Cardiac Death in Heart Failure Trial) randomized 2,521 patients with moderate heart failure (HF) to amiodarone, placebo drug, or implantable cardioverter-defibrillator (ICD) therapy. Original trial follow-up ended October 31, 2003. Over a median 45.5-month follow-up, amiodarone, compared with placebo, did not affect survival, whereas randomization to an ICD significantly decreased all-cause mortality by 23%. OBJECTIVES: This study sought to describe the extended treatment group survival of the SCD-HeFT cohort. METHODS: Mortality outcomes for the 1,855 patients alive at the end of the SCD-HeFT trial were collected between 2010 and 2011. These data were combined with the 666 deaths from the original study to compare long-term outcomes overall and for key pre-specified subgroups. RESULTS: Median (25th to 75th percentiles) follow-up was 11.0 (10.0 to 12.2) years. On the basis of intention-to-treat analysis, the ICD group had overall survival benefit versus placebo drug (hazard ratio [HR]: 0.87; 95% confidence interval [CI]: 0.76 to 0.98; p = 0.028). When treatment benefit was examined as a function of time from randomization, attenuation of the ICD benefit was observed after 6 years (p value for the interaction = 0.0015). Subgroup analysis revealed long-term ICD benefit varied according to HF etiology and New York Heart Association (NYHA) functional class: ischemic HF HR: 0.81; 95% CI: 0.69 to 0.95; p = 0.009; nonischemic HF HR: 0.97; 95% CI: 0.79 to 1.20; p = 0.802; NYHA functional class II HR: 0.76; 95% CI: 0.65 to 0.90; p = 0.001; NYHA functional class III HR: 1.06; 95% CI: 0.86 to 1.31; p = 0.575. CONCLUSIONS: Follow-up of SCD-HeFT patients to 11 years demonstrated heterogenous treatment-related patterns of long-term survival with ICD benefit most evident at 11 years for ischemic HF patients and for those with NYHA functional class II symptoms at trial enrollment. (SCD-HeFT 10 Year Follow-up [SCD-HeFT10 Yr]; NCT01058837).

6.
BMJ Open Respir Res ; 7(1)2020 07.
Artigo em Inglês | MEDLINE | ID: mdl-32624493

RESUMO

BACKGROUND: Idiopathic pulmonary fibrosis (IPF) is a progressive disease with high mortality. Patient characteristics associated with diagnostic delays are not well described. METHODS: Subjects who had not been diagnosed with IPF prior to referral and received a new diagnosis of IPF at an enrolling centre for the IPF-PRO (Idiopathic Pulmonary Fibrosis Prospective Outcomes) Registry were characterised as having a longer (>1 year) or shorter (≤1 year) time from symptom onset to diagnosis and from first imaging evidence of fibrosis to diagnosis. Patient characteristics, evaluations and time to death or lung transplant were compared between these cohorts. RESULTS: Among 347 patients with a symptom onset date, 49% were diagnosed with IPF >1 year after symptom onset. These patients were slightly younger and had more cardiac comorbidities than patients diagnosed ≤1 year after symptom onset. Among 454 patients with a date for imaging evidence of fibrosis, 78% were diagnosed with IPF ≤1 year later. A greater proportion of patients with >1 year versus ≤1 year from imaging evidence of fibrosis to diagnosis had cardiac comorbidities and gastro-oesophageal reflux. There was no significant difference in time to death or lung transplant between groups by time to diagnosis. CONCLUSIONS: The time from symptom onset to diagnosis remains over 1 year in approximately half of the patients with IPF, but once imaging evidence is obtained, most of the patients are diagnosed within a year. Cardiac conditions and gastro-oesophageal disorders were more commonly reported in patients with a longer time to diagnosis.

7.
Circ Heart Fail ; 13(7): e006833, 2020 07.
Artigo em Inglês | MEDLINE | ID: mdl-32580657

RESUMO

BACKGROUND: Among patients with heart failure (HF) with reduced ejection fraction (EF), improvements in left ventricular EF (LVEF) are associated with better outcomes and remain an important treatment goal. Patient factors associated with LVEF improvement in routine clinical practice have not been clearly defined. METHODS: CHAMP-HF (Change the Management of Patients with Heart Failure) is a prospective registry of outpatients with HF with reduced EF. Assessments of LVEF are recorded when performed for routine care. We analyzed patients with both baseline and ≥1 follow-up LVEF assessments to describe factors associated with LVEF improvement. RESULTS: In CHAMP-HF, 2623 patients had a baseline and follow-up LVEF assessment. The median age was 67 (interquartile range, 58-75) years, 40% had an ischemic cardiomyopathy, and median HF duration was 2.8 years (0.7-6.8). Median LVEF was 30% (23-35), and median change on follow-up was 4% (-2 to -13); 19% of patients had a decrease in LVEF, 31% had no change, 49% had a ≥5% increase, and 34% had a ≥10% increase. In a multivariable model, the following factors were associated with ≥5% LVEF increase: shorter HF duration (odds ratio [OR], 1.21 [95% CI, 1.17-1.25]), no implantable cardioverter defibrillator (OR, 1.46 [95% CI, 1.34-1.55]), lower LVEF (OR, 1.15 [95% CI, 1.10-1.19]), nonischemic cardiomyopathy (OR, 1.24 [95% CI, 1.09-1.36]), and no coronary disease (OR, 1.20 [95% CI, 1.03-1.35]). CONCLUSIONS: In a large cohort of outpatients with chronic HF with reduced EF, improvements in LVEF were common. Common baseline cardiac characteristics identified a population that was more likely to respond over time. These data may inform clinical decision making and should be the basis for future research on myocardial recovery.


Assuntos
Insuficiência Cardíaca/fisiopatologia , Volume Sistólico , Idoso , Assistência Ambulatorial , Doença Crônica , Estudos de Coortes , Progressão da Doença , Ecocardiografia , Feminino , Insuficiência Cardíaca/diagnóstico por imagem , Insuficiência Cardíaca/etiologia , Insuficiência Cardíaca/terapia , Humanos , Masculino , Pessoa de Meia-Idade , Estudos Prospectivos , Recuperação de Função Fisiológica , Sistema de Registros , Volume Sistólico/fisiologia , Resultado do Tratamento
8.
Circ Cardiovasc Qual Outcomes ; 13(7): e006204, 2020 Jul.
Artigo em Inglês | MEDLINE | ID: mdl-32586105

RESUMO

BACKGROUND: Catheterization laboratory (cath lab) activation time is a newly available process measure for patients with ST-segment-elevation myocardial infarction requiring inter-hospital transfers for primary percutaneous coronary intervention that reflects inter-facility communication and urgent mobilization of interventional laboratory resources. Our aim was to determine whether faster activation is associated with improved reperfusion time and outcomes in the American Heart Association Mission: Lifeline Accelerator-2 Project. METHODS AND RESULTS: From April 2015 to March 2017, treatment times of 2063 patients with ST-segment-elevation myocardial infarction requiring inter-hospital transfer for primary percutaneous coronary intervention from 12 regions around the United States were stratified by cath lab activation time (first hospital arrival to cath lab activation within [timely] or beyond 20 minutes [delayed]). Median cath lab activation time was 26 minutes, with a delayed activation observed in 1241 (60.2%) patients. Prior cardiovascular or cerebrovascular disease, arterial hypotension at admission, and black or Latino ethnicity were independent factors of delayed cath lab activation. Timely cath lab activation patients had shorter door-in door-out times (40 versus 68 minutes) and reperfusion times (98 versus 135 minutes) with 80.1% treated within the national goal of ≤120 minutes versus 39.0% in the delayed group. CONCLUSIONS: Cath lab activation within 20 minutes across a geographically diverse group of hospitals was associated with performing primary percutaneous coronary intervention within the national goal of ≤120 minutes in >75% of patients. While several confounding factors were associated with delayed activation, this work suggests that this process measure has the potential to direct resources and practices to more timely treatment of patients requiring inter-hospital transfer for primary percutaneous coronary intervention.

9.
J Am Coll Cardiol ; 75(11): 1299-1308, 2020 03 24.
Artigo em Inglês | MEDLINE | ID: mdl-32192656

RESUMO

BACKGROUND: Atrial fibrillation (AF) is common in patients with end-stage renal disease (ESRD). The impact of oral anticoagulation (OAC) in ESRD patients is uncertain. OBJECTIVES: The purpose of this study was to describe patterns of OAC use in ESRD patients with AF and their associations with cardiovascular outcomes. METHODS: Using Medicare fee-for-service 5% claims data from 2007 to 2013, we analyzed treatment and outcomes in a cohort of patients with ESRD and AF. Prescription drug benefit information was used to determine the timing of OAC therapy. Cox proportional hazards modeling was used to compare outcomes including death, all-cause stroke, ischemic stroke, hemorrhagic stroke, and bleeding hospitalizations in ESRD patients treated with or without OAC. RESULTS: The cohort included 8,410 patients with AF and ESRD. A total of 3,043 (36.2%) patients were treated with OAC at some time during the study period. Propensity scores used to match 1,519 patients with AF and ESRD on OAC with 3,018 ESRD patients without OAC. Treatment with OAC was not associated with hospitalization for stroke (hazard ratio [HR]: 1.00; 95% confidence interval [CI]: 0.23 to 1.35; p = 0.97) or death (HR: 1.02; 95% CI: 0.94 to 1.10; p = 0.62). OAC was associated with an increased risk of hospitalization for bleeding (HR: 1.26; 95% CI: 1.09 to 1.46; p = 0.0017) and intracranial hemorrhage (HR: 1.30; 95% CI: 1.07 to 1.59; p = 0.0094). CONCLUSIONS: OAC utilization was low in patients with AF and ESRD. We found no association between OAC use and reduced risk of stroke or death. OAC use was associated with increased risks of hospitalization for bleeding or intracranial hemorrhage. Alternative stroke prevention strategies are needed in patients with ESRD and AF.

10.
Ann Am Thorac Soc ; 17(6): 699-705, 2020 06.
Artigo em Inglês | MEDLINE | ID: mdl-32040340

RESUMO

Rationale: Progression of idiopathic pulmonary fibrosis (IPF) is accompanied by worsening of symptoms, exercise capacity, and health-related quality of life. However, the utility of patient-reported outcomes as predictors of mortality remains uncertain.Objectives: To assess whether patient-reported outcomes are independently associated with mortality beyond clinical risk factors in patients with IPF.Methods: Data from the observational IPF Prospective Outcomes Registry were used to examine associations between patient-reported outcomes at enrollment and the composite outcome of death or lung transplant in the following year. Associations were examined using univariable models and models adjusted for age and clinical variables that have been associated with death or lung transplant in patients with IPF in this cohort (oxygen use, forced vital capacity % predicted, and diffusing capacity of the lungs for carbon monoxide % predicted at enrollment).Results: Among 662 patients, 45 died and 12 underwent lung transplant over 1 year. In the model adjusted for age and clinical variables that were associated with death or lung transplant, worse scores on the St. George's Respiratory Questionnaire (SGRQ) total score (hazard ratio [HR], 1.22 [95% confidence interval (CI), 1.01-1.48] per 10-point increase), SGRQ activity score (HR, 1.25 [95% CI, 1.02-1.54] per 10-point increase) and SGRQ symptoms score (HR, 1.17 [95% CI, 1.01-1.36] per 10-point increase) were associated with death or lung transplant over 1 year.Conclusions: Patient-reported outcomes that assess symptoms and physical activity are independently associated with mortality in patients with IPF.

11.
Chest ; 157(5): 1188-1198, 2020 May.
Artigo em Inglês | MEDLINE | ID: mdl-31954102

RESUMO

BACKGROUND: Limited data are available on the association between clinically measured disease severity markers and quality of life (QOL) in idiopathic pulmonary fibrosis (IPF). The study examined the associations between objective disease severity metrics and QOL in a contemporary IPF population. METHODS: This study evaluated baseline data from patients enrolled in the multicenter, US-based Idiopathic Pulmonary Fibrosis Prospective Outcomes Registry between June 2014 and July 2018. Disease severity metrics included FVC % predicted, diffusing capacity for carbon monoxide (Dlco) % predicted, supplemental oxygen use with activity, supplemental oxygen use at rest, and two summary scores (the Gender-Age-Lung Physiology index, based on gender, age, and % predicted values for Dlco and FVC; and the Composite Physiologic Index, based on % predicted values for Dlco, FVC, and FEV1). Multivariable adjusted regression models were used to examine cross-sectional associations between each severity measure and St. George's Respiratory Questionnaire (SGRQ) total score. RESULTS: Among 829 patients with complete SGRQ data, the median (interquartile range) SGRQ score at enrollment was 40 (26-53), with higher scores indicating worse QOL. Modest SGRQ impairments were observed with increasing Gender-Age-Lung Physiology score (2.9 [1.8-4.0] per 1-point increase] and with increasing Composite Physiologic Index scores (3.0 [2.4-3.6] per 5-point increase). Substantial SGRQ impairments were observed for oxygen use with activity (15.6 [12.9-18.2]), oxygen use at rest (16.2 [13.0-19.4]), and decreasing Dlco (5.0 [4.0-6.1] per 10% decrease in % predicted). CONCLUSIONS: Objective measures of disease severity, including severity scores, physiologic parameters, and supplemental oxygen use, are associated with worse QOL in patients with IPF. TRIAL REGISTRY: ClinicalTrials.gov; No.: NCT01915511; URL: www.clinicaltrials.gov.

12.
Cardiol Ther ; 8(2): 283-295, 2019 Dec.
Artigo em Inglês | MEDLINE | ID: mdl-31376090

RESUMO

INTRODUCTION: Patient-reported outcomes (PROs) and satisfaction endpoints are increasingly important in clinical trials and may be associated with treatment adherence. In this post hoc substudy from ROCKET AF, we examined whether patient-reported satisfaction was associated with study drug discontinuation. METHODS: ROCKET AF (n = 14,264) compared rivaroxaban with warfarin for prevention of stroke and systemic embolism in patients with atrial fibrillation. We analyzed treatment satisfaction scores: the Anti-Clot Treatment Scale (ACTS) and Treatment Satisfaction Questionnaire for Medication version II (TSQM II). We compared satisfaction with study drug between the two treatment arms, and examined the association between satisfaction and patient-driven study drug discontinuation (stopping study drug due to withdrawal of consent, noncompliance, or loss to follow-up). RESULTS: A total of 1577 (11%) patients participated in the Patient Satisfaction substudy; 1181 (8.3%) completed both the ACTS and TSQM II 4 weeks after starting study drug. Patients receiving rivaroxaban did not experience significant differences in satisfaction compared with those receiving warfarin. During a median follow-up of 1.6 years, 448 premature study drug discontinuations occurred (213 rivaroxaban group; 235 warfarin group), of which 116 (26%) were patient-driven (52 [24%] rivaroxaban group; 64 [27%] warfarin group). No significant differences were observed between satisfaction level and rates of patient-driven study drug discontinuation. CONCLUSIONS: Study drug satisfaction did not predict rate of study drug discontinuation. No significant difference was observed between satisfaction with warfarin and rivaroxaban, as expected given the double-blind trial design. Although these results are negative, the importance of PRO data will only increase, and these analyses may inform future studies that explore the relationship between drug-satisfaction PROs, adherence, and clinical outcomes. CLINICALTRIALS.GOV: NCT00403767. FUNDING: The ROCKET AF trial was funded by Johnson & Johnson and Bayer.

13.
Respir Res ; 20(1): 105, 2019 May 30.
Artigo em Inglês | MEDLINE | ID: mdl-31142314

RESUMO

BACKGROUND: Idiopathic pulmonary fibrosis (IPF) is a progressive disease with a variable clinical course and high mortality. We used data from a large national US registry of patients with IPF to investigate relationships between patient characteristics, including markers of disease severity, and mortality. METHODS: The analysis cohort comprised patients enrolled in the IPF-PRO Registry from its inception on 5 June 2014 to 26 October 2017. The primary criterion for inclusion in this registry is that patients must be diagnosed or confirmed with IPF at the enrolling centre within 6 months. Associations between patient characteristics and markers of disease severity at enrolment and mortality outcomes were investigated using univariable, multivariable and adjustment models. RESULTS: Among 662 patients enrolled, 111 patients died or had a lung transplant over a follow-up period of 30 months. The probability of being free of both events at month 30 was 50.6% (95% CI: 40.0, 60.2). When patient characteristics and markers of disease severity were jointly examined in a multivariable analysis, oxygen use at rest (hazard ratio [HR] 2.44 [95% CI: 1.45, 4.10]), lower forced vital capacity (FVC) % predicted (HR 1.28 [95% CI: 1.10, 1.49] per 10% decrease) and diffusion capacity for carbon monoxide (DLco) % predicted (HR 1.25 [95% CI: 1.04, 1.51] per 10% decrease) were significantly associated with increased risk of death or lung transplant. The risk of death or lung transplant increased with increasing age in patients ≥62 years old (HR 1.18 [95% CI: 0.99, 1.40] per 5-year increase), and decreased with increasing age in patients <62 years old (HR 0.60 [95% CI: 0.39, 0.92] per 5-year increase). CONCLUSIONS: In an observational US registry of patients with IPF, oxygen use at rest, lower FVC % predicted, and lower DLco % predicted were associated with risk of death or lung transplant. An audio podcast of the lead author discussing these data can be downloaded from: http://www.usscicomms.com/respiratory/snyder/IPF-PROsurvival1/ . TRIAL REGISTRATION: ClinicalTrials.gov number: NCT01915511 .


Assuntos
Fibrose Pulmonar Idiopática/mortalidade , Fibrose Pulmonar Idiopática/cirurgia , Transplante de Pulmão/mortalidade , Sistema de Registros , Idoso , Idoso de 80 Anos ou mais , Estudos de Coortes , Feminino , Seguimentos , Humanos , Fibrose Pulmonar Idiopática/diagnóstico , Transplante de Pulmão/tendências , Masculino , Pessoa de Meia-Idade , Mortalidade/tendências , Valor Preditivo dos Testes
14.
J Thromb Thrombolysis ; 48(1): 27-34, 2019 Jul.
Artigo em Inglês | MEDLINE | ID: mdl-30972712

RESUMO

We explored associations between INR measures and clinical outcomes in patients with AF using warfarin, and whether INR history predicted future INR measurements. We included patients in ARISTOTLE who were randomized to and received warfarin. Among patients who had events, we included those with ≥ 3 INR values in the 180 days prior to the event, with the most recent ≤ 60 days prior to the event, who were on warfarin at the time of event (n = 545). Non-event patients were included in the control group if they had ≥ 180 days of warfarin exposure with ≥ 3 INR measurements (n = 7259). The median (25th, 75th) number of INR values per patient was 29 (21, 38) over a median follow-up of 1.8 years. A total of 87% had at least one INR value < 1.5; 49% had at least one value > 4.0. The last INRs before events (median 14 [24, 7] days) were < 3.0 for at least 75% of patients with major bleeding and > 2.0 for half of patients with ischemic stroke. Historic time in therapeutic range (TTR) was weakly associated with future TTR (R2 = 0.212). Historic TTR ≥ 80% had limited predictive ability to discriminate future TTR ≥ 80% (C index 0.61). In patients with AF receiving warfarin, most bleeding events may not have been preventable despite careful INR control. Our findings suggest that INRs collected through routine management are not sufficiently predictive to provide reassurance about future time in therapeutic range or to prevent subsequent outcomes, and might be over-interpreted in clinical practice.


Assuntos
Fibrilação Atrial/diagnóstico , Coeficiente Internacional Normatizado/normas , Idoso , Fibrilação Atrial/complicações , Fibrilação Atrial/tratamento farmacológico , Isquemia Encefálica , Estudos de Casos e Controles , Feminino , Hemorragia , Humanos , Masculino , Pessoa de Meia-Idade , Valor Preditivo dos Testes , Acidente Vascular Cerebral , Resultado do Tratamento , Varfarina/uso terapêutico
15.
Am J Cardiol ; 123(7): 1083-1095, 2019 04 01.
Artigo em Inglês | MEDLINE | ID: mdl-30685057

RESUMO

The association between admission blood pressure (BP) and outcomes in patients with transient ischemic attack (TIA) is not well defined. Patients in the United States national Get With The Guidelines-Stroke registry with a TIA were included. Admission systolic and diastolic BP was used to compute mean arterial pressure and pulse pressure (PP). A subset of this cohort was linked to Centers for Medicare and Medicaid claims data for postdischarge outcomes. The in-hospital outcomes of interest were: mortality, not discharged home, and inability to ambulate independently at discharge. Postdischarge, 30-day and 90-day outcomes of interest were mortality, readmission for stroke, and readmission for major cardiovascular event-composite of death, cerebrovascular, or cardiovascular readmission. Among the 218,803 patients with TIA, lower admission systolic blood pressure (SBP) was associated with worse in-hospital outcomes. Compared with patients with SBP of 150 mm Hg, a lower SBP of 120 mm Hg was associated with higher risk of in-hospital death (adjusted OR = 1.79; 95% CI = 1.50 to 2.12), not being discharged home (adjusted OR = 1.31; 95% CI = 1.27 to 1.36), or inability to ambulate independently at discharge (adjusted OR = 1.27; 95% CI = 1.23 to 1.31). Similarly, among the 64,352 patients in the Centers for Medicare and Medicaid-linked cohort, an inverse association between systolic BP and postdischarge mortality (p <0.0001), and major cardiovascular event (p = 0.0001) was observed at 30-days and at 90-days postdischarge. However, there was no relation between SBP and readmission for stroke either at 30-days (p = 0.35) or at 90-days (p = 0.11). Results were largely similar for diastolic BP, mean arterial pressure, PP, and outcomes. In conclusion, in patients with a transient ischemic attack, a BP paradox was observed, with higher admission BP associated with improved in-hospital, 30-day, and 90-day postdischarge outcomes.


Assuntos
Pressão Sanguínea/fisiologia , Pacientes Internados , Ataque Isquêmico Transitório/terapia , Admissão do Paciente/tendências , Sistema de Registros , Idoso , Idoso de 80 Anos ou mais , Feminino , Seguimentos , Mortalidade Hospitalar/tendências , Humanos , Ataque Isquêmico Transitório/fisiopatologia , Masculino , Pessoa de Meia-Idade , Prognóstico , Estudos Retrospectivos , Taxa de Sobrevida/tendências , Sístole , Fatores de Tempo , Estados Unidos/epidemiologia
16.
Int J Cardiol ; 274: 16-20, 2019 Jan 01.
Artigo em Inglês | MEDLINE | ID: mdl-30217419

RESUMO

BACKGROUND: Myocardial infarction (MI) presentations are more common during winter months and morning hours. However, it is unknown whether MI with obstructive coronary artery disease (MI-CAD) and non-obstructive CAD (MINOCA) display similar patterns. METHODS: We evaluated seasonal and circadian patterns of MI presentation by coronary artery disease (CAD) status and sex in patients with MI from 2007 to 2014 in the National Cardiovascular Data Registry (NCDR) Acute Coronary Treatment Intervention Outcomes Network (ACTION) Registry-Get With the Guidelines. Adult patients who underwent coronary angiography for MI were included. Patients with missing age, sex, or angiographic data, cocaine use, thrombolytic therapy prior to catheterization, or prior revascularization were excluded. Baseline demographics and characteristics of symptom onset, including season and time of day of presentation, were compared by CAD status and sex. RESULTS: Among 322,523 patients, 112,547 were female (35%); 18,918 had MINOCA (5.9%). There was no seasonal pattern of MI overall. However, both men and women with MINOCA presented more often in the summer and fall while MI-CAD presentations were equally distributed across seasons. The most common time of presentation was 8 am-2 pm regardless of CAD status or sex. A secondary peak in women with MINOCA during late afternoon hours was also identified. CONCLUSIONS: Seasonal variation of MI differed between MINOCA and MI-CAD, with a small increase in MINOCA incidence in the summer and fall. MINOCA and MI-CAD most commonly occurred in the morning, with a secondary peak in late afternoon in women with MINOCA. These differences in presentation may relate to underlying MI pathophysiology.


Assuntos
Doença da Artéria Coronariana/complicações , Infarto do Miocárdio/epidemiologia , Sistema de Registros , Estações do Ano , Idoso , Idoso de 80 Anos ou mais , Angiografia Coronária , Doença da Artéria Coronariana/diagnóstico , Feminino , Seguimentos , Humanos , Incidência , Masculino , Pessoa de Meia-Idade , Infarto do Miocárdio/diagnóstico , Infarto do Miocárdio/etiologia , Estudos Retrospectivos , Fatores de Risco , Fatores Sexuais , Fatores de Tempo , Estados Unidos/epidemiologia
17.
Eur Heart J Qual Care Clin Outcomes ; 5(2): 145-152, 2019 04 01.
Artigo em Inglês | MEDLINE | ID: mdl-30219887

RESUMO

AIMS: The management of anticoagulation therapy in patients with atrial fibrillation (AF) and cancer is challenging due to increased thrombotic and bleeding risks. We sought to determine the safety and efficacy of rivaroxaban in patients with AF and a history of cancer. METHODS AND RESULTS: ROCKET AF randomized 14 264 patients with AF to rivaroxaban or warfarin with a median follow-up of 1.9 years. Cox regression models were used to assess the association between cancer history and clinical outcomes, and the relative treatment effect of rivaroxaban vs. warfarin in these patients. A total of 640 patients enrolled in ROCKET AF had a history of cancer, with the most common types being prostate (28.6%), colorectal (16.1%), and breast (14.7%) cancer. Patients with a history of cancer were older, more frequently male, more likely to have prior vitamin K antagonist (VKA) use and had higher rates of overall bleeding [hazard ratio (HR) 1.30, 95% confidence interval (CI) 1.16-1.47; P < 0.0001] and non-cardiovascular death (HR 1.47, 95% CI 1.04-2.07; P = 0.031) compared with those with no cancer history. There were no significant associations between cancer history and stroke, venous thromboembolism, or myocardial infarction. The relative efficacy of rivaroxaban vs. warfarin for prevention of stroke/systemic embolism was similar in those with and without a history of cancer (interaction P-value = 0.21). CONCLUSION: In ROCKET AF, a history of cancer was associated with a higher risk of bleeding and non-cardiovascular death, but not ischaemic events. The relative efficacy and safety of rivaroxaban compared with warfarin were not significantly different in patients with and without a history of cancer. The results of this study are exploratory and should be taken in context of the study population, which may not be generalizable to those with advanced malignancy. Further investigation is needed to understand optimal anticoagulation strategies in patients with AF and cancer.Clinical trial registration: ClinicalTrials.gov: NCT00403767.


Assuntos
Fibrilação Atrial/tratamento farmacológico , Hemorragia/epidemiologia , Neoplasias/complicações , Rivaroxabana/administração & dosagem , Acidente Vascular Cerebral/prevenção & controle , Varfarina/administração & dosagem , Idoso , Idoso de 80 Anos ou mais , Anticoagulantes/administração & dosagem , Fibrilação Atrial/complicações , Austrália/epidemiologia , Relação Dose-Resposta a Droga , Método Duplo-Cego , Europa (Continente)/epidemiologia , Inibidores do Fator Xa/administração & dosagem , Feminino , Hemorragia/induzido quimicamente , Humanos , Incidência , Masculino , Fatores de Risco , Acidente Vascular Cerebral/epidemiologia , Resultado do Tratamento , Estados Unidos/epidemiologia
18.
Clin Cardiol ; 42(2): 256-263, 2019 Feb.
Artigo em Inglês | MEDLINE | ID: mdl-30548280

RESUMO

BACKGROUND: When used in appropriately selected heart failure (HF) patients, cardiac resynchronization therapy (CRT) reduces mortality and hospitalization. It is not understood whether CRT implantation during hospitalization for HF is associated with similar benefits. HYPOTHESIS: Timing of CRT implantation relative to hospitalization for HF is associated with clinical outcomes. METHODS: This analysis included patients eligible for CRT and discharged alive between January 2005 and December 2012 from 388 hospitals in Get With The Guidelines-HF. Participants were linked with Centers for Medicare and Medicaid Services data to evaluate outcomes of all-cause mortality and HF re-hospitalization based on CRT status (present on admission, placed during hospitalization, and prescribed at discharge; reference = no CRT). RESULTS: Of 15 619 CRT-eligible HF patients, 2408 (15%) had CRT on admission, 1269 (8%) underwent CRT implantation during hospitalization and 643 (4%) had CRT prescribed at discharge. Compared with patients without CRT, mortality was lower in those who received CRT implantation during HF hospitalization (adjusted hazard ratio [HR] 0.63; P < 0.0001) and those prescribed CRT at discharge (adjusted HR 0.78; P = 0.048). A reduction in HF re-hospitalization was observed in patients with CRT implanted during hospitalization (adjusted HR 0.64; P < 0.0001), but not in those who were prescribed CRT at discharge (adjusted HR 1.02; P = 0.77). CONCLUSION: CRT implantation during HF hospitalization was associated with lower rates of mortality and HF re-hospitalization. These data suggest that a CRT utilization strategy that does not delay implantation to the post-discharge period may be appropriate. Randomized data are needed to definitively identify optimal timing of CRT implantation.


Assuntos
Dispositivos de Terapia de Ressincronização Cardíaca , Terapia de Ressincronização Cardíaca/métodos , Insuficiência Cardíaca/terapia , Idoso , Idoso de 80 Anos ou mais , Feminino , Seguimentos , Insuficiência Cardíaca/diagnóstico , Insuficiência Cardíaca/mortalidade , Humanos , Masculino , Estudos Retrospectivos , Índice de Gravidade de Doença , Taxa de Sobrevida/tendências , Fatores de Tempo , Resultado do Tratamento , Estados Unidos/epidemiologia
19.
Am Heart J ; 208: 74-80, 2019 02.
Artigo em Inglês | MEDLINE | ID: mdl-30580129

RESUMO

BACKGROUND: Nonadherence to optimal medical therapy following myocardial infarction (MI) is associated with adverse clinical outcomes such as stent thrombosis, recurrent cardiovascular events, and death. Whether adherence to medications prior to MI predicts post-MI medication adherence is unknown. METHODS: We assessed adherence to P2Y12 inhibitors and statins before and after admission for MI among 8,147 MI patients who had Medicare insurance with Part D prescription coverage. Adherence was defined as a proportion of days covered with medication fills ≥80%. Multivariable logistic regression was used to assess the association between pre- and post-MI P2Y12 inhibitor adherence. As few patients were on P2Y12 inhibitors pre-MI, we also examined the association of pre-MI statin adherence with post-MI P2Y12 inhibitor and statin adherence. RESULTS: Pre-MI medication nonadherence was observed in 427 of 2,633 (16%) patients on preadmission P2Y12 inhibitors and 1,233 of 6,934 (18%) patients on preadmission statins. Nonadherent patients were more likely to be of nonwhite race and have multiple prior hospital admissions. Patients who were nonadherent to P2Y12 inhibitors pre-MI were substantially less likely to adhere to P2Y12 inhibitors at 90 days (adjusted odds ratio [OR] 0.33, 95% CI 0.25-0.43) and 1 year post-MI (adjusted OR 0.29, 95% CI 0.21-0.39) compared with patients who were adherent pre-MI. Pre-MI statin nonadherence was also associated with lower post-MI adherence to P2Y12 inhibitors at 90 days (adjusted OR 0.65, 95% CI 0.53-0.79) and 1 year (adjusted OR 0.37, 95% CI 0.29-0.54). CONCLUSIONS: Prior medication adherence predicts post-MI adherence to P2Y12 inhibitors. Increasing accessibility of medication adherence data in the medical record may be an important tool to identify patients at higher risk for post-MI medication nonadherence and target efforts to improve adherence.


Assuntos
Inibidores de Hidroximetilglutaril-CoA Redutases/uso terapêutico , Adesão à Medicação/estatística & dados numéricos , Infarto do Miocárdio/tratamento farmacológico , Antagonistas do Receptor Purinérgico P2Y/uso terapêutico , Idoso , Idoso de 80 Anos ou mais , Feminino , Hospitalização/estatística & dados numéricos , Humanos , Modelos Logísticos , Masculino , Medicare Part D/estatística & dados numéricos , Estados Unidos
20.
J Am Heart Assoc ; 7(15): e008755, 2018 08 07.
Artigo em Inglês | MEDLINE | ID: mdl-30371223

RESUMO

Background There is concern that selective serotonin reuptake inhibitors ( SSRI s) substantially increase bleeding risk in patients taking anticoagulants. Methods and Results We studied 737 patients taking SSRI s in the ROCKET AF (Rivaroxaban Once Daily Oral Direct Factor Xa Inhibition Compared With Vitamin K Antagonism for Prevention of Embolism and Stroke Trial in Atrial Fibrillation) trial of rivaroxaban compared with warfarin for the prevention of stroke/systemic embolism in patients with atrial fibrillation. These patients were propensity score matched 1:1 to 737 patients not taking SSRI s. The primary outcome measure was major and nonmajor clinically relevant bleeding events, the principal safety outcome in ROCKET AF . Over a mean 1.6 years of follow-up, the rate of major/ nonmajor clinically relevant bleeding was 18.57 events/100 patient-years for SSRI users versus 16.84 events/100 patient-years for matched comparators, adjusted hazard ratio ( aHR ) of 1.16 (95% confidence interval [CI], 0.95-1.43). The aHR s were similar in patients taking rivaroxaban ( aHR 1.11 [95% CI, 0.82-1.51]) and those taking warfarin ( aHR 1.21 [95% CI, 0.91-1.60]). For the rarer outcome of major bleeding, the aHR for SSRI users versus those not taking SSRI s was 1.13 (95% CI, 0.62-2.06) for rivaroxaban; for warfarin, the aHR was higher, at 1.58 (95% CI , 0.96-2.60) but not statistically significantly elevated. Conclusions We found no significant increase in bleeding risk when SSRI s were combined with anticoagulant therapy, although there was a suggestion of increased bleeding risk with SSRI s added to warfarin. While physicians should be vigilant regarding bleeding risk, our results provide reassurance that SSRI s can be safely added to anticoagulants in patients with atrial fibrillation . Clinical Trial Registration URL : https://www.clinicaltrials.gov . Unique identifier: NCT 00403767.


Assuntos
Anticoagulantes/uso terapêutico , Fibrilação Atrial/tratamento farmacológico , Hemorragia/induzido quimicamente , Inibidores de Captação de Serotonina/uso terapêutico , Acidente Vascular Cerebral/prevenção & controle , Idoso , Transtornos de Ansiedade/tratamento farmacológico , Fibrilação Atrial/complicações , Transtorno Depressivo/tratamento farmacológico , Embolia/etiologia , Embolia/prevenção & controle , Feminino , Hemorragia/epidemiologia , Humanos , Masculino , Modelos de Riscos Proporcionais , Fatores de Risco , Rivaroxabana/uso terapêutico , Acidente Vascular Cerebral/etiologia , Varfarina/uso terapêutico
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