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2.
Interv Cardiol Clin ; 9(1): 53-61, 2020 01.
Artigo em Inglês | MEDLINE | ID: mdl-31733741

RESUMO

Peripheral vascular intervention (PVI) improves quality of life and reduces major adverse limb events in patients with peripheral arterial disease. PVI is commonly performed via the femoral artery, and the most common adverse periprocedural event is a vascular access complication. Transradial access for PVI has the potential to reduce vascular access complications and improve patient outcomes. Further study is needed to elucidate the risks of stroke, acute kidney injury, and radiation exposure in the setting of transradial PVI. As transradial access for PVI progresses, it will be important to build the evidence base along with procedural experience.

3.
JAMA Cardiol ; 2019 Nov 13.
Artigo em Inglês | MEDLINE | ID: mdl-31721978

RESUMO

Importance: The Affordability and Real-World Antiplatelet Treatment Effectiveness After Myocardial Infarction Study (ARTEMIS) cluster-randomized trial found that copayment reduction for P2Y12 inhibitors improved 1-year patient persistence in taking that medication. Objective: To assess whether providing copayment reduction for P2Y12 inhibitors increases patient persistence in taking other secondary prevention cardiovascular medications. Design, Setting, and Participants: This post hoc analysis of the ARTEMIS trial includes data from 287 hospitals that enrolled patients between June 2015 and September 2016. Patients hospitalized with acute myocardial infarction were included. Data analysis occurred from May 2018 through August 2019. Interventions: Hospitals randomized to the intervention provided patients vouchers that waived copayments for P2Y12 inhibitors fills for 1 year. Hospitals randomized to usual care did not provide study vouchers. Main Outcomes and Measures: Persistence in taking ß-blocker, statin, and angiotensin-converting enzyme inhibitor or angiotensin II receptor blocker medications at 1 year, defined as the absence of a gap in medication supply of 30 or more days by pharmacy fill data in the intervention-arm (intent-to-treat) population. Results: A total of 131 hospitals (with 5109 patients) were randomized to the intervention, and 156 hospitals (with 3264 patients) randomized to the control group. Patients discharged from intervention hospitals had higher persistence in taking statins (2247 [46.1%] vs 1300 [41.9%]; adjusted odds ratio, 1.11 [95% CI, 1.00-1.24]), and ß-blockers (2235 [47.6%] vs 1277 [42.5%]; odds ratio, 1.23 [95% CI, 1.10-1.38]), although the association was smaller than that seen for P2Y12 inhibitors (odds ratio, 1.47 [95% CI, 1.29-1.66]). Persistence in taking angiotensin-converting enzyme inhibitors or angiotensin II-receptor blockers were also numerically higher among patients in the intervention arm than in the usual-care arm, but this was not significant after risk adjustment (1520 [43.9%] vs 847 [40.5%]; adjusted odds ratio, 1.10 [95% CI, 0.97-1.24]). Patients in the intervention arm reported greater financial burden associated with medication cost than the patients in the usual-care arm at baseline, but these differences were no longer significant at 1 year. Conclusions and Relevance: Reducing patient copayments for 1 medication class increased persistence not only to that therapy class but may also have modestly increased persistence to other post-myocardial infarction secondary prevention medications. These findings have important implications for the clinical utility and cost-effectiveness of medication cost-assistance programs. Trial Registration: ClinicalTrials.gov Identifier: NCT02406677.

5.
Am Heart J ; 215: 167-177, 2019 Sep.
Artigo em Inglês | MEDLINE | ID: mdl-31349108

RESUMO

BACKGROUND: Hybrid revascularization, combining percutaneous coronary intervention (PCI) and coronary artery bypass grafting (CABG), may be used differently across hospitals. How outcomes compare with multivessel PCI is unknown. METHODS: We studied hybrid revascularization use in patients in the National Cardiovascular Data Registry from 2009 to 2017 who underwent PCI for multivessel coronary artery disease (CAD) at 711 hospitals, excluding patients with prior CABG, acute ST-elevation myocardial infarction, emergency/salvage CABG, or PCI without stent placement. In-hospital mortality associated with hybrid revascularization versus multivessel PCI was compared using a multivariable logistic model. RESULTS: Among 775,000 patients with multivessel CAD, 1,126 (0.2%) underwent hybrid revascularization and 256,865 (33%) were treated with multivessel PCI. Although 358 (50.4%) hospitals performed hybrid revascularizations, most (97.3%) performed <1 per year. Most patients (68.7%) treated with hybrid revascularization underwent CABG after PCI; only 79.4% of these patients were discharged on P2Y12 inhibitors. Patients who underwent hybrid revascularization were younger and more likely to have significant left main or proximal left anterior descending disease. Unadjusted in-hospital mortality rates were higher among patients treated with hybrid revascularization than multivessel PCI (1.5% vs 0.9%, P = .02), a difference that was not significant after multivariable adjustment (odds ratio = 1.54, 95% CI = 0.92-2.59). CONCLUSIONS: Hybrid revascularization remains an infrequently used treatment modality for multivessel CAD. Risk-adjusted in-hospital mortality was no different between hybrid revascularization and multivessel PCI; however, patients who underwent hybrid revascularization were less likely to be discharged on P2Y12 inhibitor therapy despite stent implantation.

6.
Am Heart J ; 214: 184-193, 2019 Aug.
Artigo em Inglês | MEDLINE | ID: mdl-31234037

RESUMO

BACKGROUND: Little is known about the proportion of hospitals in the United States that offer clinical trial enrollment opportunities and how patient outcomes differ between hospitals that do and do not participate in clinical trials. METHODS: In the nationwide Chest Pain-MI registry, we described the proportion of hospitals that enrolled patients with acute myocardial infarction (MI) in clinical trials from 2009 to 2014. Hospital-level adherence to every eligible MI performance measure was compared between hospitals that did and did not enroll patients in clinical trials. Using linked Medicare data, we also compared 1-year major adverse cardiovascular events (MACE: death, MI, heart failure, or stroke) among patients ≥65 years old treated at trial versus nontrial hospitals. RESULTS: Among 766 hospitals, 430 (56.1%) enrolled ≥1 MI patient in a clinical trial during the study period, but the proportion of hospitals enrolling patients in clinical trials declined from 36.8% in 2009 to 26.6% in 2014. Complete adherence to performance measures was delivered to a greater proportion of patients at trial hospitals than nontrial hospitals (72.6% vs 64.9%, P < .001; adjusted OR 1.07, 95% CI 1.03-1.12). One-year MACE rates were also lower for trial hospitals (adjusted HR 0.96, 95% CI 0.93-0.99). CONCLUSIONS: Hospitals are becoming less likely to engage in clinical trials for patients with MI. Patients admitted to hospitals that participated in clinical trials more often received guideline-adherent care and had better long-term outcomes.

7.
JACC Cardiovasc Interv ; 12(8): 709-717, 2019 Apr 22.
Artigo em Inglês | MEDLINE | ID: mdl-31000008

RESUMO

OBJECTIVES: The aims of this study were to describe variability in intensive care unit (ICU) utilization for patients with uncomplicated ST-segment elevation myocardial infarction (STEMI), evaluate the proportion of these patients who developed in-hospital complications requiring ICU care, and assess whether ICU use patterns and complication rates vary across categories of first medical contact to device times. BACKGROUND: In the era of rapid primary percutaneous coronary intervention, ICUs may be overutilized as patients presenting with STEMI are less likely to develop complications requiring ICU care. METHODS: Using data from the Chest Pain-MI Registry linked to Medicare claims, the authors examined patterns of ICU utilization among hemodynamically stable patients with STEMI ≥65 years of age treated with uncomplicated primary percutaneous coronary intervention, stratified by timing of reperfusion: early (first medical contact-to-device time ≤60 min), intermediate (61 to 90 min), or late (>90 min). RESULTS: Of 19,507 patients with STEMI treated at 707 hospitals, 82.3% were treated in ICUs, with a median ICU stay of 1 day (interquartile range [IQR]: 1 to 2 days). The median FMC-to-device time was 79 min (IQR: 63 to 99 min); 22.0% of patients had early, 44.8% intermediate, and 33.2% late reperfusion. ICU utilization rates did not differ between patients with early, intermediate, and late reperfusion times (82%, 83%, and 82%; p for trend = 0.44). Overall, 3,159 patients (16.2%) developed complications requiring ICU care while hospitalized: 3.7% died, 3.7% had cardiac arrest, 8.7% shock, 0.9% stroke, 4.1% high-grade atrioventricular block requiring treatment, and 5.7% respiratory failure. Patients with longer FMC-to-device times were more likely to develop at least 1 of these complications (early 13.4%, intermediate 15.7%, and late 18.7%; p for trend <0.001; adjusted odds ratio [early as reference] for intermediate: 1.13 [95% confidence interval: 1.01 to 1.25]; adjusted odds ratio for late: 1.22 [95% confidence interval: 1.08 to 1.37]). CONCLUSIONS: Although >80% of stable patients with STEMI are treated in the ICU after primary percutaneous coronary intervention, the risk for developing a complication requiring ICU care is 16%. Implementing a risk-based triage strategy, inclusive of factors such as degree of reperfusion delay, could optimize ICU utilization for patients with STEMI.

8.
Circ Cardiovasc Interv ; 12(5): e007955, 2019 May.
Artigo em Inglês | MEDLINE | ID: mdl-31018665
9.
JAMA ; 321(11): 1069-1080, 2019 03 19.
Artigo em Inglês | MEDLINE | ID: mdl-30874755

RESUMO

Importance: Clinical decisions are ideally based on evidence generated from multiple randomized controlled trials (RCTs) evaluating clinical outcomes, but historically, few clinical guideline recommendations have been based entirely on this type of evidence. Objective: To determine the class and level of evidence (LOE) supporting current major cardiovascular society guideline recommendations, and changes in LOE over time. Data Sources: Current American College of Cardiology/American Heart Association (ACC/AHA) and European Society of Cardiology (ESC) clinical guideline documents (2008-2018), as identified on cardiovascular society websites, and immediate predecessors to these guideline documents (1999-2014), as referenced in current guideline documents. Study Selection: Comprehensive guideline documents including recommendations organized by class and LOE. Data Extraction and Synthesis: The number of recommendations and the distribution of LOE (A [supported by data from multiple RCTs or a single, large RCT], B [supported by data from observational studies or a single RCT], and C [supported by expert opinion only]) were determined for each guideline document. Main Outcomes and Measures: The proportion of guideline recommendations supported by evidence from multiple RCTs (LOE A). Results: Across 26 current ACC/AHA guidelines (2930 recommendations; median, 121 recommendations per guideline [25th-75th percentiles, 76-155]), 248 recommendations (8.5%) were classified as LOE A, 1465 (50.0%) as LOE B, and 1217 (41.5%) as LOE C. The median proportion of LOE A recommendations was 7.9% (25th-75th percentiles, 0.9%-15.2%). Across 25 current ESC guideline documents (3399 recommendations; median, 130 recommendations per guideline [25th-75th percentiles, 111-154]), 484 recommendations (14.2%) were classified as LOE A, 1053 (31.0%) as LOE B, and 1862 (54.8%) as LOE C. When comparing current guidelines with prior versions, the proportion of recommendations that were LOE A did not increase in either ACC/AHA (median, 9.0% [current] vs 11.7% [prior]) or ESC guidelines (median, 15.1% [current] vs 17.6% [prior]). Conclusions and Relevance: Among recommendations in major cardiovascular society guidelines, only a small percentage were supported by evidence from multiple RCTs or a single, large RCT. This pattern does not appear to have meaningfully improved from 2008 to 2018.


Assuntos
Cardiologia , Doenças Cardiovasculares/terapia , Medicina Baseada em Evidências , Guias de Prática Clínica como Assunto , Sociedades Médicas , American Heart Association , Europa (Continente) , Estudos Observacionais como Assunto , Ensaios Clínicos Controlados Aleatórios como Assunto , Estados Unidos
10.
Am J Cardiol ; 123(9): 1399-1405, 2019 05 01.
Artigo em Inglês | MEDLINE | ID: mdl-30771861

RESUMO

Greater optimism regarding recovery from chronic illness is associated with improved quality of life and clinical outcomes. We performed a post-hoc analysis on the association between optimism and outcomes in Ranolazine in Patients with Incomplete Revascularization after Percutaneous Coronary Intervention (RIVER-PCI), a randomized trial in patients with chronic angina pectoris who had incomplete revascularization following percutaneous coronary intervention. At baseline, patients answered how much they agreed with the phrase, "I am optimistic about my future and returning to a normal lifestyle." We evaluated the association between baseline optimism and time to ischemia-driven hospitalization or revascularization using a Cox model, and the association between baseline optimism and change in frequency of angina pectoris using a mixed measures model. Of 2,389 patients, 782 (33.2%) were very optimistic ("strongly agree"), 1,000 (42.4%) were optimistic ("agree"), 451 (19.1%) were neutral ("undecided"), and 123 (5.2%) were not optimistic ("disagree" or "strongly disagree"). Very optimistic patients had a lower prevalence of co-morbidities and less severe angina at baseline than less optimistic patients. The rate of ischemia-driven revascularization or hospitalization was higher in neutral and not optimistic patients compared with very optimistic patients; this finding persisted after adjustment for co-morbidities and baseline angina frequency (hazard ratio 1.42, 95% confidence interval 1.14 to 1.77 for neutral vs very optimistic; hazard ratio 1.38, 95% confidence interval 0.98 to 1.94 for not optimistic vs very optimistic). Neutral and not optimistic patients also had less improvement in angina than very optimistic patients. In conclusion, in patients with angina, those with more self-reported optimism had better health status outcomes. Whether structured interventions targeting optimism improve outcomes in these patients warrants further study.


Assuntos
Angina Pectoris/terapia , Nível de Saúde , Revascularização Miocárdica/métodos , Qualidade de Vida , Ranolazina/uso terapêutico , Idoso , Angina Pectoris/epidemiologia , Angina Pectoris/psicologia , Doença Crônica , Método Duplo-Cego , Feminino , Seguimentos , Humanos , Masculino , Pessoa de Meia-Idade , Morbidade/tendências , Prognóstico , Bloqueadores dos Canais de Sódio/uso terapêutico , Estados Unidos/epidemiologia
11.
Annu Rev Med ; 70: 61-75, 2019 01 27.
Artigo em Inglês | MEDLINE | ID: mdl-30477393

RESUMO

Atrial fibrillation (AF) increases a patient's stroke risk four- to five-fold. Anticoagulation with the vitamin K antagonist (VKA) warfarin reduces the risk of stroke by 67%, but warfarin carries a significant risk of major bleeding and has unpredictable pharmacodynamics with a narrow therapeutic window, necessitating frequent monitoring of its anticoagulant effect. The non-vitamin K antagonist oral anticoagulants (NOACs) dabigatran, rivaroxaban, apixaban, and edoxaban provide more predictable anticoagulant activity than warfarin with a lower risk of major bleeding, and each is noninferior to warfarin for the prevention of stroke. All have earned regulatory approval in the past eight years. At least one of the NOACs is approved for use in all patients with AF, except those with mechanical valves and rheumatic mitral valve disease, for whom warfarin remains the only option. Recent clinical trials have shown that antithrombotic regimens including NOACs are safe and effective in patients with AF who need potent antiplatelet therapy.


Assuntos
Anticoagulantes/uso terapêutico , Antitrombinas/uso terapêutico , Fibrilação Atrial/tratamento farmacológico , Hemorragia/induzido quimicamente , Acidente Vascular Cerebral/prevenção & controle , Varfarina/efeitos adversos , Administração Oral , Idoso , Idoso de 80 Anos ou mais , Fibrilação Atrial/diagnóstico , Fibrilação Atrial/mortalidade , Dabigatrana/uso terapêutico , Feminino , Hemorragia/prevenção & controle , Humanos , Masculino , Pessoa de Meia-Idade , Prognóstico , Pirazóis/uso terapêutico , Piridonas/uso terapêutico , Ensaios Clínicos Controlados Aleatórios como Assunto , Medição de Risco , Rivaroxabana/uso terapêutico , Taxa de Sobrevida , Resultado do Tratamento , Varfarina/uso terapêutico
12.
Circulation ; 139(4): 458-472, 2019 01 22.
Artigo em Inglês | MEDLINE | ID: mdl-30586696

RESUMO

BACKGROUND: Although many studies show an inverse association between operator procedural volume and short-term adverse outcomes after percutaneous coronary intervention (PCI), the association between procedural volume and longer-term outcomes is unknown. METHODS: Using the National Cardiovascular Data Registry CathPCI registry data linked with Medicare claims data, we examined the association between operator PCI volume and long-term outcomes among patients ≥65 years of age. Operators were stratified by average annual PCI volume (counting PCIs performed in patients of all ages): low- (<50 PCIs), intermediate- (50-100), and high- (>100) volume operators. One-year unadjusted rates of death and major adverse coronary events (MACEs; defined as death, readmission for myocardial infarction, or unplanned coronary revascularization) were calculated with Kaplan-Meier methods. The proportional hazards assumption was not met, and risk-adjusted associations between operator volume and outcomes were calculated separately from the time of PCI to hospital discharge and from hospital discharge to 1-year follow-up. RESULTS: Between July 1, 2009, and December 31, 2014, 723 644 PCI procedures were performed by 8936 operators: 2553 high-, 2878 intermediate-, and 3505 low-volume operators. Compared with high- and intermediate-volume operators, low-volume operators more often performed emergency PCI, and their patients had fewer cardiovascular comorbidities. Over 1-year follow-up, 15.9% of patients treated by low-volume operators had a MACE compared with 16.9% of patients treated by high-volume operators ( P=0.004). After multivariable adjustment, intermediate- and high-volume operators had a significantly lower rate of in-hospital death than low-volume operators (odds ratio, 0.91; 95% CI, 0.86-0.96 for intermediate versus low; odds ratio, 0.79; 95% CI, 0.75-0.83 for high versus low). There were no significant differences in rates of MACEs, death, myocardial infarction, or unplanned revascularization between operator cohorts from hospital discharge to 1-year follow-up (adjusted hazard ratio for MACEs, 0.99; 95% CI, 0.96-1.01 for intermediate versus low; hazard ratio, 1.01; 95% CI, 0.99-1.04 for high versus low). CONCLUSIONS: Unadjusted 1-year outcomes after PCI were worse for older adults treated by operators with higher annual volume; however, patients treated by these operators had more cardiovascular comorbidities. After risk adjustment, higher operator volume was associated with lower in-hospital mortality and no difference in postdischarge MACEs.


Assuntos
Hospitais com Alto Volume de Atendimentos/tendências , Hospitais com Baixo Volume de Atendimentos/tendências , Intervenção Coronária Percutânea/tendências , Padrões de Prática Médica/tendências , Carga de Trabalho , Idoso , Idoso de 80 Anos ou mais , Bases de Dados Factuais , Feminino , Mortalidade Hospitalar/tendências , Humanos , Masculino , Medicare , Readmissão do Paciente/tendências , Intervenção Coronária Percutânea/efeitos adversos , Intervenção Coronária Percutânea/mortalidade , Sistema de Registros , Retratamento/tendências , Estudos Retrospectivos , Fatores de Risco , Fatores de Tempo , Resultado do Tratamento , Estados Unidos
13.
Circulation ; 139(7): 863-873, 2019 02 12.
Artigo em Inglês | MEDLINE | ID: mdl-30586739

RESUMO

BACKGROUND: Modern cardiometabolic clinical trials often include cardiovascular death as a component of a composite primary outcome, requiring central adjudication by a clinical events committee to classify cause of death. However, sometimes the cause of death cannot be determined from available data. The US Food and Drug Administration has indicated that this circumstance should occur only rarely, but its prevalence has not been formally assessed. METHODS: Data from 9 global clinical trials (2009-2017) with long-term follow-up and blinded, centrally adjudicated cause of death were used to calculate the proportion of deaths attributed to cardiovascular, noncardiovascular, or undetermined causes by therapeutic area (diabetes mellitus/pre-diabetes mellitus, stable atherosclerosis, atrial fibrillation, and acute coronary syndrome), region of patient enrollment, and year of trial manuscript publication. Patient- and trial-level variables associated with undetermined cause of death were identified using a logistic model. RESULTS: Across 127 049 enrolled participants from 9 trials, there were 9259 centrally adjudicated deaths: 5012 (54.1%) attributable to cardiovascular causes, 2800 (30.2%) attributable to noncardiovascular causes, and 1447 (15.6%) attributable to undetermined causes. There was variability in the proportion of deaths ascribed to undetermined causes by trial therapeutic area, region of enrollment, and year of trial manuscript publication. On multivariable analysis, acute coronary syndrome or atrial fibrillation trial (versus atherosclerotic vascular disease or diabetes mellitus/pre-diabetes mellitus), longer time from enrollment to death, more recent trial manuscript publication year, enrollment in North America (versus Western Europe), female sex, and older age were associated with greater likelihood of death of undetermined cause. CONCLUSIONS: In 9 cardiometabolic clinical trials with long-term follow-up, approximately 16% of deaths had undetermined causes. This provides a baseline for quality assessment of clinical trials and informs operational efforts to potentially reduce the frequency of undetermined deaths in future clinical research.


Assuntos
Doenças Cardiovasculares/mortalidade , Causas de Morte/tendências , Ensaios Clínicos como Assunto/métodos , Determinação de Ponto Final , Síndrome Metabólica/mortalidade , Projetos de Pesquisa , Idoso , Doenças Cardiovasculares/diagnóstico , Doenças Cardiovasculares/terapia , Comorbidade , Feminino , Nível de Saúde , Humanos , Masculino , Síndrome Metabólica/diagnóstico , Síndrome Metabólica/terapia , Pessoa de Meia-Idade , Características de Residência , Medição de Risco , Fatores de Risco , Fatores de Tempo , Resultado do Tratamento
14.
Circ Cardiovasc Qual Outcomes ; 11(12): e004755, 2018 12.
Artigo em Inglês | MEDLINE | ID: mdl-30562068

RESUMO

Background Cardiovascular clinical trials have traditionally incorporated separate time-to-first-event analyses for their primary efficacy and safety comparisons, but this framework has a number of limitations, including limited patient-centeredness and a traditional requirement for central adjudication. Days alive and out of the hospital (DAOH) has the potential to provide additional insight. Methods and Results TRILOGY ACS (Targeted Platelet Inhibition to Clarify the Optimal Strategy to Medically Manage Acute Coronary Syndromes) was a randomized, multinational clinical trial that compared the effect of prasugrel versus clopidogrel in patients stabilized after non-ST segment elevation acute coronary syndrome treated without revascularization; the trial had a neutral result. DAOH was calculated for each patient using site-submitted adverse event reporting data. We described patterns of DAOH overall, and among younger adults (<75 years old), older adults (≥75 years old), and frail/prefrail patients over 12 months follow-up and used Poisson regression to compare DAOH for patients randomized to prasugrel versus clopidogrel. Of 9249 patients in the overall trial population, 500 (5.4%) died, and 2504 (27.1%) were hospitalized 4150 times over 12 months' follow-up; the mean±SD DAOH was 317±86. The distribution of DAOH over 12 months was left-skewed, with median DAOH 363 days. Among younger adults, older adults, and frail/prefrail patients, mean DAOH were 323, 293, and 304 days, respectively. There were no differences in DAOH by treatment arm in the overall population (rate ratio, 1.00; 95% CI, 0.99-1.01) or any subgroup. Conclusions These results support the feasibility of determining DAOH, a patient-centered outcome that can potentially overcome many of the disadvantages of the traditional time-to-composite-event framework in the clinical trial setting. Clinical Trial Registration URL: https://www.clinicaltrials.gov. Unique identifier: NCT00699998.


Assuntos
Síndrome Coronariana Aguda/tratamento farmacológico , Clopidogrel/uso terapêutico , Hospitalização , Infarto do Miocárdio sem Supradesnível do Segmento ST/tratamento farmacológico , Assistência Centrada no Paciente/métodos , Inibidores da Agregação de Plaquetas/uso terapêutico , Cloridrato de Prasugrel/uso terapêutico , Antagonistas do Receptor Purinérgico P2Y/uso terapêutico , Síndrome Coronariana Aguda/sangue , Síndrome Coronariana Aguda/diagnóstico , Síndrome Coronariana Aguda/mortalidade , Idoso , Clopidogrel/efeitos adversos , Método Duplo-Cego , Estudos de Viabilidade , Feminino , Nível de Saúde , Humanos , Tempo de Internação , Masculino , Infarto do Miocárdio sem Supradesnível do Segmento ST/sangue , Infarto do Miocárdio sem Supradesnível do Segmento ST/diagnóstico , Infarto do Miocárdio sem Supradesnível do Segmento ST/mortalidade , Inibidores da Agregação de Plaquetas/efeitos adversos , Cloridrato de Prasugrel/efeitos adversos , Antagonistas do Receptor Purinérgico P2Y/efeitos adversos , Medição de Risco , Fatores de Risco , Fatores de Tempo , Resultado do Tratamento
15.
Circ Res ; 123(4): 495-505, 2018 08 03.
Artigo em Inglês | MEDLINE | ID: mdl-30355250

RESUMO

Although clinical trials of cell-based approaches to cardiovascular disease have yielded some promising results, no cell-based therapy has achieved regulatory approval for a cardiovascular indication. To broadly assess the challenges to regulatory approval and identify strategies to facilitate this goal, the Cardiac Safety Research Consortium sponsored a session during the Texas Heart Institute International Symposium on Cardiovascular Regenerative Medicine in September 2017. This session convened leaders in cardiovascular regenerative medicine, including participants from academia, the pharmaceutical industry, the US Food and Drug Administration, and the Cardiac Safety Research Consortium, with particular focus on treatments closest to regulatory approval. A goal of the session was to identify barriers to regulatory approval and potential pathways to overcome them. Barriers identified include manufacturing and therapeutic complexity, difficulties identifying an optimal comparator group, limited industry capacity for funding pivotal clinical trials, and challenges to demonstrating efficacy on clinical end points required for regulatory decisions. Strategies to overcome these barriers include precompetitive development of a cell therapy registry network to enable dual-purposing of clinical data as part of pragmatic clinical trial design, development of standardized terminology for product activity and end points to facilitate this registry, use of innovative statistical methods and quality of life or functional end points to supplement outcomes such as death or heart failure hospitalization and reduce sample size, involvement of patients in determining the research agenda, and use of the Food and Drug Administration's new Regenerative Medicine Advanced Therapy designation to facilitate early discussion with regulatory authorities when planning development pathways.


Assuntos
Cardiologia/métodos , Congressos como Assunto , Cardiopatias/terapia , Medicina Regenerativa/métodos , Transplante de Células-Tronco/métodos , Animais , Humanos
16.
JACC Cardiovasc Interv ; 11(18): 1837-1847, 2018 09 24.
Artigo em Inglês | MEDLINE | ID: mdl-30236357

RESUMO

OBJECTIVES: The aim of this study was to describe the prevalence of pre-hospital cardiac catheterization laboratory activation and its association with reperfusion timeliness and in-hospital mortality. BACKGROUND: For patients with ST-segment elevation myocardial infarction diagnosed in the field, catheterization laboratory pre-activation may lead to more timely reperfusion and improved outcomes. METHODS: A total of 27,840 patients with ST-segment elevation myocardial infarction transported via emergency medical services to 744 percutaneous coronary intervention-capable hospitals in the ACTION Registry from January 2015 to March 2017 were evaluated, excluding patients with cardiac arrest or requiring pre-percutaneous coronary intervention intubation. Catheterization laboratory pre-activation was defined as activation >10 min prior to hospital arrival. RESULTS: Catheterization laboratory pre-activation occurred in 41% of patients (n = 11,379), with minor presenting differences between those with and without catheterization laboratory pre-activation. Compared with no catheterization laboratory pre-activation, pre-activation patients were more likely to be directly transported to the catheterization laboratory on hospital arrival (23.3% vs. 5.3%), to have shorter hospital arrival-to-catheterization laboratory arrival time (median 17 min [interquartile range (IQR): 7 to 25 min] vs. 28 min [IQR: 18 to 39 min]), to have shorter door-to-device time (40 min [IQR: 30 to 51 min] vs. 52 min [IQR: 41 to 65 min]), and to have a greater likelihood of achieving first medical contact-to-device time ≤90 min (76.6% vs. 68.6%) (p < 0.001 for all). Pre-activation was associated with lower in-hospital mortality (2.8% vs. 3.4%; p = 0.01). Patients treated at hospitals in the lowest tertile of pre-activation rates had higher mortality than those treated at hospitals in the highest tertile before and after adjustment (3.6% vs. 2.7%; adjusted odds ratio: 1.33; 95% confidence interval: 1.08 to 1.63). CONCLUSIONS: In the United States, catheterization laboratory pre-activation occurred in fewer than one-half of emergency medical services-transported patients with ST-segment elevation myocardial infarction. Its association with faster reperfusion and lower mortality supports greater use of this strategy.


Assuntos
Prestação Integrada de Cuidados de Saúde , Serviços Médicos de Emergência , Intervenção Coronária Percutânea , Infarto do Miocárdio com Supradesnível do Segmento ST/terapia , Tempo para o Tratamento , Idoso , Ambulâncias , Feminino , Disparidades em Assistência à Saúde , Mortalidade Hospitalar , Humanos , Masculino , Pessoa de Meia-Idade , Intervenção Coronária Percutânea/efeitos adversos , Intervenção Coronária Percutânea/mortalidade , Sistema de Registros , Fatores de Risco , Infarto do Miocárdio com Supradesnível do Segmento ST/diagnóstico por imagem , Infarto do Miocárdio com Supradesnível do Segmento ST/mortalidade , Fatores de Tempo , Resultado do Tratamento , Estados Unidos
18.
J Am Heart Assoc ; 7(11)2018 05 25.
Artigo em Inglês | MEDLINE | ID: mdl-29802146

RESUMO

BACKGROUND: Intensive care unit (ICU) use for initially stable patients presenting with non-ST-segment-elevation myocardial infarction (NSTEMI) varies widely across hospitals and minimally correlates with severity of illness. We aimed to develop a bedside risk score to assist in identifying high-risk patients with NSTEMI for ICU admission. METHODS AND RESULTS: Using the Acute Coronary Treatment and Intervention Outcomes Network (ACTION) Registry linked to Medicare data, we identified patients with NSTEMI aged ≥65 years without cardiogenic shock or cardiac arrest on presentation. Complications requiring ICU care were defined as subsequent development of cardiac arrest, shock, high-grade atrioventricular block, respiratory failure, stroke, or death during the index hospitalization. We developed and validated a model and integer risk score (Acute Coronary Treatment and Intervention Outcomes Network (ACTION) ICU risk score) that uses variables present at hospital admission to predict requirement for ICU care. Of 29 973 patients with NSTEMI, 4282 (14%) developed a complication requiring ICU-level care, yet 12 879 (43%) received care in an ICU. Signs or symptoms of heart failure, initial heart rate, initial systolic blood pressure, initial troponin, initial serum creatinine, prior revascularization, chronic lung disease, ST-segment depression, and age had statistically significant associations with requirement for ICU care after adjusting for other risk factors. The ACTION ICU risk score had a C-statistic of 0.72. It identified 11% of patients as having very high risk (>30%) of developing complications requiring ICU care and 49% as having low likelihood (<10%) of requiring an ICU. CONCLUSIONS: The ACTION ICU risk score quantifies the risk of initially stable patients with NSTEMI developing a complication requiring ICU care, and could be used to more effectively allocate limited ICU resources.


Assuntos
Cuidados Críticos , Técnicas de Apoio para a Decisão , Hemodinâmica , Infarto do Miocárdio sem Supradesnível do Segmento ST/terapia , Idoso , Idoso de 80 Anos ou mais , Tomada de Decisão Clínica , Feminino , Nível de Saúde , Humanos , Masculino , Medicare , Infarto do Miocárdio sem Supradesnível do Segmento ST/diagnóstico , Infarto do Miocárdio sem Supradesnível do Segmento ST/fisiopatologia , Valor Preditivo dos Testes , Prognóstico , Sistema de Registros , Reprodutibilidade dos Testes , Medição de Risco , Fatores de Risco , Estados Unidos
19.
Circ Cardiovasc Qual Outcomes ; 11(4): e004675, 2018 04.
Artigo em Inglês | MEDLINE | ID: mdl-29625993

RESUMO

BACKGROUND: Patient participation in clinical research is low, in part because of the length and complexity of the informed consent process. Video informed consent may enhance the appeal of research and help break down barriers to participation. METHODS AND RESULTS: The PALM study (Patient and Provider Assessment of Lipid Management) enrolled 7904 patients at cardiology, endocrinology, and primary care clinics across the United States to evaluate cholesterol management practices. Of 153 participating clinics, 67 (43.8%) secured institutional review board approval to use a tablet-based video informed consent tool that patients could select to navigate through the informed consent process instead of traditional text-based informed consent. At sites without institutional review board approval of video consent, all patients read a text-based informed consent document. Site activation times and enrollment volumes, as well as characteristics of enrolled patients, were compared between sites with and without video consent capability. Sites with video consent capability more often used a central institutional review board (89.6% versus 73.3%), were more often rural (16.7% versus 3.8%), and tended to have fewer providers. Compared with sites without video consent capability, sites with video consent capability had shorter times from site approach to first patient enrollment (median 178 versus 207 days; P=0.02). Sites with video consent capability enrolled similar numbers of patients as sites without video consent capability (P=0.48) but enrolled a greater proportion of patients who were ≥75 years old (27.5% versus 23.6%; P<0.001) and nonwhite (17.7% versus 14.2%; P<0.001). CONCLUSIONS: In this observational study of recruitment in a multicenter registry, sites approved for video consent use enrolled the same number of patients as sites with only traditional text-based informed consent but had faster speed to first patient enrolled and more often enrolled older and nonwhite patients. Future randomized trials are needed to assess the impact of video consent on enrollment mechanics and demographics. CLINICAL TRIAL REGISTRATION: URL: https://www.clinicaltrials.gov. Unique identifier: NCT02341664.


Assuntos
Ensaios Clínicos como Assunto/métodos , Dislipidemias/terapia , Conhecimentos, Atitudes e Prática em Saúde , Consentimento Livre e Esclarecido , Estudos Multicêntricos como Assunto/métodos , Folhetos , Seleção de Pacientes , Sujeitos da Pesquisa/psicologia , Gravação em Vídeo , Idoso , Biomarcadores/sangue , LDL-Colesterol/sangue , Compreensão , Dislipidemias/sangue , Dislipidemias/diagnóstico , Dislipidemias/psicologia , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Leitura , Sistema de Registros , Resultado do Tratamento , Estados Unidos
20.
Eur Heart J ; 39(32): 2932-2941, 2018 08 21.
Artigo em Inglês | MEDLINE | ID: mdl-29688403

RESUMO

Real-world data (RWD) has been defined as data generated outside of traditional randomized clinical trials (RCTs). Though RWD has received increasing attention from regulatory authorities and professional societies, dividing evidence into that derived from 'real-world' vs. 'non-real-world' sources provides only one element of a much larger framework for evidence evaluation. Evidence should be evaluated on the source of the data, the method of treatment allocation (whether any intervention being evaluated was assigned or simply observed as used in practice) and the context in which the evidence was generated (overall study design). Under this framework, RWD refers only to data source, and a study incorporates RWD when it primarily uses data collected for non-research purposes, such as insurance claims data or the electronic health record, regardless of study design. Separation of study design, data source, and context enables parallel evaluation of two critical elements: (i) whether a study can support claims of causal inference, which can be assured with a high degree of confidence only in studies where patients are assigned treatments by protocol; and (ii) whether the study population and clinical context mirror clinical practice, a strength of observational studies using data from clinical practice or administrative claims. In this review, we describe the strengths and weaknesses of observational and non-observational studies, and studies involving RWD and non-RWD, through the lens of anticoagulation for atrial fibrillation (AF). Observational studies employing RWD are useful for describing how oral anticoagulants are used in clinical practice, but generally cannot be used to make claims regarding comparative treatment effects. Questions regarding treatment effect generally are best answered through an RCT, and additional pragmatic RCTs are needed to compare different antithrombotic agents for the prevention of thrombotic events in AF.


Assuntos
Anticoagulantes/uso terapêutico , Fibrilação Atrial/complicações , Fibrilação Atrial/tratamento farmacológico , Coleta de Dados/métodos , Projetos de Pesquisa Epidemiológica , Acidente Vascular Cerebral/prevenção & controle , Registros Eletrônicos de Saúde , Humanos
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