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1.
JAMA Cardiol ; 8(10): 904-914, 2023 10 01.
Artigo em Inglês | MEDLINE | ID: mdl-37610731

RESUMO

Importance: Trials showing equivalent or better outcomes with initial evaluation using coronary computed tomography angiography (cCTA) compared with stress testing in patients with stable chest pain have informed guidelines but raise questions about overtesting and excess catheterization. Objective: To test a modified initial cCTA strategy designed to improve clinical efficiency vs usual testing (UT). Design, Setting, and Participants: This was a pragmatic randomized clinical trial enrolling participants from December 3, 2018, to May 18, 2021, with a median of 11.8 months of follow-up. Patients from 65 North American and European sites with stable symptoms of suspected coronary artery disease (CAD) and no prior testing were randomly assigned 1:1 to precision strategy (PS) or UT. Interventions: PS incorporated the Prospective Multicenter Imaging Study for the Evaluation of Chest Pain (PROMISE) minimal risk score to quantitatively select minimal-risk participants for deferred testing, assigning all others to cCTA with selective CT-derived fractional flow reserve (FFR-CT). UT included site-selected stress testing or catheterization. Site clinicians determined subsequent care. Main Outcomes and Measures: Outcomes were clinical efficiency (invasive catheterization without obstructive CAD) and safety (death or nonfatal myocardial infarction [MI]) combined into a composite primary end point. Secondary end points included safety components of the primary outcome and medication use. Results: A total of 2103 participants (mean [SD] age, 58.4 [11.5] years; 1056 male [50.2%]) were included in the study, and 422 [20.1%] were classified as minimal risk. The primary end point occurred in 44 of 1057 participants (4.2%) in the PS group and in 118 of 1046 participants (11.3%) in the UT group (hazard ratio [HR], 0.35; 95% CI, 0.25-0.50). Clinical efficiency was higher with PS, with lower rates of catheterization without obstructive disease (27 [2.6%]) vs UT participants (107 [10.2%]; HR, 0.24; 95% CI, 0.16-0.36). The safety composite of death/MI was similar (HR, 1.52; 95% CI, 0.73-3.15). Death occurred in 5 individuals (0.5%) in the PS group vs 7 (0.7%) in the UT group (HR, 0.71; 95% CI, 0.23-2.23), and nonfatal MI occurred in 13 individuals (1.2%) in the PS group vs 5 (0.5%) in the UT group (HR, 2.65; 95% CI, 0.96-7.36). Use of lipid-lowering (450 of 900 [50.0%] vs 365 of 873 [41.8%]) and antiplatelet (321 of 900 [35.7%] vs 237 of 873 [27.1%]) medications at 1 year was higher in the PS group compared with the UT group (both P < .001). Conclusions and Relevance: An initial diagnostic approach to stable chest pain starting with quantitative risk stratification and deferred testing for minimal-risk patients and cCTA with selective FFR-CT in all others increased clinical efficiency relative to UT at 1 year. Additional randomized clinical trials are needed to verify these findings, including safety. Trial Registration: ClinicalTrials.gov Identifier: NCT03702244.


Assuntos
Doença da Artéria Coronariana , Reserva Fracionada de Fluxo Miocárdico , Infarto do Miocárdio , Humanos , Masculino , Pessoa de Meia-Idade , Doença da Artéria Coronariana/fisiopatologia , Estudos Prospectivos , Angiografia Coronária/métodos , Infarto do Miocárdio/diagnóstico , Infarto do Miocárdio/complicações , Dor no Peito/diagnóstico , Fatores de Risco
2.
JAMA Cardiol ; 8(10): 915-924, 2023 10 01.
Artigo em Inglês | MEDLINE | ID: mdl-37610768

RESUMO

Importance: Guidelines recommend deferral of testing for symptomatic people with suspected coronary artery disease (CAD) and low pretest probability. To our knowledge, no randomized trial has prospectively evaluated such a strategy. Objective: To assess process of care and health outcomes in people identified as minimal risk for CAD when testing is deferred. Design, Setting, and Participants: This randomized, pragmatic effectiveness trial included prespecified subgroup analysis of the PRECISE trial at 65 North American and European sites. Participants identified as minimal risk by the validated PROMISE minimal risk score (PMRS) were included. Intervention: Randomization to a precision strategy using the PMRS to assign those with minimal risk to deferred testing and others to coronary computed tomography angiography with selective computed tomography-derived fractional flow reserve, or to usual testing (stress testing or catheterization with PMRS masked). Randomization was stratified by PMRS risk. Main Outcome: Composite of all-cause death, nonfatal myocardial infarction (MI), or catheterization without obstructive CAD through 12 months. Results: Among 2103 participants, 422 were identified as minimal risk (20%) and randomized to deferred testing (n = 214) or usual testing (n = 208). Mean age (SD) was 46 (8.6) years; 304 were women (72%). During follow-up, 138 of those randomized to deferred testing never had testing (64%), whereas 76 had a downstream test (36%) (at median [IQR] 48 [15-78] days) for worsening (30%), uncontrolled (10%), or new symptoms (6%), or changing clinician preference (19%) or participant preference (10%). Results were normal for 96% of these tests. The primary end point occurred in 2 deferred testing (0.9%) and 13 usual testing participants (6.3%) (hazard ratio, 0.15; 95% CI, 0.03-0.66; P = .01). No death or MI was observed in the deferred testing participants, while 1 noncardiovascular death and 1 MI occurred in the usual testing group. Two participants (0.9%) had catheterizations without obstructive CAD in the deferred testing group and 12 (5.8%) with usual testing (P = .02). At baseline, 70% of participants had frequent angina and there was similar reduction of frequent angina to less than 20% at 12 months in both groups. Conclusion and Relevance: In symptomatic participants with suspected CAD, identification of minimal risk by the PMRS guided a strategy of initially deferred testing. The strategy was safe with no observed adverse outcome events, fewer catheterizations without obstructive CAD, and similar symptom relief compared with usual testing. Trial Registration: ClinicalTrials.gov Identifier: NCT03702244.


Assuntos
Doença da Artéria Coronariana , Reserva Fracionada de Fluxo Miocárdico , Infarto do Miocárdio , Humanos , Feminino , Pessoa de Meia-Idade , Masculino , Pacientes Ambulatoriais , Angiografia Coronária/métodos , Infarto do Miocárdio/complicações , Fatores de Risco
3.
Am Heart J ; 245: 136-148, 2022 03.
Artigo em Inglês | MEDLINE | ID: mdl-34953768

RESUMO

BACKGROUND: Clinicians vary widely in their preferred diagnostic approach to patients with non-acute chest pain. Such variation exposes patients to potentially avoidable risks, as well as inefficient care with increased costs and unresolved patient concerns. METHODS: The Prospective Randomized Trial of the Optimal Evaluation of Cardiac Symptoms and Revascularization (PRECISE) trial (NCT03702244) compares an investigational "precision" diagnostic strategy to a usual care diagnostic strategy in participants with stable chest pain and suspected coronary artery disease (CAD). RESULTS: PRECISE randomized 2103 participants with stable chest pain and a clinical recommendation for testing for suspected CAD at 68 outpatient international sites. The investigational precision evaluation strategy started with a pre-test risk assessment using the PROMISE Minimal Risk Tool. Those at lowest risk were assigned to deferred testing (no immediate testing), and the remainder received coronary computed tomographic angiography (cCTA) with selective fractional flow reserve (FFRCT) for any stenosis meeting a threshold of ≥30% and <90%. For participants randomized to usual care, the clinical care team selected the initial noninvasive or invasive test (diagnostic angiography) according to customary practice. The use of cCTA as the initial diagnostic strategy was proscribed by protocol for the usual care strategy. The primary endpoint is time to a composite of major adverse cardiac events (MACE: all-cause death or non-fatal myocardial infarction) or invasive cardiac catheterization without obstructive CAD at 1 year. Secondary endpoints include health care costs and quality of life. CONCLUSIONS: PRECISE will determine whether a precision approach comprising a strategically deployed combination of risk-based deferred testing and cCTA with selective FFRCT improves the clinical outcomes and efficiency of the diagnostic evaluation of stable chest pain over usual care.


Assuntos
Doença da Artéria Coronariana , Reserva Fracionada de Fluxo Miocárdico , Angiografia por Tomografia Computadorizada/métodos , Angiografia Coronária/métodos , Doença da Artéria Coronariana/diagnóstico , Humanos , Valor Preditivo dos Testes , Estudos Prospectivos , Qualidade de Vida
4.
J Am Coll Cardiol ; 67(22): 2607-16, 2016 Jun 07.
Artigo em Inglês | MEDLINE | ID: mdl-27058908

RESUMO

BACKGROUND: Although risk stratification is an important goal of cardiac noninvasive tests (NITs), few contemporary data exist on the prognostic value of different NITs according to patient sex. OBJECTIVES: The goal of this study was to compare the results and prognostic information derived from anatomic versus stress testing in stable men and women with suspected coronary artery disease. METHODS: In 8,966 patients tested at randomization (4,500 to computed tomography angiography [CTA], 52% female; 4,466 to stress testing, 53% female), we assessed the relationship between sex and NIT results and between sex and a composite of death, myocardial infarction, or unstable angina hospitalization. RESULTS: In women, a positive CTA (≥70% stenosis) was less likely than a positive stress test result (8% vs. 12%; adjusted odds ratio: 0.67). Compared with negative test results, a positive CTA was more strongly associated with subsequent clinical events than a positive stress test result (CTA-adjusted hazard ratio of 5.86 vs. stress-adjusted hazard ratio of 2.27; adjusted p = 0.028). Men were more likely to have a positive CTA than a positive stress test result (16% vs. 14%; adjusted odds ratio: 1.23). Compared with negative test results, a positive CTA was less strongly associated with subsequent clinical events than a positive stress test result in men, although this difference was not statistically significant (adjusted p = 0.168). Negative CTA and stress test results were equally likely to predict an event in both sexes. A significant interaction between sex, NIT type, and test result (p = 0.01) suggests that sex and NIT type jointly influence the relationship between test result and clinical events. CONCLUSIONS: The prognostic value of an NIT result varies according to test type and patient sex. Women seem to derive more prognostic information from a CTA, whereas men tend to derive similar prognostic value from both test types.


Assuntos
Angiografia por Tomografia Computadorizada , Doença da Artéria Coronariana/diagnóstico , Ecocardiografia sob Estresse , Imagem de Perfusão do Miocárdio , Idoso , Angina Instável/epidemiologia , Canadá/epidemiologia , Dor no Peito/etiologia , Feminino , Coração/diagnóstico por imagem , Hospitalização , Humanos , Masculino , Pessoa de Meia-Idade , Infarto do Miocárdio/epidemiologia , Prognóstico , Fatores Sexuais , Estados Unidos/epidemiologia
5.
JACC Cardiovasc Imaging ; 9(4): 337-46, 2016 Apr.
Artigo em Inglês | MEDLINE | ID: mdl-27017234

RESUMO

OBJECTIVES: The aim of this study was to determine whether presentation, risk assessment, testing choices, and results differ by sex in stable symptomatic outpatients with suspected coronary artery disease (CAD). BACKGROUND: Although established CAD presentations differ by sex, little is known about stable, suspected CAD. METHODS: The characteristics of 10,003 men and women in the PROMISE (Prospective Multicenter Imaging Study for Evaluation of Chest Pain) trial were compared using chi-square and Wilcoxon rank-sum tests. Sex differences in test selection and predictors of test positivity were examined using logistic regression. RESULTS: Women were older (62.4 years of age vs. 59.0 years of age) and were more likely to be hypertensive (66.6% vs. 63.2%), dyslipidemic (68.9% vs. 66.3%), and to have a family history of premature CAD (34.6% vs. 29.3) (all p values <0.005). Women were less likely to smoke (45.6% vs. 57.0%; p < 0.001), although their prevalence of diabetes was similar to that in men (21.8% vs. 21.0%; p = 0.30). Chest pain was the primary symptom in 73.2% of women versus 72.3% of men (p = 0.30), and was characterized as "crushing/pressure/squeezing/tightness" in 52.5% of women versus 46.2% of men (p < 0.001). Compared with men, all risk scores characterized women as being at lower risk, and providers were more likely to characterize women as having a low (<30%) pre-test probability of CAD (40.7% vs. 34.1%; p < 0.001). Compared with men, women were more often referred to imaging tests (adjusted odds ratio: 1.21; 95% confidence interval: 1.01 to 1.44) than nonimaging tests. Women were less likely to have a positive test (9.7% vs. 15.1%; p < 0.001). Although univariate predictors of test positivity were similar, in multivariable models, age, body mass index, and Framingham risk score were predictive of a positive test in women, whereas Framingham and Diamond and Forrester risk scores were predictive in men. CONCLUSIONS: Patient sex influences the entire diagnostic pathway for possible CAD, from baseline risk factors and presentation to noninvasive test outcomes. These differences highlight the need for sex-specific approaches for the evaluation of CAD.


Assuntos
Angina Pectoris/diagnóstico , Angina Pectoris/epidemiologia , Doença da Artéria Coronariana/diagnóstico , Doença da Artéria Coronariana/epidemiologia , Disparidades nos Níveis de Saúde , Disparidades em Assistência à Saúde , Testes de Função Cardíaca , Pacientes Ambulatoriais , Idoso , Idoso de 80 Anos ou mais , Distribuição de Qui-Quadrado , Comorbidade , Feminino , Humanos , Modelos Logísticos , Masculino , Pessoa de Meia-Idade , Análise Multivariada , América do Norte , Razão de Chances , Valor Preditivo dos Testes , Prognóstico , Estudos Prospectivos , Medição de Risco , Fatores de Risco , Fatores Sexuais
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