RESUMEN
AIM: The aim of this study was to assess the recovery rates of diagnostic cardiac procedure volumes in the Oceania Region, midway through the coronavirus disease 2019 (COVID-19) pandemic. METHODS: A survey was performed comparing procedure volumes between March 2019 (pre-pandemic), April 2020 (during first wave of COVID-19 pandemic), and April 2021 (1 year into the COVID-19 pandemic). A total of 31 health care facilities within Oceania that perform cardiac diagnostic procedures were surveyed, including a mixture of metropolitan and regional, hospital and outpatient, public and private sites, as well as teaching and non-teaching hospitals. A comparison was made with 549 centres in 96 countries in the rest of the world (RoW) outside of Oceania. The total number and median percentage change in procedure volume were measured between the three timepoints, compared by test type and by facility. RESULTS: A total of 11,902 cardiac diagnostic procedures were performed in Oceania in April 2021 as compared with 11,835 pre-pandemic in March 2019 and 5,986 in April 2020; whereas, in the RoW, 499,079 procedures were performed in April 2021 compared with 497,615 pre-pandemic in March 2019 and 179,014 in April 2020. There was no significant difference in the median recovery rates for total procedure volumes between Oceania (-6%) and the RoW (-3%) (p=0.81). While there was no statistically significant difference in percentage recovery been functional ischaemia testing and anatomical coronary testing in Oceania as compared with the RoW, there was, however, a suggestion of poorer recovery in anatomical coronary testing in Oceania as compared with the RoW (CT coronary angiography -16% in Oceania vs -1% in RoW, and invasive coronary angiography -20% in Oceania vs -9% in RoW). There was no statistically significant difference in recovery rates in procedure volume between metropolitan vs regional (p=0.44), public vs private (p=0.92), hospital vs outpatient (p=0.79), or teaching vs non-teaching centres (p=0.73). CONCLUSIONS: Total cardiology procedure volumes in Oceania normalised 1 year post-pandemic compared to pre-pandemic levels, with no significant difference compared with the RoW and between the different types of health care facilities.
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COVID-19 , Cardiología , Humanos , COVID-19/epidemiología , Pandemias , Encuestas y Cuestionarios , Angiografía Coronaria , Prueba de COVID-19RESUMEN
BACKGROUND: Prognostic significance of non-obstructive left main (LM) disease was recently reported. However, the influence of diabetes mellitus (DM) on event rates in patients with and without non-obstructive LM disease is not well-known. METHODS: We evaluated 27,252 patients undergoing coronary computed tomographic angiography from the COroNary CT Angiography Evaluation For Clinical Outcomes: An InteRnational Multicenter (CONFIRM) Registry. Cumulative long-term incidence of all-cause mortality (ACM) was assessed between DM and non-DM patients by normal or non-obstructive LM disease (1-49% stenosis). RESULTS: The mean age of the study population was 57.6±12.6 years. Of the 27,252 patients, 4,434 (16%) patients had DM. A total of 899 (3%) deaths occurred during the follow-up of 3.6±1.9. years. Compared to patients with normal LM, those with non-obstructive LM had more pronounced overall coronary atherosclerosis and more cardiovascular risk factors. After clinical risk factors, segment involvement score, and stenosis severity adjustment, compared to patients without DM and normal LM, patients with DM were associated with increased ACM regardless of normal (HR 1.48, 95% CI 1.22-1.78, p<0.001) or non-obstructive LM (HR 1.46, 95% CI 1.04-2.04, p=0.029), while nonobstructive LM disease was not associated with increased ACM in patients without DM (HR 0.85, 95% CI 0.67-1.07, p=0.165) and there was no significant interaction between DM and LM status (HR 1.03, 95% CI 0.69-1.54, p=0.879). CONCLUSION: From the CONFIRM registry, we demonstrated that DM was associated with increased ACM. However, the presence of non-obstructive LM was not an independent risk marker of ACM, and there was no significant interaction between DM and non-obstructive LM disease for ACM.
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Enfermedad de la Arteria Coronaria , Diabetes Mellitus , Humanos , Persona de Mediana Edad , Anciano , Enfermedad de la Arteria Coronaria/complicaciones , Enfermedad de la Arteria Coronaria/diagnóstico , Enfermedad de la Arteria Coronaria/epidemiología , Pronóstico , Constricción Patológica , Angiografía Coronaria/métodos , Modelos de Riesgos Proporcionales , Diabetes Mellitus/epidemiología , Factores de Riesgo , Sistema de RegistrosRESUMEN
AIMS: Symptom-based pretest probability scores that estimate the likelihood of obstructive coronary artery disease (CAD) in stable chest pain have moderate accuracy. We sought to develop a machine learning (ML) model, utilizing clinical factors and the coronary artery calcium score (CACS), to predict the presence of obstructive CAD on coronary computed tomography angiography (CCTA). METHODS AND RESULTS: The study screened 35 281 participants enrolled in the CONFIRM registry, who underwent ≥64 detector row CCTA evaluation because of either suspected or previously established CAD. A boosted ensemble algorithm (XGBoost) was used, with data split into a training set (80%) on which 10-fold cross-validation was done and a test set (20%). Performance was assessed of the (1) ML model (using 25 clinical and demographic features), (2) ML + CACS, (3) CAD consortium clinical score, (4) CAD consortium clinical score + CACS, and (5) updated Diamond-Forrester (UDF) score. The study population comprised of 13 054 patients, of whom 2380 (18.2%) had obstructive CAD (≥50% stenosis). Machine learning with CACS produced the best performance [area under the curve (AUC) of 0.881] compared with ML alone (AUC of 0.773), CAD consortium clinical score (AUC of 0.734), and with CACS (AUC of 0.866) and UDF (AUC of 0.682), P < 0.05 for all comparisons. CACS, age, and gender were the highest ranking features. CONCLUSION: A ML model incorporating clinical features in addition to CACS can accurately estimate the pretest likelihood of obstructive CAD on CCTA. In clinical practice, the utilization of such an approach could improve risk stratification and help guide downstream management.
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Calcio/metabolismo , Angiografía por Tomografía Computarizada/métodos , Angiografía Coronaria/métodos , Enfermedad de la Arteria Coronaria/diagnóstico , Vasos Coronarios/diagnóstico por imagen , Aprendizaje Automático , Sistema de Registros , Enfermedad de la Arteria Coronaria/metabolismo , Femenino , Humanos , Masculino , Persona de Mediana Edad , Tomografía Computarizada Multidetector/métodos , Valor Predictivo de las Pruebas , Estudios Prospectivos , Curva ROCRESUMEN
OBJECTIVES: The INCAPS COVID Oceania study aimed to assess the impact caused by the COVID-19 pandemic on cardiac procedure volume provided in the Oceania region. METHODS: A retrospective survey was performed comparing procedure volumes within March 2019 (pre-COVID-19) with April 2020 (during first wave of COVID-19 pandemic). Sixty-three (63) health care facilities within Oceania that perform cardiac diagnostic procedures were surveyed, including a mixture of metropolitan and regional, hospital and outpatient, public and private sites, and 846 facilities outside of Oceania. The percentage change in procedure volume was measured between March 2019 and April 2020, compared by test type and by facility. RESULTS: In Oceania, the total cardiac diagnostic procedure volume was reduced by 52.2% from March 2019 to April 2020, compared to a reduction of 75.9% seen in the rest of the world (p<0.001). Within Oceania sites, this reduction varied significantly between procedure types, but not between types of health care facility. All procedure types (other than stress cardiac magnetic resonance [CMR] and positron emission tomography [PET]) saw significant reductions in volume over this time period (p<0.001). In Oceania, transthoracic echocardiography (TTE) decreased by 51.6%, transoesophageal echocardiography (TOE) by 74.0%, and stress tests by 65% overall, which was more pronounced for stress electrocardiograph (ECG) (81.8%) and stress echocardiography (76.7%) compared to stress single-photon emission computerised tomography (SPECT) (44.3%). Invasive coronary angiography decreased by 36.7% in Oceania. CONCLUSION: A significant reduction in cardiac diagnostic procedure volume was seen across all facility types in Oceania and was likely a function of recommendations from cardiac societies and directives from government to minimise spread of COVID-19 amongst patients and staff. Longer term evaluation is important to assess for negative patient outcomes which may relate to deferral of usual models of care within cardiology.
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COVID-19 , Cardiología , Humanos , Pandemias , Estudios Retrospectivos , SARS-CoV-2 , Tomografía Computarizada por Rayos XRESUMEN
Bleeding is the most common complication of anticoagulant use. The evaluation and management of the bleeding patient is a core competency of emergency medicine. As the prevalence of patients receiving anticoagulant agents and variety of anticoagulants with different mechanisms of action, pharmacokinetics, indications, and corresponding reversal agents increase, physicians and other clinicians working in the emergency department require a current and nuanced understanding of how best to assess, treat, and reverse anticoagulated patients. In this project, we convened an expert panel to create a consensus decision tree and framework for assessment of the bleeding patient receiving an anticoagulant, as well as use of anticoagulant reversal or coagulation factor replacement, and to address controversies and gaps relevant to this topic. To support decision tree interpretation, the panel also reached agreement on key definitions of life-threatening bleeding, bleeding at a critical site, and emergency surgery or urgent invasive procedure. To reach consensus recommendations, we used a structured literature review and a modified Delphi technique by an expert panel of academic and community physicians with training in emergency medicine, cardiology, hematology, internal medicine/thrombology, pharmacology, toxicology, transfusion medicine and hemostasis, neurology, and surgery, and by other key stakeholder groups.
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Anticoagulantes/administración & dosificación , Antagonismo de Drogas , Anticoagulantes/uso terapéutico , Consenso , Servicio de Urgencia en Hospital/organización & administración , Servicio de Urgencia en Hospital/estadística & datos numéricos , Testimonio de Experto , Hemorragia/tratamiento farmacológico , HumanosRESUMEN
OBJECTIVE: The Safety of Oral Anticoagulants Registry (SOAR) was designed to describe the evaluation and management of patients with oral anticoagulant (OAC)-related major bleeding or bleeding concerns who present to the emergency department (ED) with acute illness or injury. Patients in the ED are increasingly taking anticoagulants, which can cause bleeding-related complications as well as impact the acute management of related or unrelated clinical issues that prompt presentation. Modifications of emergency evaluation and management due to anticoagulation have not previously been studied. METHODS: This was a multicenter observational in-hospital study of patients who were judged to be experiencing an active OAC effect and had (a) an obvious bleeding event or (b) were deemed at risk for serious bleeding spontaneously, after injury, or during an indicated invasive procedure. Diagnostic testing, therapies employed, and clinical outcomes were collected. RESULTS: Thirty-one US hospitals contributed data to SOAR. Of 1513 subjects, acute hemorrhage (AH) qualified 78%, while 22% had a bleeding concern (BC). Warfarin was the index OAC in 37.3%, dabigatran in 13.3%, and an anti-Factor Xa in 49.4%. The most common sites of AH were gastrointestinal (51.0%) and intracranial (26.8%). In warfarin-treated patients, the mean (IQR) presenting INR was 3.1 (2.2, 4.8) in AH patients and 3.9 (2.4, 7.2) in BC patients. Three-fifths of SOAR patients were treated with factor repletion or specific reversal agents, and those patients had a longer length of stay. In addition, seven (0.76%) of the treated patients experienced an in-hospital thrombotic complication; two of these seven died on the index admission, both of fatal pulmonary embolism. Vitamin K was used and dosed inconsistently in both warfarin and NOAC cohorts. CONCLUSION: Care of anticoagulated patients in the acute care setting is inconsistent, reflecting the diversity of presentation. As the prevalence of OAC use increases with the aging of the US population, further study and targeted educational efforts are needed to drive more evidence-based care of these patients.
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Inhibidores del Factor Xa/efectos adversos , Inhibidores del Factor Xa/uso terapéutico , Hemorragia/etiología , Sistema de Registros/normas , Anciano , Anciano de 80 o más Años , Dabigatrán/efectos adversos , Dabigatrán/uso terapéutico , Servicio de Urgencia en Hospital/organización & administración , Servicio de Urgencia en Hospital/estadística & datos numéricos , Femenino , Hemorragia Gastrointestinal/epidemiología , Hemorragia Gastrointestinal/etiología , Hemorragia/epidemiología , Humanos , Hemorragias Intracraneales/epidemiología , Hemorragias Intracraneales/etiología , Masculino , Persona de Mediana Edad , Sistema de Registros/estadística & datos numéricos , Warfarina/efectos adversos , Warfarina/uso terapéuticoRESUMEN
Aim: The long-term prognostic benefit of coronary computed tomographic angiography (CCTA) findings of coronary artery disease (CAD) in asymptomatic populations is unknown. Methods and results: From the prospective multicentre international CONFIRM long-term study, we evaluated asymptomatic subjects without known CAD who underwent both coronary artery calcium scoring (CACS) and CCTA (n = 1226). Coronary computed tomographic angiography findings included the severity of coronary artery stenosis, plaque composition, and coronary segment location. Using the C-statistic and likelihood ratio tests, we evaluated the incremental prognostic utility of CCTA findings over a base model that included a panel of traditional risk factors (RFs) as well as CACS to predict long-term all-cause mortality. During a mean follow-up of 5.9 ± 1.2 years, 78 deaths occurred. Compared with the traditional RF alone (C-statistic 0.64), CCTA findings including coronary stenosis severity, plaque composition, and coronary segment location demonstrated improved incremental prognostic utility beyond traditional RF alone (C-statistics range 0.71-0.73, all P < 0.05; incremental χ2 range 20.7-25.5, all P < 0.001). However, no added prognostic benefit was offered by CCTA findings when added to a base model containing both traditional RF and CACS (C-statistics P > 0.05, for all). Conclusions: Coronary computed tomographic angiography improved prognostication of 6-year all-cause mortality beyond a set of conventional RF alone, although, no further incremental value was offered by CCTA when CCTA findings were added to a model incorporating RF and CACS.
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Enfermedades Asintomáticas/mortalidad , Angiografía Coronaria/estadística & datos numéricos , Enfermedad de la Arteria Coronaria , Tomografía Computarizada por Rayos X/estadística & datos numéricos , Adulto , Anciano , Enfermedad de la Arteria Coronaria/diagnóstico por imagen , Enfermedad de la Arteria Coronaria/mortalidad , Femenino , Estudios de Seguimiento , Humanos , Masculino , Persona de Mediana Edad , Pronóstico , Estudios Prospectivos , Factores de Riesgo , Calcificación Vascular/diagnóstico por imagen , Calcificación Vascular/mortalidadRESUMEN
Risk stratification in patients with stable ischemic heart disease is essential to guide treatment decisions. In this regard, whether coronary anatomy, physiology, or plaque morphology is the best determinant of prognosis (and driver an effective therapeutic risk reduction) remains one of the greatest ongoing debates in cardiology. In the present report, we review the evidence for each of these characteristics and explore potential algorithms that may enable a practical diagnostic and therapeutic strategy for the management of patients with stable ischemic heart disease.
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Angiografía Coronaria , Enfermedad de la Arteria Coronaria/diagnóstico por imagen , Vasos Coronarios/diagnóstico por imagen , Isquemia Miocárdica/diagnóstico por imagen , Angiografía Coronaria/métodos , Enfermedad de la Arteria Coronaria/epidemiología , Enfermedad de la Arteria Coronaria/patología , Vasos Coronarios/anatomía & histología , Vasos Coronarios/fisiología , Humanos , Isquemia Miocárdica/epidemiología , Isquemia Miocárdica/patología , Placa Aterosclerótica/diagnóstico por imagen , Placa Aterosclerótica/epidemiología , Placa Aterosclerótica/patología , Pronóstico , Medición de RiesgoRESUMEN
OBJECTIVE: Motion artifact can reduce the diagnostic accuracy of coronary CT angiography (CCTA) for coronary artery disease (CAD). The purpose of this study was to compare the diagnostic performance of an algorithm dedicated to correcting coronary motion artifact with the performance of standard reconstruction methods in a prospective international multicenter study. SUBJECTS AND METHODS: Patients referred for clinically indicated invasive coronary angiography (ICA) for suspected CAD prospectively underwent an investigational CCTA examination free from heart rate-lowering medications before they underwent ICA. Blinded core laboratory interpretations of motion-corrected and standard reconstructions for obstructive CAD (≥ 50% stenosis) were compared with ICA findings. Segments unevaluable owing to artifact were considered obstructive. The primary endpoint was per-subject diagnostic accuracy of the intracycle motion correction algorithm for obstructive CAD found at ICA. RESULTS: Among 230 patients who underwent CCTA with the motion correction algorithm and standard reconstruction, 92 (40.0%) had obstructive CAD on the basis of ICA findings. At a mean heart rate of 68.0 ± 11.7 beats/min, the motion correction algorithm reduced the number of nondiagnostic scans compared with standard reconstruction (20.4% vs 34.8%; p < 0.001). Diagnostic accuracy for obstructive CAD with the motion correction algorithm (62%; 95% CI, 56-68%) was not significantly different from that of standard reconstruction on a per-subject basis (59%; 95% CI, 53-66%; p = 0.28) but was superior on a per-vessel basis: 77% (95% CI, 74-80%) versus 72% (95% CI, 69-75%) (p = 0.02). The motion correction algorithm was superior in subgroups of patients with severely obstructive (≥ 70%) stenosis, heart rate ≥ 70 beats/min, and vessels in the atrioventricular groove. CONCLUSION: The motion correction algorithm studied reduces artifacts and improves diagnostic performance for obstructive CAD on a per-vessel basis and in selected subgroups on a per-subject basis.
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Algoritmos , Técnicas de Imagen Sincronizada Cardíacas , Angiografía por Tomografía Computarizada , Angiografía Coronaria , Enfermedad de la Arteria Coronaria/diagnóstico por imagen , Interpretación de Imagen Radiográfica Asistida por Computador/métodos , Anciano , Artefactos , Femenino , Humanos , Masculino , Persona de Mediana Edad , Estudios ProspectivosRESUMEN
Extent of coronary atherosclerotic disease (CAD) burden on coronary computed tomography angiography (CCTA) as measured by segment involvement score (SIS) has a prognostic value. We sought to investigate the incremental prognostic value of 'age adjusted SIS' (aSIS), which may be a marker of premature atherosclerosis and vascular age. Consecutive patients were prospectively enrolled into the CONFIRM (Coronary CT Angiography EvaluatioN For Clinical Outcomes: An InteRnational Multicentre) multinational observational study. Patients were followed for the outcome of all-cause death. aSIS was calculated on CCTA for each patient, and its incremental prognostic value was evaluated. A total of 22,211 patients [mean age 58.5 ± 12.7 years, 55.8% male) with a median follow-up of 27.3 months (IQR 17.8, 35.4)] were identified. After adjustment for clinical factors and presence of obstructive CAD, higher aSIS was associated with increased death on multivariable analysis, with hazard ratio (HR) 2.40 (1.83-3.16, p < 0.001), C-statistic 0.723 (0.700-0.756), net reclassification improvement (NRI) 0.36 (0.26-0.47, p < 0.001), and relative integrated discrimination improvement (IDI) 0.33 (p = 0.009). aSIS had HR 3.48 (2.33-5.18, p < 0.001) for mortality in those without obstructive CAD, compared to HR 1.79 (1.25-2.58, p = 0.02) in those with obstructive CAD. In conclusion, aSIS has an incremental prognostic value to traditional risk factors and obstructive CAD, and may enhance CCTA risk stratification.
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Envejecimiento/fisiología , Angiografía por Tomografía Computarizada/métodos , Angiografía Coronaria/métodos , Enfermedad de la Arteria Coronaria/diagnóstico por imagen , Vasos Coronarios/diagnóstico por imagen , Placa Aterosclerótica/diagnóstico por imagen , Sistema de Registros , Factores de Edad , Anciano , Femenino , Estudios de Seguimiento , Humanos , Masculino , Persona de Mediana Edad , Valor Predictivo de las Pruebas , Pronóstico , Estudios Prospectivos , Factores de Riesgo , Factores de TiempoRESUMEN
AIMS: Traditional prognostic risk assessment in patients undergoing non-invasive imaging is based upon a limited selection of clinical and imaging findings. Machine learning (ML) can consider a greater number and complexity of variables. Therefore, we investigated the feasibility and accuracy of ML to predict 5-year all-cause mortality (ACM) in patients undergoing coronary computed tomographic angiography (CCTA), and compared the performance to existing clinical or CCTA metrics. METHODS AND RESULTS: The analysis included 10 030 patients with suspected coronary artery disease and 5-year follow-up from the COronary CT Angiography EvaluatioN For Clinical Outcomes: An InteRnational Multicenter registry. All patients underwent CCTA as their standard of care. Twenty-five clinical and 44 CCTA parameters were evaluated, including segment stenosis score (SSS), segment involvement score (SIS), modified Duke index (DI), number of segments with non-calcified, mixed or calcified plaques, age, sex, gender, standard cardiovascular risk factors, and Framingham risk score (FRS). Machine learning involved automated feature selection by information gain ranking, model building with a boosted ensemble algorithm, and 10-fold stratified cross-validation. Seven hundred and forty-five patients died during 5-year follow-up. Machine learning exhibited a higher area-under-curve compared with the FRS or CCTA severity scores alone (SSS, SIS, DI) for predicting all-cause mortality (ML: 0.79 vs. FRS: 0.61, SSS: 0.64, SIS: 0.64, DI: 0.62; P< 0.001). CONCLUSIONS: Machine learning combining clinical and CCTA data was found to predict 5-year ACM significantly better than existing clinical or CCTA metrics alone.
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Enfermedad de la Arteria Coronaria/mortalidad , Causas de Muerte , Angiografía por Tomografía Computarizada , Enfermedad de la Arteria Coronaria/diagnóstico por imagen , Estudios de Factibilidad , Femenino , Humanos , Aprendizaje Automático , Masculino , Persona de Mediana Edad , Estudios Prospectivos , Sistema de Registros , Factores de RiesgoRESUMEN
Purpose To examine the effect of breast shielding on blood lymphocyte deoxyribonucleic acid (DNA) double-strand-break levels resulting from in vivo radiation and ex vivo radiation at breast-tissue level, and the effect of breast shielding on image quality. Materials and Methods The study was approved by institutional review and commpliant with HIPAA guidelines. Adult women who underwent 64-section coronary computed tomographic (CT) angiography and who provided informed consent were prospectively randomized to the use (n = 50) or absence (n = 51) of bismuth breast shields. Peripheral blood samples were obtained before and 30 minutes after in vivo radiation during CT angiography to compare DNA double-strand-break levels by γ-H2AX immunofluorescence in blood lymphocytes. To estimate DNA double-strand-break induction at breast-tissue level, a blood sample was taped to the sternum for ex vivo radiation with or without shielding. Data were analyzed by linear regression and independent sample t tests. Results Breast shielding had no effect on DNA double-strand-break levels from ex vivo radiation of blood samples under shields at breast-tissue level (unadjusted regression: ß = .08; P = .43 versus no shielding), or in vivo radiation of circulating lymphocytes (ß = -.07; P = .50). Predictors of increased DNA double-strand-break levels included total radiation dose, increasing tube potential, and tube current (P < .05). With current radiation exposures (median, 3.4 mSv), breast shielding yielded a 33% increase in image noise and 19% decrease in the rate of excellent quality ratings. Conclusion Among women who underwent coronary CT angiography, breast shielding had no effect on DNA double-strand-break levels in blood lymphocytes exposed to in vivo radiation, or ex vivo radiation at breast-tissue level. At present relatively low radiation exposures, breast shielding contributed to an increase in image noise and a decline in image quality. The findings support efforts to minimize radiation by primarily optimizing CT settings. (©) RSNA, 2016 Clinical trial registration no. NCT02617888 Online supplemental material is available for this article.
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Mama/efectos de la radiación , Angiografía por Tomografía Computarizada , Angiografía Coronaria , Roturas del ADN de Doble Cadena/efectos de la radiación , Cardiopatías/diagnóstico por imagen , Femenino , Humanos , Persona de Mediana Edad , Estudios Prospectivos , Dosis de Radiación , Protección Radiológica/métodos , Interpretación de Imagen Radiográfica Asistida por ComputadorRESUMEN
OBJECTIVE: We sought to examine the risk of mortality associated with nonobstructive coronary artery disease (CAD) and to determine the impact of baseline statin and aspirin use on mortality. APPROACH AND RESULTS: Coronary computed tomographic angiography permits direct visualization of nonobstructive CAD. To date, the prognostic implications of nonobstructive CAD and the potential benefit of directing therapy based on nonobstructive CAD have not been carefully examined. A total of 27 125 consecutive patients who underwent computed tomographic angiography (12 enrolling centers and 6 countries) were prospectively entered into the COronary CT Angiography EvaluatioN For Clinical Outcomes: An InteRnational Multicenter (CONFIRM) registry. Patients, without history of previous CAD or obstructive CAD, for whom baseline statin and aspirin use was available were analyzed. Each coronary segment was classified as normal or nonobstructive CAD (1%-49% stenosis). Patients were followed up for a median of 27.2 months for all-cause mortality. The study comprised 10 418 patients (5712 normal and 4706 with nonobstructive CAD). In multivariable analyses, patients with nonobstructive CAD had a 6% (95% confidence interval, 1%-12%) higher risk of mortality for each additional segment with nonobstructive plaque (P=0.021). Baseline statin use was associated with a reduced risk of mortality (hazard ratio, 0.44; 95% confidence interval, 0.28-0.68; P=0.0003), a benefit that was present for individuals with nonobstructive CAD (hazard ratio, 0.32; 95% confidence interval, 0.19-0.55; P<0.001) but not for those without plaque (hazard ratio, 0.66; 95% confidence interval, 0.30-1.43; P=0.287). When stratified by National Cholesterol Education Program/Adult Treatment Program III, no mortality benefit was observed in individuals without plaque. Aspirin use was not associated with mortality benefit, irrespective of the status of plaque. CONCLUSIONS: The presence and extent of nonobstructive CAD predicted mortality. Baseline statin therapy was associated with a significant reduction in mortality for individuals with nonobstructive CAD but not for individuals without CAD. CLINICAL TRIAL REGISTRATION: URL: http://clinicaltrials.gov/. Unique identifier NCT01443637.
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Aspirina/uso terapéutico , Angiografía Coronaria/métodos , Enfermedad de la Arteria Coronaria/tratamiento farmacológico , Estenosis Coronaria/tratamiento farmacológico , Inhibidores de Hidroximetilglutaril-CoA Reductasas/uso terapéutico , Inhibidores de Agregación Plaquetaria/uso terapéutico , Prevención Primaria/métodos , Tomografía Computarizada por Rayos X , Adulto , Anciano , Asia , Canadá , Enfermedad de la Arteria Coronaria/diagnóstico por imagen , Enfermedad de la Arteria Coronaria/mortalidad , Estenosis Coronaria/diagnóstico por imagen , Estenosis Coronaria/mortalidad , Europa (Continente) , Femenino , Humanos , Estimación de Kaplan-Meier , Masculino , Persona de Mediana Edad , Análisis Multivariante , Oportunidad Relativa , Valor Predictivo de las Pruebas , Modelos de Riesgos Proporcionales , Estudios Prospectivos , Factores Protectores , Sistema de Registros , Factores de Riesgo , Índice de Severidad de la Enfermedad , Factores de Tiempo , Resultado del Tratamiento , Estados UnidosRESUMEN
Direct oral anticoagulants (DOACs) have been marketed in the United States since 2010. While numerous large-scale prospective phase 3 outcomes studies have documented the effectiveness of DOACs for the prevention of stroke and systemic embolism in patients with nonvalvular atrial fibrillation, the primary safety concern with all of these drugs-as it is with the more established oral anticoagulant warfarin-is the risk of major bleeding. Postmarketing surveillance studies (PMSS) provide the opportunity to evaluate the safety of these recently approved drugs across a spectrum of patients that may be broader than those included in randomized controlled trials. This review will summarize the safety findings of numerous recently performed, large-scale PMSS evaluations, and consider the currently available evidence regarding the risks for bleeding in patients treated with DOACs, in order to give providers and patients additional evidence regarding the safety of DOACs.
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Anticoagulantes/efectos adversos , Hemorragia/inducido químicamente , Vigilancia de Productos Comercializados , Dabigatrán/efectos adversos , Humanos , Pirazoles/efectos adversos , Piridonas/efectos adversos , Rivaroxabán/efectos adversosRESUMEN
AIMS: We evaluated coronary artery disease (CAD) extent, severity, and major adverse cardiac events (MACEs) in never, past, and current smokers undergoing coronary CT angiography (CCTA). METHODS AND RESULTS: We evaluated 9456 patients (57.1 ± 12.3 years, 55.5% male) without known CAD (1588 current smokers; 2183 past smokers who quit ≥3 months before CCTA; and 5685 never smokers). By risk-adjusted Cox proportional-hazards models, we related smoking status to MACE (all-cause death or non-fatal myocardial infarction). We further performed 1:1:1 propensity matching for 1000 in each group evaluate event risk among individuals with similar age, gender, CAD risk factors, and symptom presentation. During a mean follow-up of 2.8 ± 1.9 years, 297 MACE occurred. Compared with never smokers, current and past smokers had greater atherosclerotic burden including extent of plaque defined as segments with any plaque (2.1 ± 2.8 vs. 2.6 ± 3.2 vs. 3.1 ± 3.3, P < 0.0001) and prevalence of obstructive CAD [1-vessel disease (VD): 10.6% vs. 14.9% vs. 15.2%, P < 0.001; 2-VD: 4.4% vs. 6.1% vs. 6.2%, P = 0.001; 3-VD: 3.1% vs. 5.2% vs. 4.3%, P < 0.001]. Compared with never smokers, current smokers experienced higher MACE risk [hazard ratio (HR) 1.9, 95% confidence interval (CI) 1.4-2.6, P < 0.001], while past smokers did not (HR 1.2, 95% CI 0.8-1.6, P = 0.35). Among matched individuals, current smokers had higher MACE risk (HR 2.6, 95% CI 1.6-4.2, P < 0.001), while past smokers did not (HR 1.3, 95% CI 0.7-2.4, P = 0.39). Similar findings were observed for risk of all-cause death. CONCLUSION: Among patients without known CAD undergoing CCTA, current and past smokers had increased burden of atherosclerosis compared with never smokers; however, risk of MACE was heightened only in current smokers.
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Enfermedad de la Arteria Coronaria/etiología , Fumar/efectos adversos , Angiografía Coronaria/métodos , Enfermedad de la Arteria Coronaria/diagnóstico por imagen , Enfermedad de la Arteria Coronaria/mortalidad , Métodos Epidemiológicos , Femenino , Humanos , Masculino , Persona de Mediana Edad , Infarto del Miocardio/diagnóstico por imagen , Infarto del Miocardio/etiología , Infarto del Miocardio/mortalidad , Placa Aterosclerótica/diagnóstico por imagen , Placa Aterosclerótica/etiología , Pronóstico , Tomografía Computarizada por Rayos X/métodosRESUMEN
AIM: Prior evidence observed no predictive utility of coronary CT angiography (CCTA) over the coronary artery calcium score (CACS) and the Framingham risk score (FRS), among asymptomatic individuals. Whether the prognostic value of CCTA differs for asymptomatic patients, when stratified by CACS severity, remains unknown. METHODS AND RESULTS: From a 12-centre, 6-country observational registry, 3217 asymptomatic individuals without known coronary artery disease (CAD) underwent CACS and CCTA. Individuals were categorized by CACS as: 0-10, 11-100, 101-400, 401-1000, >1000. For CCTA analysis, the number of obstructive vessels-as defined by the per-patient presence of a ≥50% luminal stenosis-was used to grade the extent and severity of CAD. The incremental prognostic value of CCTA over and above FRS was measured by the likelihood ratio (LR) χ(2), C-statistic, and continuous net reclassification improvement (NRI) for prediction, discrimination, and reclassification of all-cause mortality and non-fatal myocardial infarction. During a median follow-up of 24 months (25th-75th percentile, 17-30 months), there were 58 composite end-points. The incremental value of CCTA over FRS was demonstrated in individuals with CACS >100 (LRχ(2), 25.34; increment in C-statistic, 0.24; NRI, 0.62, all P < 0.001), but not among those with CACS ≤100 (all P > 0.05). For subgroups with CACS >100, the utility of CCTA for predicting the study end-point was evident among individuals whose CACS ranged from 101 to 400; the observed predictive benefit attenuated with increasing CACS. CONCLUSION: Coronary CT angiography provides incremental prognostic utility for prediction of mortality and non-fatal myocardial infarction for asymptomatic individuals with moderately high CACS, but not for lower or higher CACS.
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Estenosis Coronaria/diagnóstico por imagen , Calcificación Vascular/diagnóstico por imagen , Angiografía Coronaria/métodos , Angiografía Coronaria/mortalidad , Estenosis Coronaria/mortalidad , Femenino , Humanos , Estimación de Kaplan-Meier , Masculino , Persona de Mediana Edad , Infarto del Miocardio/mortalidad , Pronóstico , Medición de Riesgo , Tomografía Computarizada por Rayos X/métodos , Tomografía Computarizada por Rayos X/mortalidad , Calcificación Vascular/mortalidadRESUMEN
BACKGROUND: Abdominal aortic aneurysm (AAA) is common with unacceptably high rates of mortality and morbidity with unknown rates of complications after repair in the Department of Defense (DoD). METHODS: All patients treated at a DOD or VA clinic or medical facility with a diagnosis of AAA identified by ICD-9 code search were identified by Patient Administration Systems and Biostatistics Activity (PASBA) using the Standard Inpatient Data Record (SIDR) and Composite Ambulatory Patient Encounter Record (CAPER) from January 2006 till December 2011. The primary outcome was death, myocardial infarction (MI), stroke, and cardiac arrhythmia between subjects who underwent endovascular aortic repair (EVAR) or open aortic repair (OAR). RESULTS: A total of 8314 patients were screened to identify 632 patients who underwent surgical repair of non-ruptured AAA. EVAR was performed in 497 patients (78.6%) and OAR in 135 patients (21.4%). Mortality at 30 days was less common in EVAR patients (1.6% vs. 6.7%, p = 0.004), but was not sustained (16.9% vs. 17.8%, p = 0.797). Mean survival free from mortality was not different between the two groups (EVAR vs. OAR: 6.14 ± 0.13 years vs. 6.11 ± 0.22 years, p = 0.378). The composite endpoint of MI, stroke, arrhythmia, or death was not different between groups at 30 days (EVAR vs. OAR: 12.9% vs. 14.1%, p = 0.774) or in long-term follow-up population (EVAR vs. OAR: 40.6% vs. 31.9%, p = 0.073) though there was a trend toward higher event rates in the EVAR. The composite endpoint of MI, stroke, and arrhythmia occurred in 198 patients (31%). CONCLUSION: EVAR was associated with lower 30-day mortality rates; however, this benefit was not sustained in longer-term follow-up. There is no difference in the rates of stroke, myocardial infarction, or cardiac arrhythmia at 30 days or in long-term follow-up.
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Aneurisma de la Aorta Abdominal/mortalidad , Aneurisma de la Aorta Abdominal/cirugía , Rotura de la Aorta/cirugía , Procedimientos Quirúrgicos Electivos , Procedimientos Endovasculares , Anciano , Anciano de 80 o más Años , Aneurisma de la Aorta Abdominal/diagnóstico , Rotura de la Aorta/mortalidad , Procedimientos Quirúrgicos Electivos/métodos , Procedimientos Endovasculares/métodos , Femenino , Estudios de Seguimiento , Humanos , Incidencia , Masculino , Persona de Mediana Edad , Infarto del Miocardio/mortalidad , Medición de Riesgo , Factores de Riesgo , Accidente Cerebrovascular/mortalidad , Resultado del TratamientoRESUMEN
OBJECTIVES: Cardiac computed tomography perfusion (CTP) using stress testing is an emerging application in the field of cardiac computed tomography. We evaluated patients with acute chest pain (CP) in the emergency department (ED) with evidence of obstructive coronary artery disease (CAD), defined as >70% stenosis on coronary computed tomography angiography (CCTA) and confirmed by invasive coronary angiography (ICA), to evaluate the applicability of resting CTP in the acute CP setting. METHODS: From January to December 2013, 183 low-intermediate risk symptomatic patients with negative cardiac biomarkers and no known CAD underwent a rapid CCTA protocol in the ED. Of these, 4 patients (1.4%) had obstructive CAD (≥70% stenosis) on CCTA confirmed by ICA. All 183 CCTA studies were evaluated retrospectively with CTP software by a transmural perfusion ratio (TPR) method with a superimposed 17-segment model. A TPR value <0.99 was considered abnormal based on previously published data. RESULTS: A total of four patients were included in this pilot analysis. The duration from resolution of CP to performance of CCTA ranged from 1.6 to 5.0 hours. Three patients underwent revascularization, two with percutaneous coronary intervention (PCI) and one with coronary artery bypass grafting. The fourth patient was managed with aggressive medical therapy. Two patients had multivessel obstructive CAD and two patients had single-vessel CAD. The first patient underwent CCTA 5 hours after resolution of CP symptoms. CCTA demonstrated noncalcified obstructive CAD in the mid-LAD and mid-right coronary artery. ICA showed good correlation by quantitative coronary assessment (QCA) in both vessels and the patient underwent PCI. CTP analysis demonstrated perfusion defects in the LAD and right coronary artery territories. The second patient underwent CCTA 1.6 hours after resolution of CP symptoms with findings of obstructive ostial left main CAD. ICA confirmed obstructive left main CAD by QCA and intravascular ultrasound. The patient underwent revascularization with coronary artery bypass grafting. CTP demonstrated perfusion defects in the anterior and lateral wall segments. The third patient was evaluated for CP in the ED with CCTA demonstrating single-vessel CAD 10 hours after resolution of symptoms with findings of a noncalcified obstructive stenosis in the mid-LAD. The patient subsequently underwent ICA demonstrating good correlation to the CCTA findings in the LAD by QCA. CTP analysis revealed perfusion defects in LAD territory. He was successful treated with PCI. The final patient underwent CCTA 5.4 hours following resolution of CP with the finding of an intermediate partially calcified stenosis in the distal LAD. ICA was performed, with fractional flow reserve demonstrating a hemodynamically insignificant distal LAD at 0.86. CTP detected a perfusion defect in the LAD territory. CONCLUSIONS: When positive, rest CTP may have value in the risk stratification of patients presenting to the ED with nontraumatic acute CP.