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Background: Inability to resume employment after acute myocardial infarction (MI) has important implications for patients. We sought to assess the prevalence of and outcomes associated with adverse change in employment after MI in a national US cohort., Methods and Results: The TRANSLATE-ACS study (Treatment with Adenosine Diphosphate Receptor Inhibitors: Longitudinal Assessment of Treatment Patterns and Events after Acute Coronary Syndrome) assessed employment status at baseline and 1 year among 9319 patients with MI (mean age, 60.8 years; SD, 11.3; 27.3% women) enrolled at 233 US hospitals. We defined adverse change in employment as patients working at baseline but working less or not working at 1-year post-MI. In multivariable models, we assessed factors associated with adverse change in employment and its association with patient-reported depression, health status, persistence to evidence-based medications prescribed at discharge, and financial hardship affording medications. Half of the patients (51%; n=4730) were employed at the time of MI. By 1 year, 10% (n=492) of these reported an adverse change in employment, with 3% (n=143) working less and 7% (n=349) no longer working (only 27 of 349 reported retirement). Factors significantly associated with adverse change in employment included a number of unplanned readmissions, postdischarge bleeding complications, hypertension, and smoking. At 1 year, patients with an adverse change in employment were more likely to report depression (Patient Health Questionnaire 2 score >3: 27.4% versus 16.7%), lower health status (mean EuroQoL visual analogue scale: 73 [SD, 17.8] versus 78 [SD, 14.8]), and moderate-extreme financial hardship with medication costs (41.0% versus 28.4%; all P <0.001). There was no difference in persistence to evidence-based medications prescribed at discharge., Conclusions: Patients who experienced an adverse change in employment after MI reported lower quality of life, increased depression, and more difficulty affording medications. These results underscore the need for interventions to address this patient-centered outcome and its health impact., Clinical Trial Registration: URL: https://www.clinicaltrials.gov. Unique identifier: NCT01088503., (© 2018 American Heart Association, Inc.)

Background: Guidelines recommend P2Y 12 inhibitor therapy for 1 year after myocardial infarction (MI), yet little guidance is provided on antiplatelet management for patients with recurrent ischemic events during that year. We describe changes in P2Y 12 inhibitor type among patients with recurrent ischemic events in the first year after MI., Methods and Results: The TRANSLATE-ACS (Treatment With ADP Receptor Inhibitors: Longitudinal Assessment of Treatment Patterns and Events After Acute Coronary Syndrome) study enrolled 12 365 patients with MI treated with percutaneous coronary intervention. We examined whether P2Y 12 inhibitor choice changed among patients with recurrent MI, stent thrombosis, and/or unplanned revascularization during the first year after MI, and modeled factors associated with P2Y 12 inhibitor intensification (changing clopidogrel to prasugrel or ticagrelor). In the first year after MI, 1414 patients (11%) had a total of 1740 recurrent ischemic events (771 recurrent MIs, 969 unplanned revascularizations, and 165 stent thromboses). Median time to the first recurrent ischemic event was 154 days (25th-75th percentiles, 55-287 days). Of those with recurrent ischemic events, 101 of 1092 (9.3%) occurring in clopidogrel-treated patients led to P2Y 12 inhibitor intensification. Recurrent events involving stent thrombosis or MI were the strongest factors associated with P2Y 12 inhibitor intensification, yet only 40% of patients with stent thrombosis and 14% of patients with recurrent MI had P2Y 12 inhibitor intensification. Increasing age and longer time from the index MI were associated with lower likelihood for intensification., Conclusions: Few patients after MI with a recurrent ischemic event who were taking clopidogrel switched to a more potent P2Y 12 inhibitor, even after stent thrombosis events. Specific guidance is needed for patients who have recurrent ischemic events, particularly when closely spaced., Clinical Trial Registration: URL: https://www.clinicaltrials.gov. Unique identifier: NCT01088503., (© 2018 The Authors. Published on behalf of the American Heart Association, Inc., by Wiley.)

Background: Among patients with acute myocardial infarction (MI) who have multivessel disease, it is unclear if multivessel percutaneous coronary intervention (PCI) improves clinical and quality-of-life outcomes compared with culprit-only intervention. We sought to compare clinical and quality-of-life outcomes between multivessel and culprit-only PCI., Methods and Results: Among 6061 patients with acute MI who have multivessel disease in the TRANSLATE-ACS (Treatment With Adenosine Diphosphate Receptor Inhibitors: Longitudinal Assessment of Treatment Patterns and Events After Acute Coronary Syndrome) study, we used inverse probability-weighted propensity adjustment to study the associations between multivessel and culprit-only intervention during the index PCI and major adverse cardiovascular events, unplanned all-cause readmission, and angina frequency at 6 weeks and 1 year. Multivessel PCI was performed in 1208 (20%) of patients with MI who had multivessel disease. Relative to the culprit-only intervention, patients receiving multivessel PCI were similarly aged and more likely to be seen with non-ST-segment elevation MI or cardiogenic shock. At 6 weeks, the initial multivessel PCI strategy was associated with lower major adverse cardiovascular events and unplanned readmission risks, whereas angina frequency was not significantly different between multivessel and culprit-only PCI. At 1 year, major adverse cardiovascular event risk was persistently lower in the multivessel PCI group (adjusted hazard ratio, 0.84; 95% confidence interval, 0.72-0.99), whereas long-term readmission risk (adjusted hazard ratio, 0.94; 95% confidence interval, 0.84-1.04) and angina frequency were similar between groups (adjusted odds ratio, 1.01; 95% confidence interval, 0.82-1.24). Similar associations were seen when patients with ST-segment elevation MI and non-ST-segment elevation MI were examined separately., Conclusions: Among patients with acute MI who have multivessel disease, multivessel PCI was associated with lower risk of all-cause readmission at 6 weeks and lower risk of major adverse cardiovascular events at 6 weeks and 1 year. However, similar short- and long-term angina frequencies were noted., (© 2017 The Authors. Published on behalf of the American Heart Association, Inc., by Wiley.)

Background: The purpose of this study was to describe the magnitude and characteristics of patients who did not experience any significant major adverse cardiovascular event early (within 6 weeks) and late (during the first year) after hospital discharge for an acute myocardial infarction (AMI)., Methods and Results: Data from 12 243 patients discharged after an AMI from 233 sites across the United States in the TRANSLATE-ACS (Treatment With ADP Receptor Inhibitors: Longitudinal Assessment of Treatment Patterns and Events After Acute Coronary Syndrome) study were analyzed. Multivariable adjusted regression analyses modeled factors associated with 6-week and 1-year survivors who did not experience a recurrent AMI, stroke, unplanned coronary revascularization, or rehospitalization for unstable angina/chest pain during these time periods. The average age of this study population was 60.0 years, 72.0% were men, and 87.9% were white. In this population, 92.4% were classified as early low-risk survivors and 76.3% were classified as late low-risk survivors of an AMI. Factors associated with being an early and late postdischarge survivor included being male and having single-vessel coronary artery disease at the patient's index hospitalization. Patients who were not first seen with any chronic health condition, had an index hospital stay of ≤3 days, and had high baseline quality-of-life scores were more likely to be late low-risk survivors., Conclusions: Identifying low-risk survivors of an AMI may permit healthcare providers to focus more intensive efforts and interventions on those at higher risk of experiencing adverse cardiovascular events during the postdischarge transition period., Clinical Trial Registration: URL: http://www.clinicaltrials.gov. Unique identifier: NCT01088503., (© 2017 The Authors. Published on behalf of the American Heart Association, Inc., by Wiley.)

Importance: Pragmatic clinical trial designs have proposed the use of medical claims data to ascertain clinical events; however, the accuracy of billed diagnoses in identifying potential events is unclear., Objectives: To compare the 1-year cumulative incidences of events when events were identified by medical claims vs by physician adjudication and to assess the accuracy of bill-identified events using physician adjudication as the criterion standard., Design, Setting, and Participants: This post hoc analysis of a clinical trial assessed the medical claims forms and records for all rehospitalizations at 233 US hospitals within 1 year of the index acute myocardial infarction (MI) of 12 365 patients enrolled in the Treatment With Adenosine Diphosphate Receptor Inhibitors: Longitudinal Assessment of Treatment Patterns and Events After Acute Coronary Syndrome (TRANSLATE-ACS) study between April 1, 2010, and October 31, 2012. Fourteen patients (0.1%) died during the index hospitalization and were excluded from analysis. Recurrent MI, stroke, and bleeding events were identified per the International Classification of Diseases, Ninth Revision, Clinical Modification diagnosis and procedural codes in medical bills. These events were independently adjudicated by study physicians through medical record reviews using the prespecified criteria of recurrent MI and stroke and the bleeding definition by the Global Utilization of Streptokinase and Tissue Plasminogen Activator for Occluded Coronary Arteries (GUSTO) scale. Medical claims were reported on a Uniform Bill-04 claims form; claims were collected from all hospitals visited by patients enrolled in TRANSLATE-ACS. Agreement between medical claims-identified events and physician-adjudicated events over the 12 months after discharge was assessed with the κ statistic. Data were analyzed from January 30, 2015, to March 2, 2017., Main Outcomes and Measures: Event rates within 1 year after MI., Results: Among 12 365 patients with acute MI, 8890 (71.9%) were men and mean (SD) age was 60 (11.6) years. The cumulative 1-year incidence of events identified by medical claims was 4.3% for MI, 0.9% for stroke, and 5.0% for bleeding. Incidence rates based on physician adjudication were 4.7% for MI, 0.9% for stroke, and 5.4% for bleeding. Agreement between medical claims-identified and physician-adjudicated events was modest, with a κ of 0.76 (95% CI, 0.73 to 0.79) for MI and 0.55 (95% CI, 0.41 to 0.68) for stroke events. In contrast, agreement between medical claims-identified and physician-adjudicated bleeding events was poor, with a κ of 0.24 (95% CI, 0.19 to 0.30) for any hospitalized bleeding event and 0.15 (95% CI, 0.11 to 0.20) for moderate or severe bleeding on the GUSTO scale., Conclusions and Relevance: Event rates at 1 year after MI were lower for MI, stroke, and bleeding when medical claims were used to identify events than when adjudicated by physicians. Medical claims diagnoses were only modestly accurate in identifying MI and stroke admissions but had limited accuracy for bleeding events. An alternative approach may be needed to ensure good safety surveillance in cardiovascular studies., Trial Registration: clinicaltrials.gov Identifier: NCT01088503.

Background--Patients with end-stage renal disease undergoing percutaneous coronary intervention (PCI) have largely been excluded from trials of antithrombotic therapies leaving little data to guide agent choice in this population. Methods and Results--The National Cardiovascular Data Registry CathPCI Registry was used to identify patients with end-stage renal disease undergoing PCI who received monotherapy with either bivalirudin or unfractionated heparin (UFH) (n=71 675). In hospital bleeding and mortality were compared and adjusted using the CathPCI Registry logistic regression models with generalized estimating equations with UFH as the reference. Bivalirudin was used in 51.3% of patients versus 48.7% for UFH. The use of bivalirudin decreased over time, and in 2014, UFH became the most frequently used. Patients receiving UFH were more likely to have an acute coronary syndrome presentation (37.8% versus 27.4%) or have cardiogenic shock (3.74% versus 1.98%). The observed rates for in hospital bleeding (7.0% versus 9.5%; adjusted odds ratio,0.82; 95% confidence interval, 0.76-0.87) and mortality (2.6% versus 4.2%; adjusted odds ratio, 0.87; 95% confidence interval, 0.78-0.97) were lower for patients receiving bivalirudin compared with those receiving UFH. Conclusions--In patients with end-stage renal disease undergoing PCI, bivalirudin and UFH were used with similar frequency although the patterns of use changed over the enrollment period. Patients with end-stage renal disease undergoing PCI had a lower adjusted risk of in hospital outcomes with bivalirudin; however, given the observational nature of this analysis, a randomized trial is warranted. [ABSTRACT FROM AUTHOR]

Background: Race and sex disparities in in-hospital treatment and outcomes of patients with acute myocardial infarction (MI) have been described, but little is known about race and sex differences in post-MI angina and long-term risk of unplanned rehospitalization. We examined race and sex differences in post-MI angina frequency and 1-year unplanned rehospitalization to identify factors associated with unplanned rehospitalization, testing for whether race and sex modify these relationships.Methods: Using TRANSLATE-ACS (Treatment With Adenosine Diphosphate Receptor Inhibitors: Longitudinal Assessment of Treatment Patterns and Events after Acute Coronary Syndrome) data, we examined 6-week and 1-year angina frequency and 1-year unplanned rehospitalization stratified by race and sex among MI patients treated with percutaneous coronary intervention. We used multivariable logistic regression to assess factors associated with unplanned rehospitalization and tested for interactions among angina frequency, race, and sex.Results: A total of 11 595 MI patients survived to 1 year postdischarge; there were 66.6% white male patients, 24.3% white female patients, 5.3% black male patients, and 3.8% black female patients. Overall, 29.7% had angina at 6 weeks, and 20.6% had angina at 1 year postdischarge. Relative to white patients, black patients were more likely to have angina at 6 weeks (female: 44.2% versus 31.8%; male: 33.5% versus 27.1%; both P<0.0001) and 1 year (female: 49.4% versus 38.9%; male: 46.3% versus 31.1%; both P<0.0001). Rates of 1-year unplanned rehospitalization were highest among black female patients (44.1%), followed by white female patients (38.4%), black male patients (36.4%), and white male patients (30.2%, P<0.0001). In the multivariable model, 6-week angina was most strongly associated with unplanned rehospitalization (hazard ratio, 1.49; 95% confidence interval, 1.36-1.62; P<0.0001); this relationship was not modified by race or sex (adjusted 3-way Pinteraction=0.41).Conclusions: One-fifth of MI patients treated with percutaneous coronary intervention report 1-year postdischarge angina, with black and female patients more likely to have angina and to be rehospitalized. Better treatment of post-MI angina may improve patient quality of life and quality of care and help to lower rates of rehospitalization overall and particularly among black and female patients, given their high prevalence of post-MI angina.Clinical Trial Registration: URL: http://www.clinicaltrials.gov. Unique identifier: NCT01088503. [ABSTRACT FROM AUTHOR]

Objectives: The aim of this study was to describe differences in treatment and in-hospital mortality of early, late, and very late stent thrombosis (ST). Background: Early, late, and very late ST may differ in clinical presentation, management, and in-hospital outcomes. Methods: We analyzed definite (angiographically documented) ST cases identified from February 2009 to June 2010 in the CathPCI Registry. We stratified events by timing of presentation: early (≤1 month), late (1 to 12 months), or very late (≥12 months) following stent implantation. Multivariable logistic regression modeling was performed to compare in-hospital mortality for each type of ST after adjusting for baseline comorbidities. Results: During the study period, 7,315 ST events were identified in 7,079 of 401,662 patients (1.8%) presenting with acute coronary syndromes. This ST cohort consisted of 1,391 patients with early ST (19.6%), 1,370 with late ST (19.4%), and 4,318 with very late ST (61.0%). Subjects with early ST had a higher prevalence of black race and diabetes, whereas subjects with very late ST had a higher prevalence of white race and a lower prevalence of prior myocardial infarction or diabetes. In-hospital mortality was significantly higher in early ST (7.9%) compared with late (3.8%) and very late ST (3.6%, p < 0.001). This lower mortality for late and very late ST persisted after multivariable adjustment (odds ratio: 0.53 [95% confidence interval (CI): 0.36 to 0.79] and 0.58 [95% CI: 0.43 to 0.79], respectively). Conclusions: Significant differences exist in the presentation and outcomes of early, late, and very late ST. Among patients with acute coronary syndromes who are undergoing percutaneous coronary intervention for angiographically documented ST, early ST is associated with the highest in-hospital mortality. [Copyright &y& Elsevier]

Background-Radial access for percutaneous coronary intervention (r-PCI) is associated with reduced vascular complications; however, previous reports have shown that <2% of percutaneous coronary intervention (PCI) procedures in the United States are performed via the radial approach. Our aims were to evaluate temporal trends in r-PCI and compare procedural outcomes between r-PCI and transfemoral PCI. Methods and Results-We conducted a retrospective cohort study from the CathPCI registry (n=2 820 874 procedures from 1381 sites) between January 2007 and September 2012. Multivariable logistic regression models were used to evaluate the adjusted association between r-PCI and bleeding, vascular complications, and procedural success, using transfemoral PCI as the reference. Outcomes in high-risk subgroups such as age ≥75 years, women, and patients with acute coronary syndrome were also examined. The proportion of r-PCI procedures increased from 1.2% in quarter I 2007 to 16.1% in quarter 3 2012 and accounted for 6.3% of total procedures from 2007 to 2012 (n=178 643). After multivariable adjustment, r-PCI use in the studied cohort of patients was associated with lower risk of bleeding (adjusted odds ratio, 0.51; 95% confidence interval, 0.49-0.54) and lower risk of vascular complications (adjusted odds ratio, 0.39; 95% confidence interval, 0.31-0.50) in comparison with transfemoral PCI. The reduction in bleeding and vascular complications was consistent across important subgroups of age, sex, and clinical presentation. Conclusions-There has been increasing adoption of r-PCI in the United States. Transradial PCI now accounts for 1 of 6 PCIs performed in contemporary clinical practice. In comparison with traditional femoral access, transradial PCI is associated with lower vascular and bleeding complication rates. [ABSTRACT FROM AUTHOR]