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BACKGROUND: Results from the COORDINATE-Diabetes trial (Coordinating Cardiology Clinics Randomized Trial of Interventions to Improve Outcomes - Diabetes) demonstrated that a multifaceted, clinic-based intervention increased prescription of evidence-based medical therapies to participants with type 2 diabetes and atherosclerotic cardiovascular disease. This secondary analysis assessed whether intervention success was consistent across sex, race, and ethnicity. METHODS: COORDINATE-Diabetes, a cluster randomized trial, recruited participants from 43 US cardiology clinics (20 randomized to intervention and 23 randomized to usual care). The primary outcome was the proportion of participants prescribed all 3 groups of evidence-based therapy (high-intensity statin, angiotensin-converting enzyme inhibitor/angiotensin receptor blocker, and sodium-glucose cotransporter-2 inhibitor or glucagon-like peptide 1 receptor agonist) at last trial assessment (6 to 12 months). In this prespecified analysis, mixed-effects logistic regression models were used to assess the outcome by self-reported sex, race, and ethnicity in the intervention and usual care groups, with adjustment for baseline characteristics, medications, comorbidities, and site location. RESULTS: Among 1045 participants with type 2 diabetes and atherosclerotic cardiovascular disease, the median age was 70 years, 32% were female, 16% were Black, and 9% were Hispanic. At the last trial assessment, there was an absolute increase in the proportion of participants prescribed all 3 groups of evidence-based therapy in women (36% versus 15%), Black participants (41% versus 18%), and Hispanic participants (46% versus 18%) with the intervention compared with usual care, with consistent benefit across sex (male versus female; Pinteraction=0.44), race (Black versus White; Pinteraction=0.59), and ethnicity (Hispanic versus Non-Hispanic; Pinteraction= 0.78). CONCLUSIONS: The COORDINATE-Diabetes intervention successfully improved delivery of evidence-based care, regardless of sex, race, or ethnicity. Widespread dissemination of this intervention could improve equitable health care quality, particularly among women and minority communities who are frequently underrepresented in clinical trials. [ABSTRACT FROM AUTHOR]

BACKGROUND: Among patients hospitalized for atrial fibrillation, the frequency of off-label direct oral anticoagulant (DOAC) dosing, associated factors, hospital-level variation, and temporal trends in contemporary practice are unknown. METHODS: Using the Get With The Guidelines--Atrial Fibrillation registry, patients admitted from January 1, 2014, to March 31, 2020, and discharged on DOACs were stratified according to receipt of underdosing, overdosing, or recommended dosing. Factors associated with off-label dosing (defined as underdosing or overdosing) were identified using logistic regression. Median odds ratio (OR) and time-series analyses were used to assess hospital-level variation and temporal trends, respectively. RESULTS: Of 22 470 patients (70.1±12.1 years, 48.1% female, 82.5% White) prescribed a DOAC at discharge from hospitalization for atrial fibrillation (66% apixaban, 29% rivaroxaban, and 5% dabigatran), underdosing occurred among 2006 (8.9%), overdosing among 511 (2.3%), and recommended dosing among 19 953 (88.8%). The overall rate of offlabel dosing was 11.2%. Patient-related factors associated with off-label dose included age (underdosing: OR, 1.06 per 1-year increase [95% CI, 1.06--1.07]; overdosing: OR, 1.07 per 1-year increase [95% CI, 1.06--1.09]), dialysis dependence (underdosing: OR, 5.50 [95% CI, 3.76--8.05]; overdosing: OR, 5.47 [95% CI, 2.74--10.88]), female sex (overdosing: OR, 0.79 [95% CI, 0.63--0.99]), and weight (overdosing: OR, 0.96 per 1-kg increase [95% CI, 0.95--1.00]). Across hospitals, the adjusted median OR for off-label DOAC dose was 1.45 (95% CI, 1.34--1.65; underdosing: OR, 1.52 [95% CI, 1.39--1.76]; overdosing: OR, 1.32 [95% CI, 1.20--1.84]), indicating significant hospital-level variation. Over the study period, recommended dosing significantly increased over time (81.9%--90.9%; P<0.0001 for trend) with a corresponding decline in underdosing (14.4%--6.6%; P<0.0001 for trend) and overdosing (3.8%--2.5%; P=0.001 for trend). CONCLUSIONS: Over 1 in 10 patients hospitalized for atrial fibrillation are discharged on an off-label DOAC dose with significant variation across hospitals. While the proportion of patients receiving recommended dosing has significantly improved over time, opportunities to improve DOAC dosing persist. [ABSTRACT FROM AUTHOR]

BACKGROUND: Advances in chronic total occlusion percutaneous coronary intervention (CTO PCI) techniques have led to increased procedural success rates among operators. While utilization of CTO PCI has disseminated widely, the learning curve for new operators has not been well-defined. METHODS: Between July 2009 and December 2015, 93 875 CTO PCI cases were extracted from the CathPCI Registry. We delineated a cohort of new CTO operators performing <10 CTO PCI cases per given year. In-hospital outcomes for subsequent CTO PCIs were stratified by the number of prior cases accrued by each operator. Multivariable regression models were used to estimate differences in outcomes with increasing experience. The primary outcome was major adverse cardiovascular events defined as the composite of death, myocardial infarction, stroke, tamponade, or urgent coronary artery bypass grafting. RESULTS: Among 70 916 cases performed by 7251 new operators, procedure success rate was 61.4% and major adverse cardiovascular event rate was 4.2%. Meanwhile, the rate of major bleeding was 4.0%, myocardial infarction 2.0%, mortality 0.6%, tamponade 0.3%, and renal failure 0.2%. Adjusted regression models demonstrated piecewise linear improvements in guidewire crossing, stent placement, and procedure success with accrued volume, albeit with increased contrast use, fluoroscopy time, and bleeding. Major adverse cardiovascular event rates were stable beyond the 12th case (odds ratio per 5 case increase 1.00; 95% CI, 0.98-1.03, P=0.7980). CONCLUSIONS: Among a large number of new CTO PCI operators in the United States, there exists an experiential learning curve for procedural success. However, there were higher rates of bleeding despite case experience, while major adverse cardiovascular events remained relatively unchanged after initiation. [ABSTRACT FROM AUTHOR]

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]

The article discusses the findings of the European Cooperative Acute Stroke Study (ECASS) III which established benefit to expanding the intravenous tissue-type plasminogen activator (tPA) window from 3 to 4.5 hours for patients suffering from acute ischemic stroke (AIS). It examines the use of tPA in clinical practice before and after publication of ECASS III in Get With The Guidelines (GWTG)-Stroke program, a national systems of care quality improvement initiative.

The article discusses research on the use of and trends in evidence-based care acute myocardial infarction (AMI) processes and outcome in Asian-American and White patients in the U.S. The study made use of data from the Get With the Fuidelines-Coronary Arter Disease (GWTG-CAD) program of the American Heart Association (AHA). It found that Asian-Americans were less likely to undergo smoking cessation counseling.

Background: Percutaneous coronary intervention is performed by operators with differing experience, technique, and case mix. It is unknown if operator practice patterns impact patient outcomes. We sought to determine if a cluster algorithm can identify distinct profiles of percutaneous coronary intervention operators and if these profiles are associated with patient outcomes. Methods: Operators performing at least 25 annual procedures between 2014 and 2018 were clustered using an agglomerative hierarchical clustering algorithm. Risk-adjusted in-hospital mortality was compared between clusters. Results: We identified 4 practice profiles among 7706 operators performing 2 937 419 procedures. Cluster 1 (n=3345) demonstrated case mix and practice patterns similar to the national median. Cluster 2 (n=1993) treated patients with lower clinical acuity and were less likely to use intracoronary diagnostics, atherectomy, and radial access. Cluster 3 (n=1513) had the lowest case volume, were more likely to work at rural hospitals, and cared for a higher proportion of patients with ST-segment-elevation myocardial infarction and cardiogenic shock. Cluster 4 (n=855) had the highest case volume, were most likely to treat patients with high anatomic complexity and use atherectomy, intracoronary diagnostics, and mechanical support. Compared with cluster 1, adjusted in-hospital mortality was similar for cluster 2 (estimated difference, -0.03 [95% CI, -0.10 to 0.04]), higher for cluster 3 (0.14 [0.07-0.22]), and lower for cluster 4 (-0.15 [-0.24 to -0.06]). Conclusions: Distinct percutaneous coronary intervention operator profiles are differentially associated with patient outcomes. A phenotypic approach to physician assessment may provide actionable feedback for quality improvement. * Practice patterns of percutaneous coronary intervention operators in the United States vary regarding case mix and use of contemporary procedural techniques. * Differences in patient outcomes may be associated with operator factors such as case volume. * A novel machine-learning algorithm clusters percutaneous coronary intervention operators into 4 distinct profiles that differ by patient case mix and use of procedural techniques. * The cluster that most closely corresponds to proposed standards for optimal percutaneous coronary intervention practice-high annual volume, frequent use of contemporary procedural techniques, high clinical, and anatomic complexity-had the lowest adjusted in-hospital mortality rates. [ABSTRACT FROM AUTHOR]

To simultaneously adjust for confounding by multiple cardiovascular risk factors, recently published pharmacoepidemiologic studies have used an index of risk of cardiovascular disease (a cardiovascular risk score). This summary measure is a multivariate confounder score created from regression models relating these risk factors to the outcome. The score is then used in regression models to adjust for potential confounding of the exposure of interest. Although this summary score has a number of advantages, there is concern that it may result in underestimation of the standard error of the exposure estimate and thus inflate the number of statistically significant results.We conducted simulation studies comparing regression models adjusting for all risk factors directly to models using this summary risk score for large cohort studies.Results indicated that, as long as there was not a high degree of intercorrelation between the potential confounders and the exposure, estimated standard errors from the regression models using this summary risk score approximate their empirical standard errors well and are similar to the standard errors from the regression models directly adjusting for all risk factors.Based on these simulation results, using this summary risk score can be a reasonable approach for summarizing many risk factors in large cohort studies. [ABSTRACT FROM AUTHOR]

Background: Cost is frequently cited as a barrier to optimal medication use, but the extent to which copayment assistance interventions are used when available, and their impact on evidence-based medication persistence and major adverse cardiovascular events is unknown.Methods and Results: The ARTEMIS trial (Affordability and Real-World Antiplatelet Treatment Effectiveness After Myocardial Infarction Study) randomized 301 hospitals to usual care versus the ability to provide patients with vouchers that offset copayment costs when filling P2Y12 inhibitors in the 1 year post-myocardial infarction. In the intervention group, we used multivariable logistic regression to identify patient and medication cost characteristics associated with voucher use. We then used this model to stratify both intervention and usual care patients by likelihood of voucher use, and examined the impact of the voucher intervention on 1-year P2Y12 inhibitor persistence (no gap in pharmacy supply >30 days) and major adverse cardiovascular events (all-cause death, myocardial infarction, or stroke). Among 10 102 enrolled patients, 6135 patients were treated at hospitals randomized to the copayment intervention. Of these, 1742 (28.4%) never used the voucher, although 1729 (99.2%) voucher never-users filled at least one P2Y12 inhibitor prescription in the 1 year post-myocardial infarction. Characteristics most associated with voucher use included: discharge on ticagrelor, planned 1-year course of P2Y12 inhibitor treatment, white race, commercial insurance, and higher out-of-pocket medication costs (c-statistic 0.74). Applying this propensity model to stratify all enrolled patients by likelihood of voucher use, the intervention improved medication persistence the most in patients with high likelihood of voucher use (adjusted interaction P=0.03, odds ratio, 1.86 [95% CI, 1.48-2.33]). The intervention did not significantly reduce major adverse cardiovascular events in any voucher use likelihood group, although the odds ratio was lowest (0.86 [95% CI, 0.56-1.16]) among patients with high likelihood of voucher use (adjusted interaction P=0.04).Conclusions: Among patients discharged after myocardial infarction, those with higher copayments and greater out-of-pocket medication costs were more likely to use a copayment assistance voucher, but some classes of patients were less likely to use a copayment assistance voucher. Patients at low likelihood of voucher use benefitted least from copayment assistance, and other interventions may be needed to improve medication-taking behaviors and clinical outcomes in these patients. Registration: URL: https://www.clinicaltrials.gov. Unique identifier: NCT02406677. [ABSTRACT FROM AUTHOR]

Supplemental Digital Content is available in the text. Background: Adjunctive coronary atherectomy (CA) can be utilized in treating severely calcified coronary lesions; however, the temporal trends, patient selection, and variation in use of CA have not been well described. We sought to assess the trends in usage, interhospital variability, and outcomes with CA among patients undergoing percutaneous coronary intervention (PCI). Methods: All patients undergoing PCI in the National Cardiovascular Data Registry CathPCI Registry from July 1, 2009 to December 31, 2016 (N=3 864 377) were analyzed based on utilization of either rotational or orbital CA. Intervals using date of index CA grouped into 2009 Q3 to 2010, 2011 to 2012, 2013 to 2014, and 2015 to 2016 and hospital-level quartiles based on annual CA volumes were evaluated. The primary outcome measure was in-hospital major adverse cardiac events defined as a composite of all-cause mortality, periprocedural myocardial infarction, or stroke. Independent variables associated with outcomes were determined. Results: CA represented 1.7% (n=65 033) of the total PCI volume. Among hospitals performing PCI (n=1672), 577 (34.5%) did not perform any CA. Patients treated with CA were elderly, more often male, and had a history of diabetes, prior myocardial infarction, PCI, and coronary artery bypass grafting. The utilization of CA increased from 1.1% in Q3 2009 to 3.0% in Q4 of 2016 (5% quarterly increase in odds of CA; OR [95% CI], 1.05 [1.04–1.06], P <0.001). Among patients undergoing CA, there was a temporal decline in major adverse cardiac events (0.98 [0.97–0.99], P <0.001) and myocardial infarction (0.97 [0.96–0.98], P <0.001). In adjusted analyses, increasing hospital CA volume was associated with lower mortality (0.85 [0.76–0.96], P =0.01) and lower rates of PCI failure or complication requiring coronary artery bypass grafting (0.67 [0.56–0.79], P <0.001) but was associated with small increase in coronary perforation (1.18 [1.04–1.35], P <0.01). Conclusions: Although CA is performed infrequently, its use has increased over time. After accounting for potential confounders, higher CA volume was associated with lower risk of major adverse events counterbalanced by small risk of coronary perforation. [ABSTRACT FROM AUTHOR]

Supplemental Digital Content is available in the text. Background: SAFE-PCI for Women (Study of Access Site for Enhancement of PCI for Women), a randomized controlled trial comparing radial and femoral access in women undergoing cardiac catheterization or percutaneous coronary intervention (PCI), was terminated early for lower than expected event rates. Whether this was because of patient selection or better access site practice among trial patients is unknown. Methods and Results: SAFE-PCI was conducted within the National Cardiovascular Data Registry CathPCI registry. Using the National Cardiovascular Research Infrastructure Identification, PCI date, and age, patients enrolled in SAFE-PCI were compared with trial-eligible female CathPCI registry patients 1 year before, during, and 1 year after SAFE-PCI enrollment. Patient and procedure characteristics, predicted bleeding and mortality, and post-PCI bleeding were compared between groups. Enrolled SAFE-PCI patients and registry patients from the 3 time periods were linked to Centers for Medicare and Medicaid Services data to compare 30-day death and unplanned revascularization rates. At 54 SAFE-PCI sites, there were 496 SAFE-PCI trial patients with a PCI visit within the CathPCI registry. There were 24 958 registry patients from 1 year before and 1 year after SAFE-PCI enrollment and 15 904 trial-eligible registry patients during trial enrollment. Trial patients were younger, had lower predicted bleeding and mortality, and had lower rates of post-PCI bleeding within 72 hours compared with registry patients. Among 12 212 Centers for Medicare and Medicaid Services–linked patients, there were no significant differences in 30-day death and unplanned revascularization among the 4 groups. Conclusions: Lower predicted risk of bleeding and mortality among SAFE-PCI trial patients compared with registry patients suggests that lower-risk patients were selectively enrolled for the trial. These data demonstrate how registry-based randomized trials may offer methods for enrollment feedback to curb selection bias in recruitment. Clinical Trial Registration: URL: https://www.clinicaltrials.gov. Unique identifier: NCT01406236. [ABSTRACT FROM AUTHOR]

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. [ABSTRACT FROM AUTHOR]

Background: Asian-Americans represent an important United States minority population, yet there are limited data regarding the clinical care and outcomes of Asian-Americans following acute myocardial infarction (AMI). Using data from the American Heart Association Get With The Guidelines-Coronary Artery Disease (GWTG-CAD) program, we compared use of and trends in evidence-based care AMI processes and outcome in Asian-American versus white patients., Methods and Results: We analyzed 107,403 AMI patients (4412 Asian-Americans, 4.1%) from 382 United States centers participating in the Get With The Guidelines-Coronary Artery Disease program between 2003 and 2008. Use of 6 AMI performance measures, composite "defect-free" care (proportion receiving all eligible performance measures), door-to-balloon time, and in-hospital mortality were examined. Trends in care over this time period were explored. Compared with whites, Asian-American AMI patients were significantly older, more likely to be covered by Medicaid and recruited in the west region, and had a higher prevalence of diabetes, hypertension, heart failure, and smoking. In-hospital unadjusted mortality was higher among Asian-American patients. Overall, Asian-Americans were comparable with whites regarding the baseline quality of care, except that Asian-Americans were less likely to get smoking cessation counseling (65.6% versus 81.5%). Asian-American AMI patients experienced improvement in the 6 individual measures (P≤0.048), defect-free care (P<0.001), and door-to-balloon time (P<0.001). The improvement rates were similar for both Asian-Americans and whites. Compared with whites, the adjusted in-hospital mortality rate was higher for Asian-Americans (adjusted relative risk: 1.16; 95% confidence interval: 1.00-1.35; P=0.04)., Conclusions: Evidence-based care for AMI processes improved significantly over the period of 2003 to 2008 for Asian-American and white patients in the Get With The Guidelines-Coronary Artery Disease program. Differences in care between Asian-Americans and whites, when present, were reduced over time.