Lisa A. McCoy

An updated bleeding model to predict the risk of post-procedure bleeding among patients undergoing percutaneous coronary intervention: a report using an expanded bleeding definition from the National Cardiovascular Data Registry CathPCI Registry.

OBJECTIVES This study sought to develop a model that predicts bleeding complications using an expanded bleeding definition among patients undergoing percutaneous coronary intervention (PCI) in contemporary clinical practice. BACKGROUND New knowledge about the importance of periprocedural bleeding combined with techniques to mitigate its occurrence and the inclusion of new data in the updated CathPCI Registry data collection forms encouraged us to develop a new bleeding definition and risk model to improve the monitoring and safety of PCI. METHODS Detailed clinical data from 1,043,759 PCI procedures at 1,142 centers from February 2008 through April 2011 participating in the CathPCI Registry were used to identify factors associated with major bleeding complications occurring within 72 h post-PCI. Risk models (full and simplified risk scores) were developed in 80% of the cohort and validated in the remaining 20%. Model discrimination and calibration were assessed in the overall population and among the following pre-specified patient subgroups: females, those older than 70 years of age, those with diabetes mellitus, those with ST-segment elevation myocardial infarction, and those who did not undergo in-hospital coronary artery bypass grafting. RESULTS Using the updated definition, the rate of bleeding was 5.8%. The full model included 31 variables, and the risk score had 10. The full model had similar discriminatory value across pre-specified subgroups and was well calibrated across the PCI risk spectrum. CONCLUSIONS The updated bleeding definition identifies important post-PCI bleeding events. Risk models that use this expanded definition provide accurate estimates of post-PCI bleeding risk, thereby better informing clinical decision making and facilitating risk-adjusted provider feedback to support quality improvement.

Temporal Trends and Outcomes of Patients Undergoing Percutaneous Coronary Interventions for Cardiogenic Shock in the Setting of Acute Myocardial Infarction: A Report From the CathPCI Registry

OBJECTIVES The purpose of this study was to examine the temporal trends in demographics, clinical characteristics, management strategies, and in-hospital outcomes in patients with acute myocardial infarction complicated by cardiogenic shock (CS-AMI) who underwent percutaneous coronary intervention (PCI) from the Cath-PCI Registry (2005 to 2013). BACKGROUND The authors examined contemporary use and outcomes of PCI in patients with CS-AMI. METHODS The authors used the Cath-PCI Registry to evaluate 56,497 patients (January 2005 to December 2013) undergoing PCI for CS-AMI. Temporal trends in clinical variables and outcomes were assessed. RESULTS Compared with cases performed from 2005 to 2006, CS-AMI patients receiving PCI from 2011 to 2013 were more likely to have diabetes, hypertension, dyslipidemia, previous PCI, dialysis, but less likely to have chronic lung disease, peripheral vascular disease, or heart failure within 2 weeks (p < 0.01). Between 2005 and 2006 to 2011 and 2013, intra-aortic balloon pump use decreased (49.5% to 44.9%; p < 0.01), drug-eluting stent use declined (65% to 46%; p < 0.01), and the use of bivalirudin increased (12.6% to 45.6%). Adjusted in-hospital mortality; increased (27.6% in 2005 to 2006 vs. 30.6% in 2011 to 2013, adjusted odds ratio: 1.09, 95% confidence interval: 1.005 to .173; p = 0.04) for patients who were managed with an early invasive strategy (<24 h from symptoms). CONCLUSIONS Our study shows that despite the evolution of medical technology and use of contemporary therapeutic measures, in-hospital mortality in CS-AMI patients who are managed invasively continues to rise. Additional research and targeted efforts are indicated to improve outcomes in this high-risk cohort.

Sex‐Based Differences in Outcomes After Percutaneous Coronary Intervention for Acute Myocardial Infarction: A Report From TRANSLATE‐ACS

Background Data regarding sex‐based outcomes after percutaneous coronary intervention (PCI) for myocardial infarction are mixed. We sought to examine whether sex differences in outcomes exist in contemporary practice. Methods and Results We examined acute myocardial infarction patients undergoing PCI between April 2010 and October 2012 at 210 US hospitals participating in the Treatment with Adenosine Diphosphate Receptor Inhibitors: Longitudinal Assessment of Treatment Patterns and Events after Acute Coronary Syndrome (TRANSLATE‐ACS) observational study. Outcomes included 1‐year risk of major adverse cardiac events and bleeding according to Global Utilization of Strategies To Open Occluded Arteries (GUSTO) and Bleeding Academic Research Consortium (BARC) definitions. Among 6218 patients, 27.5% (n=1712) were female. Compared with men, women were older, had more comorbidities, and had lower functional status. Use of multivessel PCI and drug‐eluting stents was similar between sexes, while women received less prasugrel. Unadjusted cumulative incidence of 1‐year major adverse cardiac events was higher for women than for men (15.7% versus 13.6%, P=0.02), but female sex was no longer associated with higher incidence of major adverse cardiac events after multivariable adjustment (hazard ratio 0.98, 95% CI 0.83 to 1.15). Female sex was associated with higher risks of post‐PCI GUSTO bleeding (9.1% versus 5.7%, P<0.0001) and postdischarge BARC bleeding (39.6% versus 27.9%, P<0.0001). Differences persisted after adjustment (GUSTO: hazard ratio 1.32, 95% CI 1.06 to 1.64; BARC: incidence rate ratio 1.42, 95% CI 1.27 to 1.56). Conclusions Female and male myocardial infarction patients undergoing PCI differ regarding demographic, clinical, and treatment profiles. These differences appear to explain the higher observed major adverse cardiac event rate but not higher adjusted bleeding risk for women versus men.

Use of Mechanical Circulatory Support in Patients Undergoing Percutaneous Coronary Intervention Insights From the National Cardiovascular Data Registry

Background— Little is known about the contemporary use of intra-aortic balloon pump (IABP) and other mechanical circulatory support (O-MCS) devices in patients undergoing percutaneous coronary intervention (PCI) in the setting of cardiogenic shock. Methods and Results— We identified 76 474 patients who underwent PCI in the setting of cardiogenic shock at one of 1429 National Cardiovascular Data Registry CathPCI participating hospitals from 2009 to 2013. Temporal trends and hospital-level variation in the use of IABP and O-MCS were evaluated. No mechanical circulatory support was used in 41 286 (54%) patients, 29 730 (39%) received IABP only, 2711 (3.5%) received O-MCS only, and 2747 (3.6%) received both IABP and O-MCS. At the start of the study period, 45% of patients undergoing PCI in the setting of cardiogenic shock received an IABP and 6.7% received O-MCS. The proportion of patients receiving IABP declined at an average rate of 0.3% per quarter, whereas the rate of O-MCS use was unchanged over the study period. The predicted probability of IABP use varied significantly by site (hospital median 42%, interquartile range 33% to 51%, range 8% to 85%). The probability of O-MCS use was <5% for half of hospitals and >20% in less than one-tenth of hospitals. Conclusions— In this large national registry, the use of IABP in the setting of PCI for cardiogenic shock decreased over time without a concurrent increase in O-MCS use. The probability of IABP and O-MCS use varied across hospitals, and the use of O-MCS was clustered at a small number of hospitals.

Timing of First Postdischarge Follow-up and Medication Adherence After Acute Myocardial Infarction

IMPORTANCE The use of evidence-based medication therapy in patients after acute myocardial infarction (AMI) improves long-term prognosis, yet the current rates of adherence are poor. OBJECTIVE To determine whether earlier outpatient follow-up after AMI is associated with higher rates of medication adherence. DESIGN, SETTING, AND PARTICIPANTS A retrospective analysis was conducted of 20 976 Medicare patients older than 65 years discharged alive after an AMI between January 2, 2007, and October 1, 2010, from 461 Acute Coronary Treatment and Intervention Outcomes Network Registry-Get With the Guidelines hospitals in the United States. Patients were grouped based on the timing of first follow-up clinic visit within 1 week, 1 to 2 weeks, 2 to 6 weeks, or more than 6 weeks after hospital discharge. Data analysis was conducted from September 26, 2014, to April 22, 2015. MAIN OUTCOMES AND MEASURES Medication adherence was defined as the proportion of days with more than 80% coverage using Medicare Part D prescription fill records and was examined at 90 days and 1 year after discharge for β-blockers, platelet P2Y12 receptor inhibitors, statins, and angiotensin-converting enzyme inhibitors or angiotensin receptor blockers. RESULTS Among 20 976 Medicare-insured patients discharged alive after acute MI, 10 381 (49.5%) were men; mean (SD) age was 75.8 (7.5) years. The median time to the first outpatient follow-up visit after hospital discharge was 14 days (interquartile range, 7-28 days). Overall, the first follow-up clinic visit occurred 1 week or less after discharge in 5542 (26.4%) patients, 1 to 2 weeks in 5246 (25.0%), 2 to 6 weeks in 6830 (32.6%), and more than 6 weeks in 3358 (16.0%) individuals. Rates of medication adherence for secondary prevention therapies ranged from 63.4% to 68.7% at 90 days and 54.4% to 63.5% at 1 year. Compared with patients with follow-up visits within 1 week, those with follow-up in 1 to 2 weeks and 2 to 6 weeks had no significant difference in medication adherence; however, patients with follow-up more than 6 weeks after discharge had lower adherence at both 90 days (56.8%-61.3% vs 64.7%-69.3%; P < .001) and 1 year (49.5%-57.7% vs 55.4%-64.1%; P < .001). Patients with delayed follow-up more than 6 weeks were more likely to reside in communities with lower household incomes and educational levels (both P < .001); however, their clinical characteristics were similar to those of patients with earlier follow-up. After adjusting for these differences, delayed follow-up of more than 6 weeks remained associated with lower medication adherence at 90 days (odds ratio [OR], 0.74 [95% CI, 0.70-0.78]) and 1 year (OR, 0.79 [95% CI, 0.73-0.85]) compared with follow-up of 6 weeks or less. CONCLUSIONS AND RELEVANCE Delayed outpatient follow-up beyond the first 6 weeks after AMI is associated with worse short-term and long-term patient medication adherence. These data support the concept that medication adherence is modifiable via improved care transitions.

Utility of Socioeconomic Status in Predicting 30-Day Outcomes After Heart Failure Hospitalization

Background—An individual’s socioeconomic status (SES) is associated with health outcomes and mortality, yet it is unknown whether accounting for SES can improve risk-adjustment models for 30-day outcomes among Centers for Medicare & Medicaid Services beneficiaries hospitalized with heart failure. Methods and Results—We linked clinical data on hospitalized patients with heart failure in the Get With The Guidelines-Heart Failure database (January 2005 to December 2011) with Centers for Medicare & Medicaid Services claims and county-level SES data from the 2012 Area Health Resources Files. We compared the discriminatory capabilities of multivariable models that adjusted for SES, patient, and hospital characteristics to determine whether county-level SES data improved prediction or changed hospital rankings for 30-day all-cause mortality and rehospitalization. After adjusting for patient and hospital characteristics, median household income (per

Association of Discharge Aspirin Dose With Outcomes After Acute Myocardial Infarction: Insights From the Treatment with ADP Receptor Inhibitors: Longitudinal Assessment of Treatment Patterns and Events after Acute Coronary Syndrome (TRANSLATE-ACS) Study.

5000 increase) was inversely associated with odds of 30-day mortality (odds ratio, 0.97; 95% confidence interval, 0.95–1.00; P=0.032) and the percentage of people with at least a high school diploma (per 5 U increase) was associated with lower odds of 30-day rehospitalization (odds ratio, 0.95; 95% confidence interval, 0.91–0.99). After adjustment for county-level SES data, relative to whites, Hispanic ethnicity (odds ratio, 0.70; 95% confidence interval, 0.58–0.83) and black race (odds ratio, 0.57; 95% confidence interval, 0.50–0.65) remained significantly associated with lower 30-day mortality, but had similar 30-day rehospitalization. County-level SES did not improve risk adjustment or change hospital rankings for 30-day mortality or rehospitalization. Conclusions—County-level SES data are modestly associated with 30-day outcomes for Centers for Medicare & Medicaid Services beneficiaries hospitalized with heart failure, but do not improve risk adjustment models based on patient characteristics alone.

Contemporary Trends and Predictors of Postacute Service Use and Routine Discharge Home After Stroke

Background— Aspirin is the most widely used antiplatelet drug postmyocardial infarction, yet its optimal maintenance dose after percutaneous coronary intervention with stenting remains uncertain. Methods and Results— We compared outcomes of 10 213 patients with myocardial infarction who underwent percutaneous coronary intervention and were discharged on dual-antiplatelet therapy at 228 US hospitals in the Treatment with ADP Receptor Inhibitors: Longitudinal Assessment of Treatment Patterns and Events after Acute Coronary Syndrome (TRANSLATE-ACS) study from 2010 to 2012. Major adverse cardiovascular events and bleeding within 6 months postdischarge were compared between high-dose (325 mg) and low-dose aspirin (81 mg) by using regression models with inverse probability-weighted propensity adjustment. Overall, 6387 patients (63%) received high-dose aspirin at discharge. Major adverse cardiovascular events risk was not significantly different between groups (high versus low: unadjusted 8.2% versus 9.2%; adjusted hazard ratio, 0.99; 95% confidence interval, 0.85–1.17). High-dose aspirin use was associated with greater risk of any Bleeding Academic Research Consortium–defined bleeding events (unadjusted 24.2% versus 22.7%; adjusted odds ratio, 1.19; 95% confidence interval, 1.06–1.33), driven mostly by minor Bleeding Academic Research Consortium type 1 or 2 bleeding events not requiring hospitalization (unadjusted 21.4% versus 19.5%; adjusted odds ratio, 1.19; 95% confidence interval, 1.05–1.34). Bleeding events requiring hospitalization were similar by aspirin dosing groups (unadjusted 2.8% versus 3.2%, adjusted odds ratio, 1.22; 95% confidence interval, 0.87–1.70). Similar associations were observed in landmark analyses accounting for aspirin dosing change over time, and across subgroup analyses by age, sex, baseline aspirin use, and type of ADP receptor inhibitor (clopidogrel versus prasugrel/ticagrelor). Conclusions— Among percutaneous coronary intervention–treated patients with myocardial infarction, high-maintenance-dose aspirin was associated with similar rates of major adverse cardiovascular events, but a greater risk of minor bleeding than those discharged on low-dose aspirin.

Patterns of Stress Testing and Diagnostic Catheterization After Coronary Stenting in 250 350 Medicare Beneficiaries

Background Returning home after the hospital is a primary aim for healthcare; however, additional postacute care (PAC) services are sometimes necessary for returning stroke patients to their pre‐event status. Recent trends in hospital discharge disposition specifying PAC use have not been examined across age groups or health insurance types. Methods and Results We examined trends in discharge to inpatient rehabilitation facilities (IRFs), skilled nursing facilities (SNFs), home with home health (HH), and home without services for 849 780 patients ≥18 years of age with ischemic or hemorrhagic stroke at 1687 hospitals participating in Get With The Guidelines—Stroke. Multivariable analysis was used to identify factors associated with discharge to any PAC (IRF, SNF, or HH) versus discharge home without services. From 2003 to 2011, there was a 2.1% increase (unadjusted P=0.001) in PAC use after a stroke hospitalization. Change was greatest in SNF use, an 8.3% decrease over the period. IRF and HH increased 6.9% and 3.6%, respectively. The 2 strongest clinical predictors of PAC use after acute care were patients not ambulating on the second day of their hospital stay (ambulation odds ratio [OR], 3.03; 95% confidence interval [CI], 2.86 to 3.23) and those who failed a dysphagia screen or had an order restricting oral intake (OR, 2.48; 95% CI, 2.37 to 2.59). Conclusions Four in 10 stroke patients are discharged home without services. Although little has changed overall in PAC use since 2003, further research is needed to explain the shift in service use by type and its effect on outcomes.

Impact of Bleeding on Quality of Life in Patients on DAPT: Insights From TRANSLATE-ACS

Background—Patterns of noninvasive stress test (ST) and invasive coronary angiography (CA) utilization after percutaneous coronary intervention (PCI) are not well described in older populations. Methods and Results—We linked National Cardiovascular Data Registry CathPCI Registry data with longitudinal Medicare claims data for 250 350 patients undergoing PCI from 2005 to 2007 and described subsequent testing and outcomes. Between 60 days post-PCI and end of follow-up (median 24 months), 49% (n=122 894) received ST first, 10% (n=25 512) underwent invasive CA first, and 41% (n=101 944) had no testing. Several clinical risk factors at time of index PCI were associated with decreased likelihood of downstream testing (ST or CA, P<0.05 for all), including older age (hazard ratio [HR] 0.784 per 10-year increase), male sex (HR 0.946), heart failure (HR 0.925), diabetes mellitus (HR 0.954), smoking (HR 0.804), and renal failure (HR 0.880). Fifteen percent of patients with ST first proceeded to subsequent CA within 90 days of testing (n=18 472/101 884); of these, 48% (n=8831) underwent revascularization within 90 days, compared with 53% (n=13 316) of CA first patients (P<0.0001). Conclusions—In this descriptive analysis, ST and invasive CA were common in older patients after PCI. Paradoxically, patients with higher risk features at baseline were less likely to undergo post-PCI testing. The revascularization yield was low on patients referred for ST after PCI, with only 9% undergoing revascularization within 90 days.