Tracy Y. Wang

Baseline Risk of Major Bleeding in Non–ST-Segment–Elevation Myocardial Infarction The CRUSADE (Can Rapid risk stratification of Unstable angina patients Suppress ADverse outcomes with Early implementation of the ACC/AHA guidelines) Bleeding Score

Treatment of non–ST-segment elevation myocardial infarction (NSTEMI) has traditionally focused on preventing or minimizing ischemic complications with potent antithrombotic medications and catheter-based interventions.1–3 Yet these reductions in recurrent ischemic events have come at the cost of increased major bleeding,4–7 which is itself associated with worse clinical outcomes.7–13 Bleeding complications have received attention recently, in part because newer antithrombotic agents for NSTEMI have unique ischemia and bleeding profiles. Some agents demonstrate low rates of major bleeding with similar efficacy,5,14 while others demonstrate higher rates of major bleeding with superior efficacy.15 Given the importance of safety and efficacy,12 the recent American College of Cardiology (ACC)/American Heart Association (AHA) practice guidelines placed renewed emphasis on risk stratification to guide treatment for NSTEMI.3 While tools for ischemic risk stratification are well described (i.e., TIMI, PURSUIT, and GRACE risk scores),16–18 bleeding risk stratification is more limited. The few bleeding risk stratification models in existence include treatments known to influence bleeding or are derived from subgroups or trial populations not representative of those at greatest risk.10,13,19 Consequently, better estimation of baseline risk of bleeding in NSTEMI patients is needed to facilitate optimal treatment selection. Using data from the Can Rapid risk stratification of Unstable angina patients Suppress ADverse outcomes with Early implementation of the ACC/AHA guidelines (CRUSADE) Quality Improvement Initiative, we developed and validated a scoring system to estimate baseline risk of in-hospital major bleeding in patients with NSTEMI. The CRUSADE bleeding score provides a tool that equips clinicians with the means to consider safety outcomes when making treatment decisions for patients with NSTEMI.Background— Treatments for non–ST-segment–elevation myocardial infarction (NSTEMI) reduce ischemic events but increase bleeding. Baseline prediction of bleeding risk can complement ischemic risk prediction for optimization of NSTEMI care; however, existing models are not well suited for this purpose. Methods and Results— We developed (n=71 277) and validated (n=17 857) a model that identifies 8 independent baseline predictors of in-hospital major bleeding among community-treated NSTEMI patients enrolled in the Can Rapid risk stratification of Unstable angina patients Suppress ADverse outcomes with Early implementation of the ACC/AHA guidelines (CRUSADE) Quality Improvement Initiative. Model performance was tested by c statistics in the derivation and validation cohorts and according to postadmission treatment (ie, invasive and antithrombotic therapy). The CRUSADE bleeding score (range 1 to 100 points) was created by assignment of weighted integers that corresponded to the coefficient of each variable. The rate of major bleeding increased by bleeding risk score quintiles: 3.1% for those at very low risk (score ≤20); 5.5% for those at low risk (score 21–30); 8.6% for those at moderate risk (score 31–40); 11.9% for those at high risk (score 41–50); and 19.5% for those at very high risk (score >50; Ptrend <0.001). The c statistics for the major bleeding model (derivation=0.72 and validation=0.71) and risk score (derivation=0.71 and validation=0.70) were similar. The c statistics for the model among treatment subgroups were as follows: ≥2 antithrombotics=0.72; <2 antithrombotics=0.73; invasive approach=0.73; conservative approach=0.68. Conclusions— The CRUSADE bleeding score quantifies risk for in-hospital major bleeding across all postadmission treatments, which enhances baseline risk assessment for NSTEMI care.

Trends in the Prevalence and Outcomes of Radial and Femoral Approaches to Percutaneous Coronary Intervention: A Report From the National Cardiovascular Data Registry

OBJECTIVES Our goal was to compare trends in the prevalence and outcomes of the radial and femoral approaches to percutaneous coronary intervention (PCI) in contemporary clinical practice. BACKGROUND There are few current data on the use and outcomes of the radial approach to PCI (r-PCI) in clinical practice. METHODS Data from 593,094 procedures in the National Cardiovascular Data Registry (606 sites; 2004 to 2007) were analyzed to evaluate trends in use and outcomes of r-PCI. Logistic regression was used to evaluate the adjusted association between r-PCI and procedural success, bleeding complications, and vascular complications. Outcomes in elderly patients, women, and patients with acute coronary syndrome were specifically examined. RESULTS Although the proportion of r-PCI procedures has recently increased, it only accounts for 1.32% of total procedures (n = 7,804). Compared with the femoral approach, the use of r-PCI was associated with a similar rate of procedural success (adjusted odds ratio: 1.02 [95% confidence interval: 0.93 to 1.12]) but a significantly lower risk for bleeding complications (odds ratio: 0.42 [95% confidence interval: 0.31 to 0.56]) after multivariable adjustment. The reduction in bleeding complications was more pronounced among patients <75 years old, women, and patients undergoing PCI for acute coronary syndrome. CONCLUSIONS The use of r-PCI is rare in contemporary clinical practice, but it is associated with a rate of procedural success similar to the femoral approach and with lower rates of bleeding and vascular complications, even among high-risk groups. These results suggest that wider adoption of r-PCI in clinical practice may improve the safety of PCI.

Representation of Women in Randomized Clinical Trials of Cardiovascular Disease Prevention

Cardiovascular disease (CVD) is the leading cause of mortality in women. Differences in pathophysiology, diagnosis, and treatment of women with cardiovascular disease compared with men have become a major focus during the past decades. Guideline of CVD prevention in women drew heavily on the results of randomized clinical trials (RCT). However, data from RCT in women was limited, leading to concerns of women been underrepresented in clinical trials from which guidelines were generated. During the past several years, researchers, physicians, and regulators have made substantial efforts to improve understanding of the sex difference in CVD and to recognize the importance of heart disease in women. The purpose of this review is to evaluate contemporary sex differences in CVD disease management, current representation of women in RCT, and examine factors that may improve women’s representation and quality of care in CVD prevention in women.

The National Cardiovascular Data Registry (NCDR) Data Quality Brief : The NCDR Data Quality Program in 2012

OBJECTIVES The National Cardiovascular Data Registry (NCDR) developed the Data Quality Program to meet the objectives of ensuring the completeness, consistency, and accuracy of data submitted to the observational clinical registries. The Data Quality Program consists of 3 main components: 1) a data quality report; 2) a set of internal quality assurance protocols; and 3) a yearly data audit program. BACKGROUND Since its inception in 1997, the NCDR has been the basis for the development of performance and quality metrics, site-level quality improvement programs, and peer-reviewed health outcomes research. METHODS Before inclusion in the registry, data are filtered through the registry-specific algorithms that require predetermined levels of completeness and consistency for submitted data fields as part of the data quality report. Internal quality assurance protocols enforce data standards before reporting. Within each registry, 300 to 625 records are audited annually in 25 randomly identified sites (i.e., 12 to 25 records per audited site). RESULTS In the 2010 audits, the participant average raw accuracy of data abstraction for the CathPCI Registry, ICD Registry, and ACTION Registry-GWTG were, respectively, 93.1% (range, 89.4% minimum, 97.4% maximum), 91.2% (range, 83.7% minimum, 95.7% maximum), and 89.7.% (range, 85% minimum, 95% maximum). CONCLUSIONS The 2010 audits provided evidence that many fields in the NCDR accurately represent the data from the medical charts. The American College of Cardiology Foundation is undertaking a series of initiatives aimed at creating a quality assurance rapid learning system, which, when complete, will monitor, evaluate, and improve data quality.

Acute Myocardial Infarction in Women: A Scientific Statement From the American Heart Association

Cardiovascular disease is the leading cause of mortality in American women. Since 1984, the annual cardiovascular disease mortality rate has remained greater for women than men; however, over the last decade, there have been marked reductions in cardiovascular disease mortality in women. The dramatic decline in mortality rates for women is attributed partly to an increase in awareness, a greater focus on women and cardiovascular disease risk, and the increased application of evidence-based treatments for established coronary heart disease. This is the first scientific statement from the American Heart Association on acute myocardial infarction in women. Sex-specific differences exist in the presentation, pathophysiological mechanisms, and outcomes in patients with acute myocardial infarction. This statement provides a comprehensive review of the current evidence of the clinical presentation, pathophysiology, treatment, and outcomes of women with acute myocardial infarction.

In-Hospital Major Bleeding During ST-Elevation and Non–ST-Elevation Myocardial Infarction Care: Derivation and Validation of a Model from the ACTION Registry®-GWTG™

Bleeding, a common complication of acute myocardial infarction (AMI) treatment, is associated with worse outcomes. A contemporary model for major bleeding associated with AMI treatment can stratify patients at elevated risk for bleeding and is needed to risk-adjust AMI practice and outcomes. Using the Acute Coronary Treatment and Intervention Outcomes Network Registry-Get With the Guidelines (ACTION Registry-GWTG) database, an in-hospital major bleeding risk model was developed in a population of patients with ST-segment elevation myocardial infarction and non-ST-segment elevation myocardial infarction. The model used only baseline variables and was developed (n = 72,313) and validated (n = 17,960) in patients with AMI (at 251 United States centers from January 2007 to December 2008). The 12 most statistically and clinically significant variables were incorporated into the final regression model. The calibration plots are shown, and the model discrimination is demonstrated in derivation and validation cohorts, as well as across key subgroups. The rate of major bleeding in the overall population was 10.8%. The 12 factors associated with major bleeding in the model were heart rate, baseline hemoglobin, female gender, baseline serum creatinine, age, electrocardiographic changes, heart failure or shock, diabetes, peripheral artery disease, body weight, systolic blood pressure, and home warfarin use. The risk model discriminated well in the derivation (C-statistic = 0.73) and validation (C-statistic = 0.71) cohorts. A risk score for major bleeding corresponded well with observed bleeding: very low risk (3.9%), low risk (7.3%), moderate risk (16.1%), high risk (29.0%), and very high risk (39.8%). In conclusion, the ACTION Registry-GWTG in-hospital major bleeding model stratifies risk for major bleeding using variables at presentation and enables risk-adjusted bleeding outcomes for quality improvement initiatives and clinical decision making.

Association of Door-In to Door-Out Time With Reperfusion Delays and Outcomes Among Patients Transferred for Primary Percutaneous Coronary Intervention

CONTEXT Patients with ST-elevation myocardial infarction (STEMI) requiring interhospital transfer for primary percutaneous coronary intervention (PCI) often have prolonged overall door-to-balloon (DTB) times from first hospital presentation to second hospital PCI. Door-in to door-out (DIDO) time, defined as the duration of time from arrival to discharge at the first or STEMI referral hospital, is a new clinical performance measure, and a DIDO time of 30 minutes or less is recommended to expedite reperfusion care. OBJECTIVE To characterize time to reperfusion and patient outcomes associated with a DIDO time of 30 minutes or less. DESIGN, SETTING, AND PATIENTS Retrospective cohort of 14,821 patients with STEMI transferred to 298 STEMI receiving centers for primary PCI in the ACTION Registry-Get With the Guidelines between January 2007 and March 2010. MAIN OUTCOME MEASURES Factors associated with a DIDO time greater than 30 minutes, overall DTB times, and risk-adjusted in-hospital mortality. RESULTS Median DIDO time was 68 minutes (interquartile range, 43-120 minutes), and only 1627 patients (11%) had DIDO times of 30 minutes or less. Significant factors associated with a DIDO time greater than 30 minutes included older age, female sex, off-hours presentation, and non-emergency medical services transport to the first hospital. Patients with a DIDO time of 30 minutes or less were significantly more likely to have an overall DTB time of 90 minutes or less compared with patients with DIDO times greater than 30 minutes (60% [95% confidence interval {CI}, 57%-62%] vs 13% [95% CI, 12%-13%]; P < .001). Among patients with DIDO times greater than 30 minutes, only 0.6% (95% CI, 0.5%-0.8%) had an absolute contraindication to fibrinolysis. Observed in-hospital mortality was significantly higher among patients with DIDO times greater than 30 minutes vs patients with DIDO times of 30 minutes or less (5.9% [95% CI, 5.5%-6.3%] vs 2.7% [95% CI, 1.9%-3.5%]; P < .001; adjusted odds ratio for in-hospital mortality, 1.56 [95% CI, 1.15-2.12]). CONCLUSION A DIDO time of 30 minutes or less was observed in only a small proportion of patients transferred for primary PCI but was associated with shorter reperfusion delays and lower in-hospital mortality.

Risk adjustment for in-hospital mortality of contemporary patients with acute myocardial infarction: The Acute Coronary Treatment and Intervention Outcomes Network (ACTION) Registry®–Get With The Guidelines (GWTG)™ acute myocardial infarction mortality model and risk score

BACKGROUND accurate risk adjustment is needed to guide quality improvement initiatives and research to improve care of patients with acute myocardial infarction (MI). We developed and validated a model to predict the risk of in-hospital mortality for contemporary patients with acute MI treated in routine clinical practice. METHODS the Acute Coronary Treatment and Intervention Outcomes Network (ACTION) Registry-Get With The Guidelines (GWTG) database of patients with acute MI was used to derive (n = 65,668 from 248 US sites) and validate (n = 16,336) a multivariable logistic regression model to predict the likelihood of in-hospital mortality (4.9% in each cohort). RESULTS factors with the highest independent significance in terms of mortality prediction included age, baseline serum creatinine, systolic blood pressure, troponin elevation, heart failure and/or cardiogenic shock at presentation, ST-segment changes, heart rate, and prior peripheral arterial disease. The model showed very good discrimination, with c statistics of 0.85 and 0.84 in the derivation and validation cohorts, respectively. The model calibrated well overall and in key patient subgroups including males versus females, age <75 versus ≥ 75 years, diabetes versus no diabetes, and ST-elevation MI versus non-ST-elevation MI. The ACTION Registry-GWTG in-hospital mortality risk score was also developed from the model. Patients with a risk score of ≤ 40 had an observed mortality rate of <4% compared with those with a risk score of 41-50 (12%) and risk scores >50 (34%). CONCLUSION the ACTION Registry-GWTG™ in-hospital mortality model and risk score represent simple, accurate risk adjustment tools for contemporary patients with acute MI.

Clinical Presentation, Management, and Outcomes of Angiographically Documented Early, Late, and Very Late Stent Thrombosis

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.

Use of Emergency Medical Service Transport Among Patients With ST-Segment–Elevation Myocardial Infarction Findings From the National Cardiovascular Data Registry Acute Coronary Treatment Intervention Outcomes Network Registry–Get With the Guidelines

Background— Activation of emergency medical services (EMS) is critical for the early triage and treatment of patients experiencing ST-segment–elevation myocardial infarction, yet data regarding EMS use and its association with subsequent clinical care are limited. Methods and Results— We performed an observational analysis of 37 634 ST-segment–elevation myocardial infarction patients treated at 372 US hospitals participating in the National Cardiovascular Data Registry Acute Coronary Treatment and Intervention Outcomes Network Registry–Get With the Guidelines between January 2007 and September 2009, and examined independent patient factors associated with EMS transportation versus patient self-transportation. We found that EMS transport was used in only 60% of ST-segment–elevation myocardial infarction patients. Older patients, those living farther from the hospital, and those with hemodynamic compromise were more likely to use EMS transport. In contrast, race, income, and education level did not appear to be associated with the mode of transport. Compared with self-transported patients, EMS-transported patients had significantly shorter delays in both symptom-onset-to-arrival time (median, 89 versus 120 minutes; P<0.0001) and door-to-reperfusion time (median door-to-balloon time, 63 versus 76 minutes; P<0.0001; median door-to-needle time, 23 versus 29 minutes; P<0.0001). Conclusions— Emergency medical services transportation to the hospital is underused among contemporary ST-segment–elevation myocardial infarction patients. Nevertheless, use of EMS transportation is associated with substantial reductions in ischemic time and treatment delays. Community education efforts are needed to improve the use of emergency transport as part of system-wide strategies to improve ST-segment–elevation myocardial infarction reperfusion care.