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1.  Impact of Human Development Index on the profile and outcomes of patients with acute coronary syndrome 
Heart  2014;101(4):279-286.
Objective
To study the impact of national economic and human development status on patient profiles and outcomes in the setting of acute coronary syndrome (ACS).
Methods
We conducted a retrospective analysis of the Targeted Platelet Inhibition to Clarify the Optimal Strategy to Medically Manage Acute Coronary Syndromes trial (TRILOGY ACS) population (51 countries; 9301 patients). Outcome measures compared baseline characteristics and clinical outcomes through 30 months by 2010 country-level United Nations Human Development Indices (HDIs) and per-capita gross national income.
Results
TRILOGY ACS enrolled 3659 patients from 27 very-high HDI countries, 3744 from 18 high-HDI countries and 1898 from 6 medium-HDI countries. Baseline characteristics of groups varied significantly, with the medium-HDI group having a lower mean age (63.0 years, vs 65.0 and 68.0 years for high-HDI and very-high HDI, respectively; p<0.001), lower baseline Global Registry of Acute Coronary Events risk score and lower rate of non-ST-segment elevation myocardial infarction (58.0%, vs 62.2% and 83.9% among high-HDI and very-high HDI, respectively). Medium-HDI and high-HDI patients had lower unadjusted 30-month rates for the composite of cardiovascular death/myocardial infarction/stroke (17.6%, 16.9% and 23.1% for medium-HDI, high-HDI and very-high HDI, respectively); this difference disappeared after adjusting for baseline characteristics. Adjusted HRs for the composite endpoint were lower in lower-income/middle-income countries vs upper-income/middle-income (0.791(95% CI 0.632 to 0.990)) and high-income countries (0.756 (95% CI 0.616 to 0.928)), with differences largely attributable to myocardial infarction rates.
Conclusions
Clinical patient profiles differed substantially by country HDI groupings. Lower unadjusted event rates in medium-HDI countries may be explained by younger age and lower comorbidity burden among these countries’ patients. This heterogeneity in patient recruitment across country HDI groupings may have important implications for future global ACS trial design.
Trial registration number
NCT00699998.
doi:10.1136/heartjnl-2014-306389
PMCID: PMC4345920  PMID: 25538134
3.  Independent data monitoring committees: Preparing a path for the future 
American heart journal  2014;168(2):135-41.e1.
Independent data monitoring committees (IDMCs) were introduced to monitor patient safety and study conduct in randomized clinical trials (RCTs), but certain challenges regarding the utilization of IDMCs have developed. First, the roles and responsibilities of IDMCs are expanding, perhaps due to increasing trial complexity and heterogeneity regarding medical, ethical, legal, regulatory, and financial issues. Second, no standard for IDMC operating procedures exists, and there is uncertainty about who should determine standards and whether standards should vary with trial size and design. Third, considerable variability in communication pathways exist across IDMC interfaces with regulatory agencies, academic coordinating centers, and sponsors. Finally, there has been a substantial increase in the number of RCTs using IDMCs, yet there is no set of qualifications to help guide the training and development of the next generation of IDMC members. Recently, an expert panel of representatives from government, industry, and academia assembled at the Duke Clinical Research Institute to address these challenges and to develop recommendations for the future utilization of IDMCs in RCTs.
doi:10.1016/j.ahj.2014.05.003
PMCID: PMC4181557  PMID: 25066551
5.  The Association of Early Physician Follow-up and 30-Day Readmission after Non-ST-Segment Elevation Myocardial Infarction among Older Patients 
Circulation  2013;128(11):1206-1213.
Background
Hospital readmission rates within 30 days following acute myocardial infarction (AMI) are a national performance metric. Prior data suggest that early physician follow-up after heart failure hospitalizations can reduce readmissions; whether these results can be extended to AMI is unclear.
Methods and Results
We analyzed data from the CRUSADE Registry linked with Medicare claims from 2003–2006 for 25,872 non–ST-segment elevation myocardial infarction (NSTEMI) patients ≥65 years old discharged home from 228 hospitals with >25 patients and full revascularization capabilities. After adjusting for patient, treatment, and hospital characteristics, we examined the relationship between hospital-level physician follow-up within 7 days of discharge and 30-day all-cause readmission using logistic regression. The median hospital-level percentage of patients receiving early physician follow-up was 23.3% (IQR 17.1%–29.1%). Among 24,165 patients with Medicare fee-for-service eligibility 30 days after discharge, 18.5% of patients were readmitted within 30 days of index hospitalization. Unadjusted and adjusted rates of 30-day readmission did not differ among quartiles of hospital-level early physician follow-up. Similarly, each 5% increase in hospital early follow-up was associated with an insignificant change in risk for readmission (adjusted OR 0.99; 95% CI 0.97, 1.02; p=0.60). Sensitivity analyses extended these null findings to 30-day cardiovascular readmissions, high-risk subgroups, and early cardiology follow-up.
Conclusions
While rates of early physician follow-up after AMI varied among U.S. hospitals, hospitals with higher early follow-up rates did not have lower 30-day readmission rates. Targeting strategies other than early physician follow-up may be necessary to reduce readmission rates in this population.
doi:10.1161/CIRCULATIONAHA.113.004569
PMCID: PMC3926095  PMID: 23946265
early physician follow-up; acute myocardial infarction; non–ST-segment elevation myocardial infarction
6.  Careers in Clinical Cardiovascular Research 
Circulation  2009;119(22):2945-2950.
doi:10.1161/CIRCULATIONAHA.107.752717
PMCID: PMC4145852  PMID: 19506126
7.  Standardized Cardiovascular Data for Clinical Research, Registries, and Patient Care 
Relatively little attention has been focused on standardization of data exchange in clinical research studies and patient care activities. Both are usually managed locally using separate and generally incompatible data systems at individual hospitals or clinics. In the past decade there have been nascent efforts to create data standards for clinical research and patient care data, and to some extent these are helpful in providing a degree of uniformity. Nevertheless these data standards generally have not been converted into accepted computer-based language structures that could permit reliable data exchange across computer networks. The National Cardiovascular Research Infrastructure (NCRI) project was initiated with a major objective of creating a model framework for standard data exchange in all clinical research, clinical registry, and patient care environments, including all electronic health records. The goal is complete syntactic and semantic interoperability. A Data Standards Workgroup was established to create or identify and then harmonize clinical definitions for a base set of standardized cardiovascular data elements that could be used in this network infrastructure. Recognizing the need for continuity with prior efforts, the Workgroup examined existing data standards sources. A basic set of 353 elements was selected. The NCRI staff then collaborated with the two major technical standards organizations in healthcare, the Clinical Data Interchange Standards Consortium and Health Level 7 International, as well as with staff from the National Cancer Institute Enterprise Vocabulary Services. Modeling and mapping were performed to represent (instantiate) the data elements in appropriate technical computer language structures for endorsement as an accepted data standard for public access and use. Fully implemented, these elements will facilitate clinical research, registry reporting, administrative reporting and regulatory compliance, and patient care.
doi:10.1016/j.jacc.2012.12.047
PMCID: PMC3664644  PMID: 23500238
8.  Early Clopidogrel Versus Prasugrel Use Among Contemporary STEMI and NSTEMI Patients in the US: Insights From the National Cardiovascular Data Registry 
Background
P2Y12 antagonist therapy improves outcomes in acute myocardial infarction (MI) patients. Novel agents in this class are now available in the US. We studied the introduction of prasugrel into contemporary MI practice to understand the appropriateness of its use and assess for changes in antiplatelet management practices.
Methods and Results
Using ACTION Registry‐GWTG (Get‐with‐the‐Guidelines), we evaluated patterns of P2Y12 antagonist use within 24 hours of admission in 100 228 ST elevation myocardial infarction (STEMI) and 158 492 Non‐ST elevation myocardial infarction (NSTEMI) patients at 548 hospitals between October 2009 and September 2012. Rates of early P2Y12 antagonist use were approximately 90% among STEMI and 57% among NSTEMI patients. From 2009 to 2012, prasugrel use increased significantly from 3% to 18% (5% to 30% in STEMI; 2% to 10% in NSTEMI; P for trend <0.001 for all). During the same period, we observed a decrease in use of early but not discharge P2Y12 antagonist among NSTEMI patients. Although contraindicated, 3.0% of patients with prior stroke received prasugrel. Prasugrel was used in 1.9% of patients ≥75 years and 4.5% of patients with weight <60 kg. In both STEMI and NSTEMI, prasugrel was most frequently used in patients at the lowest predicted risk for bleeding and mortality. Despite lack of supporting evidence, prasugrel was initiated before cardiac catheterization in 18% of NSTEMI patients.
Conclusions
With prasugrel as an antiplatelet treatment option, contemporary practice shows low uptake of prasugrel and delays in P2Y12 antagonist initiation among NSTEMI patients. We also note concerning evidence of inappropriate use of prasugrel, and inadequate targeting of this more potent therapy to maximize the benefit/risk ratio.
doi:10.1161/JAHA.114.000849
PMCID: PMC4187510  PMID: 24732921
myocardial infarction; P2Y12 antagonist; prasugrel
9.  Contemporary Mortality Risk Prediction for Percutaneous Coronary Intervention: Results from 588,398 Procedures in the National Cardiovascular Data Registry 
Objective
We sought to create contemporary models for predicting mortality risk following percutaneous coronary intervention (PCI).
Background
There is a need to identify PCI risk factors and accurately quantify procedural risks to facilitate comparative effectiveness research, provider comparisons, and informed patient decision making.
Methods
Data from 181,775 procedures performed from January 2004 to March 2006 were used to develop risk models based on pre-procedural and/or angiographic factors using logistic regression. These models were independently evaluated in two validation cohorts: contemporary (n=121,183, January 2004 to March 2006) and prospective (n=285,440, March 2006 to March 2007).
Results
Overall, PCI in-hospital mortality was 1.27%, ranging from 0.65% in elective PCI to 4.81% in STEMI patients. Multiple pre-procedural clinical factors were significantly associated with in-hospital mortality. Angiographic variables provided only modest incremental information to pre-procedural risk assessments. The overall NCDR model, as well as a simplified NCDR risk score (based on 8 key pre-procedure factors), had excellent discrimination (c-index 0.93 and 0.91, respectively). Discrimination and calibration of both risk tools were retained among specific patient subgroups, in the validation samples, and when used to estimate 30-day mortality rates among Medicare patients.
Conclusions
Risks for early mortality following PCI can be accurately predicted in contemporary practice. Incorporation of such risk tools should facilitate research, clinical, and policy applications.
doi:10.1016/j.jacc.2010.02.005
PMCID: PMC3925678  PMID: 20430263
10.  Temporal Trends in and Factors Associated With Bleeding Complications Among Patients Undergoing Percutaneous Coronary Intervention 
Objectives
The purpose of this study was to examine temporal trends in post-percutaneous coronary intervention (PCI) bleeding among patients with elective PCI, unstable angina (UA)/non–ST-segment elevation myocardial infarction (NSTEMI), and ST-segment elevation myocardial infarction (STEMI).
Background
The impact of bleeding avoidance strategies on post-PCI bleeding rates over time is unknown.
Methods
Using the CathPCI Registry, we examined temporal trends in post-PCI bleeding from 2005 to 2009 among patients with elective PCI (n = 599,524), UA/NSTEMI (n = 836,103), and STEMI (n = 267,632). We quantified the linear time trend in bleeding using 3 sequential logistic regression models: 1) clinical factors; 2) clinical + vascular access strategies (femoral vs. radial, use of closure devices); and 3) clinical, vascular strategies + antithrombotic treatments (anticoagulant ± glycoprotein IIb/IIIa inhibitor [GPI]). Changes in the odds ratio for time trend in bleeding were compared using bootstrapping and converted to risk ratio.
Results
An approximate 20% reduction in post-PCI bleeding was seen (elective PCI: 1.4% to 1.1%; UA/NSTEMI: 2.3% to 1.8; STEMI: 4.9% to 4.5%). Radial approach remained low (<3%), and closure device use increased marginally from 44% to 49%. Bivalirudin use increased (17% to 30%), whereas any heparin + GPI decreased (41% to 28%). There was a significant 6% to 8% per year reduction in annual bleeding risk in UA/NSTEMI and elective PCI, but not in STEMI. Antithrombotic strategies were associated with roughly half of the reduction in annual bleeding risk: change in risk ratio from 7.5% to 4% for elective PCI, and 5.7% to 2.8% for UA/NSTEMI (both p <0.001).
Conclusions
The nearly 20% reduction in post-PCI bleeding over time was largely due to temporal changes in antithrombotic strategies. Further reductions in bleeding complications may be possible as bleeding avoidance strategies evolve, especially in STEMI.
doi:10.1016/j.jacc.2011.12.045
PMCID: PMC3908898  PMID: 22595404
bleeding; catheterization; outcomes
11.  Identifying Factors that Influence Hospital Length of Stay in Patients with Non-ST-segment Elevation Myocardial Infarction: Insights from the Acute Coronary Treatment Intervention Outcomes Network Registry®-Get With The Guidelines™ 
The American journal of medicine  2012;125(11):10.1016/j.amjmed.2012.04.038.
PURPOSE
Substantial heterogeneity in hospital length of stay (LOS) exists among patients admitted with non-ST-segment elevation myocardial infarction (NSTEMI). Furthermore, little is known about the factors that impact LOS and our ability to modify them.
METHODS
We examined 39,107 NSTEMI patients admitted to 351 ACTION Registry®-GWTG™ hospitals from 1/1/07–3/31/09 who underwent cardiac catheterization and survived to discharge. Length of stay was categorized into four groups (≤2, 3–4, 5–7, and ≥8 days), where prolonged LOS was defined as >4 days.
RESULTS
The overall median (25th, 75th) LOS was 3 (2, 5) days. Patients with a LOS of >2 days were older with more comorbidities, but were less likely to receive evidence-based therapies or percutaneous coronary intervention (PCI). Among the factors associated with prolonged LOS >4 days were delay to cardiac catheterization >48 hours, heart failure or shock on admission, female gender, insurance type, and admission to the hospital on a Friday afternoon or evening. Hospital characteristics such as number of beds, academic versus non-academic, or urban versus rural setting, were not associated with prolonged LOS.
CONCLUSION
Patients with longer LOS have more comorbidities and in-hospital complications, yet paradoxically, are less often treated with evidence-based medications and are less likely to receive PCI. Hospital admission on a Friday afternoon or evening and delays to catheterization appear to significantly impact LOS. A better understanding of factors associated with LOS in patients with NSTEMI is needed to promote safe and early discharge in an era of increasingly restrictive healthcare resources.
doi:10.1016/j.amjmed.2012.04.038
PMCID: PMC3884687  PMID: 22921886
non-ST-segment elevation myocardial infarction; length of stay; hospital discharge
12.  Diagnostic Time Course, Treatment, and In-Hospital Outcomes for STEMI Patients Presenting with Non-Diagnostic Initial ECG: A Report from the AHA Mission: Lifeline Program 
American heart journal  2012;165(1):50-56.
Background
Prior studies indicate that a subset of patients diagnosed with ST-segment elevation myocardial infarction (STEMI) will have an initial non-diagnostic ECG during evaluation. However, the timing of diagnostic ECG changes in this group is unknown. Our primary aim was to describe the timing of ECG diagnosis of STEMI in patients whose initial ECG was non-diagnostic. Secondarily, we sought to compare the delivery of ACC/AHA guidelines-based care and in-hospital outcomes in this group compared to patients diagnosed with STEMI on initial ECG.
Methods
We analyzed data from 41,560 patients diagnosed with STEMI included in the NCDR® ACTION Registry®-GWTG™ from 01/2007 to 12/2010. We divided this study population into two groups: those diagnosed on initial ECG (N= 36,994) and those with an initial non-diagnostic ECG that were diagnosed on a follow-up ECG (N= 4,566).
Results
In general, baseline characteristics and clinical presentations were similar between the two groups. For patients with an initial non-diagnostic ECG, 72.4% (N= 3,305)had an ECG diagnostic for STEMI within 90 minutes of their initial ECG. There did not appear to be significant differences in the administration of guidelines-recommended treatments for STEMI, in-hospital major bleeding (p 0.926), or death (p 0.475) between these groups.
Conclusions
In a national sample of patients diagnosed with STEMI, 11.0% had an initial non-diagnostic ECG. Of those patients, 72.4% had a follow-up diagnostic ECG within 90 minutes of their initial ECG. There did not appear to be clinically meaningful differences in guidelines-based treatment or major in-hospital outcomes between patients diagnosed with STEMI on an initial versus follow-up ECG.
doi:10.1016/j.ahj.2012.10.027
PMCID: PMC3523309  PMID: 23237133
13.  Baseline Risk of Major Bleeding in Non–ST-segment Elevation Myocardial Infarction: The CRUSADE Bleeding Score 
Circulation  2009;119(14):1873-1882.
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 optimizing 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 CRUSADE Quality Improvement Initiative. Model performance was tested by c statistics in the derivation and validation cohorts and according to post-admission treatment (i.e., invasive and antithrombotic therapy). The CRUSADE bleeding score (range 1–100 points) was created by assigning weighted integers corresponding to the coefficient of each variable. The rate of major bleeding increased by bleeding risk score quintiles: 3.1% very low risk (≤20); 5.5% low risk (21–30); 8.6% moderate risk (31–40); 11.9% high risk (41–50); and 19.5% very high risk (>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: ≥2 antithrombotics=0.72; <2 antithrombotics=0.73; invasive approach=0.73; conservative approach=0.68.
Conclusion
The CRUSADE bleeding score quantifies risk for in-hospital major bleeding across all post-admission treatments, enhancing baseline risk assessment for NSTEMI care.
doi:10.1161/CIRCULATIONAHA.108.828541
PMCID: PMC3767035  PMID: 19332461
non-ST-segment elevation myocardial infarction; bleeding; risk assessment
14.  Effect of Prior Stroke on the Use of Evidence-Based Therapies and In-Hospital Outcomes in Patients With Myocardial Infarction (from the NCDR ACTION GWTG Registry) 
The American journal of cardiology  2011;107(10):1441-1446.
Patients with previous stroke are at high-risk for myocardial infarction (MI). Concern regarding increased risk of bleeding or recurrent stroke in this patient population might alter therapeutic decisions. Data were collected from 281 hospitals in the United States in the NCDR ACTION Registry. Patients with ST-segment elevation MI (STEMI; n = 15,997) or non-STEMI (NSTEMI; n = 25,514) entered into the registry from January 1, 2007 through December 31, 2007 were included. We assessed use of evidence-based medications and procedures in patients with and without previous stroke. Risk-adjusted odds ratio of death, major bleeding not related to coronary artery bypass grafting, and a composite outcome (major adverse cardiac events [MACEs], i.e., death/MI/stroke/cardiogenic shock/congestive heart failure) were calculated using logistic regression. Previous stroke was reported in 5.1% of patients with STEMI and 9.3% of those with NSTEMI. Of patients with STEMI eligible for reperfusion therapy, those with previous stroke were less likely to receive reperfusion therapy compared to patients without previous stroke. Patients with previous stroke had longer door-to-needle and door-to-balloon times. Of patients with STEMI and NSTEMI, those with previous stroke were less likely to receive evidence-based therapies. Death, MACEs, and major bleeding were more common with previous stroke. When adjusted for baseline risk, patients with previous stroke were at increased risk of death (only those with STEMI) and MACEs but not bleeding. In conclusion, patients with STEMI and previous stroke are at increased risk for death and patients with STEMI and NSTEMI are at increased risk of MACE. Despite this, previous stroke patients are less likely to receive guideline-based MI therapies.
doi:10.1016/j.amjcard.2011.01.020
PMCID: PMC3743416  PMID: 21420059
15.  The association of in-hospital major bleeding with short-, intermediate-, and long-term mortality among older patients with non-ST-segment elevation myocardial infarction 
European Heart Journal  2012;33(16):2044-2053.
Aims
Bleeding complications have been associated with short-term mortality in patients with non-ST-segment elevation myocardial infarction (NSTEMI). Their association with long-term outcomes is less clear. This study examines mortality associated with in-hospital bleeding during NSTEMI over time intervals starting from hospital discharge and extending past 3 years.
Methods and results
We studied 32 895 NSTEMI patients aged ≥65 years, using patient-level data from the CRUSADE registry linked with Medicare claims data. We assessed the association of in-hospital major bleeding with short (30 days), intermediate (1 year), and long-term (3 years) mortality among hospital survivors overall, as well as in those patients treated with or without a percutaneous coronary intervention (PCI). We calculated adjusted hazard ratios (HRs) for mortality for bleeders vs. non-bleeders over time intervals from: (i) discharge to 30 days; (ii) 31 days to 1 year; (iii) 1 year to 3 years; and (iv) beyond 3 years. Overall, 11.9% (n = 3902) had an in-hospital major bleeding event. Cumulative mortality was higher in those who had a major bleed vs. those without at 30 days, 1 year, and 3 years. Even after adjustment, major bleeding continued to be significantly associated with higher mortality over time in the overall population: (i) discharge to 30 days [adjusted HR 1.33; 95% confidence interval (CI) 1.18–1.51]; (ii) 31 days to 1 year (1.19; 95% CI 1.10–1.29); (iii) 1 year to 3 years (1.09; 95% CI 1.01–1.18), and (iv) attenuating beyond 3 years (1.14; 95% CI 0.99–1.31). In-hospital bleeding among patients treated with PCI continued to be significantly associated with higher adjusted mortality even beyond 3 years (1.25; 95% CI 1.01–1.54).
Conclusion
In-hospital major bleeding is associated with short-, intermediate-, and long-term mortality among older patients hospitalized for NSTEMI—this association is strongest within the first 30 days, but remains significant long term, particularly among PCI-treated patients. Despite a probable early hazard related to bleeding, the longer duration of risk in patients who bleed casts doubt on its causal relationship with long-term mortality. Rather, major bleeding likely identifies patients with an underlying risk for mortality.
doi:10.1093/eurheartj/ehs012
PMCID: PMC3418508  PMID: 22396323
Bleeding; Outcomes; Elderly patients; Acute myocardial infarction; Percutaneous coronary intervention
16.  Polyvascular Disease and Long-term Cardiovascular Outcomes in Older Patients with Non–ST-segment Elevation Myocardial Infarction 
Background
The impact of polyvascular disease (peripheral arterial disease [PAD] and/or cerebrovascular disease [CVD]) on long-term cardiovascular outcomes among older patients with acute myocardial infarction (MI) has not been well studied.
Methods
Non–ST-elevation MI (NSTEMI) patients aged ≥65 years from the CRUSADE registry who survived to hospital discharge were linked to longitudinal data from the Centers for Medicare and Medicaid Services (n=34,205). All patients were presumed to have coronary artery disease (CAD) and were classified into 4 groups: 10.7% had prior CVD (CAD+CVD group); 11.5% had prior PAD (CAD+PAD); 3.1% had prior PAD and CVD (CAD+PAD+CVD); and 74.7% had no polyvascular disease (CAD alone). Cox proportional hazard modeling was used to examine the hazard of long-term mortality and the composite of death, readmission for MI, or readmission for stroke (median follow-up 35 months, IQR 17–49) among the 4 groups.
Results
Compared with the CAD-alone group, patients with polyvascular disease had a greater comorbidity burden, were less likely to undergo revascularization, and less often received recommended discharge interventions. Three-year mortality rates increased with a greater number of arterial beds involved: 33% for CAD alone, 49% for CAD+PAD, 52% for CAD+CVD, and 59% for CAD+PAD+CVD. Relative to the CAD-alone group, patients with all 3 arterial beds involved had the highest risk of long-term mortality (adjusted HR [95% CI]: 1.49 [1.38–1.61], with a lower risk for those with CAD+CVD, 1.38 [1.31–1.44], and those with CAD+PAD, 1.29 [1.23–1.35]). Similarly, the adjusted risk of long-term composite ischemic events was highest among the CAD+PAD+CVD group.
Conclusions
Older NSTEMI patients with polyvascular disease have substantially higher long-term risk, such that the 3-year mortality rate is >50%. Future studies targeting greater adherance to secondary prevention strategies and novel therapies are needed to help reduce long-term cardiovascular events in this vulnerable population.
doi:10.1161/CIRCOUTCOMES.111.964379
PMCID: PMC3707283  PMID: 22715460
17.  Short-term Outcomes of Acute Myocardial Infarction in Patients with Acute Kidney Injury: A Report from the National Cardiovascular Data Registry 
Circulation  2011;125(3):497-504.
Background
Acute kidney injury (AKI) is a risk factor for long-term adverse outcomes including acute myocardial infarction (MI) and death. However, the relationship between severity of AKI and in-hospital outcomes in the setting of acute MI has not been well-documented.
Methods and Results
The study population (n=59,970) was drawn from the ACTION Registry®-GWTG(tm), a nation-wide sample of MI patients admitted to 383 hospitals in the United States between July 2008 and September, 2009. AKI was defined using absolute changes in serum creatinine (SCr; peak SCr – admission SCr), and categorized as no AKI (SCr change<0.3 mg/dl), mild AKI (SCr change 0.3-<0.5 mg/dl), moderate AKI (SCr change 0.5-<1.0 mg/dl), and severe AKI (SCr change ≥1.0 mg/dl). Overall, 16.1% had AKI, including 6.5% with mild AKI, 5.6% with moderate AKI, and 4.0% with severe AKI. In-hospital mortality rates for those with mild, moderate and severe AKI were 6.6%, 14.2%, and 31.8% compared to 2.1% without AKI. The odds ratio for in-hospital death were 2.4 (95% CI 2.0-2.7), 4.5 (95% CI 3.9-5.1), and 12.6 (95% CI 11.1-14.3) for mild, moderate, and severe AKI compared to those without AKI. Although patients with AKI were less likely to undergo early invasive care or to receive antiplatelet therapies, rates of major bleeding ranged from 8.4% (no AKI) to 32.7% (severe AKI).
Conclusions
AKI is common and associated with mortality and bleeding, underscoring the importance of efforts to identify risk factors and prevent AKI in AMI care.
doi:10.1161/CIRCULATIONAHA.111.039909
PMCID: PMC3411118  PMID: 22179533
acute myocardial infarction; mortality; myocardial infarction; renal; acute kidney injury
18.  Impact of Body Weight and Extreme Obesity on the Presentation, Treatment, and In-Hospital Outcomes of 50,149 Patients With ST-Segment Elevation Myocardial Infarction 
Objectives
The aim of this study was to assess the impact of extreme (class III) obesity (body mass index [BMI] ≥40 kg/m2) on care and outcomes in patients with ST-segment elevation myocardial infarction (STEMI).
Background
Although its prevalence is increasing rapidly, little is known about the impact of extreme obesity on STEMI presentation, treatments, complication rates, and outcomes.
Methods
The relationship between BMI and baseline characteristics, treatment patterns, and risk-adjusted in-hospital outcomes was quantified for 50,149 patients with STEMI from the National Cardiovascular Data Registry (NCDR) ACTION Registry–GWTG.
Results
The proportions of patients with STEMI by BMI category were as follows: underweight (BMI <18.5 kg/m2) 1.6%, normal weight (18.5 kg/m2 ≤BMI <25 kg/m2) 23.5%, overweight (25 kg/m2 ≤BMI <30 kg/m2) 38.7%, class I obese (30 kg/m2 ≤ BMI <35 kg/m2) 22.4%, class II obese (35 kg/m2 ≤ BMI <40 kg/m2) 8.7%, and class III obese 5.1%. Extreme obesity was associated with younger age at STEMI presentation (median age 55 years for class III obese vs. 66 years for normal weight); a higher prevalence of diabetes, hypertension, and dyslipidemia; a lower prevalence of smoking; and less extensive coronary artery disease and higher left ventricular ejection fraction. Process-of-care measures were similar across BMI categories, including the extremely obese. Using class I obesity as the referent, risk-adjusted in-hospital mortality rates were significantly higher only for class III obese patients (adjusted odds ratio: 1.64; 95% confidence interval: 1.32 to 2.03).
Conclusions
Patients with extreme obesity present with STEMI at younger ages and have less extensive coronary artery disease, better left ventricular systolic function, and similar processes and quality of care. Despite these advantages, extreme obesity remains independently associated with higher in-hospital mortality.
doi:10.1016/j.jacc.2011.09.030
PMCID: PMC3523323  PMID: 22152950
extreme obesity; obesity; outcomes; quality of care; STEMI
19.  Temporal trends and practice variations in clopidogrel loading doses in patients with non-ST-elevation myocardial infarction, from the NCDR 
American heart journal  2011;161(4):689-697.
Background
A higher loading dose of clopidogrel achieves a more rapid and consistent degree of platelet inhibition than standard dosing, although the clinical benefit of higher doses has not been clearly established. The use of the different doses in clinical practice is not known. We evaluated the patient, procedural and hospital characteristics associated clopidogrel loading doses given to patients with non-ST-segment elevation myocardial infarction (NSTEMI).
Methods
The NCDR ACTION-GWTG Registry was queried for patients with NSTEMI admitted from 2007–2008. Demographic, clinical, and procedural information was collected on standardized data forms. Patients were categorized according to the clopidogrel loading dose received. Temporal trends in the use of different doses were evaluated in quarterly time intervals.
Results
Between January 1, 2007 and December 31, 2008, the use of a 600 mg clopidogrel loading dose increased steadily from 36.4% to 45.5%, while the use of 300 mg decreased slightly from 40.1% to 37.1%. Patients loaded with clopidogrel prior to cardiac catheterization were more likely to receive 300 mg, while those receiving a loading dose at the time of catheterization more often received 600 mg. The temporal increase in the use of 600 mg clopidogrel loading doses was not explained by temporal changes in peri-procedural loading, use of early invasive management of NSTEMI patients, or use of antithrombotics or glycoprotein 2b/3a inhibitors.
Conclusions
Higher loading dose clopidogrel increased between 2007–2008. Higher dose clopidogrel was more frequently used in lower-risk patients undergoing an early invasive strategy and receiving peri-procedural loading.
doi:10.1016/j.ahj.2010.12.025
PMCID: PMC3086530  PMID: 21473967
20.  No Association between Hemoglobin A1c and In-Hospital Mortality in Patients with Diabetes and Acute Myocardial Infarction 
American heart journal  2011;161(4):657-663.e1.
Background
Patients with diabetes have increased in-hospital mortality following acute myocardial infarction (AMI), with studies suggesting higher risk with both hypoglycemia and hyperglycemia. We assessed whether a J-shaped relation exists between hemoglobin A1C (A1C) in patients with diabetes and AMI.
Methods
We assessed the associations between A1C and in-hospital mortality using data from a nationwide sample of AMI patients who had both prior diabetes and measurement of A1C (n=15,337).
Results
When evaluated continuously, we observed no evidence of a J-shaped relation between A1C and in-hospital mortality in multivariable analysis (test for linearity p=0.89). Patients with lowest (<5.5%) and highest A1C (≥9.5%) had a crude mortality rate of 4.6% and 2.8%, respectively, compared with 3.8% among those in the referent A1C category (6.5 to <7%). In multivariable regression, we observed no association between low A1C (<5.5%, odds ratio [OR] 0.81, 95% CI 0.47-1.39) or high A1C (A1C ≥9.5, OR 1.31, 95% CI 0.94-1.83) with mortality as compared to the referent group.
Conclusion
In this large contemporary cohort of patients with diabetes presenting with AMI, we did not observe a J-shaped association between A1C and mortality.
doi:10.1016/j.ahj.2010.12.004
PMCID: PMC3199292  PMID: 21473963
21.  Randomized Trial of Targeted Performance Feedback to Facilitate Quality Improvement in Acute Myocardial Infarction Care 
Background
Efforts to improve quality of care for patients with acute myocardial infarction (AMI) are a national priority. To date, there have been few studies that have prospectively evaluated hospital quality improvement (QI) interventions.
Methods and Results
Using hospitals in the National Cardiovascular Data Registry (NCDR®) ACTION Registry®–GWTG™, a cluster randomized trial of the effectiveness of targeted performance feedback to facilitate process improvement for AMI care will be conducted. ACTION Registry–GWTG hospitals with a minimum of 50 AMI patients per two quarters are eligible for randomization. The control arm receives standard performance feedback reports while the intervention arm receives standard performance feedback reports in addition to a supplemental report on the “top three” centrally-identified, hospital-specific performance gaps. The primary outcome will be improvement in a composite of all metrics, and the secondary outcome will be improvement in the targeted metrics. At study inception in January 2009, 149 sites were randomized; 76 to the intervention arm and 73 to the control arm. Intervention and control sites were well-balanced in terms of baseline performance, center characteristics, and AMI volume (~70 patients per quarter). The intervention phase will continue for 5 feedback cycles, each containing two quarters of data feedback over 18 months. A final trial outcome report will follow.
Conclusions
This randomized trial will evaluate a novel hospital-level QI intervention of targeted performance feedback for AMI, thereby demonstrating the effective use of national registries for QI and furthering our understanding of effective QI methods.
Clinical Trial Registration Information
ClinicalTrials.gov NCT00952250: Targeted Feedback Reports to Improve Acute Coronary Syndromes (ACS) Care
doi:10.1161/CIRCOUTCOMES.110.958470
PMCID: PMC3061815  PMID: 21245461
randomized controlled trials; quality improvement; acute myocardial infarction
22.  Changes in glycoprotein IIb/IIIa inhibitor excess dosing with site-specific safety feedback in the CRUSADE initiative 
American heart journal  2010;160(6):1072-1078.
Background
Glycoprotein (GP) IIb/IIIa inhibitors can improve outcomes in patients with non–ST-segment elevation acute coronary syndromes (NSTE ACS) but raise the risk of bleeding, particularly if dosed in excess. The impact of GP IIb/IIIa dosing feedback on safety and major bleeding is unknown.
Methods
GP IIb/IIIa dosing feedback was added to the CRUSADE quarterly site reports in the first quarter (Q1) of 2006. We describe GP IIb/IIIa use and dosing among 25,641 NSTE ACS patients from Q4 2005–Q4 2006.
Results
11,846 patients received GP IIb/IIIa inhibitors, including 4031 women and 2609 elderly patients (age ≥75 years). Among GP IIb/IIIa-treated patients, unadjusted rates of excess GP IIb/IIIa dosing declined overall (26.4–22.4%, Ptrend=0.01) and among the elderly (65.6–52.1%, Ptrend<0.001). After adjustment, declines in excess dosing remained significant only for the elderly, though over half of GP IIb/IIIa-treated elderly patients continued to receive excess dosing at the end of the study period (64.1–51.3%, Ptrend<0.001). There were concurrent declines in unadjusted major bleeding rates overall (9.6–8.0%, Ptrend=0.02), but declines among women (14.4–11.5%, Ptrend=0.08) and the elderly (17.1–11.0%, Ptrend=0.05) did not reach statistical significance. After adjustment for baseline characteristics and excess dosing, declines in major bleeding rates were no longer significant overall or for any subgroup.
Conclusion
Within 9 months of initiating a safety feedback program, we observed early decreases in excess GP IIb/IIIa dosing among the elderly but minimal changes in excess dosing overall. Further work is needed to promote safe and effective medication use in vulnerable patients who are most at risk of harm.
doi:10.1016/j.ahj.2010.08.008
PMCID: PMC3058758  PMID: 21146660
23.  Ticagrelor versus clopidogrel in patients with acute coronary syndromes intended for non-invasive management: substudy from prospective randomised PLATelet inhibition and patient Outcomes (PLATO) trial 
Objective To evaluate efficacy and safety outcomes in patients in the PLATelet inhibition and patient Outcomes (PLATO) trial who at randomisation were planned for a non-invasive treatment strategy.
Design Pre-specified analysis of pre-randomisation defined subgroup of prospective randomised clinical trial.
Setting 862 centres in 43 countries.
Participants 5216 (28%) of 18 624 patients admitted to hospital for acute coronary syndrome who were specified as planned for non-invasive management.
Interventions Randomised treatment with ticagrelor (n=2601) versus clopidogrel (2615).
Main outcome measurements Primary composite end point of cardiovascular death, myocardial infarction, and stroke; their individual components; and PLATO defined major bleeding during one year.
Results 2183 (41.9%) patients had coronary angiography during their initial hospital admission, 1065 (20.4%) had percutaneous coronary intervention, and 208 (4.0%) had coronary artery bypass surgery. Cumulatively, 3143 (60.3%) patients had been managed non-invasively by the end of follow-up. The incidence of the primary end point was lower with ticagrelor than with clopidogrel (12.0% (n=295) v 14.3% (346); hazard ratio 0.85, 95% confidence interval 0.73 to 1.00; P=0.04). Overall mortality was also lower (6.1% (147) v 8.2% (195); 0.75, 0.61 to 0.93; P=0.01). The incidence of total major bleeding (11.9% (272) v 10.3% (238); 1.17, 0.98 to 1.39; P=0.08) and non-coronary artery bypass grafting related major bleeding (4.0% (90) v 3.1% (71); 1.30, 0.95 to 1.77; P=0.10) was numerically higher with ticagrelor than with clopidogrel.
Conclusions In patients with acute coronary syndrome initially intended for non-invasive management, the benefits of ticagrelor over clopidogrel were consistent with those from the overall PLATO results, indicating the broad benefits of P2Y12 inhibition with ticagrelor regardless of intended management strategy.
Trial registration Clinical trials NCT00391872.
doi:10.1136/bmj.d3527
PMCID: PMC3117310  PMID: 21685437
24.  Use of Evidence-Based Therapies in and Short-term Outcomes of STEMI and NSTEMI in Patients with Chronic Kidney Disease: A Report from the National Cardiovascular Data ACTION Registry 
Circulation  2010;121(3):357-365.
Background
Chronic kidney disease (CKD) is a risk factor for myocardial infarction (MI) and death. Our goal was to characterize the association between CKD severity and short-term outcomes and the use of in-hospital evidence-based therapies among patients with STEMI and NSTEMI.
Methods and Results
The study sample was drawn from the ACTION Registry, a nation-wide sample of STEMI (n=19,029) and NSTEMI (n=30,462) patients. Estimated glomerular filtration rate (eGFR) was calculated using the Modification of Diet in Renal Disease (MDRD) equation in relation to use of acute (first 24 hours) therapies and early (first 48 hours) cardiac catheterization as well as in-hospital major bleeding events and death. Overall, 30.5% and 42.9% of patients with STEMI and NSTEMI, respectively, had CKD. Regardless of MI type, patients with progressively more severe CKD had higher rates of death. For STEMI, the odds ratio for Stage 3a, 3b, 4, and 5 CKD compared to patients with no CKD was 2.49, 3.72, 4.82, and 7.97 (p-value for trend<0.0001). For NSTEMI, the analogous odds ratios were 1.81, 2.41, 3.50, and 4.09 (p-value for trend<0.0001). In addition, patients with progressively more severe CKD were less likely to receive acute evidence-based therapies including aspirin, beta-blockers or clopidogrel, undergo any reperfusion (STEMI) or revascularization (NSTEMI), and had higher rates of bleeding.
Conclusions
Reports over the past decade have highlighted the importance of CKD among patients with MI. Data from this contemporary cohort suggest patients with CKD still receive fewer evidence-based therapies and have substantially higher mortality rates.
doi:10.1161/CIRCULATIONAHA.109.865352
PMCID: PMC2874063  PMID: 20065168
Chronic kidney disease; end-stage renal disease; dialysis; STEMI; NSTEMI; outcomes; resource utilization
25.  Relation of Patient Age and Mortality to Reported Contraindications to Early Beta-blocker Use for Non-ST Elevation Acute Coronary Syndrome 
The American journal of cardiology  2009;104(10):1324-1329.
We evaluated reported contraindications to early beta-blocker use and associated mortality within and across patient age groups. Contraindications to early beta-blocker use were evaluated in CRUSADE patients with non-ST elevation acute coronary syndrome from 2/2003–12/2006. Prevalence, reasons, and trends in contraindications were evaluated by age (≤65, 66–74, ≥75). Associations between reported contraindications and in-hospital mortality were determined within and compared across age groups using logistic generalized estimating equations method adjusting for baseline patient characteristics. Of 112,448 patients, 11,711 (10.4%) had a reported contraindication to early beta-blocker. Prevalence varied by age (≤65, 7.9%; 66–74, 10.6%; ≥75, 13.4%; P<0.0001); there were no significant changes over time except for a small increase in patients ≤65 (P=0.001). Among hospitals with >40 patients in the registry, the median hospital-level rate of reported contraindications was 9.9% (IQR: 6.7–14.3%). The distribution of rates was more widespread among the hospitals’ older versus younger patients. In all age groups, there was a statistically significant greater association with in-hospital mortality in those with reported contraindications versus those without contraindications who received a beta-blocker (adjusted OR [95% CI]: 2.81 [2.28–3.46]; 2.50 [2.07–3.03]; 2.11 [1.88–2.37], for ages ≤65, 66–74, and ≥ 75); the strength of the association was similar across age groups (interaction P=0.19). Reported contraindications to early beta-blocker use were common and increased with age. Contraindications were independently associated with higher in-hospital mortality, underscoring the importance of accurately identifying contraindications. In conclusion, the results did not indicate any disparity in reporting contraindications based upon patient age.
doi:10.1016/j.amjcard.2009.06.054
PMCID: PMC2791368  PMID: 19892045
beta-blockers; contraindications; non-ST elevation acute coronary syndrome; age; mortality

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