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The relation between operator volume and mortality of primary percutaneous coronary intervention (PPCI) procedures for ST-elevation myocardial infarction has not been studied comprehensively. This study included patients who underwent PPCI between 2010 and 2017 in all nonfederal hospitals approved to perform PCI in New York State. We compared risk-adjusted in-hospital/30-day mortality for radial access (RA) and femoral access (FA) and the relation between risk-adjusted mortality and procedure volume for each access site. In 44,540 patients in the study period, the use of RA rose from 8% in 2,010% to 43% in 2017 (p0.0001). There was no significant change in PPCI risk-adjusted mortality during the period (p=0.27 for trend). RA was associated with lower mortality when imposing operator exclusion criteria used in recent trials. There was a significant operator inverse volume-mortality relation for FA procedures but not for RA procedures. FA procedures performed by lower volume FA operators (lowest quartile) were associated with higher risk-adjusted mortality compared with RA procedures (3.71% vs 3.06%, p = 0.01) or compared with FA procedures performed by higher volume FA operators (3.71% vs 3.16%, p = 0.01). In conclusion, in patients with ST-elevation myocardial infarction referred for primary PCI in New York State, there was a significant uptake in the use of RA along with relatively constant in-hospital/30-day mortality. There was a significant inverse operator volume-mortality relation for FA procedures accompanied by higher mortality for FA procedures performed by low volume FA operators than for all other primary PCI procedures. In conclusion, this information underscores the need for operators to remain vigilant in maintaining FA skills and monitoring FA outcomes.

Background: Orthopedic surgery is one of the least diverse medical specialties. Other medical specialties have employed diversity-related initiatives to increase the number of students underrepresented in medicine (URM). Furthermore, with the suspension of visiting student rotations during the COVID-19 pandemic, medical students used residency program Web sites as a main source of program-specific information. Aims/Purpose: The purpose of this study was to measure the extent to which orthopedic surgery residency program Web sites describe diversity and inclusion initiatives. Methods: The Electronic Residency Application Service (ERAS) was used to identify U.S. orthopedic surgery residency programs. The programs’ Web sites were reviewed, and data on commitments to diversity and inclusion were collected. Descriptive statistics of these data were generated. Results: There were 192 residency programs identified and 3 were excluded from the analysis due to lack of Web sites. Of the remaining 189 residency program Web sites, only 55 (29.10%) contained information on diversity and inclusion. Information on a commitment to improving diversity and inclusion was the most prevalent data point found among program Web sites, although it was found on only 15% of program Web sites. Conclusion: Orthopedic surgery residency programs rarely address topics related to diversity and inclusion on their program Web sites. An emphasis on opportunities for URM students and initiatives related to diversity and inclusion on program Web sites may improve URM outreach and serve as one method for increasing URM matriculation into orthopedic surgery.

Background: Intravascular ultrasound (IVUS) has several benefits during percutaneous coronary interventions (PCIs), including more accurate vessel sizing, improved stent expansion, and better strut apposition. Prior clinical trials have demonstrated a reduction in cardiac events when IVUS is used. However, there is limited information about the utilization of IVUS and the outcomes of IVUS-guided versus angiography-guided PCI in patients with complex lesions in a contemporary population-based setting. Methods: New York’s PCI registry was used to identify 44 305 patients with complex lesions (lesions that complicate stenting or that require multiple stents) undergoing PCI with and without IVUS guidance and discharged between December 1, 2013 and November 30, 2018. Trends and inter-hospital variation in IVUS use were examined. Risk-adjusted mortality and target vessel revascularization were compared. Results: A total of 6174 (13.9%) PCI patients underwent IVUS-guided PCI. The median follow-up period was 2.5 years. The percent of patients with complex lesions who underwent IVUS-guided PCI rose from 13.4% in 2014 to 16.5% in 2018 ( P 5% of their study patients. IVUS-guided PCI patients experienced significantly lower mortality (adjusted hazard ratio=0.89 [0.79–0.98] after adjustment using a Cox proportional hazards model, and HR=0.88 [0.78–0.99] for propensity-matched patients). We also found that IVUS-guided PCI patients had a lower rate of target vessel revascularization (adjusted hazard ratio=0.88 [0.80–0.97]) after adjusting using Cox proportional hazards with competing risk of mortality and after propensity matching (0.88 [0.79–0.99]). Conclusions: Utilization of IVUS for complex lesions has increased but contemporary rates remain low, and there are large inter-hospital variations. The use of IVUS for complex lesions was associated with lower risk of medium-term mortality and target vessel revascularization.

Background Numerous studies have identified the association of socio-economic factors with outcomes of cardiac surgical procedures. Most have focused on easily measured demographic factors or on socio-economic characteristics of patients’ 5-digit zip codes. The impact of socio-economic information that is derived from smaller geographic regions has rarely been studied. Methods The association of the Area Deprivation Index (ADI) with short-term mortality and readmissions was tested for patients undergoing percutaneous coronary intervention (PCI) in New York while adjusting for numerous patient risk factors, including race, ethnicity, and payer. Changes in hospitals’ risk-adjusted outcomes and outlier status with the addition of socio-economic factors were examined. Results After adjustment, patients in the two most deprived ADI quintiles were more likely to experience in-hospital/30-day mortality following PCI (AOR = 1.39 (1.18, 1.65) and AOR = 1.24 (1.03, 1.49)), respectively, than patients in the first quintile (least deprived). Also, patients in the second (1.12 (1.01, 1.25)) and fifth (1.17 (1.04, 1.32)) ADI quintiles had higher 30-day readmissions rates than patients in the first quintile. Medicare patients had higher mortality and readmission rates, Hispanics had lower mortality, and Medicaid patients had higher readmission rates. Conclusions Patients with the most deprived ADIs are more likely to experience short-term mortality and readmissions following PCI. Ethnicity and payer are significantly associated with adverse outcomes even while adjusting for ADI. This information should be considered when identifying patients who are at the highest risk for adverse events following PCI, and when risk-adjusting hospital outcomes and assessing quality of care.

Background Target lesion percutaneous coronary intervention (TLPCI) within 1 year of PCI has been proposed by critics of public reporting of short-term mortality as an alternative measure for PCI reporting. Methods New York's PCI registry was used to identify 1-year repeat TLPCI and 1-year repeat TLPCI/mortality for patients discharged between December 1, 2013 and November 30, 2014. Significant independent predictors of the outcomes were identified. Hospital and cardiologist risk-adjusted outcomes were calculated, and outlier status and correlations of risk-adjusted rates were examined for the three outcomes. Results The adverse outcome rates were 1.30, 4.21, and 8.97% for in-hospital/30-day mortality, 1-year repeat TLPCI, and 1-year repeat TLPCI/mortality. There were many commonalities but also many differences in significant predictors of the outcomes. Hospital and cardiologist risk-adjusted 1-year repeat TLPCI rates and repeat TLPCI/mortality rates were poorly correlated with risk-adjusted in-hospital/30-day mortality rates (eg, Spearman R = -.16 [p = .23] and .27 [p = .04], respectively, for hospital 1-year repeat TLPCI vs. in-hospital/30-day mortality). Many more providers were found to have significantly higher and lower rates for repeat TLPCI than for short-term mortality. Conclusions Hospital and cardiologist quality assessments are very different for TLPCI and repeat TLPCI/mortality than they are for short-term mortality. Repeat TLPCI/mortality rates are highly correlated with repeat TLPCI rates, but outlier providers differ. More study of repeat TLPCI and all the patient, cardiologist, and hospital factors associated with it may be required before using it as a supplement to, or in lieu of, short-term mortality in public reporting of PCI outcomes.

OBJECTIVES To compare mortality for women and men hospitalized with ST-elevation myocardial infarction (STEMI) by age and revascularization status. BACKGROUND There is little information on the mortality of men and women not undergoing revascularization, and the impact of age on relative male-female mortality needs to be revisited. METHODS AND RESULTS An observational database of 23,809 patients with STEMI presenting at nonfederal New York State hospitals between 2013 and 2015 was used to compare risk-adjusted inhospital/30-day mortality for women and men and to explore the impact of age on those differences. Women had significantly higher mortality than men overall (adjusted odds ratio [AOR] = 1.15, 95% CI [1.04, 1.28]), and among patients aged 65 and older. Women had lower revascularization rates in general (AOR = 0.64 [0.59, 0.69]) and for all age groups. Among revascularized STEMI patients, women overall (AOR = 1.30 [1.10, 1.53]) and over 65 had higher mortality than men. Among patients not revascularized, women between the ages of 45 and 64 had lower mortality (AOR = 0.68 [0.48, 0.97]). CONCLUSIONS Women with STEMI, and especially older women, had higher inhospital/30-day mortality rates than their male counterparts. Women had higher mortality among revascularized patients, but not among patients who were not revascularized.

Background The exceptional competitiveness of the orthopedic surgery specialty, combined with the unclear impact of the COVID-19 pandemic on residency recruitment, has presented significant challenges to applicants and residency program directors. With limited in-person opportunities in the 2020-2021 application cycle, applicants have been pressed to gauge chances and best fit by browsing program websites. Objective The aim of the study was to assess the accessibility and content of accredited orthopedic surgery residency program websites during the COVID-19 pandemic. Methods Using the online database of the Electronic Residency Application Service (ERAS), we compiled a list of accredited orthopedic surgery residency programs in the United States. Program websites were evaluated across four domains: program overview, education, research opportunities, and application details. Each website was assessed twice in July 2020, during a period of adjustment to the COVID-19 pandemic, and twice in November 2020, following the October ERAS application deadline. Results A total of 189 accredited orthopedic surgery residency programs were identified through ERAS. Of these programs, 3 (1.6%) did not have functional website links on ERAS. Data analysis of content in each domain revealed that most websites included program details, a description of the didactic curriculum, and sample rotation schedules. Between the two evaluation periods in July and November 2020, the percentage of program websites containing informative videos and virtual tours rose from 12.2% (23/189) to 48.1% (91/189; P Conclusions Most residency program websites offered program details and an overview of educational and research opportunities; however, few addressed the virtual transition of interviews and subinternships during the COVID-19 pandemic.

Little is known about regional differences in volume, treatment, and outcomes of STEMI patients undergoing PCI during the pandemic. The objectives of this study were to compare COVID-19 pandemic and prepandemic periods with respect to regional volumes, outcomes, and treatment of patients undergoing percutaneous coronary intervention (PCI) for ST-elevation myocardial infarction (STEMI) between January 1, 2019 and March 14, 2020 (pre-COVID period) and between March 15, 2020 and April 4, 2020 (COVID period) in 51 New York State hospitals certified to perform PCI. The hospitals were classified as being in either high-density or low-density COVID-19 counties on the basis of deaths/10,000 population. There was a decrease of 43% in procedures/week in high-density COVID-19 counties (p

Objective— Ceramides are sphingolipids involved with cellular signaling. Synthesis of ceramides occurs in all tissues. Ceramides accumulate within tissues and the blood plasma during metabolic dysfunction, dyslipidemia, and inflammation. Elevations of ceramides are predictive of cardiovascular mortality. We sought to verify the utility of plasma concentrations of 4 ceramides: N-palmitoyl-sphingosine [Cer(16:0)], N-stearoyl-sphingosine [Cer(18:0)], N-nervonoyl-sphingosine [Cer(24:1)], and N-lignoceroyl-sphingosine [Cer(24:0)] in predicting major adverse cardiovascular events in a diverse patient population referred for coronary angiography. Approach and Results— Plasma ceramides were measured in 495 participants before nonurgent coronary angiography. Coronary artery disease, defined as >50% stenosis in ≥1 coronary artery, was identified 265 (54%) cases. Ceramides were not significantly associated with coronary artery disease. Patients were followed for a combined primary end point of myocardial infarction, percutaneous intervention, coronary artery bypass, stroke, or death within 4 years. Ceramides were significantly predictive of outcomes after adjusting for age, sex, body mass index, hypertension, smoking, LDL (low-density lipoprotein) cholesterol, HDL (high-density lipoprotein) cholesterol, triglycerides, serum glucose, and family history of coronary artery disease. The fully adjusted per SD hazard ratios (95% confidence interval) were 1.50 (1.16–1.93) for Cer(16:0), 1.42 (1.11–1.83) for Cer(18:0), 1.43 (1.08–1.89) for Cer(24:1), and 1.58 (1.22–2.04) for the ceramide risk score. Conclusions— Elevated plasma concentrations of ceramides are independently associated with major adverse cardiovascular events in patients with and without coronary artery disease.

Objectives The purpose of this study is to revisit cases rated as “inappropriate” in the 2012 appropriate use criteria (AUC) using the 2017 AUC. Background AUC for coronary revascularization in patients with stable ischemic heart disease (SIHD) were released in January 2017. Earlier 2012 AUC identified a relatively high percentage of New York State patients for whom percutaneous coronary intervention (PCI) was rated as “inappropriate” versus optimal medical therapy alone. Methods New York State’s PCI registry was used to rate inappropriateness of patients undergoing PCI in 2014 using the 2012 and 2017 AUC, and to examine patient characteristics for patients rated differently. Results A total of 911 of 9,261 (9.8%) patients who underwent PCI in New York State in 2014 with SIHD without prior coronary artery bypass grafting were rated as “inappropriate” using the 2012 AUC, but only 171 (1.8%) patients were rated as “rarely appropriate” (“inappropriate” in 2012 AUC terminology) using the 2017 AUC. A total of 26% of all 8,407 patients undergoing PCI in New York State with 1- to 2-vessel SIHD were without high-risk findings on noninvasive testing and were either asymptomatic or without antianginal therapy. No current or past randomized controlled trials have focused on these patients. Conclusions The percentage of 2014 New York State PCI patients with SIHD who are rated “rarely appropriate” has decreased substantially using 2017 AUC in comparison with the older 2012 AUC. However, for many low-risk patients undergoing the procedure, the relative benefits of optimal medical therapy with and without PCI are unknown. Randomized controlled trials are needed to study these groups.

Background: Regional variations in reperfusion times and mortality in patients with ST-segment–elevation myocardial infarction are influenced by differences in coordinating care between emergency medical services (EMS) and hospitals. Building on the Accelerator-1 Project, we hypothesized that time to reperfusion could be further reduced with enhanced regional efforts. Methods: Between April 2015 and March 2017, we worked with 12 metropolitan regions across the United States with 132 percutaneous coronary intervention–capable hospitals and 946 EMS agencies. Data were collected in the ACTION (Acute Coronary Treatment and Intervention Outcomes Network)-Get With The Guidelines Registry for quarterly Mission: Lifeline reports. The primary end point was the change in the proportion of EMS-transported patients with first medical contact to device time ≤90 minutes from baseline to final quarter. We also compared treatment times and mortality with patients treated in hospitals not participating in the project during the corresponding time period. Results: During the study period, 10 730 patients were transported to percutaneous coronary intervention–capable hospitals, including 974 in the baseline quarter and 972 in the final quarter who met inclusion criteria. Median age was 61 years; 27% were women, 6% had cardiac arrest, and 6% had shock on admission; 10% were black, 12% were Latino, and 10% were uninsured. By the end of the intervention, all process measures reflecting coordination between EMS and hospitals had improved, including the proportion of patients with a first medical contact to device time of ≤90 minutes (67%–74%; P P P P =0.001) that was not apparent in hospitals not participating in the project during the same time period. Conclusions: Organization of care among EMS and hospitals in 12 regions was associated with significant reductions in time to reperfusion in patients with ST-segment–elevation myocardial infarction as well as in in-hospital mortality. These findings support a more intensive regional approach to emergency care for patients with ST-segment–elevation myocardial infarction.

Objectives The authors examined the impact of including shock patients in public reporting of percutaneous coronary intervention (PCI) risk-adjusted mortality. Background There is concern that an unintended consequence of statewide public reporting of medical outcomes is the avoidance of appropriate interventions for high-risk patients. Methods New York State’s PCI registry was used to compare hospital and physician risk-adjusted mortality rates and outliers from New York’s public report models with rates and outliers based on statistical models that include refractory shock patients and exclude both refractory shock and other shock patients. Results Correlations between the public report model and each of the other 2 models were above 0.92 for hospital risk-adjusted rates and were 0.99 for all physician risk-adjusted rates (p Conclusions Risk-adjusted hospital and physician mortality rates are highly correlated regardless of whether shock patients are included in public reporting. The numbers of outliers are similar, and outlier changes are minimal, although 10% to 15% of cardiologists who were outliers in either exclusion rule were not outliers in the other one. This information can form a basis for subsequent discussions regarding the exclusion of high-risk patients from public reporting.

Background Statin pretreatment has been associated with reduced infarct volume in nonlacunar strokes. The effect of statins on functional outcomes of strokes related to atrial fibrillation (AF) is unknown. We aimed to define the influence of prestroke statin use on functional outcome in AF. Methods We assembled a cohort of consecutive ischemic stroke patients from 2006 to 2010. All patients underwent CT or MRI and were adjudicated by site investigators. AF was confirmed by electrocardiogram in 100% of patients. Site neurologists blinded to the study hypothesis affirmed the type of stroke and assessed the severity of disability at the time of hospital discharge. The frequency of death at 30-days was calculated. Results Ischemic stroke ( n =1030) resulted in a severe neurological deficit or death (modified Rankin scale ≥4) at 30days in 711 patients (69%). Using multivariable logistic regression models adjusting for factors associated with statin treatment and factors associated with functional outcome, prestroke statin use was associated with a 32% reduction in frequency of severe stroke (odds ratio [OR], 0.68; 95% confidence interval [CI], 0.50–0.92; P =0.011). Other independent factors associated with severe stroke included older age, female sex, non-White race, diabetes mellitus, prior ischemic stroke, prior venous thromboembolism, and dementia. Conclusion Ischemic strokes in AF are associated with high mortality and morbidity. Statin use at time of stroke onset among patients with AF was associated in this study with less severe stroke and warrant validation.

OBJECTIVES To evaluate physical function and return to independence of geriatric trauma patients, to compare physical function outcomes of geriatric patients who sustained high-energy trauma with that of those who sustained low-energy trauma, and to identify predictors of physical function outcomes. DESIGN Retrospective. SETTING Urban Level I trauma center. PATIENTS Study group of 216 patients with high-energy trauma and comparison group of 117 patients with low-energy trauma. INTERVENTION Injury mechanism (high- vs. low-energy mechanism). MAIN OUTCOME MEASUREMENT Patient-Reported Outcomes Measurement Information System Physical Function (PROMIS PF) patient-reported outcome measure, and change in living situation and mobility. RESULTS Physical function outcomes and return to independence differed between patients with high-energy and low-energy injuries. High-energy geriatric trauma patients had significantly higher PROMIS PF scores compared with low-energy geriatric trauma patients (PROMIS PF score 42.2 ± 10.4 vs. 24.6 ± 10.4, P < 0.001). High-energy geriatric trauma patients were able to ambulate outdoors without an assistive device in 67% of cases and were living independently 74% of the time in comparison with 28% and 45% of low-energy geriatric trauma patients, respectively (P < 0.001, P < 0.001). Multivariate linear regression analysis demonstrated that low-energy mechanism injury was independently associated with a 13.2 point reduction in PROMIS PF score (P < 0.001). CONCLUSIONS Geriatric patients greater than 1 year out from sustaining a high-energy traumatic injury seem to be functioning within the expected range for their age, whereas low-energy trauma patients seem to be functioning substantially worse than both age-adjusted norms and their high-energy cohorts. LEVEL OF EVIDENCE Prognostic Level III. See Instructions for Authors for a complete description of levels of evidence.

Background: Many studies have revealed no outcome differences among patients undergoing percutaneous coronary intervention (PCI) in hospitals with and without surgery on-site (SOS), but one earlier study found differences in target vessel PCI rates and in mortality for patients with acute myocardial infarction who did not undergo PCI. It is important to examine outcome differences between SOS and non-SOS hospitals with more contemporary data. Methods and Results: A total of 21 924 propensity-matched patients who were discharged between January 1, 2013, and November 30, 2015, who were in the New York PCI registry and other hospital databases were used to compare outcomes in hospitals with and without SOS for all patients and for patients with and without ST-segment–elevation myocardial infarction (STEMI) undergoing PCI. Also, 30-day mortality was compared for patients with STEMI regardless of whether they underwent PCI. For all patients with PCI and patients without STEMI, there were no significant differences in in-hospital/30-day mortality, 2-year mortality, or 2-year repeat target lesion PCI. For patients with STEMI, there were no significant mortality differences between patients in SOS and non-SOS hospitals. Patients with STEMI in SOS hospitals had significantly lower 2-year repeat target lesion PCI rates (adjusted hazard ratio, 0.68 [0.49–0.94]). There was no difference in the percentage of patients undergoing PCI in the 2 types of hospitals (75.7% versus 74.6%; P =0.21) or in 30-day mortality of all patients with STEMI (patients who did and did not undergo PCI, 10.86% versus 11.32%; adjusted odds ratio, 1.06 [0.88–1.29]). Conclusions: Short-term and long-term outcomes were not different in SOS and non-SOS hospitals except that 2-year repeat target lesion PCI rates were lower in SOS hospitals for patients with STEMI.

Objectives: The study sought to compare the clinical efficacy and safety of P2Y12 inhibitors in patients with ST-segment elevation myocardial infarction (STEMI) undergoing primary percutane...

Hospitals' risk-standardized mortality rates and outlier status (significantly higher/lower rates) are reported by the Centers for Medicare and Medicaid Services (CMS) for acute myocardial infarction (AMI) patients using Medicare claims data. New York now has AMI claims data with blood pressure and heart rate added.The objective of this study was to see whether the appended database yields different hospital assessments than standard claims data.New York State clinically appended claims data for AMI were used to create 2 different risk models based on CMS methods: 1 with and 1 without the added clinical data. Model discrimination was compared, and differences between the models in hospital outlier status and tertile status were examined.Mean arterial pressure and heart rate were both significant predictors of mortality in the clinically appended model. The C statistic for the model with the clinical variables added was significantly higher (0.803 vs. 0.773, P0.001). The model without clinical variables identified 10 low outliers and all of them were percutaneous coronary intervention hospitals. When clinical variables were included in the model, only 6 of those 10 hospitals were low outliers, but there were 2 new low outliers. The model without clinical variables had only 3 high outliers, and the model with clinical variables included identified 2 new high outliers.Appending even a small number of clinical data elements to administrative data resulted in a difference in the assessment of hospital mortality outliers for AMI. The strategy of adding limited but important clinical data elements to administrative datasets should be considered when evaluating hospital quality for procedures and other medical conditions.

Objective To examine the influence of smoking on the antiplatelet effect of clopidogrel following percutaneous coronary intervention (PCI). Background Certain studies suggest smokers may have enhanced clopidogrel-induced platelet inhibition compared to non-smokers after PCI. Whether this is affected by clopidogrel dose is unknown. Methods In this study, we conducted an analysis of 5,429 patients in the Gauging Responsiveness With A VerifyNow P2Y12 Assay: Impact on Thrombosis and Safety (GRAVITAS) trial. Platelet reactivity was assessed 12–24 hr after PCI (baseline). Patients with high on-treatment platelet reactivity (OTR) (P2Y12 reaction units [PRU] ≥ 230) were randomized to clopidogrel 75 mg or 150 mg daily. Reactivity was subsequently assessed at 30-days, and 6-months. Patients were stratified by smoking status. Results Smoking was independently associated with lower PRU (P = 0.001), and smokers were less likely to have high OTR (odds ratio 0.80, 95% confidence interval 0.68–0.94; P = 0.006) at baseline. Among patients assigned to clopidogrel 75 mg, smokers had lower PRU and were less likely to still have high OTR at 30-days (P

Objective- Ceramides are sphingolipids involved with cellular signaling. Synthesis of ceramides occurs in all tissues. Ceramides accumulate within tissues and the blood plasma during metabolic dysfunction, dyslipidemia, and inflammation. Elevations of ceramides are predictive of cardiovascular mortality. We sought to verify the utility of plasma concentrations of 4 ceramides: N-palmitoyl-sphingosine [Cer(16:0)], N-stearoyl-sphingosine [Cer(18:0)], N-nervonoyl-sphingosine [Cer(24:1)], and N-lignoceroyl-sphingosine [Cer(24:0)] in predicting major adverse cardiovascular events in a diverse patient population referred for coronary angiography. Approach and Results- Plasma ceramides were measured in 495 participants before nonurgent coronary angiography. Coronary artery disease, defined as50% stenosis in ≥1 coronary artery, was identified 265 (54%) cases. Ceramides were not significantly associated with coronary artery disease. Patients were followed for a combined primary end point of myocardial infarction, percutaneous intervention, coronary artery bypass, stroke, or death within 4 years. Ceramides were significantly predictive of outcomes after adjusting for age, sex, body mass index, hypertension, smoking, LDL (low-density lipoprotein) cholesterol, HDL (high-density lipoprotein) cholesterol, triglycerides, serum glucose, and family history of coronary artery disease. The fully adjusted per SD hazard ratios (95% confidence interval) were 1.50 (1.16-1.93) for Cer(16:0), 1.42 (1.11-1.83) for Cer(18:0), 1.43 (1.08-1.89) for Cer(24:1), and 1.58 (1.22-2.04) for the ceramide risk score. Conclusions- Elevated plasma concentrations of ceramides are independently associated with major adverse cardiovascular events in patients with and without coronary artery disease.

Introduction: Rehospitalization after discharge for a wide variety of medical conditions is common and is associated with increased morbidity and cost. We investigated the rates of rehospitalization for stroke in a population of patients hospitalized with atrial fibrillation (AF) who were at risk of stroke. Methods: Using the Premier Healthcare Database (representing 1 in 5 US hospital discharges), we identified 1,147,866 patients hospitalized from January 1, 2011 through June 30, 2015 with AF and a guideline indication for an oral anticoagulant based on a CHA 2 DS 2 -VaSC score ≥ 2. The primary outcome was readmission within 90 days due to acute ischemic stroke (AIS) or intracranial hemorrhage (ICH). Multivariable logistic regression was used to compare rehospitalization rates for patients receiving various oral antithrombotic therapies, while controlling for numerous patient risk factors, reasons for current hospitalization, and hospital characteristics. Confidence intervals and p-values were adjusted for multiple comparisons using Holm-Bonferroni. Results: Patients were 53% female with a mean age of 77 (±11) years. The distribution of patients on various antithrombotic agents at discharge was 23% with no therapy, 20% ASA only, 1% dual-antiplatelet therapy (DAPT), 17% non-vitamin K oral anticoagulants (NOAC), and 39% warfarin. Table 1 displays rehospitalization rates, unadjusted (therapy only), and adjusted for all covariates using logistic regression analysis. Conclusions: AF patients discharged on ASA alone or no antithrombotic therapy, compared to warfarin, were more likely to have early rehospitalization for acute ischemic stroke. Patients treated with NOACs had early ischemic stroke rehospitalization rates similar to warfarin, but were less likely to be have early rehospitalization for ICH when compared to warfarin. Table 1: 90-Day Rehospitalization Rates by Antithrombotic Agents

This study sought to examine whether quality improvement initiatives across multiple ST-segment elevation myocardial infarction (STEMI) systems translated to faster first medical contact (FMC)-to-device times for patients presenting with cardiogenic shock (CS).There are limited data describing contemporary rates of achieving guideline-directed FMC-to-device times for STEMI patients with CS.From 2012 to 2014, the American Heart Association Mission: Lifeline STEMI Systems Accelerator project established a protocol-guided approach to STEMI reperfusion systems in 484 U.S. hospitals. The study was stratified by CS versus no CS at presentation and performed Cochrane-Armitage tests to evaluate trends of achieving FMC-to-device time targets. A multivariable logistic regression model assessed the association between achieving guideline-directed FMC-to-device times and mortality.Among 23,785 STEMI patients, 1,993 (8.4%) experienced CS at presentation. For direct presenters, patients with CS were less likely to achieve the 90-min FMC-to-device time compared with no-CS patients (37% vs. 54%; p 0.001). For transferred patients, CS patients were even less likely to reach the 120-min FMC-to-device time compared with no-CS patients (34% vs. 47%; p 0.0001). The Accelerator intervention did not result in improvements in the FMC-to-device times for direct-presenting CS patients (p for trend = 0.53), although there was an improvement for transferred patients (p for trend = 0.04). Direct-presenting patients arriving within 90 min had lower mortality rates compared with patients who reached after 90 min (20.49% vs. 39.12%; p 0.001).Fewer than 40% of STEMI patients presenting with CS achieved guideline-directed FMC-to-device targets; delays in reperfusion for direct-presenting patients were associated with higher mortality.

Dual antiplatelet therapy (DAPT) with aspirin and a P2Y12 receptor inhibitor is the mainstay of treatment for acute coronary syndrome (ACS) patients, whether they undergo a percutaneous coronary intervention (PCI) or are managed medically. In recent years, the most appropriate timing for initiation and duration of P2Y12 receptor inhibition has been a focus of great interest. Many observational studies and a single prospective trial (CREDO) utilizing clopidogrel had focused on whether pre-treatment with clopidogrel, i.e. its administration upstream of coronary angiography and PCI, is beneficial. Although the rationale for pre-treatment is obvious, large-scale randomized trials supporting a pre-treatment strategy with clopidogrel or with the newer P2Y12 inhibitors prasugrel and ticagrelor did not exist. Proponents of a pre-treatment strategy had to rely on their best guess, on non-randomized studies, or on negative studies in which a trend for a benefit had been demonstrated. Recently, however, two randomized trials directly evaluated the value of pre-treatment—one in patients with a non-STE elevation myocardial infarction (NSTEMI)—the Comparison of Prasugrel at the Time of Percutaneous Coronary Intervention or as Pretreatment at the Time of Diagnosis in Patients with Non-ST Elevation Myocardial Infarction (ACCOAST) trial, and a second trial evaluating the use of ticagrelor in ST-elevation myocardial infarction (STEMI) patients, the Administration of Ticagrelor in the Cath Lab or in the Ambulance for New ST-elevation myocardial Infarction to open the Coronary artery (ATLANTIC) trial. Neither of the two trials, however, answered all the questions clinicians have about pre-treatment. And given the recent approval of the intravenous and rapidly acting P2Y12 inhibitor cangrelor, the choice of who should receive treatment with a P2Y12 inhibitor, which one should be used, and when it should be administered, should be carefully re-evaluated for all patients. This clinical review aims at evaluating the available evidence regarding the value of pre-treatment with the now four available oral and intravenous P2Y12 inhibitors that can be administered to patients in whom coronary angiography followed by a possible PCI is planned.

Although platelet function and pharmacogenomic testing have been studied in clinical trials, their adoption into contemporary practice is unknown.We studied patterns of platelet function and pharmacogenomic testing among 10,048 patients with acute myocardial infarction treated with percutaneous coronary intervention at 226 US hospitals in the TRANSLATE-ACS observational study between April 2010 and October 2012, excluding those receiving research protocol-mandated testing. Inverse probability-weighted propensity adjustment was used to compare 1-year bleeding and major adverse cardiac event risks between patients with and without testing.Overall, 337 (3.4%) patients underwent predischarge platelet function testing, whereas 85 (0.9%) underwent pharmacogenomic testing; 82% and 93% of hospitals never performed any platelet function or pharmacogenomic testing, respectively. Patients undergoing testing were more likely to be on an adenosine diphosphate receptor inhibitor preadmission or to have percutaneous coronary intervention of a previously treated lesion. Tested patients were more likely than nontested patients to be switched from clopidogrel to prasugrel/ticagrelor (25.7% vs 9.7%, P.001) and were more likely to be on prasugrel/ticagrelor 6 months postdischarge (33.8% vs 25.1%, P.001). No significant differences in 1-year bleeding and major adverse cardiac event risks were observed between tested and nontested patients (adjusted hazard ratios 1.06 [95% CI 0.68-1.65] and 1.21 [95% CI 0.94-1.54], respectively).Platelet function and pharmacogenomic testing are rarely performed in contemporary myocardial infarction patients in the United States. When tested, patients were more likely to be treated with higher-potency adenosine diphosphate receptor inhibitors, yet no significant differences in longitudinal outcomes were observed.

Objective We sought to examine the relationship between preoperative platelet function and perioperative bleeding in patients undergoing CABG. Background There are many ways to measure platelet aggregability. Little is known about their correlations with one another, or with bleeding. Methods We prospectively studied 50 patients undergoing a first isolated off-pump CABG. Thirty-four were exposed to a thienopyridine prior to surgery; 16 were not. Preoperative platelet function was measured by VerifyNow®, TEG®, AggreGuide™, Plateletworks®, vasodilator-stimulated phosphoprotein (VASP) phosphorylation, and light transmission aggregometry. Bleeding was assessed 2 ways: drop from pre- to nadir postoperative hematocrit, and chest tube drainage. Correlation coefficients were calculated using Spearman's rank-order correlation. Results Mean age was 62 years. Patient characteristics and surgical details were similar between the thienopyridine-exposed and non-exposed patients. The correlation coefficients between the 4 point-of-care platelet function measurements and hematocrit change ranged from −0.2274 to 0.2882. Only Plateletworks® correlated with drop in hematocrit (r = 0.2882, P = 0.0470). The correlation coefficients between each of the 4 point-of-care platelet function tests and the chest tube drainage were also poor, ranging from −0.3073 to 0.2272. Both AggreGuide™ (r = −0.3073, P = 0.0317) and VASP (r = −0.3187, P = 0.0272) were weakly but significantly correlated with chest tube drainage. The correlation among the 4 point-of-care platelet function measurements was poor, with coefficients ranging from −0.2504 to 0.1968. Conclusions We observed little correlation among 4 platelet function tests, and between those assays and perioperative bleeding defined 2 different ways. Whether any of these assays should be used to guide decision making in individual patients is unclear. (J Interven Cardiol 2015;28:223–232)

Background— Because of its association with death and disability, stroke is a focus of outcomes in atrial fibrillation (AF) research. International Classification of Disease-Ninth Revision ( ICD-9 ) edition codes are commonly used to identify stroke in research, particularly in large administrative data. We sought to assess the validity of ICD-9 codes in stroke case ascertainment and for AF across 3 institutions. Methods and Results— Participating centers included Boston Medical Center (safety net hospital), Geisinger Health System (rural Pennsylvania), and the University of Alabama (academic center in the southeastern stroke belt). ICD-9 codes for ischemic stroke (433–434, 436) and intracranial hemorrhage (430–432) identified 1812 stroke cases with an associated code for AF (427.31) from 2006 to 2010. Cases were vetted through chart review with final adjudication by a stroke neurologist. Review considered 94.2% of ICD-9 identified stroke cases valid with decreased accuracy for concurrent AF diagnosis (82.28%) and stroke attributable to AF (72.8%). Among events with “without infarction” modifiers, 7.2% were valid strokes. ICD-9 stroke code accuracy did not differ by stroke type or site. Stroke code 434 displayed higher accuracy than 433 (94.4% versus 85.2%; P P Conclusions— Using ICD-9 stroke and AF codes to identify patients with stroke plus AF resulted in inaccuracies. Given the expanded financial and policy implications of patient-oriented research, conclusions derived solely from administrative data without validation of outcome events should be interpreted with caution.

[Figure][1] An opinion paper endorsed by the ACC Interventional Council and Board of Governors addressed the issue of public reporting of percutaneous coronary intervention outcomes in this issue of JACC: Cardiovascular Interventions [(1)][2]. This topic has for some years been discussed at

Evaluate whether mortality after discharge is elevated in geriatric fracture patients whose lower extremity weight-bearing is restricted.Retrospective cohort study SETTING: Urban Level 1 trauma center PATIENTS/PARTICIPANTS: 1746 patients65 years of age INTERVENTION: Post-operative lower extremity weight-bearing status MAIN OUTCOME MEASURE: Mortality, as determined by the Social Security Death Index RESULTS: Univariate analysis demonstrated that patients who were weight-bearing as tolerated on bilateral lower extremities (BLE) had significantly higher 5-year mortality compared to patients with restricted weight-bearing on one lower extremity and restricted weight-bearing on BLE (30%, 21% and 22% respectively, p 0.001). Cox regression analysis controlling for variables including age, Charlson Comorbidity Index, Injury Severity Scale, combined UE/LE injury, injury mechanism (high vs low), sex, BMI and GCS demonstrated that, in comparison to patients who were weight bearing as tolerated on BLE, restricted weight-bearing on one lower extremity had a hazard ratio (HR) of 0.97 (95% confidence interval 0.78 to 1.20, p = 0.76) and restricted weight-bearing in BLE had a HR of 0.91 (95% confidence interval 0.60 to 1.36, p = 0.73).In geriatric patients, prescribed weight-bearing status did not have a statistically significant association with mortality after discharge, when controlling for age, sex, body mass index, medical comorbidities, Injury Severity Scale (ISS), mechanism of injury, nonoperative treatment and admission GCS. This remained true in when the analysis was restricted to operative injuries only.

The purpose of this study is to revisit cases rated as "inappropriate" in the 2012 appropriate use criteria (AUC) using the 2017 AUC.AUC for coronary revascularization in patients with stable ischemic heart disease (SIHD) were released in January 2017. Earlier 2012 AUC identified a relatively high percentage of New York State patients for whom percutaneous coronary intervention (PCI) was rated as "inappropriate" versus optimal medical therapy alone.New York State's PCI registry was used to rate inappropriateness of patients undergoing PCI in 2014 using the 2012 and 2017 AUC, and to examine patient characteristics for patients rated differently.A total of 911 of 9,261 (9.8%) patients who underwent PCI in New York State in 2014 with SIHD without prior coronary artery bypass grafting were rated as "inappropriate" using the 2012 AUC, but only 171 (1.8%) patients were rated as "rarely appropriate" ("inappropriate" in 2012 AUC terminology) using the 2017 AUC. A total of 26% of all 8,407 patients undergoing PCI in New York State with 1- to 2-vessel SIHD were without high-risk findings on noninvasive testing and were either asymptomatic or without antianginal therapy. No current or past randomized controlled trials have focused on these patients.The percentage of 2014 New York State PCI patients with SIHD who are rated "rarely appropriate" has decreased substantially using 2017 AUC in comparison with the older 2012 AUC. However, for many low-risk patients undergoing the procedure, the relative benefits of optimal medical therapy with and without PCI are unknown. Randomized controlled trials are needed to study these groups.

Background The American Heart Association Mission: Lifeline STEMI ( ST ‐segment–elevation myocardial infarction) Systems Accelerator program, conducted in 16 regions across the United States to improve key care processes, resulted in more patients being treated within national guideline goals (time from first medical contact to device: Methods and Results In total, 23 809 patients (29.3% female, 82.3% white, and 10.7% black) presented with acute STEMI between July 2012 and March 2014. Change in the proportion of patients treated within guideline goals was compared between sex and race subgroups for patients presenting directly to hospitals capable of performing percutaneous coronary intervention (n=18 267) and patients requiring transfer (n=5542). The intervention was associated with an increase in the proportion of men treated within guideline goals that presented directly (58.7–62.1%, P =0.01) or were transferred (43.3–50.7%, P P =0.02) or were transferred (43.9–48.8%, P Conclusion The STEMI Systems Accelerator project was associated with an increase in the proportion of patients meeting guideline reperfusion targets for male and white patients but not for female or black patients. Efforts to organize systems of STEMI care should implement additional processes targeting barriers to timely reperfusion among female and black patients.

Background The Centers for Medicare and Medicaid Services (CMS) model for publicly reporting national 30-day-risk-adjusted mortality rates for patients admitted with heart failure fails to include clinical variables known to impact total mortality or take into consideration the culture of end-of-life care. We sought to determine if those variables were related to the 30-day mortality of heart failure patients at Geisinger Medical Center. Methods Electronic records were searched for patients with a diagnosis of heart failure who died from any cause during hospitalization or within 30 days of admission. Results There were 646 heart-failure-related admissions among 530 patients (1.2 admissions/patient). Sixty-seven of the 530 (13%) patients died: 35 (52%) died during their hospitalization and 32 (48%) died after discharge but within 30 days of admission; of these, 27 (40%) had been transferred in for higher-acuity care. Fifty-one (76%) died from heart failure, and 16 (24%) from other causes. Fifty-five (82%) patients were classified as American Heart Association Stage D, 58 (87%) as New York Heart Association Class IV, and 30 (45%) had right-ventricular systolic dysfunction. None of the 32 patients who died after discharge met recommendations for beta-blockers. Criteria for prescribing angiotensin-converting enzyme inhibitors, angiotensin receptor blockers, and mineralocorticoid receptor blockers were not met by 33 of the 34 patients (97%) with heart failure with reduced ejection fraction not on one of those drugs. Fifty-seven patients (85%) had a do-not-resuscitate (DNR) status. Conclusion A majority of heart failure-related mortality was among patients who opted for a DNR status with end-stage heart failure, limiting the appropriateness of administering evidence-based therapies. No care gaps were identified that contributed to mortality at our institution. The CMS 30-day model fails to take important variables into consideration.

Erlotinib is metabolized by cytochrome p450 (CYP) 3A and CYP1A. This study assessed CYP3A4 (midazolam) and CYP1A2 (caffeine) phenotyping in plasma and dried blood spots (DBS) for predicting the pharmacokinetics and toxicity of erlotinib in 36 patients with advanced NSCLC. On day 1, erlotinib 150 mg OD was initiated, and the two oral probe drugs midazolam (2 mg) and caffeine (100 mg) were added on day 1. Plasma and DBS were collected for erlotinib, OSI-420 and probe drugs for up to 6 hr on day 1 and 2-weekly up to week 10. Probe drugs, erlotinib and OSI-420 were analysed using LC-MS-MS, and PK data were processed using population modelling. A high correlation was found between plasma and DBS concentrations for erlotinib (R2 = 0.960, p

Introduction: Patient understanding of available therapies for atrial fibrillation (AF) is foundational to shared medical decision making and long term medication adherence. Yet, there is a paucity of data regarding the extent to which patients newly diagnosed with AF in routine community practice understand their options. Hypotheses: 1) Understanding of warfarin, novel oral anticoagulants (NOAC), rhythm control therapy, cardioversion and radio frequency ablation changes little from baseline to 6 months and 2) treatment rates at 6 months are associated with patient understanding of therapies at baseline. Methods: We analyzed survey data from SATELLITE, a substudy of new-onset AF patients enrolled at 56 US sites participating in the ORBIT-AF registry. Patients were surveyed at the baseline and 6 month follow up clinic visit using Likert scales. Agreement between time points was assessed with the McNemar test, and the relationship between understanding and treatment was assessed only for the subset not on treatment at baseline. Results: Of 1000 patients enrolled in SATELLITE, 506 had 6-month survey data (data collection is continuing). Among these, the median age was 69.0 years (IQR 63.0 - 76.0) and 93.7% (474 of 506) were white. There was evidence of improvement in the self-reported understanding of warfarin and NOACs from baseline to 6 months, but not for rhythm control, ablation or cardioversion. The proportion reporting high understanding improved significantly for warfarin (p Conclusions: Patients with new-onset AF had improved self-reported understanding of some treatment options over the first 6-months from diagnosis; however, factors other than patient understanding may influence AF treatments received at 6 months. Patient understanding of AF treatments remains suboptimal at 6 months, and our results suggest a need for ongoing patient education.

Background— The Mission: Lifeline STEMI Systems Accelerator program, implemented in 16 US metropolitan regions, resulted in more patients receiving timely reperfusion. We assessed whether implementing key care processes was associated with system performance improvement. Methods and Results— Hospitals (n=167 with 23 498 ST-segment–elevation myocardial infarction patients) were surveyed before (March 2012) and after (July 2014) program intervention. Data were merged with patient-level clinical data over the same period. For reperfusion, hospitals were grouped by whether a specific process of care was implemented, preexisting, or never implemented. Uptake of 4 key care processes increased after intervention: prehospital catheterization laboratory activation (62%–91%; P P P =0.002) and transfers (56%–79%; P =0.001). There were significant differences in median first medical contact-to-device times among groups implementing prehospital activation (88 minutes implementers versus 89 minutes preexisting versus 98 minutes nonimplementers; P P P P Conclusions— The Accelerator program increased uptake of key care processes, which were associated with improved system performance. These findings support efforts to implement regional ST-segment–elevation myocardial infarction networks focused on prehospital catheterization laboratory activation, single call transfer protocols, and emergency department bypass.

Background: Few recent studies have compared the outcomes of coronary artery bypass graft (CABG) surgery with percutaneous coronary interventions (PCIs) in patients with isolated (single ve...

ObjectivesThe aim of this study was to assess the influence of pro-inflammatory interleukin (IL)-1 genotype status on the risk for coronary artery disease (CAD), defined as >50% diameter stenosis, and cardiovascular events mediated by oxidized phospholipids (OxPLs) and lipoprotein (Lp) (a).BackgroundOxPLs are pro-inflammatory, circulate on Lp(a), and mediate CAD. Genetic variations in the IL-1 region are associated with increased inflammatory mediators.MethodsIL-1 genotypes, OxPL on apolipoprotein B-100 (OxPL/apoB), and Lp(a) levels were measured in 499 patients undergoing coronary angiography. The composite genotype termed IL-1(+) was defined by 3 single-nucleotide polymorphisms in the IL-1 gene cluster associated with higher levels of pro-inflammatory cytokines. All other IL-1 genotypes were termed IL-1(−).ResultsAmong IL-1(+) patients, the highest quartile of OxPL/apoB was significantly associated with a higher risk for CAD compared with the lowest quartile (odds ratio [OR]: 2.84; p = 0.001). This effect was accentuated in patients age ≤60 years (OR: 7.03; p < 0.001). In IL-1(−) patients, OxPL/apoB levels showed no association with CAD. The interaction was significant for OxPL/apoB (OR: 1.99; p = 0.004) and Lp(a) (OR: 1.96; p < 0.001) in the IL-1(+) group versus the IL-1(−) group in patients age ≤60 years but not in those age >60 years. In IL-1(+) patients age ≤60 years, after adjustment for established risk factors, high-sensitivity C-reactive protein, and Lp(a), OxPL/apoB remained an independent predictor of CAD. IL-1(+) patients above the median OxPL/apoB presented to the cardiac catheterization laboratory a mean of 3.9 years earlier (p = 0.002) and had worse 4-year event-free survival (death, myocardial infarction, stroke, and need for revascularization) compared with other groups (p = 0.006).ConclusionsOur study suggests that IL-1 genotype status can stratify population risk for CAD and cardiovascular events mediated by OxPL. These data suggest a clinically relevant biological link between pro-inflammatory IL-1 genotype, oxidation of phospholipids, Lp(a), and genetic predisposition to CAD and cardiovascular events.

ObjectivesThis study sought to determine the utilization and outcomes for radial access for percutaneous coronary intervention (PCI) for ST-segment elevation acute myocardial infarction (STEMI) in common practice.BackgroundRadial access for PCI has been studied considerably, but mostly in clinical trials.MethodsAll patients undergoing PCI for STEMI in 2009 to 2010 in New York were studied to determine the frequency and the patient-level predictors of radial access. Differences in in-hospital/30-day mortality between radial and femoral access were also studied.ResultsRadial access increased from 4.9% in the first quarter of 2009 to 11.9% in the last quarter of 2010. Significant independent predictors were higher body surface area, non-Hispanic ethnicity, Caucasian race, stable hemodynamic state, ejection fraction

Background— A simple risk score to predict long-term mortality after percutaneous coronary intervention (PCI) using preprocedural risk factors is currently not available. In this study, we created one by simplifying the results of a Cox proportional hazards model. Methods and Results— A total of 11 897 patients who underwent PCI from October through December 2003 in New York State were randomly divided into derivation and validation samples. Patients’ vital statuses were tracked using the National Death Index through the end of 2008. A Cox proportional hazards model was fit to predict death after PCI using the derivation sample, and a simplified risk score was created. The Cox model identified 12 separate risk factors for mortality including older age, extreme body mass indexes, multivessel disease, a lower ejection fraction, unstable hemodynamic state or shock, several comorbidities (cerebrovascular disease, peripheral vascular disease, congestive heart failure, chronic obstructive pulmonary disease, diabetes mellitus, and renal failure), and a history of coronary artery bypass graft surgery. The C statistics of this model when applied to the validation sample were 0.787, 0.785, and 0.773 for risks of death within 1, 3, and 5 years after PCI, respectively. In addition, the point-based risk score demonstrated good agreement between patients’ observed and predicted risks of death. Conclusions— A simple risk score created from a more complicated Cox proportional hazards model can be used to accurately predict a patient’s risk of long-term mortality after PCI.

Frailty is a common reason that patients with atrial fibrillation (AF) are not treated with an oral anticoagulant (OAC) for stroke prevention. Included patients from the Premier Health Database were age ≥ 40 years, admitted January 2011 to June 2015 with a primary or secondary AF diagnosis

Renal function has been associated with outcomes of patients anticoagulated for atrial fibrillation (AF). We hypothesize that oral anticoagulant (OAC) prescribing patterns and clinical outcomes change based on chronic kidney disease (CKD) status. Included patients from the Premier Health Database

Introduction In ISAR-REACT-4 (abciximab and heparin vs. bivalirudin for non-ST-elevation myocardial infarction [NSTEMI]), bivalirudin reduced the risk of bleeding after percutaneous coronary intervention (PCI) compared with unfractionated heparin plus abciximab (UFH + abciximab). Vascular closure devices (VCDs) may also prevent bleeding complications, and thus attenuate the benefit of bivalirudin. This analysis examined whether there exists an interaction on bleeding between VCDs and bivalirudin versus UFH + abciximab after PCI. Methods Patients with NSTEMI were randomly assigned to either receive UFH + abciximab or bivalirudin for PCI. The use of a VCD after femoral access was left to the operator's discretion. The effect of randomized treatment in patients who received a VCD was compared to that in patients with manual compression of the femoral access site. The primary end-point of this analysis was the 30-day incidence of ISAR-REACT-4 major bleeding. Results A total of 1,711 patients were enrolled in this analysis. Among the 365 (21.3%) patients receiving a VCD, 188 (51.5%) were treated with UFH + abciximab and 177 (48.5%) with bivalirudin. ISAR- REACT-4 major bleeding was higher with UFH + abciximab than with bivalirudin, independent of whether a VCD was used (4.8% vs. 2.3% with VCD and 4.6% vs. 2.7% without VCD, Pint = 0.76). There were also no interactions between randomized treatment and VCDs with respect to any of the ischemic end-points or net clinical outcome (Pint > 0.56). Conclusions In patients undergoing PCI for NSTEMI, the reduction of major bleeding by bivalirudin compared with UFH + abciximab was not affected whether a VCD was used.

AIMS Thirty-day results of the double-blind, randomised Intracoronary Stenting and Antithrombotic Regimen -Rapid Early Action for Coronary Treatment (ISAR-REACT) 4 trial showed no difference in ischaemic complications and a reduction in bleeding by bivalirudin versus abciximab and heparin in 1,721 patients with non-ST-segment elevation myocardial infarction (NSTEMI) undergoing percutaneous coronary intervention (PCI). A longer follow-up may be required to assess the whole potential benefit of a periprocedural antithrombotic therapy. METHODS AND RESULTS The primary outcome for this analysis was the composite of death, myocardial infarction or target vessel revascularisation one year after randomisation. Secondary outcome was the composite of death or myocardial infarction. At one year, the primary outcome occurred in 21.3% of patients assigned to abciximab and heparin versus 21.5% assigned to bivalirudin (hazard ratio [HR] 0.99; 95% confidence interval [CI]: 0.80-1.21; p=0.94). The combined incidence of death or myocardial infarction was 15.7% in the abciximab and heparin group versus 16.0% in the bivalirudin group (HR 0.99; 95% CI: 0.78-1.26; p=0.94). The mortality rates were 4.0% and 4.7%, respectively (HR 0.85; 95% CI: 0.54-1.34; p=0.48). At one year, no significant differences in the primary outcome were observed with abciximab and heparin versus bivalirudin in any of the subgroups analysed. CONCLUSIONS In patients with NSTEMI undergoing PCI, abciximab with heparin and bivalirudin provide comparable outcomes at one year, although bivalirudin reduced the rate of bleeding at 30 days. CLINICAL TRIAL REGISTRATION INFORMATION URL www.clinicaltrials.gov; Unique identifier NCT00373451.