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Objectives: The aim of this study was to explore whether the use of bleeding avoidance strategies (BAS) explains variability in hospital-level bleeding following percutaneous coronary intervention., Background: Prior studies have reported that bleeding rates following percutaneous coronary intervention vary markedly among hospitals, but the extent to which use of BAS explains this variation is unknown., Methods: Using the American College of Cardiology National Cardiovascular Data Registry's CathPCI Registry, estimated hospital-level bleeding rates from 2,459,686 procedures at 1,358 sites were determined. A series of models were fit to estimate random-effect variance, adjusting for patient risk (using the validated CathPCI bleeding risk model, C statistic = 0.77) and various combinations of BAS (transradial access, bivalirudin, vascular closure device use). The rate of any BAS use was also estimated for each hospital, and the association between percentage BAS use and predicted bleeding rates was determined., Results: In total, 125,361 bleeding events (5.1%) were observed; patients experiencing bleeding events had lower rates of radial access (5.0% vs. 11.2%; p < 0.001), bivalirudin therapy (43.8% vs. 59.4%), and vascular closure device use (32.9% vs. 42.4%, p < 0.001) than those without bleeding. There was significant variation in bleeding rates across hospitals (median 5.0%; interquartile range [IQR]: 2.7% to 6.6%), which persisted after incorporating patient-level risk (median 5.1%; IQR: 4.0% to 4.4%). Patient factors accounted for 20% of the overall hospital-level variation, and radial access plus bivalirudin use accounted for an additional 7.8% of the overall hospital-level variation. The median hospital rate of any BAS use was 86.6% (IQR: 72.5% to 94.1%). A significant decrease in observed hospital-level bleeding was seen in hospitals above the median in BAS use (adjusted odds ratio: 0.90; 95% confidence interval: 0.88 to 0.93)., Conclusions: A modest proportion of the variation in hospitals' rates of bleeding following percutaneous coronary intervention is attributable to differential use of BAS. Further analyses are required to determine the remaining approximately 70% causes of variation in percutaneous coronary intervention bleeding seen among hospitals., (Copyright © 2016 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Background: Post-percutaneous coronary intervention (PCI) bleeding complications are an important quality metric. We sought to characterize site-level variation in post-PCI bleeding and explore the influence of patient and procedural factors on hospital bleeding performance., Methods and Results: Hospital-level bleeding performance was compared pre- and postadjustment using the newly revised CathPCI Registry(®) bleeding risk model (c-index, 0.77) among 1292 National Cardiovascular Data Registry(®) hospitals performing >50 PCIs from 7/2009 to 9/2012 (n=1,984,998 procedures). Using random effects models, outlier sites were identified based on 95% confidence intervals around the hospital's random intercept. Bleeding 72 hours post-PCI was defined as: arterial access site, retroperitoneal, gastrointestinal, or genitourinary bleeding; intracranial hemorrhage; cardiac tamponade; nonbypass surgery-related blood transfusion with preprocedure hemoglobin ≥ 8 g/dL; or absolute decrease in hemoglobin value ≥ 3 g/dL with preprocedure hemoglobin ≤ 16 g/dL. Overall, the median unadjusted post-PCI bleeding rate was 5.2% and varied among hospitals from 2.6% to 10.4% (5th, 95th percentiles). Center-level bleeding variation persisted after case-mix adjustment (2.8%-9.5%; 5th, 95th percentiles). Although hospitals' observed and risk-adjusted bleeding ranks were correlated (Spearman ρ: 0.88), individual rankings shifted after risk-adjustment (median Δ rank order: ± 91.5; interquartile range: 37.0, 185.5). Outlier classification changed postadjustment for 29.3%, 16.1%, and 26.5% of low-, non-, and high-outlier sites, respectively. Hospital use of bleeding avoidance strategies (bivalirudin, radial access, or vascular closure device) was associated with risk-adjusted bleeding rates., Conclusions: Despite adjustment for patient case-mix, there is wide variation in rates of hospital PCI-related bleeding in the United States. Opportunities may exist for best performers to share practices with other sites., (© 2014 American Heart Association, Inc.)

Objectives: This study sought to develop a model that predicts bleeding complications using an expanded bleeding definition among patients undergoing percutaneous coronary intervention (PCI) in contemporary clinical practice., Background: New knowledge about the importance of periprocedural bleeding combined with techniques to mitigate its occurrence and the inclusion of new data in the updated CathPCI Registry data collection forms encouraged us to develop a new bleeding definition and risk model to improve the monitoring and safety of PCI., Methods: Detailed clinical data from 1,043,759 PCI procedures at 1,142 centers from February 2008 through April 2011 participating in the CathPCI Registry were used to identify factors associated with major bleeding complications occurring within 72 h post-PCI. Risk models (full and simplified risk scores) were developed in 80% of the cohort and validated in the remaining 20%. Model discrimination and calibration were assessed in the overall population and among the following pre-specified patient subgroups: females, those older than 70 years of age, those with diabetes mellitus, those with ST-segment elevation myocardial infarction, and those who did not undergo in-hospital coronary artery bypass grafting., Results: Using the updated definition, the rate of bleeding was 5.8%. The full model included 31 variables, and the risk score had 10. The full model had similar discriminatory value across pre-specified subgroups and was well calibrated across the PCI risk spectrum., Conclusions: The updated bleeding definition identifies important post-PCI bleeding events. Risk models that use this expanded definition provide accurate estimates of post-PCI bleeding risk, thereby better informing clinical decision making and facilitating risk-adjusted provider feedback to support quality improvement., (Copyright © 2013 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Objectives This study sought to compare in-hospital mortality and bleeding complications for procedures performed by sleep-deprived versus non–sleep-deprived operators. Background To optimize the safety of percutaneous coronary intervention (PCI), it is essential to determine whether physicians performing emergent, middle-of-the-night procedures, and who may be sleep-deprived as a consequence, have equally safe outcomes when performing cases the following day. Methods We used CathPCI registry data to compare in-hospital mortality and bleeding complications for procedures performed by sleep-deprived versus non–sleep-deprived operators using logistic regression with generalized estimating equations to account for within-operator clustering. Outcomes were risk-adjusted using previously validated models for in-hospital mortality and bleeding. Our cohort included 1,509,096 daytime PCI procedures performed by 5,014 operators between 7 am and midnight from July 1, 2009, through June 30, 2012. Operators were assumed to be acutely sleep-deprived if they began a middle-of-the-night PCI between midnight and 6:59 am and performed a next-day PCI between 7 am and midnight, and chronically sleep deprived if they had performed multiple middle-of-the-night PCI procedures during the previous 7 days. Results Only 2.4% of all daytime PCI procedures were performed by operators who had performed at least 1 middle-of-the-night PCI procedure earlier that day. In adjusted analyses, when comparing procedures performed by acutely sleep-deprived with non–sleep-deprived operators, there were no significant differences in mortality (odds ratio [OR]: 1.02, 95% confidence interval [CI]: 0.94 to 1.12; p = 0.61) or bleeding (OR: 1.03, 95% CI: 0.98 to 1.08; p = 0.19). However, a greater degree of chronic sleep deprivation was associated with a higher adjusted risk of bleeding (OR: 1.19, 95% CI: 1.05 to 1.34; p = 0.007). Conclusions Daytime PCI procedures are uncommonly performed by sleep-deprived operators. We found no signal of increased complications when acutely sleep-deprived operators performed PCI but an increased risk of bleeding associated with procedures performed by operators with greater degrees of chronic sleep deprivation. [ABSTRACT FROM AUTHOR]

Background: Prolonged dual antiplatelet therapy (DAPT) is recommended after an acute myocardial infarction (AMI) to reduce ischemic events but is associated with increased rates of major and minor bleeding.Objectives: This study sought to determine the incidence of post-percutaneous coronary intervention (PCI) bleeding that occurs on contemporary DAPT and its impact on quality of life (QOL).Methods: We studied 9,290 AMI patients treated with PCI and discharged alive between April 2010 and September 2012. Post-discharge bleeding was categorized according to the Bleeding Academic Research Consortium (BARC) definition. The primary outcome was the 6-month Euro QOL-5 Dimension (EQ-5D) index score (a measure of health utility); a secondary outcome was the EQ-5D visual analog scale (VAS) at 6 months.Results: Of the 9,290 patients with AMI, bleeding events occurred as follows: any BARC bleeding: 24.2%; BARC 1: 9.1%; BARC 2: 13.8%; BARC 3: 1.1%; BARC 4: 0.03%; and BARC 5: 0%. Those who experienced any BARC bleeding had lower scores across all 5 EQ-5D domains (mobility, self-care, usual activities, pain, and anxiety), as well as lower EQ-5D VAS and EQ-5D index scores. After clinical risk adjustment, any BARC bleeding was independently associated with 6-month EQ-5D index score (p < 0.0001) and lower QOL (p < 0.001). Both the EQ-5D index and the VAS score declined in a stepwise fashion with increasing BARC severity.Conclusions: Among patients undergoing PCI for AMI, bleeding during follow-up was associated with worse 6-month utility and QOL. Although even minor bleeding was associated with impaired health status and QOL, the degree of impairment increased in a stepwise fashion with bleeding severity. [ABSTRACT FROM AUTHOR]

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