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Seifu M Abera,1,2 Colin O’Donnell,3 Taufiq Salahuddin,1,2 Krishna Prabhu,4 Carol E Simons,1 P Michael Ho,5,6 Stephen W Waldo,3,5,6 Jacob A Doll1– 3 1Section of Cardiology, VA Puget Sound Health Care System, Seattle, WA, USA; 2Department of Medicine, University of Washington, Seattle, WA, USA; 3Department of Veterans Affairs Clinical Assessment, Reporting, and Tracking Program, VHA Office of Quality and Patient Safety, Washington, DC, USA; 4Hennepin County Medical Center, Minneapolis, MN, USA; 5Rocky Mountain Regional VA Medical Center, Aurora, CO, USA; 6Department of Medicine, University of Colorado School of Medicine, Aurora, CO, USACorrespondence: Jacob A Doll, VA Puget Sound Health Care System, 1660 S. Columbian Way, S111-CARDIO, Seattle, WA, 98108, USA, Tel +1 206-277-6199, Fax +1 206-764-2257, Email jdoll@uw.eduObjective: Adherence to anti-platelet medications is critical following coronary stenting, but prior studies indicate that clinician assessment and patient self-assessment of adherence are poorly correlated with future medication-taking behavior. We therefore sought to determine if integrated pharmacy data can be used to identify patients at high risk of non-adherence after percutaneous coronary interventions (PCI).Methods: Using Veteran Affairs (VA) Clinical Assessment, Reporting, and Tracking (CART) data linked with pharmacy records, we assessed adherence to cardiovascular medications from 2012 to 2018. Adherence was defined as the proportion of days covered (PDC) ≥ 0.80. We assessed the association of pre-PCI adherence with post-PCI adherence to P2Y12 inhibitors and clinical outcomes using logistic regression and Cox proportional hazard models, respectively.Results: Among 56,357 patients, 66.0% filled at least 1 cardiovascular medication within VA for the year prior to PCI and were evaluable for adherence. Pre-PCI non-adherence was 20.7%, and non-adherent patients were more likely to be younger and present non-electively. Non-adherent patients were less likely to adhere to P2Y12 inhibitor therapy after PCI (Adjusted OR 0.45 C.I. 0.41– 0.46), compared with adherent patients, and had a higher adjusted risk of mortality (HR 1.17 C.I. 1.03– 1.33).Conclusion: Adherence to cardiovascular medications prior to PCI can be assessed for most patients using pharmacy data, and past adherence is associated with future adherence and mortality after PCI. Use of integrated pharmacy data to identify high-risk patients could improve outcomes and cost-effectiveness of adherence interventions.Plain Language Summary: Why was the study done?: Non-adherence to anti-platelet medications is common following coronary stenting procedures and is associated with worse outcomes, but predicting non-adherence is challenging.What did the researchers do and find?: The researchers examined pharmacy fill-based adherence assessments before and after stenting procedures. Pharmacy data can provide adherence estimates for most patients receiving percutaneous coronary intervention, and these estimates are associated with downstream medication-taking behavior and clinical outcomes.What do the results mean?: Health systems should seek to integrate pharmacy-based adherence estimates into routine care for patients with cardiovascular disease. Identification and targeting of patients at high-risk for non-adherence may improve the impact and cost-effectiveness of future research and health policy interventions aimed at improving adherence.Keywords: percutaneous coronary intervention, medication adherence

Objectives: To elucidate the mechanism of transforming growth factor (TGF)-β1 overexpression in prostate cancer cells.Methods: Malignant (PC3, DU145) and benign (RWPE1, BPH1) prostate epithelial cells were used. Phosphatase activity was measured using a commercial kit. Recruitment of the regulatory subunit, Bα, of protein phosphatase 2A (PP2A-Bα) by TGF-β type I receptor (TβRI) was monitored by coimmunoprecipitation. Blockade of TGF-β1 signaling in cells was accomplished either by using TGF-β-neutralizing monoclonal antibody or by transduction of a dominant negative TGF-β type II receptor retroviral vector.Results: Basal levels of TGF-β1 in malignant cells were significantly higher than those in benign cells. Blockade of TGF-β signaling resulted in a significant decrease in TGF-β1 expression in malignant cells, but not in benign cells. Upon TGF-β1 treatment (10 ng/mL), TGF-β1 expression was increased in malignant cells, but not in benign cells. This differential TGF-β1 auto-induction between benign and malignant cells correlated with differential activation of extracellular signal-regulated kinase (ERK). Following TGF-β1 treatment, the activity of serine/threonine phosphatase and recruitment of PP2A-Bα by TβRI increased in benign cells, but not in malignant cells. Inhibition of PP2A in benign cells resulted in an increase in ERK activation and in TGF-β1 auto-induction after TGF-β1 (10 ng/mL) treatment.Conclusions: These results suggest that TGF-β1 overexpression in malignant cells is caused, at least in part, by a runaway of TGF-β1 auto-induction through ERK activation because of a defective recruitment of PP2A-Bα by TβRI. [ABSTRACT FROM AUTHOR]

Background: Case-based peer review of percutaneous coronary intervention (PCI) is used by many hospitals for quality improvement and to make decisions regarding physician competency. However, there are no studies testing the reliability or validity of peer review for PCI performance evaluation., Methods: We recruited interventional cardiologists from 12 Veterans Affairs Health System facilities throughout the United States to provide PCI cases for review. Ten reviewers performed blinded reviews such that each case was reviewed twice. Cases were rated on a scale of 1 to 5 (with 5 being the best) for 6 care domains (Appropriateness, Lesion Suitability, Strategy, Technical Performance, Outcome, and Documentation) with a summary performance score calculated as the average of all domains. Separately, reviewers determined whether the standard of care was met. Interobserver reliability of the summary performance score was calculated using interclass correlation coefficient. We examined procedural complications and 30-day mortality and major adverse cardiac events for all PCIs performed by these operators from 2019 to 2022 when stratified in tertiles by summary performance score., Results: Of the 65 cases provided by 13 operators, the mean summary performance score was 3.90 (SD=0.78) out of 5. The interclass correlation coefficient was 0.53, indicating moderate interobserver reliability. For 19 cases (29.2%), 1 reviewer indicated that the performance did not meet the standard of care; however, the second reviewer disagreed in all these cases. Average performance scores ranged from 3.35 to 4.38. Among the 3390 PCIs performed by reviewed cardiologists from 2019 to 2022, the lowest-rated tertile had higher rates of complications (2.9% versus 1.8%, P <0.01) and major adverse cardiac events (10.6% versus 8.0%, P <0.01) compared with the highest-rated tertile., Conclusions: Case-based peer review identifies variation in physician performance that is correlated with PCI outcomes. However, reviewer disagreements about the standard of care raise concerns about the use of peer review for high-stakes assessments of physician competency.

Background: Failure to rescue (FTR) describes in-hospital mortality following a procedural complication and has been adopted as a quality metric in multiple specialties. However, FTR has not been studied for percutaneous coronary intervention (PCI) complications., Methods: This is a retrospective study of patients undergoing PCI from the American College of Cardiology National Cardiovascular Data Registry's CathPCI Registry between April 1, 2018, and June 30, 2021. PCI complications evaluated were significant coronary dissection, coronary artery perforation, vascular complication, significant bleeding within 48 hours, new cardiogenic shock, and tamponade. Secular trends for FTR were evaluated with descriptive analysis, and hospital-level variation and clinical predictors were analyzed with logistic regression., Results: Among 2 196 661 patients undergoing PCI at 1483 hospitals, 3.5% had at least 1 PCI complication. In-hospital mortality occurred more frequently following a complication compared with cases without a complication (19.7% versus 1.3%). FTR increased during the study period from 17.1% to 20.1% ( P <0.001). The median odds ratio for FTR was 1.48 (95% CI, 1.44-1.53) indicating significant hospital-level variation. Spearman rank correlation demonstrated the modest correlation between FTR and in-hospital mortality, 0.525 ( P <0.001)., Conclusions: Major procedural complications during PCI are infrequent, but FTR occurs in roughly 1 in 5 patients following a PCI procedural complication with significant hospital-level variation. Improved understanding of practices associated with low FTR could meaningfully improve patient outcomes following a PCI complication., Competing Interests: Dr Wang received research grants to Duke University from AstraZeneca, Bristol Myers Squibb, Boston Scientific, Chiesi, Artivion (formerly Cryolife) and consulting honoraria from AstraZeneca, Bristol Myers Squibb, Artivion, Novartis, and CSL Behring. Dr Hira received consulting for Abbott Vascular Inc.

Background: Little is known about the procedural characteristics, case volumes, and mortality rates for early- vs non-early-career interventional cardiologists in the United States., Objectives: This study examined operator-level data for patients who underwent percutaneous coronary intervention (PCI) between April 2018 and June 2022., Methods: Data were collected from the National Cardiovascular Data Registry CathPCI Registry, American Board of Internal Medicine certification database, and National Plan and Provider Enumeration System database. Early-career operators were within 5 years of the end of training. Annual case volume, expected mortality and bleeding risk, and observed/predicted mortality and bleeding outcomes were evaluated., Results: A total of 1,451 operators were early career; 1,011 changed their career status during the study; and 6,251 were non-early career. Overall, 514,540 patients were treated by early-career and 2,296,576 patients by non-early-career operators. The median annual case volume per operator was 59 (Q1-Q3: 31-97) for early-career and 57 (Q1-Q3: 28-100) for non-early-career operators. Early-career operators were more likely to treat patients presenting with ST-segment elevation myocardial infarction and urgent indications for PCI (both P < 0.001). The median predicted mortality risk was 2.0% (Q1-Q3: 1.5%-2.7%) for early-career and 1.8% (Q1-Q3: 1.2%-2.4%) for non-early-career operators. The median predicted bleeding risk was 4.9% (Q1-Q3: 4.2%-5.7%) for early-career and 4.4% (Q1-Q3: 3.7%-5.3%) for non-early-career operators. After adjustment, an increased risk of mortality (OR: 1.08; 95% CI: 1.05-1.17; P < 0.0001) and bleeding (OR: 1.08; 95% CI: 1.05-1.12; P < 0.0001) were associated with early-career status., Conclusions: Early-career operators are caring for patients with more acute presentations and higher predicted risk of mortality and bleeding compared with more experienced colleagues, with modestly worse outcomes. These data should inform institutional practices to support the development of early-career proceduralists., Competing Interests: Funding Support and Author Disclosures Funding was provided by the American College of Cardiology National Cardiovascular Data Registry. Dr Rymer has received research funding from the National Heart, Lung, and Blood Institute, Novo Nordisk, Chiesi, Abiomed, and Pfizer. Dr Damluji has received research funding from the Pepper Scholars Program of the Johns Hopkins University Claude D. Pepper Older Americans Independence Center funded by the National Institute on Aging P30-AG021334; and has received a mentored patient-oriented research career development award from the National Heart, Lung, and Blood Institute K23-HL153771-01. Dr Shah has received grant funding from the VA Office of Research and Development and National Institutes of Health/National Heart, Lung, and Blood Institute; and has served on the advisory board for Philips Volcano. Dr Nanna has received research support from the American College of Cardiology Foundation supported by the George F. and Ann Harris Bellows Foundation, the Patient-Centered Outcomes Research Institute (PCORI), the Yale Claude D. Pepper Older Americans Independence Center (P30AG021342), and the National Institute on Aging/National Institutes of Health from R03AG074067 (GEMSSTAR award); and has served as a consultant for Heartflow, Inc and Merck. Dr Kearney has performed consulting for and received honoraria from Abbott, Abiomed, Boston Scientific, Medtronic, Teleflex, and Philip. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose., (Copyright © 2024 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Competing Interests: Declaration of competing interest Dr. Doll is supported by a VA Career Development Award (1IK2HX002590). Dr. Waldo has received investigator-initiated research support to the Denver Research Institute from Abiomed, Cardiovascular Systems Incorporated, Janssen Pharmaceuticals, National Institutes of Health and VA Health Services Research and Development. Dr. Hira reports honoraria from Abbott Vascular, Boston Scientific, and Abiomed. All other authors have nothing to disclose.

Revascularization is an effective adjunct to medical therapy for some patients with chronic coronary disease. Despite numerous randomized trials, there remains significant uncertainty regarding if and how to revascularize many patients. Coronary artery bypass grafting is a class I indication for patients with significant left main stenosis or multivessel disease with ejection fraction ≤ 35%. For other patients, clinicians must carefully consider the potential benefits of symptom improvement and reduction of future myocardial infarction or CV death against the risk and cost of revascularization. Although guidelines provide a framework for these decisions, each individual patient will have distinct coronary anatomy, clinical factors, and preferences., Competing Interests: Disclosure Neither author reports any potential financial conflicts of interest., (Copyright © 2023 Elsevier Inc. All rights reserved.)

Background: We assessed trends in novel cardiovascular medication utilization in US Veterans Affairs (VA) for angiotensin receptor-neprilysin inhibitors (ARNI), sodium-glucose cotransporter-2 Inhibitors (SGLT2i), and glucagon-like peptide-1 receptor agonists (GLP-1 RA)., Methods: We retrospectively identified cohorts from 114 VA hospitals with admission for prevalent 1) systolic heart failure (HF, N = 82,375) or 2) coronary artery disease and diabetes (CAD+T2D, N = 74,209). Site-level data for prevalent filled prescriptions were assessed at hospital admission, discharge, or within 6 months of discharge. Variability among sites was estimated with median odds ratios (mOR), and within-site Pearson correlations of utilization of each medication class were calculated. Site- and patient-level characteristics were compared by high-, mixed-, and low-utilizing sites., Results: ARNI and SGTL2i use for HF increased from <5% to 20% and 21%, respectively, while SGTL2i or GLP-1 RA use for CAD+T2D increased from <5% to 30% from 2017 to 2021. Adjusted mOR and 95% confidence intervals for ARNI, SGTL2i for HF, and SGTL2i or GLP-1 RA for CAD+T2D were 1.73 (1.64-1.91), 1.72 (1.59-1.81), and 1.53 (1.45-1.62), respectively. Utilization of each medication class correlated poorly with use of other novel classes (Pearson <0.38 for all). Higher patient volume, number of beds, and hospital complexity correlated with high-utilizing sites., Conclusions: Utilization of novel medications has increased over time but remains suboptimal for US Veterans with HF and CAD+T2D, with substantial site-level heterogeneity despite a universal medication formulary and low out-of-pocket costs for patients. Future work should include further characterization of hospital- and clinician-level practice patterns to serve as targets to increase implementation., Competing Interests: Disclosures The views expressed in this article are those of the authors and do not necessarily reflect the position or policy of the Department of Veterans Affairs, the U.S. Government, or National Institutes of Health. TS receives support from NHLBI grant 5T32HL007828. HG is supported by Career Development Award Number 1IK2HX002587-01A1 from the United States Department of Veterans Affairs Health Services Research & Development Service of the VA Office of Research and Development. FR reports consulting fees from Novartis, Janssen, NovoNordisk, Amgen, and HealthPals outside the submitted work. SWW has received investigator-initiated research support to the Denver Research Institute from Abiomed, Cardiovascular Systems Incorporated, and Janssen Pharmaceuticals as well as grants from the National Institutes of Health and VA Health Services Research. The remaining authors report no relevant disclosures., (Copyright © 2023. Published by Elsevier Inc.)

Cardiac catheterization laboratory (CCL) morbidity and mortality conferences (MMCs) are a critical component of CCL quality improvement programs and are important for the education of cardiology trainees and the lifelong learning of CCL physicians and team members. Despite their fundamental role in the functioning of the CCL, no consensus exists on how CCL MMCs should identify and select cases for review, how they should be conducted, and how results should be used to improve CCL quality. In addition, medicolegal ramifications of CCL MMCs are not well understood. This document from the American College of Cardiology's Interventional Section attempts to clarify current issues and options in the conduct of CCL MMCs and to recommend best practices for their conduct., Competing Interests: Funding Support and Author Disclosures The authors have reported that they have no relationships relevant to the contents of this paper to disclose., (Copyright © 2023 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Background: Public reporting of percutaneous coronary intervention (PCI) outcomes has been associated with risk-averse attitudes, and pressure to avoid negative outcomes may hinder the care of high-risk patients referred for PCI in public reporting environments. It is unknown whether the occurrence of PCI-related major adverse events (MAEs) influences future case selection in nonpublic reporting environments. Here, we describe trends in PCI case selection among patients undergoing coronary angiography following MAEs in Veterans Affairs (VA) cardiac catheterization laboratories participating in a mandatory internal quality improvement program without public reporting of outcomes., Methods: Patients who underwent coronary angiography between October 1, 2010, and September 30, 2018, were identified and stratified by VA 30-day PCI mortality risk. The association between MAEs and changes in the proportion of patients proceeding from coronary angiography to PCI within 14 days was assessed., Results: A total of 251,526 patients and 913 MAEs were included in the analysis. For each prespecified time period of 1, 2, and 4 weeks following an MAE, there were no significant changes in the proportion of patients undergoing coronary angiography who proceeded to PCI within 14 days for the overall cohort and for each tercile of VA 30-day PCI mortality risk., Conclusions: There were no deviations from routine PCI referral practices following MAEs in this analysis of VA cardiac catheterization laboratories. Nonpublic reporting environments and quality improvement programs may be influential in mitigating PCI risk-aversion behaviors.

Background It is unclear how to geographically distribute percutaneous coronary intervention (PCI) programs to optimize patient outcomes. The Washington State Certificate of Need program seeks to balance hospital volume and patient access through regulation of elective PCI. Methods and Results We performed a retrospective cohort study of all non-Veterans Affairs hospitals with PCI programs in Washington State from 2009 to 2018. Hospitals were classified as having (1) full PCI services and surgical backup ( legacy hospitals, n=17); (2) full services without surgical backup ( new certificate of need [CON] hospitals, n=9); or (3) only nonelective PCI without surgical backup ( myocardial infarction [MI] access hospitals, n=9). Annual median hospital-level volumes were highest at legacy hospitals (605, interquartile range, 466-780), followed by new CON , (243, interquartile range, 146-287) and MI access , (61, interquartile range, 23-145). Compared with MI access hospitals, risk-adjusted mortality for nonelective patients was lower for legacy (odds ratio [OR], 0.59 [95% CI, 0.48-0.72]) and new-CON hospitals (OR, 0.55 [95% CI, 0.45-0.65]). Legacy hospitals provided access within 60 minutes for 90% of the population; addition of new CON and MI access hospitals resulted in only an additional 1.5% of the population having access within 60 minutes. Conclusions Many PCI programs in Washington State do not meet minimum volume standards despite regulation designed to consolidate elective PCI procedures. This CON strategy has resulted in a tiered system that includes low-volume centers treating high-risk patients with poor outcomes, without significant increase in geographic access. CON policies should re-evaluate the number and distribution of PCI programs.

Background: There is significant variability in the performance and outcomes of invasive medical procedures such as percutaneous coronary intervention, endoscopy, and bronchoscopy. Peer evaluation is a common mechanism for assessment of clinician performance and care quality, and may be ideally suited for the evaluation of medical procedures. We therefore sought to perform a systematic review to identify and characterize peer evaluation tools for practicing clinicians, assess evidence supporting the validity of peer evaluation, and describe best practices of peer evaluation programs across multiple invasive medical procedures., Methods: A systematic search of Medline and Embase (through September 7, 2021) was conducted to identify studies of peer evaluation and feedback relating to procedures in the field of internal medicine and related subspecialties. The methodological quality of the studies was assessed. Data were extracted on peer evaluation methods, feedback structures, and the validity and reproducibility of peer evaluations, including inter-observer agreement and associations with other quality measures when available., Results: Of 2,135 retrieved references, 32 studies met inclusion criteria. Of these, 21 were from the field of gastroenterology, 5 from cardiology, 3 from pulmonology, and 3 from interventional radiology. Overall, 22 studies described the development or testing of peer scoring systems and 18 reported inter-observer agreement, which was good or excellent in all but 2 studies. Only 4 studies, all from gastroenterology, tested the association of scoring systems with other quality measures, and no studies tested the impact of peer evaluation on patient outcomes. Best practices included standardized scoring systems, prospective criteria for case selection, and collaborative and non-judgmental review., Conclusions: Peer evaluation of invasive medical procedures is feasible and generally demonstrates good or excellent inter-observer agreement when performed with structured tools. Our review identifies common elements of successful interventions across specialties. However, there is limited evidence that peer-evaluated performance is linked to other quality measures or that feedback to clinicians improves patient care or outcomes. Additional research is needed to develop and test peer evaluation and feedback interventions., (© 2022. The Author(s).)

Background: Recent analyses of the volume-outcome relationship for percutaneous coronary intervention (PCI) have suggested a less robust association than previously reported. It is unknown if novel factors such as lifetime operator experience influence this relationship., Objectives: To assess the relationship between annual volumes and outcomes for PCI and determine whether lifetime operator experience modulates the association., Methods: Annual PCI volumes for facilities and operators within the Veterans Affairs Healthcare System and their relationship with 30-day mortality following PCI were described. The influence of operator lifetime experience on the volume-outcome relationship was assessed. Hierarchical logistic regression was used to adjust for patient and procedural factors., Results: 57,608 PCIs performed from 2013 to 2018 by 382 operators and 63 institutions were analyzed. Operator annualized PCI volume averaged 47.6 (standard deviation [SD] 49.1) and site annualized volume averaged 189.2 (SD 105.2). Median operator experience was 9.0 years (interquartile range [IQR] 4.0-15.0). There was no independent relationship between operator annual volume, institutional volume, or operator lifetime experience with 30-day mortality (p > 0.10). However, the interaction between operator volume and lifetime experience was associated with a marginal decrease in mortality (odds ratio [OR] 0.9998, 95% CI 0.9996-0.9999)., Conclusions: There were no significant associations between facility or operator-level procedural volume and 30-day mortality following PCI in a nationally integrated healthcare system. There was a marginal association between the interaction of operator lifetime experience, operator annual volume, and 30-day mortality that is unlikely to be clinically relevant, though does suggest an opportunity to explore novel factors that may influence the volume-outcome relationship., Competing Interests: Declaration of competing interest The views expressed in this article are those of the authors and do not necessarily reflect the position or policy of the Department of Veterans Affairs or the U.S. Government. Dr. Valle has received unrelated consulting fees from Philips Medical, Medtronic, and Cardiovascular Systems Incorporated. Dr. Waldo has received grants from the National Institutes of Health and VA Health Services Research and investigator-initiated research support to the Denver Research Institute from Abiomed, Cardiovascular Systems Incorporated, and Janssen Pharmaceuticals; and serves as the National Director of the VA Clinical Assessment, Reporting, and Tracking (CART) Program, the national quality and safety oversight organization for invasive cardiac procedures within the Veterans Affairs (VA) Healthcare System. The other authors have no relevant disclosures., (Published by Elsevier Inc.)

Background: Prior studies of radial access for cardiac catheterization have focused on early adopters of the technique, and some have described a risk/treatment paradox of low radial access use among high bleeding risk patients. This study aimed to determine (1) trends in radial access use over time, (2) if increasing use of radial access is driven by new invasive and interventional cardiologists (operators) or existing operators changing their practice, and (3) if increasing radial rates are associated with lower bleeding rates and elimination of the risk/treatment paradox., Methods: In this cross-sectional study using data from the Clinical Assessment, Reporting, and Tracking Program, we calculated radial access rates and risk-adjusted postprocedural bleeding rates of patients undergoing diagnostic angiography or percutaneous coronary intervention (PCI) between 2011 and 2018 in Veterans Affairs hospitals. We used separate bleeding risk models for diagnostic angiography and PCI and assessed temporal trends with the Kendall Tau-b test., Results: Among 253 179 diagnostic angiograms and 93 614 PCIs, radial access rates increased over time for both diagnostic (17.5%-60.4%; P <0.01)) and PCI procedures (14.0%-51.8%; P <0.01). Existing operators and new operators increased their use at similar rates, but new operators entered practice with higher baseline rates. Nearly all operators used radial access at least once in 2018. Overall adjusted rates of bleeding declined, a trend that was significant for diagnostic angiography (2.4%-1.4%, P =0.02) but not PCI (3.4%-2.5%, P =0.20). Femoral access patients had a higher predicted risk for bleeding., Conclusions: A steady rise in radial access for diagnostic angiography and PCI was driven by increasing use among existing operators and high use by new operators. While this was associated with decreasing bleeding rates, a risk/treatment paradox for access site selection persists; patients at higher bleeding risk were still more likely to receive femoral access.

Background: We sought to determine national trends and long term outcomes of post myocardial infarction (MI) heart failure. An MI can be complicated by heart failure; there are limited data describing the contemporary patterns and clinical implications of post-MI heart failure., Methods and Results: We studied patients with an MI aged 65 years or older from 2000 to 2013 in a Medicare database. New-onset heart failure after an MI was defined as either heart failure during the index MI admission or a hospitalization for heart failure within 1 year of the index MI event. A trend analysis of the incidence of heart failure was performed, and differences were examined by Gray tests. The 5-year mortality rates were evaluated and differences among heart failure cohorts were ascertained by Gray tests. There were a total of 1,531,638 patients with an MI and 565,291 patients had heart failure (36.0%). The rate of heart failure during index admission was 32.3% and the frequency of heart failure hospitalization within 1 year was 10.4%. Patients with heart failure were older (81 years vs 77 years). The temporal trend from 2001 to 2012 suggested a decrease in the incidence of heart failure during index admission (2001: 34.7%, 2012: 31.2%, P trend < .01), as well as heart failure hospitalization within 1 year (2001: 11.3%, 2012: 8.7%, P trend < .01). The 5-year mortality rate among patients without heart failure was 38.4% and for patients with any heart failure it was 68.7%., Conclusions: Post-MI heart failure in older adults occurs in 1 in 3 patients within 1 year; heart failure portends significantly higher long-term mortality., (Copyright © 2021 Elsevier Inc. All rights reserved.)

Background Effective transitions from the procedural to outpatient setting are essential to ensure high-quality cardiovascular care across health care systems, particularly among patients undergoing invasive cardiac procedures. We evaluated the association of postprocedural follow-up visits and antiplatelet prescriptions with clinical outcomes among patients undergoing percutaneous coronary intervention for stable angina at community or Veterans Affairs (VA) hospitals. Methods and Results Patients who actively received care within the VA Healthcare System and underwent percutaneous coronary intervention for stable angina at a community or VA hospital between October 1, 2015, and September 30, 2019, were identified. We compared mortality for patients receiving community or VA care, and among subgroups of community-treated patients by the presence of a postprocedural follow-up visit within 30 days or prescription for antiplatelet (P2Y12) medication within 120 days of the procedure. Among 12 837 patients who survived the first 30 days, 5133 were treated at community hospitals, and 7704 were treated in the VA. Prescriptions for antiplatelet therapy were less common for those treated in the community (85%) compared with the VA at 1 year (95%; hazard ratio [HR], 0.46; 95% CI, 0.44-47). Compared with VA-treated patients, the hazards for death were similar for patients treated in the community with a follow-up visit (HR, 1.17; 95% CI, 0.97-1.40) or with a fill for an antiplatelet therapy (HR, 1.08; 95% CI, 0.90-1.30). However, patients treated in the community without a follow-up visit had an 86% (HR, 1.86; 95% CI, 1.40-2.48) increased hazard of death, and those without antiplatelet prescription fill had a 144% increased hazard of death (HR, 2.44; 95% CI, 1.85-3.21) compared with all VA-treated patients. Conclusions Patients treated at community facilities have a decreased chance of receiving antiplatelet prescriptions after percutaneous coronary intervention with a concordant increased hazard of mortality, emphasizing the importance of transitions of care across health care systems when assessing cardiovascular quality.

Background: Percutaneous coronary intervention is performed by operators with differing experience, technique, and case mix. It is unknown if operator practice patterns impact patient outcomes. We sought to determine if a cluster algorithm can identify distinct profiles of percutaneous coronary intervention operators and if these profiles are associated with patient outcomes., Methods: Operators performing at least 25 annual procedures between 2014 and 2018 were clustered using an agglomerative hierarchical clustering algorithm. Risk-adjusted in-hospital mortality was compared between clusters., Results: We identified 4 practice profiles among 7706 operators performing 2 937 419 procedures. Cluster 1 (n=3345) demonstrated case mix and practice patterns similar to the national median. Cluster 2 (n=1993) treated patients with lower clinical acuity and were less likely to use intracoronary diagnostics, atherectomy, and radial access. Cluster 3 (n=1513) had the lowest case volume, were more likely to work at rural hospitals, and cared for a higher proportion of patients with ST-segment-elevation myocardial infarction and cardiogenic shock. Cluster 4 (n=855) had the highest case volume, were most likely to treat patients with high anatomic complexity and use atherectomy, intracoronary diagnostics, and mechanical support. Compared with cluster 1, adjusted in-hospital mortality was similar for cluster 2 (estimated difference, -0.03 [95% CI, -0.10 to 0.04]), higher for cluster 3 (0.14 [0.07-0.22]), and lower for cluster 4 (-0.15 [-0.24 to -0.06])., Conclusions: Distinct percutaneous coronary intervention operator profiles are differentially associated with patient outcomes. A phenotypic approach to physician assessment may provide actionable feedback for quality improvement.

Background: Percutaneous coronary intervention (PCI) procedures are increasing in clinical and anatomic complexity, likely increasing the calculated risk of mortality. There is need for a real-time risk prediction tool that includes clinical and coronary anatomic information that is integrated into the electronic medical record system., Methods: We assessed 70 503 PCIs performed in 73 Veterans Affairs hospitals from 2008 to 2019. We used regression and machine-learning strategies to develop a prediction model for 30-day mortality following PCI. We assessed model performance with and without inclusion of the Veterans Affairs SYNTAX score (Synergy Between Percutaneous Coronary Intervention With Taxus and Cardiac Surgery), an assessment of anatomic complexity. Finally, the discriminatory ability of the Veterans Affairs model was compared with the CathPCI mortality model., Results: The overall 30-day morality rate was 1.7%. The final model included 14 variables. Presentation status (salvage, emergent, urgent), ST-segment-elevation myocardial infarction, cardiogenic shock, age, congestive heart failure, prior valve disease, chronic kidney disease, chronic lung disease, atrial fibrillation, elevated international normalized ratio, and the Veterans Affairs SYNTAX score were all associated with increased risk of death, while increasing body mass index, hemoglobin level, and prior coronary artery bypass graft surgery were associated with lower risk of death. C-index for the development cohort was 0.93 (95% CI, 0.92-0.94) and for the 2019 validation cohort and the site validation cohort was 0.87 (95% CI, 0.83-0.92) and 0.86 (95% CI, 0.83-0.89), respectively. The positive likelihood ratio of predicting a mortality event in the top decile was 2.87% more accurate than the CathPCI mortality model. Inclusion of anatomic information in the model resulted in significant improvement in model performance (likelihood ratio test P <0.01)., Conclusions: This contemporary risk model accurately predicts 30-day post-PCI mortality using a combination of clinical and anatomic variables. This can be immediately implemented into clinical practice to promote personalized informed consent discussions and appropriate preparation for high-risk PCI cases.

Background: Bleeding is a common complication of percutaneous coronary intervention (PCI) that is associated with worse clinical outcomes and increased costs. Improved pre-procedural bleeding risk prediction could promote strategies that have been shown to reduce post-PCI bleeding, including increased adoption of radial access., Methods: We studied patients in the Veterans Affairs Clinical Assessment, Reporting, and Tracking (VA CART) program receiving PCI in VA hospitals. Logistic regression was performed to develop a model for major in-hospital bleeding using demographic, clinical, and procedural variables. The discriminatory ability of the model was compared to the existing National Cardiovascular Data Registry (NCDR) CathPCI bleeding risk model., Results: Among 107,451 patients treated from 2008 to 2019, 5218 (4.86%) experienced an in-hospital bleeding event. Twelve variables were associated with bleeding risk. Predictors of bleeding included emergency or salvage status, cardiogenic shock, NSTEMI, Atrial fibrillation, elevated INR, and peripheral vascular disease, while radial access, greater body surface area, and stable or unstable angina were associated with lower risk of bleeding. The developed model had superior discrimination compared with the NCDR CathPCI model (c-index 0.756, 95% CI 0.749-0.764 vs. 0.707, 95% CI 0.700-0.714, p < 0.001), especially among the highest risk patients. A web-based tool has been created to facilitate calculation of bleeding risk using this model at the point of care., Conclusion: The VA CART bleeding risk model uses baseline clinical and procedural variables to predict post-PCI in-hospital bleeding events and has improved discrimination compared to other available models in this patient population. Implementation of this model can facilitate risk stratification at the point of care and permit improved risk-adjustment for quality assessment., Competing Interests: Declaration of competing interest Dr. Waldo receives investigator-initiated research support to the Denver Research Institute from Abiomed, Cardiovascular Systems Incorporated, Janssen Pharmaceuticals, and Merck Pharmaceuticals. He serves as the national director and Dr. Doll serves as an assistant director for the Clinical Assessment, Reporting, and Tracking Program. The remaining authors have no disclosures to report., (Published by Elsevier Inc.)

Mortality rates for patients with ST-segment elevation myocardial infarction (STEMI) remain high despite development of novel drugs and interventions over the past several decades. There is significant variability between hospitals in use of evidence-based treatments, and substantial opportunities exist to optimize care pathways and reduce disparities in care delivery. Quality improvement interventions implemented at local, regional, and national levels have improved care processes and patient outcomes. This article reviews evidence for quality improvement interventions along the spectrum of STEMI care, describes existing systems for quality measurement, and examines local and national policy interventions, with special attention to public reporting programs., (Published by Elsevier Inc.)

Background: Interventional cardiologists receive feedback on their clinical care from a variety of sources including registry-based quality measures, case conferences, and informal peer interactions. However, the impact of this feedback on clinical care is unclear., Methods: We interviewed interventional cardiologists regarding the use of feedback to improve their care of percutaneous coronary intervention (PCI) patients. Interviews were assessed with template analysis using deductive and inductive techniques., Results: Among 20 interventional cardiologists from private, academic, and Department of Veterans Affairs practice, 85% were male, 75% performed at least 100 PCIs annually, and 55% were in practice for 5 years or more. All reported receiving feedback on their practice, including formal quality measures and peer learning activities. Many respondents were critical of quality measure reporting, citing lack of trust in outcomes measures and poor applicability to clinical care. Some respondents reported the use of process measures such as contrast volume and fluoroscopy time for benchmarking their performance. Case conferences and informal peer feedback were perceived as timelier and more impactful on clinical care. Respondents identified facilitators of successful feedback interventions including transparent processes, respectful and reciprocal peer relationships, and integration of feedback into collective goals. Hierarchy and competitive environments inhibited useful feedback., Conclusions: Despite substantial resources dedicated to performance measurement and feedback for PCI, interventional cardiologists perceive existing quality measures to be of only modest value for improving clinical care. Catherization laboratories should seek to integrate quality measures into a holistic quality program that emphasizes peer learning, collective goals and mutual respect., (Published by Elsevier Inc.)

Background: Professional society consensus statements articulate the clinical and anatomic complexity of patients that may undergo percutaneous coronary intervention (PCI) without on-site cardiothoracic surgery, although compliance with these recommendations has not been assessed. We sought to evaluate the clinical and anatomic complexity of patients undergoing PCI with and without cardiothoracic surgery on-site., Methods: We identified all patients undergoing PCI in the Veterans Affairs health care system between October 2009 and September 2017. The clinical and anatomic complexity of patients treated at sites with or without cardiothoracic surgery was evaluated with a comparative interrupted time series, and mortality was ascertained in a propensity-matched cohort., Results: We identified 75 564 patients who underwent PCI, with the majority (53 708, 71%) treated at sites with cardiothoracic surgery. The overall clinical complexity was statistically greater for those treated at sites with cardiothoracic surgery (National Cardiovascular Data Registries CathPCI: 18.4) compared with those at sites without (17.8, P <0.001) throughout the study, with similar annual increases in complexity before (2% versus 3%; P =0.107) and after (3% versus 3%; P =0.704) January 2014. The anatomic complexity of patients treated was also statistically greater (Veterans Affairs SYNTAX: 11.0 versus 10.2; P <0.001) and increased at comparable rates (2% versus 1%, P =0.731) before 2014. After publication of the consensus statement, anatomic complexity declined at sites with cardiothoracic surgery (-2%) but increased at sites without on-site surgery (5%, P =0.025) such that it was similar at the end of the study ( P =0.622). Referrals for emergent cardiothoracic surgery were rare regardless of treatment venue (61, 0.08%) and the hazard for mortality was similar (hazard ratio, 0.883 [95% CI, 0.662-1.176]) after propensity matching., Conclusions: There are minor differences in complexity of patients undergoing coronary intervention at sites with and without cardiothoracic surgery. Clinical outcomes are similar regardless of treatment venue, suggesting an opportunity to improve access to complex interventional care without sacrificing quality.

Background: For patients presenting with ST-segment-elevation myocardial infarction, national quality initiatives monitor hospitals' proportion of cases with door-to-balloon (D2B) time under 90 minutes. Hospitals are allowed to exclude patients from reporting and may modify behavior to improve performance. We sought to identify whether there is a discontinuity in the number of cases included in the D2B time metric at 90 minutes and whether operators were increasingly likely to pursue femoral access in patients with less time to meet the 90-minute quality metric., Methods: Adult patients with ST-segment-elevation myocardial infarction undergoing primary percutaneous coronary intervention from 2011 to 2018 were identified from the Cardiac Care Outcomes Assessment Program, a quality improvement registry in Washington state. We used the regression discontinuity framework to test for discontinuity at 90 minutes among the included cases. We defined a novel variable, remaining D2B as 90 minutes minus the time between hospital arrival and catheterization laboratory arrival. We estimated multivariable logistic regression models to assess the relationship between remaining D2B time and access site., Results: A total of 19 348 patients underwent primary percutaneous coronary intervention and were included in the analysis. Overall, 7436 (38.4%) were excluded from the metric. There appeared to be a visual discontinuity in included cases around 90 minutes; however, local quadratic regression around the 90-minute cutoff did not reveal evidence of a significant discontinuity ( P =0.66). Multivariable analysis showed no significant relationship between remaining D2B time and the odds of undergoing femoral access ( P =0.73)., Conclusions: Among patients undergoing percutaneous coronary intervention for ST-segment-elevation myocardial infarction, we did not find evidence of a statistically significant discontinuity in the frequency of included cases around 90 minutes or an increased preference for femoral access correlated with decreasing time to meet the 90-minute D2B time quality metric. Together, these findings indicate no evidence of widespread inappropriate methods to improve performance on D2B time metrics.

Background Patient selection and outcomes for percutaneous coronary intervention (PCI) and coronary artery bypass grafting (CABG) have changed over the past decade. However, there is limited information on outcomes for both revascularization strategies in the same population. The study evaluated temporal changes in risk profile, procedural characteristics, and clinical outcomes for PCI- and CABG-treated patients. Methods and Results We analyzed all PCI and isolated CABG between 2005 and 2017 in nonfederal hospitals in Washington State. Descriptive analysis was performed to evaluate temporal changes in risk profile and, risk-adjusted in-hospital mortality. Over the study period, 178 474 PCI and 36 592 CABG procedures were performed. PCI and CABG volume decreased by 2.9% and 22.6%, respectively. Compared with 2005-2009, patients receiving either form of revascularization between 2014 and 2017 had a higher prevalence of comorbidities including diabetes mellitus and hypertension and dialysis. Presentation with ST-segment-elevation myocardial infarction (17% versus 20%) and cardiogenic shock (2.4% versus 3.4%) increased for patients with PCI compared with CABG. Conversely, clinical acuity decreased for patients receiving CABG over the study period. From 2005 to 2017, mean National Cardiovascular Data Registry CathPCI mortality score increased for patients treated with PCI (20.1 versus 22.4, P <0.0001) and decreased for patients treated with CABG (18.8 versus 17.8, P <0.0001). Adjusted observed/expected in-hospital mortality ratio increased for PCI (0.98 versus 1.19, P <0.0001) but decreased for CABG (1.21 versus 0.74, P <0.0001) over the study period. Conclusions Clinical acuity increased for patients treated with PCI rather than CABG. This resulted in an increase in adjusted observed/expected mortality ratio for patients undergoing PCI and a decrease for CABG. These shifts may reflect an increased use of PCI instead of CABG for patients considered to be at high surgical risk.

Complications of percutaneous coronary intervention (PCI) may have significant impact on patient survival and healthcare costs. PCI procedural complexity and patient risk are increasing, and operators must be prepared to recognize and treat complications, such as perforations, dissections, hemodynamic collapse, no-reflow, and entrapped equipment. Unfortunately, few resources exist to train operators in PCI complication management. Uncertainty regarding complication management could contribute to the undertreatment of patients with high-complexity coronary disease. We, therefore, coordinated the Learning From Complications: How to Be a Better Interventionalist courses to disseminate the collective experience of high-volume PCI operators with extensive experience in chronic total occlusion and high-risk PCI. From these conferences in 2018 and 2019, we developed algorithms that emphasize early recognition, effective treatment, and team-based care of PCI complications. We think that an algorithmic approach will result in a logical and systematic response to life-threatening complications. This construct may be useful for operators who plan to perform complex PCI procedures.

Background Hospitals commonly provide a short-term supply of free P2Y 12 inhibitors at discharge after myocardial infarction, but it is unclear if these programs improve medication persistence and outcomes. The ARTEMIS (Affordability and Real-World Antiplatelet Treatment Effectiveness After Myocardial Infarction Study) trial randomized hospitals to usual care versus waived P2Y 12 inhibitor copayment costs for 1-year post-myocardial infarction. Whether the impact of this intervention differed between hospitals with and without pre-existing medication assistance programs is unknown. Methods and Results In this post hoc analysis of the ARTEMIS trial, we examined the associations of pre-study free medication programs and the randomized copayment voucher intervention with P2Y 12 inhibitor persistence (measured by pharmacy fills and patient report) and major adverse cardiovascular events using logistic regression models including a propensity score. Among 262 hospitals, 129 (49%) offered pre-study free medication assistance. One-year P2Y 12 inhibitor persistence and major adverse cardiovascular events risks were similar between patients treated at hospitals with and without free medication programs (adjusted odds ratio 0.93, 95% CI, 0.82-1.05 and hazard ratio 0.92, 95% CI, 0.80-1.07, respectively). The randomized copayment voucher intervention improved persistence, assessed by pharmacy fills, in both hospitals with (53.6% versus 44.0%, adjusted odds ratio 1.45, 95% CI, 1.20-1.75) and without (59.0% versus 48.3%, adjusted odds ratio 1.46, 95% CI, 1.25-1.70) free medication programs ( P interaction =0.71). Differences in patient-reported persistence were not significant after adjustment. Conclusions While hospitals commonly report the ability to provide free short-term P2Y 12 inhibitors, we did not find association of this with medication persistence or major adverse cardiovascular events among patients with insurance coverage for prescription medication enrolled in the ARTEMIS trial. An intervention that provided copayment assistance vouchers for 1 year was successful in improving medication persistence in hospitals with and without pre-existing short-term medication programs. Registration URL: https://www.clini​caltr​ials.gov/. Unique identifier: NCT02406677.

Importance: In hospitals outside of the US Department of Veterans Affairs (VA) system, 1 in 10 percutaneous coronary interventions (PCIs) for stable coronary artery disease is considered rarely appropriate by the appropriate use criteria, with variation across hospitals. The appropriateness of PCIs in VA hospitals has not been documented., Objective: To characterize the appropriateness of PCIs in VA hospitals., Design, Setting, and Participants: This retrospective cohort study included patients with stable coronary artery disease undergoing elective PCI from November 1, 2013, to October 31, 2015, within the VA Clinical Assessment, Reporting, and Tracking Program, an operational program that includes 59 VA hospitals. Data were analyzed from March 1, 2019, to August 8, 2019., Exposures: Elective PCI at a VA hospital., Main Outcomes and Measures: Proportion of PCIs classified as appropriate, may be appropriate, or rarely appropriate; extent of hospital-level variation in rarely appropriate PCIs using criteria issued by cardiovascular professional societies in 2012. The extent of hospital-level variation in rates of rarely appropriate PCI was characterized using hospital proportions and random-effect logistic regression., Results: Among 2611 patients undergoing elective PCI (mean [SD] age, 66.3 [7.6] years; 2577 [98.7%] men) at 59 hospitals, a total of 778 PCIs (29.8%) were classified as appropriate, 1561 PCIs (59.8%) were classified as may be appropriate, and 272 PCIs (10.4%) were classified as rarely appropriate. Rarely appropriate PCIs were more commonly performed in patients who had low-risk stress test findings (220 patients [89.1%]), who were taking no (100 patients [36.8%]) or 1 (167 patients [61.4%]) antianginal medication, or who had 1 coronary artery stenosis (185 patients [68.0%]). The unadjusted hospital-level rates of rarely appropriate PCIs ranged from 0% to 28.6%, with a median (interquartile range) of 9.7% (6.3%-13.9%). Random-effect models yielded an estimated median (interquartile range) rate of rarely appropriate PCI of 10.4% (8.7%-12.3%)., Conclusions and Relevance: These findings suggest that in VA practice, most PCIs for stable coronary artery disease were classified as appropriate or may be appropriate. However, 1 in 10 PCIs was classified as rarely appropriate, with variation across VA hospitals. Efforts to improve patient selection are needed.

Background Physicians have expressed significant mistrust with public reporting of interventional cardiology outcomes. Similar data are not available on alternative reporting structures, including nonpublic quality improvement programs with internally distributed measures of interventional quality. We thus sought to evaluate the perceptions of public and nonpublic reporting of interventional cardiology outcomes and its impact on clinical practice. Methods and Results A standardized survey was distributed to 218 interventional cardiologists in the Veterans Affairs Healthcare System, with responses received from 62 (28%). The majority of respondents (90%) expressed some or a great deal of trust in the analytic methods used to generate reports in a nonpublic quality improvement system within Veterans Affairs, while a minority (35%) expressed similar trust in the analytic methods in a public reporting system that operates outside Veterans Affairs ( P <0.001). Similarly, a minority of respondents (44%) felt that in-hospital and 30-day mortality accurately reflected interventional quality in a nonpublic quality improvement system, though a smaller proportion of survey participants (15%) felt that the same outcome reflected procedural quality in public reporting systems ( P <0.001). Despite these sentiments, the majority of operators did not feel pressured to avoid (82% and 75%; P =0.383) or perform (72% and 63%; P =0.096) high-risk procedures within or outside Veterans Affairs. Conclusions Interventional cardiologists express greater trust in analytic methods and clinical outcomes reported in a nonpublic quality improvement program than external public reporting environments. The majority of physicians did not feel pressured to avoid or perform high-risk procedures, which may improve access to interventional care among high-risk patients.

Importance: Peer review is recommended for quality assessment in all cardiac catheterization programs, but, to our knowledge, the content of peer reviews and the potential for quality improvement has not been described., Objective: To characterize the quality improvement content of cardiac catheterization peer reviews., Design, Setting, and Participants: This quality improvement study used retrospective case review of diagnostic angiography and percutaneous coronary intervention procedures to characterize the major adverse event review process of the US Department of Veterans Affairs Clinical Assessment, Reporting, and Tracking (CART) program from January 1, 2012, to December 31, 2016. Data review and analysis took place from November 2017 to August 2018., Main Outcomes and Measures: Percentage of peer reviews reporting substandard care and opportunities for quality improvement., Results: A total of 196 643 diagnostic coronary angiograms and 62 576 percutaneous coronary interventions were performed in the Department of Veterans Affairs. Of these, 168 (0.1%) were triggered for review because of a self-reported major adverse event during the procedure. Of 152 cases with complete peer review data, care was adjudicated as not meeting the standard of care in 25 cases (16.4%). Concerns about operator judgment were identified in 46 cases (30.3%), about case selection in 26 (17.1%), about trainee supervision in 21 (13.8%), and about technical performance in 46 (30.3%). Reviewers made recommendations to improve operator performance in 63 cases (41.4%) and catheterization laboratory or hospital processes in 58 (38.2%)., Conclusions and Relevance: While substandard care is infrequently identified in peer review of catheterization laboratory complications in the Department of Veterans Affairs, the process often generates recommendations for quality improvement. Peer review programs should focus on identifying quality improvement opportunities and providing meaningful feedback to operators.

Background Although recommended in the guidelines, the safety of chronic P2Y 12 inhibitor therapy in patients with chronic kidney disease ( CKD ) after an acute myocardial infarction ( MI ) is not well studied. Methods and Results The TRANSLATE -ACS (Treatment with ADP Inhibitors: Longitudinal Assessment of Treatment Patterns and Events After Acute Coronary Syndrome) study included 11 108 MI patients treated with percutaneous coronary intervention and discharged alive on a P2Y 12 inhibitor from 233 US hospitals. We compared rates of GUSTO (Global Use of Strategies to Open Occluded Arteries) severe/moderate bleeding and premature discontinuation of P2Y 12 inhibitor by 1 year after MI among patients with varying CKD severity. The majority of MI patients treated with percutaneous coronary intervention had CKD : 42% had stage 2 (mild), 27% had stage 3 (moderate), and 4% had stage ≥4 (severe/end stage). Higher potency P2Y 12 inhibitors (prasugrel or ticagrelor) were prescribed at discharge in 39%, 35%, 23%, and 15% ( P<0.01) of patients with stages 1, 2, 3, and ≥4, respectively. One-year GUSTO severe/moderate bleeding rates were higher with each stage of CKD : 1% in patients with CKD stage 1 or no CKD , 2% with an adjusted hazard ratio of 1.61 (95% CI, 1.05-2.35) for CKD stage 2, 4% with an adjusted hazard ratio of 1.92 (95% CI, 1.21-3.02) for CKD stage 3, and 10% with an adjusted hazard ratio of 2.44 (95% CI, 1.40-4.23) for patients with CKD stage ≥4. By 1 year after MI , 16% of patients overall had prematurely discontinued P2Y 12 inhibitor therapy; however, this rate was not largely affected by CKD stage. Premature P2Y 12 inhibitor-discontinuation rates were higher for patients discharged on higher potency P2Y 12 inhibitors in patients with CKD stage ≥2 ( P<0.01). Conclusions CKD severity was associated with a higher bleeding risk among those with acute MI treated with a P2Y 12 inhibitor. Patients with more advanced CKD were not significantly more likely than those with less advance CKD to prematurely discontinue P2Y 12 inhibitor therapy.

Background: Nonadherence to optimal medical therapy following myocardial infarction (MI) is associated with adverse clinical outcomes such as stent thrombosis, recurrent cardiovascular events, and death. Whether adherence to medications prior to MI predicts post-MI medication adherence is unknown., Methods: We assessed adherence to P2Y 12 inhibitors and statins before and after admission for MI among 8,147 MI patients who had Medicare insurance with Part D prescription coverage. Adherence was defined as a proportion of days covered with medication fills ≥80%. Multivariable logistic regression was used to assess the association between pre- and post-MI P2Y 12 inhibitor adherence. As few patients were on P2Y 12 inhibitors pre-MI, we also examined the association of pre-MI statin adherence with post-MI P2Y 12 inhibitor and statin adherence., Results: Pre-MI medication nonadherence was observed in 427 of 2,633 (16%) patients on preadmission P2Y 12 inhibitors and 1,233 of 6,934 (18%) patients on preadmission statins. Nonadherent patients were more likely to be of nonwhite race and have multiple prior hospital admissions. Patients who were nonadherent to P2Y 12 inhibitors pre-MI were substantially less likely to adhere to P2Y 12 inhibitors at 90 days (adjusted odds ratio [OR] 0.33, 95% CI 0.25-0.43) and 1 year post-MI (adjusted OR 0.29, 95% CI 0.21-0.39) compared with patients who were adherent pre-MI. Pre-MI statin nonadherence was also associated with lower post-MI adherence to P2Y 12 inhibitors at 90 days (adjusted OR 0.65, 95% CI 0.53-0.79) and 1 year (adjusted OR 0.37, 95% CI 0.29-0.54)., Conclusions: Prior medication adherence predicts post-MI adherence to P2Y 12 inhibitors. Increasing accessibility of medication adherence data in the medical record may be an important tool to identify patients at higher risk for post-MI medication nonadherence and target efforts to improve adherence., (Published by Elsevier Inc.)

Background Guidelines recommend patient engagement in shared decision-making regarding coronary revascularization, but studies demonstrate poor patient understanding of risks, benefits, and alternatives. Effective strategies are needed to integrate informed patient preferences into clinical care, particularly for patients undergoing diagnostic coronary angiography. Methods and Results We developed a web-based decision aid to educate patients and survey their treatment preferences before angiography. We compared knowledge, attitudes, and preferences of 203 patients with and without use of the decision aid. In a pilot cluster-randomized study, cardiologists were assigned to receive versus not receive patient preferences, with subsequent assessment of treatment decisions. The median age of participants was 64 years, 62% were men, 74% were white, and a similar number had acute presentation (49% non-ST-segment-elevation myocardial infarction or unstable angina) and stable presentation (51% stable angina or atypical symptoms). Most patients preferred treatment with percutaneous coronary intervention compared with either medical therapy alone (63% versus 21%) or coronary artery bypass graft surgery (81% versus 7%). The decision aid was associated with improved performance on a 6-item knowledge scale (mean, 2.7 versus 2.2 questions correct; P<0.01) and greater interest in shared decision-making but not an overall change in patient preferences. The pilot cluster-randomized study demonstrated the feasibility of integrating patient preference information into clinical care, although providing preferences to the clinicians did not improve concordance between preference and treatment. Conclusions A web-based decision aid was associated with improved patient knowledge and greater desire to participate in shared decision-making for coronary revascularization. Most patients preferred percutaneous coronary intervention to either medical therapy alone or coronary artery bypass graft surgery. Further investigation is needed to determine the impact of patient preferences on clinical decision-making and outcomes. Clinical Trial Registration URL: https://www.clinicaltrials.gov. Unique identifier: NCT02272062.

Background Cardiac rehabilitation (CR) is strongly recommended after percutaneous coronary intervention (PCI), but it is underused. We sought to evaluate CR participation variation after PCI and its association with mortality among veterans. Methods and Results Patients undergoing PCI between 2007 and 2011 were identified in the Veterans Affairs Clinical Assessment, Reporting, and Tracking database and followed up until January 25, 2017. We excluded patients who died within 30 days of PCI and calculated the percentage participating in ≥1 outpatient CR visits within 12 months after PCI. We constructed multivariable hierarchical logistic regression models for CR participation, clustered by facility. We estimated propensity scores for CR participation, matched participants and nonparticipants by propensity score, calculated mortality rates, and estimated the association with mortality using Cox proportional hazards models. Participation in CR after PCI was 6.9% (2986/43 319) and varied significantly by PCI facility (range, 0%-36%). After 6.1 years median follow-up, CR participants had a 33% lower mortality rate than all nonparticipants (3.8 versus 5.7 deaths/100 person-years; hazard ratio, 0.67; 95% confidence interval, 0.61-0.75; P<0.001) and a 26% lower mortality rate than 2986 propensity-matched nonparticipants (3.8 versus 5.1 deaths/100 person-years; hazard ratio, 0.74; 95% confidence interval, 0.65-0.84; P<0.001). Participants attending ≥36 sessions had the lowest mortality rate (2.4 deaths/100 person-years; hazard ratio, 0.47; 95% confidence interval, 0.36-0.60; P<0.001). Conclusions CR participation after PCI among veterans is low overall, with significant facility-level variation. CR participation is associated with lower mortality rates in veterans. Additional efforts are needed to promote CR participation after PCI among veterans.

Background: The 2013 American College of Cardiology/American Heart Association cholesterol guidelines recommend high-intensity statins for patients after myocardial infarction (MI) rather than treating to a low-density lipoprotein cholesterol goal, as the previous ATP III (Adult Treatment Panel third report) guidelines had advised., Methods and Results: To evaluate the frequency of postdischarge lipid testing and high-intensity statin use among MI patients discharged on a statin during the ATP III guidelines era, we linked ACTION (Acute Coronary Treatment and Intervention Outcomes Network) Registry data to Medicare claims for 11 046 MI patients aged ≥65 years who were discharged alive on a statin from 347 hospitals (2007-2009). Multivariable regression was used to evaluate the association between lipid testing and 1-year high-intensity statin use. Only 21% of MI patients were discharged on a high-intensity statin. By 90 days after MI, 44% of patients discharged on a statin underwent lipid testing (43% on low- or moderate-intensity statins and 49% on high-intensity statins; P =0.001). Follow-up lipid testing rates were 47% among patients with in-hospital low-density lipoprotein cholesterol ≥100 mg/dL and 47% among newly prescribed statin recipients. By 1 year, only 14% of patients were on high-intensity statins. Only 4% of patients discharged on low- or moderate-dose statin were uptitrated to high intensity; postdischarge lipid testing was associated with a slightly higher likelihood of high-intensity statin use by 1 year (5.4% versus 2.9%, adjusted odds ratio: 1.92; 95% confidence interval, 1.52-2.41)., Conclusions: Previous guidelines recommended low-density lipoprotein cholesterol goal-directed statin therapy, but lipid testing and high-intensity statin use were infrequent after MI. The American College of Cardiology/American Heart Association guidelines may promote more intensive cardiovascular risk reduction by eliminating treatment dependence on lipid testing., (© 2018 The Authors. Published on behalf of the American Heart Association, Inc., by Wiley.)

Aims: We sought to determine the association of clopidogrel reloading with in-hospital bleeding and mortality in contemporary practice., Methods and Results: We examined clopidogrel reloading for ST-segment elevation myocardial infarction (STEMI) and non-ST-segment elevation myocardial infarction (NSTEMI) patients on pre-admission clopidogrel therapy in the ACTION Registry-GWTG from 2009 to 2014. We used inverse probability weighted propensity adjustment to compare in-hospital mortality and major bleeding risks between patients reloaded in the first 24 h with ≥300 mg of clopidogrel vs. those continued on a maintenance (<300 mg) dose. Among the 12 366 patients on pre-admission clopidogrel therapy who were admitted with STEMI, 9369 (75.8%) received a loading dose. Of 39 158 patients with NSTEMI, 10 144 (25.9%) were reloaded. Reloaded patients were younger, had fewer comorbid conditions, and were more likely to be treated with primary PCI (STEMI) or an early invasive strategy (NSTEMI). Risks of major bleeding were not significantly different between patients with and without reloading, whether presenting with STEMI (OR 0.98, 95% CI 0.85-1.13) or NSTEMI (OR 1.00, 95% CI 0.90-1.11). Among STEMI patients, clopidogrel reloading was associated with lower risks of in-hospital mortality (OR 0.80, 95% CI 0.66-0.96), however no significant mortality difference was observed among NSTEMI patients (OR 1.13, 95% CI 0.93-1.37)., Conclusion: Clopidogrel reloading occurs frequently among MI patients who are on pre-admission clopidogrel therapy, particularly among STEMI patients. We did not observe increased bleeding or mortality risk with clopidogrel reloading, and therefore reloading could be safe for most MI patients., (Published on behalf of the European Society of Cardiology. All rights reserved. © The Author 2017. For permissions, please email: journals.permissions@oup.com.)

Background: Morbidity and mortality conference is a common educational and quality improvement activity performed in cardiac catheterization laboratories, but best practices for case selection and for maximizing the effectiveness of peer review have not been determined., Methods and Results: We reviewed the 10-year percutaneous coronary intervention morbidity and mortality conference experience of an academic medical center. Cases were triggered for review by the occurrence of prespecified procedural events. Summary reports from morbidity and mortality conference discussions were linked to clinical data from the Duke Databank for Cardiovascular Disease to compare baseline and procedural characteristics and to assess postdischarge outcomes. Of 11 786 procedures, from 2004 to 2013, 157 (1.3%) were triggered for review. The most frequent triggering events were cardioversion/defibrillation (72, 0.6%), unplanned use of mechanical circulatory support (64, 0.5%), and major dissection (41, 0.3%). Selected procedures were more likely to include high-risk features, such as ST-segment-elevation myocardial infarction, cardiogenic shock, and multivessel disease, and were associated with higher mortality at 30 days. Only a minority of triggering events were caused by controversial or unacceptable physician behavior., Conclusions: This 10-year experience outlines the processes for conduct of an effective percutaneous coronary intervention morbidity and mortality conference, including a novel approach to case selection and structured peer review leading to actionable quality interventions. The prespecified clinical triggers, captured in the natural workflow by laboratory staff, identified complex cases that were associated with poor patient outcomes., (© 2017 American Heart Association, Inc.)

Objectives: This study sought to determine variability and stability in risk-standardized mortality rates (RSMR) of percutaneous coronary intervention (PCI) operators meeting minimum case volume standards and identify differences in case mix and practice patterns that may account for RSMR variability., Background: RSMR has been suggested as a metric to evaluate the performance of PCI operators; however, variability of operator-level RSMR and the stability of this metric over time among the same operator are unknown., Methods: The authors calculated mean RSMRs for PCI operators with average annual volume of ≥50 cases in the National Cardiovascular Data Registry CathPCI Registry. Funnel plots were used to account for operator case volume. Demographic, clinical, and treatment variables of patients treated by operators with outlying high or low RSMRs (identified by RMSR greater than or less than 2 σ above or below the mean [analogous to 2 SD], respectively) were compared with nonoutlier operators. RMSR stability was assessed by calculating average annual operator RMSR during the study period and by determining if operators were consistently classified into RMSR categories in each year., Results: Between October 1, 2009, and September 30, 2014, a total of 2,352,174 PCIs were performed at 1,373 hospitals by 3,760 operators. Of these, 242 operators (6.5%) had RSMR >2 σ above the mean and 156 operators (4.1%) had RSMR >2 σ below the mean. Both high and low RSMR outlier operators treated patients with lower expected mortality risk, compared with nonoutlier operators. There was significant instability in annual operator RMSR during the study period., Conclusions: There is significant variability in risk-standardized PCI mortality among U.S. operators meeting minimum volume standards that is not explained by case mix or procedure characteristics. Operator RMSR was unstable from year to year, thus limiting its utility as a sole performance measure for PCI quality., (Published by Elsevier Inc.)

Background: Race and sex disparities in in-hospital treatment and outcomes of patients with acute myocardial infarction (MI) have been described, but little is known about race and sex differences in post-MI angina and long-term risk of unplanned rehospitalization. We examined race and sex differences in post-MI angina frequency and 1-year unplanned rehospitalization to identify factors associated with unplanned rehospitalization, testing for whether race and sex modify these relationships., Methods: Using TRANSLATE-ACS (Treatment With Adenosine Diphosphate Receptor Inhibitors: Longitudinal Assessment of Treatment Patterns and Events after Acute Coronary Syndrome) data, we examined 6-week and 1-year angina frequency and 1-year unplanned rehospitalization stratified by race and sex among MI patients treated with percutaneous coronary intervention. We used multivariable logistic regression to assess factors associated with unplanned rehospitalization and tested for interactions among angina frequency, race, and sex., Results: A total of 11 595 MI patients survived to 1 year postdischarge; there were 66.6% white male patients, 24.3% white female patients, 5.3% black male patients, and 3.8% black female patients. Overall, 29.7% had angina at 6 weeks, and 20.6% had angina at 1 year postdischarge. Relative to white patients, black patients were more likely to have angina at 6 weeks (female: 44.2% versus 31.8%; male: 33.5% versus 27.1%; both P<0.0001) and 1 year (female: 49.4% versus 38.9%; male: 46.3% versus 31.1%; both P<0.0001). Rates of 1-year unplanned rehospitalization were highest among black female patients (44.1%), followed by white female patients (38.4%), black male patients (36.4%), and white male patients (30.2%, P<0.0001). In the multivariable model, 6-week angina was most strongly associated with unplanned rehospitalization (hazard ratio, 1.49; 95% confidence interval, 1.36-1.62; P<0.0001); this relationship was not modified by race or sex (adjusted 3-way P interaction =0.41)., Conclusions: One-fifth of MI patients treated with percutaneous coronary intervention report 1-year postdischarge angina, with black and female patients more likely to have angina and to be rehospitalized. Better treatment of post-MI angina may improve patient quality of life and quality of care and help to lower rates of rehospitalization overall and particularly among black and female patients, given their high prevalence of post-MI angina., Clinical Trial Registration: URL: http://www.clinicaltrials.gov. Unique identifier: NCT01088503., (© 2017 American Heart Association, Inc.)

Importance: Intensive care unit (ICU) utilization may have important implications for the care and outcomes of patients with non-ST-segment elevation myocardial infarction (NSTEMI)., Objectives: To examine interhospital variation in ICU utilization in the United States for older adults with hemodynamically stable NSTEMI and outcomes associated with ICU utilization among patients with low, moderate, or high mortality risk., Design, Setting, and Participants: This study was a retrospective analysis of 28 018 Medicare patients 65 years or older admitted with NSTEMI to 346 hospitals participating in the Acute Coronary Treatment and Intervention Outcomes Network (ACTION)-Get With the Guidelines from April 1, 2011, through December 31, 2012. Patients with cardiogenic shock or cardiac arrest on presentation were excluded. Data analysis was performed from May 7 through October 8, 2015., Exposures: Hospitals with high (>70% of patients with NSTEMI treated in an ICU during the index hospitalization), intermediate (30%-70%), or low (<30%) ICU utilization., Main Outcomes and Measures: Thirty-day mortality., Results: Of 28 018 patients with NSTEMI 65 years or older (median age, 77 years [interquartile range, 71-84 years]; female, 13 055 [46.6%]; nonwhite race, 3931 [14.0%]), 11 934 (42.6%) had an ICU stay. The proportion of patients with NSTEMI treated in the ICU varied across hospitals (median, 38%; interquartile range, 26%-54%), but no significant differences were found in hospital or patient characteristics among high, intermediate, or low ICU utilization hospitals. Compared with high ICU utilization hospitals, low or intermediate ICU utilization hospitals were only marginally more selective of higher-risk patients, as determined by ACTION in-hospital mortality risk score or initial troponin level. The median ACTION risk score for patients treated in the ICU at low and intermediate ICU utilization hospitals was 34 compared with 33 for patients not treated in the ICU; at high ICU utilization hospitals, the median ACTION mortality risk score was 33 for patients treated in the ICU and 34 for patients not treated in the ICU. Thirty-day mortality rates did not significantly differ based on hospital ICU utilization (high vs low: 8.7% vs 8.7%; adjusted odds ratio, 0.91; 95% CI, 0.76-1.08; intermediate vs low: 9.6% vs 8.7%; adjusted odds ratio, 1.06; 95% CI, 0.94-1.20). The association between hospital ICU utilization and mortality did not change when considered among patients with ACTION risk scores greater than 40, 30 to 40, and less than 30 (adjusted interaction P = .86)., Conclusions and Relevance: Utilization of the ICU for older patients with NSTEMI varied significantly among hospitals. This variability was not explained by hospital characteristics or driven by patient risk. Mortality after myocardial infarction did not significantly differ among high, intermediate, or low ICU utilization hospitals.

Importance: Patients with dual Medicare-Medicaid eligibility have a higher burden of chronic disease conditions and increased health care utilization compared with patients with Medicare coverage alone, but the treatment patterns and outcomes of dual-eligible patients with myocardial infarction (MI) are unknown., Objective: To examine the association of dual-eligible status with clinical outcomes and adherence to medication regimens (hereinafter "medication adherence") among older adults after MI., Design, Setting, and Participants: In this retrospective study conducted from February 2015 to April 2016, we linked patients 65 years or older enrolled in a national myocardial infarction registry (the Acute Coronary Treatment Intervention Outcomes Network Registry-Get With the Guidelines [ACTION Registry-GWTG]) from July 1, 2007, to December 31, 2009, to Medicare claims data to obtain 1-year follow-up and medication adherence data. The ACTION Registry-GWTG is the largest quality-improvement registry of patients with MI in the United States. Included patients were all 65 years or older; had Medicare Parts A, B, and D; presented with MI; and survived to hospital discharge., Exposures: Dual Medicare and Medicaid eligibility., Main Outcomes and Measures: Death, readmission, major adverse cardiovascular events (death, recurrent MI, stroke), and medication adherence at 1 year., Results: Of 17 419 Medicare patients discharged alive after MI, 4674 (27%) were dual eligible. Dual-eligible patients were more likely to be female (64% vs 49%) and nonwhite (29% vs 6%), with a higher prevalence of comorbid conditions and more frequent presentation with non-ST elevation MI (non-STEMI) (75% vs 69%). Dual-eligible patients were less likely to receive primary percutaneous coronary intervention for STEMI (77% vs 81%), revascularization for non-STEMI (58% vs 65%), and prescription of secondary prevention medications at discharge. After multivariable adjustment, dual eligibility status was associated with a higher risk of readmission at 30 days (hazard ratio [HR], 1.16; 95% CI, 1.06-1.26), death at 1 year (HR, 1.24; 95% CI, 1.14-1.36), and major adverse cardiac events at 1 year (HR, 1.21; 95% CI, 1.12-1.31). Dual-eligible patients had higher 1-year adherence to medications prescribed at discharge (HR, 1.55; 95% CI, 1.39-1.74) than Medicare-only patients., Conclusions and Relevance: Compared with Medicare-only patients, older adults with dual Medicare-Medicaid eligibility presenting with MI have superior rates of medication adherence but higher rates of postdischarge readmission and adverse cardiovascular outcomes.

Cardiogenic shock is a common clinical condition with high in-hospital mortality. Early application of appropriate interventions for cardiogenic shock-including medical therapies, revascularization, temporary hemodynamic support devices, and durable mechanical circulatory support-may improve outcomes. The number and complexity of therapies for cardiogenic shock are increasing, making time-dependent decision-making more challenging. A multidisciplinary cardiogenic shock team is recommended to guide the rapid and efficient use of these available treatments. © 2015 Wiley Periodicals, Inc., (© 2015 Wiley Periodicals, Inc.)

Background: The use of oral P2Y12 receptor inhibitors after acute myocardial infarction (MI) can reduce risks of subsequent major adverse cardiovascular events (composite of all-cause death, recurrent MI, and stroke), yet medication persistence is suboptimal. Although copayment cost has been implicated as a factor influencing medication persistence, it remains unclear whether reducing or eliminating these costs can improve medication persistence and/or downstream clinical outcomes., Design: ARTEMIS is a multicenter, cluster-randomized clinical trial designed to examine whether eliminating patient copayment for P2Y12 receptor inhibitor therapy affects medication persistence and clinical outcomes. We will enroll approximately 11,000 patients hospitalized for acute ST-elevation and non-ST-elevation MI at 300 hospitals. Choice and duration of treatment with a P2Y12 receptor inhibitor will be determined by the treating physician. Hospitals randomized to the copayment intervention will provide vouchers to cover patients' copayments for their P2Y12 receptor inhibitor for up to 1 year after discharge. The coprimary end points are 1-year P2Y12 receptor inhibitor persistence and major adverse cardiovascular events. Secondary end points include choice of P2Y12 receptor inhibitor, patient-reported outcomes, and postdischarge cost of care., Conclusion: ARTEMIS will be the largest randomized assessment of a medication copayment reduction intervention on medication persistence, clinical outcomes, treatment selection, and cost of care after acute MI., (Copyright © 2016 Elsevier Inc. All rights reserved.)

Background: Angina is common both before and after myocardial infarction (MI). Whether the change in angina status within the first 30 days after MI is associated with subsequent readmission and angina persistence is unknown., Methods and Results: We studied 2915 MI patients enrolled at 24 hospitals in the Translational Research Investigating Underlying Disparities in Acute Myocardial Infarction Patients' Health Status (TRIUMPH) registry. Angina before and 30 days after MI was assessed with the Seattle Angina Questionnaire. Patients were divided into angina-free pre- and post-MI (-/-), resolved angina (+/-), new angina (-/+), and persistent angina (+/+) groups. Multivariable proportional hazards and hierarchical modified Poisson models were performed to assess the association of each group with all-cause readmission, readmission for MI or unplanned revascularization, and angina persistence at 1 year. Overall, 1293 patients (44%) had angina before their MI and 849 (29%) reported angina within 30 days of discharge. Patients with post-MI angina were more likely to be younger, nonwhite, and uninsured. Compared with patients who were angina-free pre- and post-MI, 1-year all-cause readmission risks were significantly higher for patients with persistent angina (hazard ratio [HR], 1.35; 95% CI 1.06-1.71) or new angina (HR, 1.40; 95% CI, 1.08-1.82). At 1 year, angina was present in 22% of patients and was more likely if angina was persistent (HR, 3.55; 95% CI, 3.05-4.13) or new (HR, 3.38; 95% CI, 2.59-4.42) at 30 days compared with patients who were angina-free pre- and post-MI., Conclusions: Post-MI angina, whether new or persistent, is associated with higher likelihood of readmission. Prioritizing post-MI angina management is a potential means of improving 1-year outcomes., (© 2016 The Authors. Published on behalf of the American Heart Association, Inc., by Wiley Blackwell.)

Background: Certain alleles of the CYP2C19 gene are associated with higher platelet reactivity and increased ischemic events among patients treated with clopidogrel. However, the relationship of CYP2C19 genotype and outcomes in medically managed patients with acute coronary syndromes (ACS) is not known., Objectives: This study sought to assess the effect of CYP2C19 genotype on ischemic outcomes in patients with ACS initially managed medically without revascularization who were randomized to either clopidogrel or prasugrel., Methods: We classified patients as extensive metabolizers (EM) or reduced metabolizers (RM) based on CYP2C19 genotype and evaluated ischemic outcomes and platelet reactivity. Among 9,326 patients enrolled from 2008 to 2011, 5,736 participated in the genetics cohort; of these, 2,236 had platelet function testing data., Results: There was no association between CYP2C19 metabolizer status (EM vs. RM) and the primary composite endpoint of cardiovascular death, myocardial infarction (MI), or stroke (hazard ratio [HR]: 0.86). EM and RM patients had similar rates of the primary endpoint whether treated with prasugrel (HR: 0.82) or clopidogrel (HR: 0.91; p for interaction = 0.495). After adjusting for clinical and treatment variables, EM patients had a lower risk of MI versus RM patients (HR: 0.80), but risks of other outcomes were similar. RM patients had significantly higher mean P2Y12 reaction units versus EM patients when treated with clopidogrel (39.93), but not with prasugrel (3.87)., Conclusions: CYP2C19 metabolizer status is not associated with the composite outcome of cardiovascular death, MI, or stroke in medically managed ACS patients treated with clopidogrel or prasugrel. Our findings do not support routine CYP2C19 genetic testing in this population. (A Comparison of Prasugrel and Clopidogrel in Acute Coronary Syndrome Subjects [TRILOGY ACS]; NCT00699998)., (Copyright © 2016 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)