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Background: Randomized clinical trials are the gold standard to assess the causal relationship between an intervention and subsequent outcomes, also known as clinical endpoints. In order to limit bias, central clinical events committees (CEC) are established to ensure consistent event reporting across participating centers, as well as complete and accurate ascertainment of endpoints. However, defining independence is challenging., Methods: This consensus statement was generated by teleconferences and electronic communications among clinical research organizations from the United States, Europe and Australia. This document does not constitute regulatory guidance., Results: An independent CEC is defined when the adjudicators are not primarily involved in designing, funding, sponsoring, organizing, conducting, analyzing or regulating the clinical trial for which they serve as an adjudicator, beyond their role as CEC member. Moreover, independence requires absence of conflicts of interest with the steering committee, sponsor, grant giver, manufacturer, coordinating center, other independent committees, core laboratories, medical monitor, safety physician, participating clinical sites, statistician or data manager, regulatory agencies or authorities, which could influence (or be perceived to influence) a member's objectivity in evaluating trial data. Such conflicts of interest include financial benefits, directing or advisory role (paid or unpaid), decision-making position, as well as being a direct relative. An independent adjudicator has no other role within a clinical trial., Conclusions: This consensus statement presents a standardized definition of an independent CEC to be considered by clinical research organizations, manufacturers, and investigators. In addition, it provides recommendations on best practices for implementation of an independent CEC., (Copyright © 2022. Published by Elsevier Inc.)

Background: Novel P2Y12 inhibitors prasugrel and ticagrelor were approved for patients with acute coronary syndrome (ACS) in 2009 and 2011, respectively. We assessed the association of racial, ethnic, and socioeconomic factors with initiation of and adherence to novel P2Y12 inhibitors in a commercially insured population., Methods: We performed a retrospective cohort analysis of adults undergoing percutaneous coronary intervention with placement of a drug-eluting stent, stratified by ACS status, between January 2008 and December 2016 using Clinformatics Data Mart (OptumInsight). We estimated multivariable logistic regression models to identify factors associated with the initiation of clopidogrel vs novel P2Y12 inhibitors as well as subsequent 6-month medication adherence, assessed via pharmacy records., Results: A total of 55,664 patients were included in the analysis. Hispanic ethnicity was independently associated with the initiation of clopidogrel compared with novel P2Y12 inhibitors among ACS patients (odds ratio [OR], 1.19; 95% confidence interval [CI], 1.04-1.36; P<.01). ACS patients with an annual median household income of over $100,000 were less likely to be started on clopidogrel when compared with those who earned less than $40,000 (OR, 0.67; 95% CI, 0.61-0.75; P<.01). Black race, Hispanic ethnicity, and lower household income were each associated with significantly reduced odds of P2Y12 inhibitor adherence., Conclusion: Hispanic ethnicity and lower household income were associated with novel P2Y12 inhibitor initiation, and non-White race and ethnicity were associated with lower P2Y12 inhibitor adherence over 6-month follow-up. These findings highlight continued inequity of care, even in an insured population, and point to a need for new strategies to close these gaps.

Background: The use of apixaban instead of vitamin K antagonists (VKA) as well as dropping aspirin results in less bleeding and comparable ischemic events in patients with atrial fibrillation and acute coronary syndrome and/or percutaneous coronary intervention treated with a P2Y 12 inhibitor., Objectives: The authors assessed the safety and efficacy of antithrombotic regimens according to HAS-BLED and CHA 2 DS 2 -VASc scores in AUGUSTUS (The Open-Label, 2 × 2 Factorial, Randomized, Controlled Clinical Trial to Evaluate the Safety of Apixaban vs. Vitamin K Antagonist and Aspirin vs. Placebo in Patients with Atrial Fibrillation and Acute Coronary Syndrome and/or Percutaneous Coronary Intervention)., Methods: In AUGUSTUS, 4,614 patients were randomized in a 2-by-2 factorial design to open-label apixaban or VKA and blinded aspirin or placebo. The primary endpoint was major or clinically relevant nonmajor bleeding over 6 months of follow-up. Cox proportional hazards models were used to assess treatment effects by baseline HAS-BLED (≤2 vs ≥3) and CHA 2 DS 2 -VASc (≤2 vs ≥3) scores., Results: Of 4,386 (95.1%) patients with calculable scores, 66.8% had HAS-BLED ≥3 and 81.7% had CHA 2 DS 2 -VASc ≥3. Bleeding rates were lower with apixaban than VKA irrespective of baseline risk (HR: 0.57; 95% CI: 0.41-0.78 [HAS-BLED ≤2]; HR: 0.72; 95% CI: 0.59-0.88 [HAS-BLED ≥3]; interaction P = 0.23). Aspirin increased bleeding irrespective of baseline risk (HR: 1.86; 95% CI: 1.36-2.56 [HAS-BLED ≤2]; HR: 1.81; 95% CI: 1.47-2.23 [HAS-BLED ≥3]; interaction P = 0.88). Apixaban resulted in a lower risk of death or hospitalization than VKA without a significant interaction with baseline stroke risk (HR: 0.92; 95% CI: 0.67-1.25 [CHA 2 DS 2 -VASc ≤2]; HR: 0.82; 95% CI: 0.73-0.94 [CHA 2 DS 2 -VASc ≥3]; interaction P = 0.53)., Conclusions: Our findings support the use of apixaban and a P2Y 12 inhibitor without aspirin for most patients with atrial fibrillation and acute coronary syndrome and/or percutaneous coronary intervention, irrespective of a patient's baseline bleeding and stroke risk (NCT02415400)., Competing Interests: Funding Support and Author Disclosures The AUGUSTUS trial and this analysis were supported by Bristol Myers Squibb and Pfizer. Dr Fanaroff has received research grants and consulting fees from the American Heart Association; and has received research grants from Boston Scientific. Dr Lopes has received institutional research grants and consulting fees from Bristol Myers Squibb, Pfizer, GlaxoSmithKline, Medtronic PLC, and Sanofi; and has received consulting fees from Amgen, Bayer, and Boehringer Ingelheim. Dr Goodman has received research grant support (eg, steering committee or data and safety monitoring committee) and/or speaker/consulting honoraria (eg, advisory boards) from Amgen, AstraZeneca, Bayer, Boehringer Ingelheim, Bristol Myers Squibb, CSL Behring, Daiichi-Sankyo/American Regent, Eli Lilly, Esperion, Ferring Pharmaceuticals, GlaxoSmithKline, HLS Therapeutics, JAMP Pharma, Janssen/Johnson and Johnson, Merck, Novartis, Novo Nordisk A/C, Pendopharm, Pfizer, Regeneron, Sanofi, Servier, and Valeo Pharma; and has received salary support/honoraria from the Heart and Stroke Foundation of Ontario/University of Toronto (Polo) (Chair), Canadian Heart Research Centre and MD Primer, Canadian VIGOUR Centre, Cleveland Clinic Coordinating Centre for Clinical Research, Duke Clinical Research Institute, New York University Clinical Coordinating Centre, and PERFUSE Research Institute. Dr Thomas has received institutional research grants from Akili Interactive Labs Inc, Amgen Inc, Gilead, and Novartis. Dr Aronson is an employee of Bristol Myers Squibb. Dr Windecker has received Institutional research and educational grants from Abbott, Amgen, Bayer, Bristol Myers Squibb, CSL Behring, Boston Scientific, Biotronik, Edwards Lifesciences, Medtronic, Polares, and Sinomed. Dr Mehran has received institutional research grants from AstraZeneca, Bayer, Beth Israel Deaconess, Bristol Myers Squibb/Sanofi, CSL Behring, Eli Lilly/Daiichi-Sankyo, Medtronic, Novartis, and OrbusNeich; has received consulting fees from Boston Scientific, Abbott Vascular, Medscape, Siemens Medical Solutions, Roivant Sciences Inc, and Sanofi; has performed consulting (no fees) for Regeneron Pharmaceuticals; has received institutional consulting fees from Abbott Vascular, Spectranetics/Phillips/Volcano Corporation, Bristol Myers Squibb, Novartis, and Watermark Research; has served as an executive committee member for Janssen Pharmaceuticals and Bristol Myers Squibb; and has <1% equity in Claret Medical and Elixir Medical. Dr Granger has received research grants from Bayer, Boehringer Ingelheim, Bristol Myers Squibb, Daiichi-Sankyo, Janssen, Pfizer, Armetheon, AstraZeneca, the U.S. Food and Drug Administration, GlaxoSmithKline, The Medicines Company, Medtronic Foundation, Medtronic Inc, and Novartis; and has received consulting fees from Bayer, Boehringer Ingelheim, Boston Scientific, Bristol Myers Squibb, Daiichi-Sankyo, Janssen, Pfizer, Abbvie, Armetheon, AstraZeneca, Eli Lilly, Gilead, GlaxoSmithKline, Hoffmann-La Roche, The Medicines Company, National Institutes of Health, Novartis, Sirtex, Verseon, Apple, Medscape, LLC, Merck, Novo Nordisk, Roche Diagnostics, and Rho Pharmaceuticals. Dr Alexander has received institutional research grants and consulting fees/honoraria from Bristol Myers Squibb and CSL Behring; has received institutional research grants from AstraZeneca, CryoLife, the U.S. Food and Drug Administration, National Institutes of Health, Sanofi, VoluMetrix, and Boehringer Ingelheim; and has received consulting fees/honoraria from Pfizer, AbbVie Pharmaceuticals, NovoNordisk, Portola Pharmaceuticals, Quantum Genetics, Teikoku Pharmaceuticals, VA Cooperative Studies Program, and Zafgen. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose., (Copyright © 2022 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Transcatheter aortic valve replacement (TAVR) has revolutionized the treatment of aortic stenosis, with the number of procedures and sites offering the procedure steadily rising over the past decade in the United States. Despite this, growth into certain markets has been limited as hospitals have to balance high TAVR costs with the ability to offer a complete array of state-of-the-art therapies for aortic stenosis. This trade-off often results in decreased access to TAVR services by patients cared for in hospitals that cannot afford these services or have difficulty meeting procedural requirements, recruiting skilled physicians, and initiating and then maintaining a functioning TAVR program. The lack of access is more common among patients of color or those who are socioeconomically disadvantaged. The purpose of this review is to describe the hospital-level economic considerations of TAVR in the United States and the resulting effects on geographic, racial, ethnic, and socioeconomic access for Americans.

Peripheral vascular intervention (PVI) improves quality of life and reduces major adverse limb events in patients with peripheral arterial disease. PVI is commonly performed via the femoral artery, and the most common adverse periprocedural event is a vascular access complication. Transradial access for PVI has the potential to reduce vascular access complications and improve patient outcomes. Further study is needed to elucidate the risks of stroke, acute kidney injury, and radiation exposure in the setting of transradial PVI. As transradial access for PVI progresses, it will be important to build the evidence base along with procedural experience., (Copyright © 2019 Elsevier Inc. All rights reserved.)

Greater optimism regarding recovery from chronic illness is associated with improved quality of life and clinical outcomes. We performed a post-hoc analysis on the association between optimism and outcomes in Ranolazine in Patients with Incomplete Revascularization after Percutaneous Coronary Intervention (RIVER-PCI), a randomized trial in patients with chronic angina pectoris who had incomplete revascularization following percutaneous coronary intervention. At baseline, patients answered how much they agreed with the phrase, "I am optimistic about my future and returning to a normal lifestyle." We evaluated the association between baseline optimism and time to ischemia-driven hospitalization or revascularization using a Cox model, and the association between baseline optimism and change in frequency of angina pectoris using a mixed measures model. Of 2,389 patients, 782 (33.2%) were very optimistic ("strongly agree"), 1,000 (42.4%) were optimistic ("agree"), 451 (19.1%) were neutral ("undecided"), and 123 (5.2%) were not optimistic ("disagree" or "strongly disagree"). Very optimistic patients had a lower prevalence of co-morbidities and less severe angina at baseline than less optimistic patients. The rate of ischemia-driven revascularization or hospitalization was higher in neutral and not optimistic patients compared with very optimistic patients; this finding persisted after adjustment for co-morbidities and baseline angina frequency (hazard ratio 1.42, 95% confidence interval 1.14 to 1.77 for neutral vs very optimistic; hazard ratio 1.38, 95% confidence interval 0.98 to 1.94 for not optimistic vs very optimistic). Neutral and not optimistic patients also had less improvement in angina than very optimistic patients. In conclusion, in patients with angina, those with more self-reported optimism had better health status outcomes. Whether structured interventions targeting optimism improve outcomes in these patients warrants further study., (Copyright © 2019 Elsevier Inc. All rights reserved.)

Objectives: The aims of this study were to describe variability in intensive care unit (ICU) utilization for patients with uncomplicated ST-segment elevation myocardial infarction (STEMI), evaluate the proportion of these patients who developed in-hospital complications requiring ICU care, and assess whether ICU use patterns and complication rates vary across categories of first medical contact to device times., Background: In the era of rapid primary percutaneous coronary intervention, ICUs may be overutilized as patients presenting with STEMI are less likely to develop complications requiring ICU care., Methods: Using data from the Chest Pain-MI Registry linked to Medicare claims, the authors examined patterns of ICU utilization among hemodynamically stable patients with STEMI ≥65 years of age treated with uncomplicated primary percutaneous coronary intervention, stratified by timing of reperfusion: early (first medical contact-to-device time ≤60 min), intermediate (61 to 90 min), or late (>90 min)., Results: Of 19,507 patients with STEMI treated at 707 hospitals, 82.3% were treated in ICUs, with a median ICU stay of 1 day (interquartile range [IQR]: 1 to 2 days). The median FMC-to-device time was 79 min (IQR: 63 to 99 min); 22.0% of patients had early, 44.8% intermediate, and 33.2% late reperfusion. ICU utilization rates did not differ between patients with early, intermediate, and late reperfusion times (82%, 83%, and 82%; p for trend = 0.44). Overall, 3,159 patients (16.2%) developed complications requiring ICU care while hospitalized: 3.7% died, 3.7% had cardiac arrest, 8.7% shock, 0.9% stroke, 4.1% high-grade atrioventricular block requiring treatment, and 5.7% respiratory failure. Patients with longer FMC-to-device times were more likely to develop at least 1 of these complications (early 13.4%, intermediate 15.7%, and late 18.7%; p for trend <0.001; adjusted odds ratio [early as reference] for intermediate: 1.13 [95% confidence interval: 1.01 to 1.25]; adjusted odds ratio for late: 1.22 [95% confidence interval: 1.08 to 1.37])., Conclusions: Although >80% of stable patients with STEMI are treated in the ICU after primary percutaneous coronary intervention, the risk for developing a complication requiring ICU care is 16%. Implementing a risk-based triage strategy, inclusive of factors such as degree of reperfusion delay, could optimize ICU utilization for patients with STEMI., (Copyright © 2019 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Objectives: The aim of this study was to describe the prevalence of pre-hospital cardiac catheterization laboratory activation and its association with reperfusion timeliness and in-hospital mortality., Background: For patients with ST-segment elevation myocardial infarction diagnosed in the field, catheterization laboratory pre-activation may lead to more timely reperfusion and improved outcomes., Methods: A total of 27,840 patients with ST-segment elevation myocardial infarction transported via emergency medical services to 744 percutaneous coronary intervention-capable hospitals in the ACTION Registry from January 2015 to March 2017 were evaluated, excluding patients with cardiac arrest or requiring pre-percutaneous coronary intervention intubation. Catheterization laboratory pre-activation was defined as activation >10 min prior to hospital arrival., Results: Catheterization laboratory pre-activation occurred in 41% of patients (n = 11,379), with minor presenting differences between those with and without catheterization laboratory pre-activation. Compared with no catheterization laboratory pre-activation, pre-activation patients were more likely to be directly transported to the catheterization laboratory on hospital arrival (23.3% vs. 5.3%), to have shorter hospital arrival-to-catheterization laboratory arrival time (median 17 min [interquartile range (IQR): 7 to 25 min] vs. 28 min [IQR: 18 to 39 min]), to have shorter door-to-device time (40 min [IQR: 30 to 51 min] vs. 52 min [IQR: 41 to 65 min]), and to have a greater likelihood of achieving first medical contact-to-device time ≤90 min (76.6% vs. 68.6%) (p < 0.001 for all). Pre-activation was associated with lower in-hospital mortality (2.8% vs. 3.4%; p = 0.01). Patients treated at hospitals in the lowest tertile of pre-activation rates had higher mortality than those treated at hospitals in the highest tertile before and after adjustment (3.6% vs. 2.7%; adjusted odds ratio: 1.33; 95% confidence interval: 1.08 to 1.63)., Conclusions: In the United States, catheterization laboratory pre-activation occurred in fewer than one-half of emergency medical services-transported patients with ST-segment elevation myocardial infarction. Its association with faster reperfusion and lower mortality supports greater use of this strategy., (Copyright © 2018 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Background: Angina has important implications for patients' quality of life and healthcare utilization. Angina management after acute myocardial infarction (MI) treated with percutaneous coronary intervention (PCI) is unknown., Methods and Results: TRANSLATE-ACS (Treatment With Adenosine Diphosphate Receptor Inhibitors: Longitudinal Assessment of Treatment Patterns and Events After Acute Coronary Syndrome) was a longitudinal study of MI patients treated with percutaneous coronary intervention at 233 US hospitals from 2010 to 2012. Among patients with self-reported angina at 6 weeks post-MI, we described patterns of angina and antianginal medication use through 1 year postdischarge. Of 10 870 percutaneous coronary intervention-treated MI patients, 3190 (29.3%) reported angina symptoms at 6 weeks post-MI; of these, 658 (20.6%) had daily/weekly angina while 2532 (79.4%) had monthly angina. Among patients with 6-week angina, 2936 (92.0%) received β-blockers during the 1 year post-MI, yet only 743 (23.3%) were treated with other antianginal medications. At 1 year, 1056 patients (33.1%) with 6-week angina reported persistent angina symptoms. Of these, only 31.2% had been prescribed non-β-blocker antianginal medications at any time in the past year. Among patients undergoing revascularization during follow-up, only 25.9% were on ≥1 non-β-blocker anti-anginal medication at the time of the procedure., Conclusions: Angina is present in one third of percutaneous coronary intervention-treated MI patients as early as 6 weeks after discharge, and many of these patients have persistent angina at 1 year. Non-β-blocker antianginal medications are infrequently used in these patients, even among those with persistent angina and those undergoing revascularization., (© 2017 The Authors. Published on behalf of the American Heart Association, Inc., by Wiley.)