Faculty Bibliography

BACKGROUND:Phase II trials of asundexian were underpowered to detect important differences in bleeding. OBJECTIVES/OBJECTIVE:The goal of this study was to obtain best estimates of effects of asundexian vs active control/placebo on major and clinically relevant nonmajor (CRNM) and all bleeding, describe most common sites of bleeding, and explore association between asundexian exposure and bleeding. METHODS:We performed a pooled analysis of 3 phase II trials of asundexian in patients with atrial fibrillation (AF), recent acute myocardial infarction (AMI), or stroke. Bleeding was defined according to the International Society on Thrombosis and Hemostasis (ISTH) criteria. RESULTS:In patients with AF (n = 755), both asundexian 20 mg and 50 mg once daily vs apixaban had fewer major/CRNM events (3 of 249; incidence rate [IR] per 100 patient-years 5.47 vs 1 of 254 [IR: not calculable] vs 6 of 250 [IR: 11.10]) and all bleeding (12 of 249 [IR: 22.26] vs 10 of 254 [IR: 18.21] vs 26 of 250 [IR: 50.56]). In patients with recent AMI or stroke (n = 3,409), asundexian 10 mg, 20 mg, and 50 mg once daily compared with placebo had similar rates of major/CRNM events (44 of 840 [IR: 7.55] vs 42 of 843 [IR: 7.04] vs 56 of 845 [IR: 9.63] vs 41 of 851 [IR: 6.99]) and all bleeding (107 of 840 [IR: 19.57] vs 123 of 843 [IR: 22.45] vs 130 of 845 [IR: 24.19] vs 129 of 851 [IR: 23.84]). Most common sites of major/CRNM bleeding with asundexian were gastrointestinal, respiratory, urogenital, and skin. There was no significant association between asundexian exposure and major/CRNM bleeding. CONCLUSIONS:Analyses of phase II trials involving >500 bleeds highlight the potential for improved safety of asundexian compared with apixaban and similar safety compared with placebo. Further evidence on the efficacy of asundexian awaits the results of ongoing phase III trials.

BACKGROUND/UNASSIGNED:Calcified coronary lesions are a challenge for percutaneous coronary interventions (PCIs). Coronary intravascular lithotripsy (IVL) is a novel calcium modification technology approved for commercial use in February 2021, but little is known about its uptake in US clinical practice. METHODS/UNASSIGNED:We described trends in use of calcium modification strategies, variation in use across hospitals, and predictors of calcium modification and IVL use in PCI. We included National Cardiovascular Data Registry CathPCI Registry patients who underwent PCI between April 1, 2018, and December 31, 2022. We examined trends and hospital variation in calcium modification and IVL use. We used multivariate hierarchical logistic regression to identify predictors of calcium modification and IVL use at hospitals in 2022. RESULTS/UNASSIGNED:Of 2,733,494 PCIs across 1676 hospitals over 4.75 years, 11.4% were performed with calcium modification. Coronary IVL use increased rapidly from 0% of PCIs in Q4 2020 to 7.8% of PCIs in Q4 2022, which was accompanied by an overall increase in use of all calcium modification strategies (11.1%-16.0%) during this period with a slight corresponding decrease in coronary atherectomy use (5.4%-4.4%). In 2022, there was wide variation in IVL use across hospitals (median, 3.86%; IQR, 0%-8.19%), with IVL being the most common calcium modification strategy in 48% of hospitals. The treating hospital was the strongest predictor of calcium modification (median odds ratio [OR], 2.49; 95% CI, 2.40-2.57) and IVL use (median OR, 2.89; 95% CI, 2.74-3.04). CONCLUSIONS/UNASSIGNED:IVL has rapidly changed the landscape of calcium modification use for PCI, although there remains wide variation across hospitals.

Several studies suggest differences in burnout and coping mechanisms between female and male physicians. We conducted an international, online survey exploring sex-based differences in the well-being of interventional cardiologists. Of 1251 participants, 121 (9.7%) were women. Compared with men, women were more likely to be single and under 50 years old, and they asked more often for development opportunities and better communication with administration. Overall burnout was similar between women and men, but women interventional cardiology attendings were more likely to think that they were achieving less than they should. Improved communication with administration and access to career development opportunities may help prevent or mitigate burnout in women interventional cardiologists.

BACKGROUND:In ST-segment elevation myocardial infarction (STEMI), complete revascularization with percutaneous coronary intervention (PCI) reduces major cardiovascular events compared with culprit-lesion-only PCI. Whether age influences these results remains unknown. METHODS:COMPLETE was a multinational, randomized trial evaluating a strategy of staged complete revascularization, consisting of angiography-guided PCI of all suitable nonculprit lesions, versus a strategy of culprit-lesion-only PCI. In this prespecified subgroup analysis, treatment effect according to age (≥65 years vs <65 years) was determined for the first coprimary outcome of cardiovascular (CV) death or new myocardial infarction (MI) and the second coprimary outcome of CV death, new MI, or ischemia-driven revascularization (IDR). Median follow-up was 35.8 months (interquartile range [IQR]: 27.6-44.3 months). RESULTS:Of 4,041 patients randomized in COMPLETE, 1,613 were aged ≥ 65 years (39.9%). Higher event rates were observed for both coprimary outcomes in patients aged ≥ 65 years comparted with those aged < 65 years (11.2% vs 7.9%, HR 1.49, 95% CI 1.22-1.83; 14.4% vs 11.8%, HR 1.28, 95% CI 1.07-1.52, respectively). Complete revascularization reduced the first coprimary outcome in patients ≥ 65 years (9.7% vs 12.5%, HR 0.77; 95% CI, 0.58-1.04) and < 65 years (6.7% vs 9.1%, HR 0.72; 95% CI, 0.54-0.96)(interaction P = .74). The second coprimary outcome was reduced in those ≥ 65 years (HR 0.56, 95% CI, 0.43-0.74) and < 65 years (HR 0.48, 95% CI, 0.37-0.61 (interaction P = .37). A sensitivity analysis was performed with consistent results demonstrated using a 75-year threshold (albeit attenuated). CONCLUSIONS:In patients with STEMI and multivessel CAD, complete revascularization compared with culprit-lesion-only PCI reduced major cardiovascular events regardless of patient age and could be considered as a revascularization strategy in older adults.

BACKGROUND:A strategy of administering a transfusion only when the hemoglobin level falls below 7 or 8 g per deciliter has been widely adopted. However, patients with acute myocardial infarction may benefit from a higher hemoglobin level. METHODS:In this phase 3, interventional trial, we randomly assigned patients with myocardial infarction and a hemoglobin level of less than 10 g per deciliter to a restrictive transfusion strategy (hemoglobin cutoff for transfusion, 7 or 8 g per deciliter) or a liberal transfusion strategy (hemoglobin cutoff, <10 g per deciliter). The primary outcome was a composite of myocardial infarction or death at 30 days. RESULTS:A total of 3504 patients were included in the primary analysis. The mean (±SD) number of red-cell units that were transfused was 0.7±1.6 in the restrictive-strategy group and 2.5±2.3 in the liberal-strategy group. The mean hemoglobin level was 1.3 to 1.6 g per deciliter lower in the restrictive-strategy group than in the liberal-strategy group on days 1 to 3 after randomization. A primary-outcome event occurred in 295 of 1749 patients (16.9%) in the restrictive-strategy group and in 255 of 1755 patients (14.5%) in the liberal-strategy group (risk ratio modeled with multiple imputation for incomplete follow-up, 1.15; 95% confidence interval [CI], 0.99 to 1.34; P = 0.07). Death occurred in 9.9% of the patients with the restrictive strategy and in 8.3% of the patients with the liberal strategy (risk ratio, 1.19; 95% CI, 0.96 to 1.47); myocardial infarction occurred in 8.5% and 7.2% of the patients, respectively (risk ratio, 1.19; 95% CI, 0.94 to 1.49). CONCLUSIONS:In patients with acute myocardial infarction and anemia, a liberal transfusion strategy did not significantly reduce the risk of recurrent myocardial infarction or death at 30 days. However, potential harms of a restrictive transfusion strategy cannot be excluded. (Funded by the National Heart, Lung, and Blood Institute and others; MINT ClinicalTrials.gov number, NCT02981407.).

As a result of increasing adoption of imaging screening, the number of adult patients with a diagnosis of anomalous aortic origin of the coronary arteries (AAOCA) has grown in recent years. Existing guidelines provide a framework for management and treatment, but patients with AAOCA present with a wide range of anomalies and symptoms that make general recommendations of limited applicability. In particular, a large spectrum of interventions can be used for treatment, and there is no consensus on the optimal approach to be used. In this paper, a multidisciplinary group of clinical and interventional cardiologists and cardiac surgeons performed a systematic review and critical evaluation of the available evidence on the interventional treatment of AAOCA in adult patients. Using a structured Delphi process, the group agreed on expert recommendations that are intended to complement existing clinical practice guidelines.

As a result of increasing adoption of imaging screening, the number of adult patients with a diagnosis of anomalous aortic origin of the coronary arteries (AAOCA) has grown in recent years. Existing guidelines provide a framework for management and treatment, but patients with AAOCA present with a wide range of anomalies and symptoms that make general recommendations of limited applicability. In particular, a large spectrum of interventions can be used for treatment, and there is no consensus on the optimal approach to be used. In this paper, a multidisciplinary group of clinical and interventional cardiologists and cardiac surgeons performed a systematic review and critical evaluation of the available evidence on the interventional treatment of AAOCA in adult patients. Using a structured Delphi process, the group agreed on expert recommendations that are intended to complement existing clinical practice guidelines.

Total occlusion of both coronary ostia is a rare and potentially life-threatening complication following surgical aortic valve replacement. This report presents a case of a patient with known total occlusion of both coronary artery ostia following combined coronary artery bypass graft surgery and aortic valve replacement who underwent successful percutaneous coronary intervention through a retrograde approach.

AIMS/OBJECTIVE:Prior trials have demonstrated that intravascular imaging (IVI)-guided percutaneous coronary intervention (PCI) results in less frequent target lesion revascularization and major adverse cardiovascular events (MACEs) compared with standard angiographic guidance. The uptake and associated outcomes of IVI-guided PCI in contemporary clinical practice in the USA remain unclear. Accordingly, temporal trends and comparative outcomes of IVI-guided PCI relative to PCI with angiographic guidance alone were examined in a broad, unselected population of Medicare beneficiaries. METHODS AND RESULTS/RESULTS:Retrospective cohort study of Medicare beneficiary data from 1 January 2013, through 31 December 2019 to evaluate temporal trends and comparative outcomes of IVI-guided PCI as compared with PCI with angiography guidance alone in both the inpatient and outpatient settings. The primary outcomes were 1 year mortality and MACE, defined as the composite of death, myocardial infarction (MI), repeat PCI, or coronary artery bypass graft surgery. Secondary outcomes were MI or repeat PCI at 1 year. Multivariable Cox regression was used to estimate the adjusted association between IVI guidance and outcomes. Falsification endpoints (hospitalized pneumonia and hip fracture) were used to assess for potential unmeasured confounding. The study population included 1 189 470 patients undergoing PCI (38.0% female, 89.8% White, 65.1% with MI). Overall, IVI was used in 10.5% of the PCIs, increasing from 9.5% in 2013% to 15.4% in 2019. Operator IVI use was variable, with the median operator use of IVI 3.92% (interquartile range 0.36%-12.82%). IVI use during PCI was associated with lower adjusted rates of 1 year mortality [adjusted hazard ratio (aHR) 0.96, 95% confidence interval (CI) 0.94-0.98], MI (aHR 0.97, 95% CI 0.95-0.99), repeat PCI (aHR 0.74, 95% CI 0.73-0.75), and MACE (aHR 0.85, 95% CI 0.84-0.86). There was no association with the falsification endpoint of hospitalized pneumonia (aHR 1.02, 95% CI 0.99-1.04) or hip fracture (aHR 1.02, 95% CI 0.94-1.10). CONCLUSION/CONCLUSIONS:Among Medicare beneficiaries undergoing PCI, use of IVI has increased over the previous decade but remains relatively infrequent. IVI-guided PCI was associated with lower risk-adjusted mortality, acute MI, repeat PCI, and MACE.

BACKGROUND:Based on recent clinical data, the 2020 ESC guidelines on non-ST elevation acute coronary syndrome (NSTE-ACS) suggest to tailor antithrombotic strategy on individual thrombotic risk. Nonetheless, prevalence and prognostic impact of the high thrombotic risk (HTR) criteria proposed are yet to be described. METHODS AND RESULTS/RESULTS:PROMETHEUS was a multicenter prospective study comparing prasugrel vs. clopidogrel in ACS patients undergoing PCI. In this analysis, we assessed prevalence and prognostic impact of HTR, defined according to the 2020 ESC NSTE-ACS guidelines, and if the benefits associated with prasugrel vs. clopidogrel vary with thrombotic risk. Patients were at HTR if presenting with one clinical plus one procedural risk feature. The primary endpoint was major adverse cardiac events (MACE), composite of death, myocardial infarction, stroke, or unplanned revascularization, at 1 year. Adjusted hazard ratio (adjHR) and 95% confidence intervals (CI) were calculated with propensity score stratification and multivariable Cox regression.Among 16065 patients, 4293 (26.7%) were at HTR and 11772 (73.3%) at low-to-moderate thrombotic risk. HTR conferred increased incidence of MACE (23.3 vs. 13.6%, HR 1.85, 95% CI 1.71 - 2.00, p < 0.001) and its single components. Prasugrel was prescribed in patients with less comorbidities and risk factors and was associated with reduced risk of MACE (HTR: adjHR 0.83, 95%CI 0.68-1.02; low-to-moderate risk: adjHR 0.75, 95%CI 0.64-0.88; pinteraction = 0.32). CONCLUSION/CONCLUSIONS:High thrombotic risk, as defined by the 2020 ESC NSTE-ACS guidelines, is highly prevalent among ACS patients undergoing PCI. The high thrombotic risk definition had a strong prognostic impact, as it successfully identified patients at increased 1-year risk of ischemic events.