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Dual antiplatelet therapy (DAPT) after percutaneous coronary intervention is necessary for preventing stent thrombosis and ensuring long-term cardiovascular protection. It is important to be thoughtful in balancing thrombotic and bleeding risk when deciding therapy regimen and duration. Revascularization randomized trials have studied many specific, at-risk populations; however, women remain underrepresented. Although there is evidence to support shortened DAPT duration in women, especially those at higher bleeding risk or on chronic oral anticoagulation, we need trials specifically enrolling and focusing on women., (Copyright © 2024 Elsevier Inc. All rights reserved.)

Background: The prediction of mortality, bleeding, and acute kidney injury (AKI) after percutaneous coronary intervention (PCI) traditionally relied on race-based estimates of the glomerular filtration rate (GFR). Recently, race agnostic equations were developed to advance equity., Objectives: The authors aimed to compare the accuracy and implications of various GFR equations when used to predict AKI after PCI., Methods: Using the National Cardiovascular Data Registry (NCDR) CathPCI data set, we identified patients undergoing PCI in 2020 and calculated their AKI risk using the 2014 NCDR AKI risk model. We created 4 AKI models per patient for each estimate of baseline renal function: the traditional GFR equation with a race term, 2 GFR equations without a race term, and serum creatinine alone. We then compared each model's performance predicting AKI., Results: Among 455,806 PCI encounters, the median age was 67 years, 32.2% were women, and 8.5% were Black. In Black patients, risk models without a race term were better calibrated than models incorporating an equation with a race term (intercept: -0.01 vs 0.15). Race-agnostic models reclassified 6% of Black patients into higher-risk categories, potentially prompting appropriate mitigation efforts. However, even with a race-agnostic model, AKI occurred in Black patients 18% more often than expected, which was not explained by captured patient or procedural characteristics., Conclusions: Incorporating a GFR estimate without a Black race term into the NCDR AKI risk prediction model yielded more accurate prediction of AKI risk for Black patients, which has important implications for reducing disparities and benchmarking., Competing Interests: Funding Support and Author Disclosures Dr Uzendu is supported by the National Heart, Lung and Blood Institutes of Health under Award Number 5T32H110837. The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health. Dr Chertow serves on the Board of Directors of Satellite Healthcare, a nonprofit dialysis provider; has served as a steering committee member or chair for clinical trials sponsored by Akebia, AstraZeneca, CSL Behring, Gilead, Sanifit, and Vertex; has served as an advisor to Ardelyx, Durect, Eliaz Therapeutics, Miromatrix, Outset, Reata, Renibus, and Unicycive; and has served as Data Safety and Monitoring Board member or chair for trials sponsored by Bayer, Gilead, Mineralys, Palladio, and ReCor. Dr Giri has received research funds to his institution; and has served on advisory boards for Boston Scientific, Abiomed, Abbot Vascular, Inari Medical, Biosense Webster, and Recor Medical. Dr Rymer has served on the advisory board for Chiesi; has received a research grant from Chiesi; and has received research funding from Idorsia, Pfizer, and Abbott. Dr Bangalore has served on the advisory board for Abbott Vascular, Boston Scientific, Amgen, Pfizer, Merck, Inari, and Truvic. Dr Spertus has provided consultative services on patient-reported outcomes and evidence evaluation to Alnylam, AstraZeneca, Bayer, Merck, Janssen, Bristol Meyers Squibb, Edwards Lifesciences, Kineksia, 4DT Medical, Terumo, Cytokinetics, Imbria, and United Healthcare; holds research grants from Bristol Meyers Squibb, Abbott Vascular, and Janssen; owns the copyright to the Seattle Angina Questionnaire, Kansas City Cardiomyopathy Questionnaire, and Peripheral Artery Questionnaire; and serves on the Board of Directors for Blue Cross Blue Shield of Kansas City. All other 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: Acute kidney injury (AKI) is the most common complication after percutaneous coronary intervention (PCI). Accurately estimating patients' risks not only creates a means of benchmarking performance but can also be used prospectively to inform practice., Objectives: The authors sought to update the 2014 National Cardiovascular Data Registry (NCDR) AKI risk model to provide contemporary estimates of AKI risk after PCI to further improve care., Methods: Using the NCDR CathPCI Registry, we identified all 2020 PCIs, excluding those on dialysis or lacking postprocedural creatinine. The cohort was randomly split into a 70% derivation cohort and a 30% validation cohort, and logistic regression models were built to predict AKI (an absolute increase of 0.3 mg/dL in creatinine or a 50% increase from preprocedure baseline) and AKI requiring dialysis. Bedside risk scores were created to facilitate prospective use in clinical care, along with threshold contrast doses to reduce AKI. We tested model calibration and discrimination in the validation cohort., Results: Among 455,806 PCI procedures, the median age was 67 years (IQR: 58.0-75.0 years), 68.8% were men, and 86.8% were White. The incidence of AKI and new dialysis was 7.2% and 0.7%, respectively. Baseline renal function and variables associated with clinical instability were the strongest predictors of AKI. The final AKI model included 13 variables, with a C-statistic of 0.798 and excellent calibration (intercept = -0.03 and slope = 0.97) in the validation cohort., Conclusions: The updated NCDR AKI risk model further refines AKI prediction after PCI, facilitating enhanced clinical care, benchmarking, and quality improvement., Competing Interests: Funding Support and Author Disclosures Dr Anezi Uzendu is supported by the National Heart, Lung and Blood Institutes of Health under Award Number 5T32H110837. The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health. Dr Chertow serves on the Board of Directors of Satellite Healthcare, a nonprofit dialysis provider; has served as a steering committee member or chair for clinical trials sponsored by Akebia, AstraZeneca, CSL Behring, Gilead, Sanifit, and Vertex; has served as an advisor to Ardelyx, Durect, Eliaz Therapeutics, Miromatrix, Outset, Reata, Renibus, and Unicycive; and has served as a Data Safety and Monitoring Board member or chair for trials sponsored by Bayer, Gilead, Mineralys, Palladio, and ReCor. Dr Giri has received research funds to his institution; and has served on advisory boards for Boston Scientific, Abiomed, Abbott Vascular, Inari Medical, Biosense Webster, and Recor Medical. Dr Rymer has served on the advisory board for Chiesi; has received a research grant from Chiesi; and receives research funding from Idorsia, Pfizer, and Abbott. Dr Bangalore discloses has served on the advisory board for Abbott Vascular, Boston Scientific, Amgen, Pfizer, Merck, Inari, and Truvic. Dr Wang has received research grants to the Duke Clinical Research Institute from Abbott, AstraZeneca, Bristol Myers Squibb, Boston Scientific, Artivion (formerly Cryolife), Chiesi, Merck, Portola, and Regeneron; and has received consulting honoraria from AstraZeneca, Bristol Myers Squibb, Artivion (formerly Cryolife), CSL Behring, and Novartis. Dr Curtis has an institutional contract with the American College of Cardiology for his role as chief scientific adviser of the NCDR; and has equity in Medtronic. Dr Spertus has provided consultative services on patient-reported outcomes and evidence evaluation to Alnylam, AstraZeneca, Bayer, Merck, Janssen, Bristol Meyers Squibb, Edwards Lifesciences, Kineksia, 4DT Medical, Terumo, Cytokinetics, Imbria, and United Healthcare; holds research grants from Bristol Meyers Squibb, Abbott Vascular, and Janssen; owns the copyright to the Seattle Angina Questionnaire, Kansas City Cardiomyopathy Questionnaire, and Peripheral Artery Questionnaire; and serves on the Board of Directors for Blue Cross Blue Shield of Kansas City. All other 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.)

Competing Interests: Funding Support and Author Disclosures Dr Seto has received speaker fees from Terumo and is a consultant for Medtronic. Dr Velagapudi has received travel funding from Boston Scientific and Medtronic; and has received speaker fees from Medtronic. Dr Carr holds equity in an ASC OBL and is a consultant for Abbott. Dr Blankenship is a principal investigator for research on supersaturated oxygen infusion after anterior MI funded by Zoll. Dr Abbott is a consultant for Boston Scientific. Dr Mamas has received speaker fees from Terumo; and is a principal investigator for registry-based research on complex PCI outcomes funded by Abbott. Dr Vidovich holds equity of intellectual property related to catheter technology and is a principal investigator for research on optical coherence tomography in left main funded by Boston Scientific. Dr Kent is a consultant for Medtronic; and is an adviser to Abbott. Dr Curzen is a chief investigator for the RIPCORD 2 (A Randomised Controlled Trial to Compare Routine Pressure Wire Assessment With Conventional Angiography in the Management of Patients With Coronary Artery Disease) trial, funded by Boston Scientific, and the FORECAST (Fractional Flow Reserve Derived From Computed Tomography Coronary Angiography in the Assessment and Management of Stable Chest Pain) trial, funded by HeartFlow; has received research grants from Boston Scientific and Beckmann Coulter; has received speaker fees from Abbott, Boston Scientific, and Edwards Lifesciences; has received travel funds from Biosensors, Medtronic, Edwards Lifesciences, and Boston Scientific; and is a consultant for Abbott, Boston Scientific, and Edwards Lifesciences. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose.

Introduction: The COVID-19 pandemic had an unprecedented impact on cardiovascular clinical research. The decision-making and state of study operations in cardiovascular trials 1-year after interruption has not been previously described., Methods: In the spring of 2020, we created a pandemic impact task force to develop a landscape of use case scenarios from 17 device trials of peripheral artery disease (PAD) and coronary artery disease (CAD) interventions. In conjunction with publicly available (clinictrials.gov) study inclusion criteria, primary endpoints and study design, information was shared for this use-case landscape by trial leadership and data owners., Results: A total of 17 actively enrolling trials (9 CAD and 8 PAD) volunteered to populate the use case landscape. All 17 were multicenter studies (12 in North America and 5 international). Fifteen studies were industry-sponsored, of which 13 were FDA approved IDEs, one was PCORI-sponsored and two were sponsored by the NIH. Enrollment targets ranged from 150 to 9000 pts. At the time of interruption, 5 trials were <20 % enrolled, 9 trials were 50-80 % enrolled and 3 trials were >80 % enrolled. At 1 year, the majority of studies were continuing to enroll in the context of more sporadic but ongoing pandemic activity., Conclusions: At 1 year from the first surge interruptions, most trials had resumed enrollment. Trials most heavily interrupted were trials early in enrollment and those trials not able to pivot to virtual patient and site visits. Further work is needed to determine the overall impact on vascular intervention trials disrupted during the COVID-19 pandemic., Competing Interests: Declaration of competing interest AK: Institutional funding to Columbia University and/or Cardiovascular Research Foundation from Medtronic, Boston Scientific, Abbott Vascular, Amgen, CSI, Philips, ReCor Medical, Neurotronic, Biotronik, Chiesi, Bolt Medical, Magenta Medical, Canon, and SoniVie. In addition to research grants, institutional funding includes fees paid to Columbia University and/or Cardiovascular Research Foundation for consulting and/or speaking engagements in which Dr. Kirtane controlled the content. Personal: Consulting from IMDS; Travel Expenses/Meals from Medtronic, Boston Scientific, Abbott Vascular, CSI, Siemens, Philips, ReCor Medical, Chiesi, OpSens, Zoll, and Regeneron. MJ: Part-Time employee, Boston Scientific Corporation; Advisor, Gilde Healthcare; Advisor, Nectero Medical; Board Member, Access Vascular Corporation. Personal investment: Efemoral; Embolitech; R3 Vascular; Vascular Therapies; Venarum. KS: Employee of Mercator MedSytems. DS: DS is an employee of Boston Scientific. JAR, AF, MM, MB, and MK has no relevant funding., (Copyright © 2022 Elsevier Inc. All rights reserved.)

Objectives: The aims of this study were to examine rates of radial artery access in post-coronary artery bypass grafting (CABG) patients undergoing diagnostic catherization and/or percutaneous coronary intervention (PCI), whether operators with higher procedural volumes and higher percentage radial use were more likely to perform diagnostic catherization and/or PCI via the radial approach in post-CABG patients, and clinical and procedural outcomes in post-CABG patients who undergo diagnostic catherization and/or PCI via the radial or femoral approach., Background: There are limited data comparing outcomes of patients with prior CABG undergoing transradial or transfemoral diagnostic catheterization and/or PCI., Methods: Using the National Cardiovascular Data Registry CathPCI Registry, all diagnostic catheterizations and PCIs performed in patients with prior CABG from July 1, 2009, to March 31, 2018 (n = 1,279,058, 1,173 sites) were evaluated. Temporal trends in transradial access were examined, and mortality, bleeding, vascular complications, and procedural metrics were compared between transradial and transfemoral access., Results: The rate of transradial access increased from 1.4% to 18.7% over the study period. Transradial access was associated with decreased mortality (adjusted odds ratio [OR]: 0.83; 95% confidence interval [CI]: 0.75 to 0.91), decreased bleeding (OR: 0.57; 95% CI: 0.51 to 0.63), decreased vascular complications (OR: 0.38; 95% CI: 0.30 to 0.47), increased PCI procedural success (OR: 1.11; 95% CI: 1.06 to 1.16; p < 0.0001), and significantly decreased contrast volume across all procedure types. Transradial access was associated with shorter fluoroscopy time for PCI-only procedures but longer fluoroscopy time for diagnostic procedures plus ad hoc PCI and diagnostic procedures only. Operators with a higher rate of transradial access in non-CABG patients were more likely to perform transradial access in patients with prior CABG., Conclusions: The rate of transradial artery access in patients with prior CABG undergoing diagnostic catheterization and/or PCI has increased over the past decade in the United States, and it was more often performed by operators using a transradial approach in non-CABG patients. Compared with transfemoral access, transradial access was associated with improved clinical outcomes in patients with prior CABG., Competing Interests: Funding Support and Author Disclosures The American College of Cardiology National Cardiovascular Data Registry is an initiative of the American College of Cardiology Foundation. This research was supported by the American College of Cardiology Foundation’s National Cardiovascular Data Registry. Dr. Rymer has received research grants from Boston Scientific and Abbott Pharmaceuticals. Dr. Swaminathan receives research support from ACIST Medical; and provides consulting services for Medtronic. Dr. Abbott has received grant support with no personal compensation from Sinomed, CSL Behring, AstraZeneca, Bristol Myers Squibb, and Abbott Vascular; and provides consulting services for Recor and Philips. Dr. Gilchrist provides consulting services for Cardinal Health and Terumo Medical Corporation. Dr. Panetta is the co-owner of the medical device company LP Medical. Dr. Brilakis provides consulting services for Abbott Vascular, the American Heart Association (associate editor, Circulation), Amgen, Biotronik, Boston Scientific, Cardiovascular Innovations Foundation (Board of Directors), ControlRad, CSI, Ebix, Elsevier, GE Healthcare, InfraRedx, Medtronic, Siemens, and Teleflex; receives research support from Regeneron and Siemens; and is a shareholder in MHI Ventures. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose., (Copyright © 2021 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Objectives: The aim of this study was to assess the real-world impact of transcatheter mitral valve repair (TMVR) on hospitalizations and Medicare costs pre- versus post-TMVR., Background: TMVR is effective in degenerative mitral regurgitation (MR) and appropriately selected patients with functional MR with high surgical risk., Methods: Patients undergoing TMVR in the Society of Thoracic Surgeons/American College of Cardiology TVT (Transcatheter Valve Therapy) Registry from 2013 to 2018 were linked to Medicare claims data. Rates of hospitalizations, hospitalized days, and Medicare costs were compared 1-year pre-TMVR to 1-year post-TMVR., Results: Across 246 sites, 4,970 patients with a median age of 83 years (interquartile range: 77 to 87 years) were analyzed. The TMVR indication was degenerative MR in 77.5% and functional MR in 16.7%. From pre- to post-TMVR, heart failure (HF) hospitalization rates (479 vs. 370 hospitalizations/1,000 person-years; rate ratio [RR]: 0.77) and cardiovascular hospitalizations (838 vs. 632; RR: 0.75) decreased significantly (p < 0.001 for all). Similarly, the rates of hospitalized days decreased for HF and cardiovascular causes (p < 0.05 for all). Following TMVR, the odds of having no Medicare costs for HF hospitalizations increased (69% vs. 79%; odds ratio: 1.67; p < 0.001). However, the average total Medicare costs per day alive among patients with any HF hospitalizations after TMVR increased significantly (p < 0.001). The HF hospitalization rates decreased for patients with functional MR (683 vs. 502; RR: 0.74) and those with degenerative MR (431 vs. 337; RR: 0.78) (p < 0.001)., Conclusions: TMVR is associated with a decrease in cardiovascular and HF hospitalizations and a greater likelihood of having no HF Medicare costs in the year after TMVR, regardless of MR etiology. Further work is necessary to elucidate the reasons for increased costs among patients with HF hospitalizations post-TMVR., (Copyright © 2019 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Objectives: This study sought to evaluate the outcomes and factors associated with aborted procedures among patients undergoing elective transcatheter aortic valve replacement (TAVR)., Background: Elective TAVR procedures can be aborted because of device limitations or aborted for other reasons, including patient and procedural factors. Little is known about 30-day outcomes and factors associated with aborted procedures and procedures aborted because of device limitations (ADs)., Methods: Patients undergoing elective TAVR procedures from 2011 to 2017 in the Society of Thoracic Surgeons/American College of Cardiology TVT (Transcatheter Valve Therapy) Registry were examined. The incidence of aborted procedures, both ADs and procedures aborted for other reasons (AOs), was examined. Rates of 30-day all-cause death or stroke and a composite of vascular complications and bleeding events were compared between patients with and those without aborted procedures and between patients with ADs and those with AOs. Multivariate modeling identified factors associated with aborted procedures and ADs., Results: Among 106,169 patients who underwent TAVR between 2011 and 2017, procedures were aborted in 1,150 (1.1%) (581 ADs and 569 AOs). Patients with aborted procedures were more likely female with peripheral artery disease and more often treated at lower volume centers compared with those with nonaborted procedures (p < 0.01 for all). The incidence of aborted procedures and ADs decreased over the study period (p < 0.01). The adjusted rates of 30-day death and stroke were greater for aborted versus nonaborted procedures (odds ratio: 5.02; 95% confidence interval: 4.13 to 6.11). Peripheral artery disease, alternative access, and low institutional TAVR volume were factors associated with aborted procedures and ADs (p < 0.05 for all)., Conclusions: The incidence of aborted procedures is declining, but peripheral artery disease and low institutional TAVR volume remain associated with aborted procedures. A thorough pre-procedural assessment and referral of challenging cases to high-volume centers may be strategies to minimize aborted procedures., (Copyright © 2019 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)