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1. Model-Based Algorithms for Detecting Peripheral Artery Disease Using Administrative Data From an Electronic Health Record Data System: Algorithm Development Study

Author

Weissler, Elizabeth Hope, Lippmann, Steven J, Smerek, Michelle M, Ward, Rachael A, Kansal, Aman, Brock, Adam, Sullivan, Robert C, Long, Chandler, Patel, Manesh R, Greiner, Melissa A, Hardy, N Chantelle, Curtis, Lesley H, and Jones, W Schuyler

Subjects
Computer applications to medicine. Medical informatics, R858-859.7
Abstract

BackgroundPeripheral artery disease (PAD) affects 8 to 10 million Americans, who face significantly elevated risks of both mortality and major limb events such as amputation. Unfortunately, PAD is relatively underdiagnosed, undertreated, and underresearched, leading to wide variations in treatment patterns and outcomes. Efforts to improve PAD care and outcomes have been hampered by persistent difficulties identifying patients with PAD for clinical and investigatory purposes. ObjectiveThe aim of this study is to develop and validate a model-based algorithm to detect patients with peripheral artery disease (PAD) using data from an electronic health record (EHR) system. MethodsAn initial query of the EHR in a large health system identified all patients with PAD-related diagnosis codes for any encounter during the study period. Clinical adjudication of PAD diagnosis was performed by chart review on a random subgroup. A binary logistic regression to predict PAD was built and validated using a least absolute shrinkage and selection operator (LASSO) approach in the adjudicated patients. The algorithm was then applied to the nonsampled records to further evaluate its performance. ResultsThe initial EHR data query using 406 diagnostic codes yielded 15,406 patients. Overall, 2500 patients were randomly selected for ground truth PAD status adjudication. In the end, 108 code flags remained after removing rarely- and never-used codes. We entered these code flags plus administrative encounter, imaging, procedure, and specialist flags into a LASSO model. The area under the curve for this model was 0.862. ConclusionsThe algorithm we constructed has two main advantages over other approaches to the identification of patients with PAD. First, it was derived from a broad population of patients with many different PAD manifestations and treatment pathways across a large health system. Second, our model does not rely on clinical notes and can be applied in situations in which only administrative billing data (eg, large administrative data sets) are available. A combination of diagnosis codes and administrative flags can accurately identify patients with PAD in large cohorts.

Published
2020
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4. Completeness of revascularization by FFRCT in stable angina: Association to adverse cardiovascular outcomes

Author

Madsen, Kristian Tækker, Nørgaard, Bjarne Linde, Øvrehus, Kristian Altern, Jensen, Jesper Møller, Parner, Erik, Grove, Erik Lerkevang, Mortensen, Martin B., Iraqi, Nadia, Fairbairn, Timothy A., Nieman, Koen, Patel, Manesh R., Rogers, Campbell, Mullen, Sarah, Mickley, Hans, Thomsen, Kristian Korsgaard, Bøtker, Hans Erik, Leipsic, Jonathon, and Rønnow Sand, Niels Peter

Published
2024
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6. Framework of the strengths and challenges of clinically integrated trials: An expert panel report

Author

Peters, Anthony E., Jones, W. Schuyler, Anderson, Brian, Bramante, Carolyn T., Broedl, Uli, Hornik, Christoph P., Kehoe, Lindsay, Knowlton, Kirk U., Krofah, Esther, Landray, Martin, Locke, Trevan, Patel, Manesh R., Psotka, Mitchell, Rockhold, Frank W., Roessig, Lothar, Rothman, Russell L., Schofield, Lesley, Stockbridge, Norman, Trontell, Anne, Curtis, Lesley H., Tenaerts, Pamela, and Hernandez, Adrian F.

Published
2024
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8. Endovascular ablation of the right greater splanchnic nerve in heart failure with preserved ejection fraction: early results of the REBALANCE‐HF trial roll‐in cohort

Author

Fudim, Marat, Fail, Peter S, Litwin, Sheldon E, Shaburishvili, Tamaz, Goyal, Parag, Hummel, Scott L, Borlaug, Barry A, Mohan, Rajeev C, Patel, Ravi B, Mitter, Sumeet S, Klein, Liviu, Rocha‐Singh, Krishna, Patel, Manesh R, Reddy, Vivek Y, Burkhoff, Daniel, and Shah, Sanjiv J

Subjects
Biomedical and Clinical Sciences, Cardiovascular Medicine and Haematology, Clinical Sciences, Clinical Research, Clinical Trials and Supportive Activities, Patient Safety, Prevention, Heart Disease, Cardiovascular, Aged, Female, Heart Failure, Humans, Male, Pulmonary Wedge Pressure, Splanchnic Nerves, Stroke Volume, Ventricular Function, Left, Heart failure with preserved ejection fraction, Splanchnic nerve ablation, Therapeutics, Clinical trial, Cardiorespiratory Medicine and Haematology, Cardiovascular System & Hematology, Cardiovascular medicine and haematology
Abstract

AimsIn heart failure (HF) with preserved ejection fraction (HFpEF), excessive redistribution of blood volume into the central circulation leads to elevations of intracardiac pressures with exercise limitations. Splanchnic ablation for volume management (SAVM) has been proposed as a therapeutic intervention. Here we present preliminary safety and efficacy data from the initial roll-in cohort of the REBALANCE-HF trial.Methods and resultsThe open-label (roll-in) arm of REBALANCE-HF will enrol up to 30 patients, followed by the randomized, sham-controlled portion of the trial (up to 80 additional patients). Patients with HF, left ventricular ejection fraction (LVEF) ≥50%, and invasive peak exercise pulmonary capillary wedge pressure (PCWP) ≥25 mmHg underwent SAVM. Baseline and follow-up assessments included resting and exercise PCWP, New York Heart Association (NYHA) class, Kansas City Cardiomyopathy Questionnaire (KCCQ), 6-min walk test, and N-terminal pro-B-type natriuretic peptide (NT-proBNP). Efficacy and safety were assessed at 1 and 3 months. Here we report on the first 18 patients with HFpEF that have been enrolled into the roll-in, open-label arm of the study across nine centres; 14 (78%) female; 16 (89%) in NYHA class III; and median (interquartile range) age 75.2 (68.4-81) years, LVEF 61.0 (56.0-63.2)%, and average (standard deviation) 20 W exercise PCWP 36.4 (±8.6) mmHg. All 18 patients were successfully treated. Three non-serious moderate device/procedure-related adverse events were reported. At 1-month, the mean PCWP at 20 W exercise decreased from 36.4 (±8.6) to 28.9 (±7.8) mmHg (p

Published
2022

9. Endovascular Ablation of the Right Greater Splanchnic Nerve in Heart Failure With Preserved Ejection Fraction: Rationale, Design and Lead-in Phase Results of the REBALANCE-HF Trial

Author

Fudim, Marat, Litwin, Sheldon E., Borlaug, Barry A., Mohan, Rajeev C., Price, Matthew J., Fail, Peter, Zirakashvili, Teona, Shaburishvili, Tamaz, Goyal, Parag, Hummel, Scott L., Patel, Ravi B., Reddy, Vivek Y., Burkhoff, Daniel, Patel, Manesh R., Somo, Sami I., and Shah, Sanjiv J.

Published
2024
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11. A systematic review of patient-reported outcome measures patients with chronic limb-threatening ischemia

Author

Goodney, Philip, Shah, Samir, Hu, Yiyuan David, Suckow, Bjoern, Kinlay, Scott, Armstrong, David G, Geraghty, Patrick, Patterson, Megan, Menard, Matthew, Patel, Manesh R, and Conte, Michael S

Subjects
Biomedical and Clinical Sciences, Clinical Sciences, Clinical Trials and Supportive Activities, Clinical Research, 7.3 Management and decision making, 7.1 Individual care needs, Management of diseases and conditions, Good Health and Well Being, Aged, Amputation, Surgical, Chronic Disease, Chronic Limb-Threatening Ischemia, Humans, Ischemia, Limb Salvage, Patient Reported Outcome Measures, Peripheral Arterial Disease, Quality of Life, Retrospective Studies, Risk Factors, Treatment Outcome, Peripheral artery disease, Chronic limb-threatening ischemia, Critical limb ischemia, Amputation, Patient reported outcome, Decision aid, Decision tool, Surgical decision, Surgical decision-making, Shared decision-making, Medical and Health Sciences, Cardiovascular System & Hematology, Cardiovascular medicine and haematology, Clinical sciences
Abstract

Chronic limb-threatening ischemia (CLTI) causes significant morbidity with profound negative effects on health-related quality of life. As the prevalence of peripheral artery disease and diabetes continue to rise in our aging population, the public health impact of CLTI has escalated. Patient-reported outcome measures (PROMs) have become common and important measures for clinical evaluation in both clinical care and research. PROMs are important for the measurement of clinical effectiveness and cost effectiveness and for shared decision-making on treatment options. However, the PROMs used to describe the experience of patients with CLTI are heterogeneous, incomplete, and lack specific applicability to the underlying disease processes and diverse populations. For example, certain PROMs exist for patients with extremity wounds, and other PROMs exist for patients with pain, and still others exist for patients with vascular disease. Despite this multiplicity of tools, no single PROM encompasses all of the components necessary to describe the experiences of patients with CLTI. This significant unmet need is evident from both published reports and contemporary large-scale clinical trials in the field. In this systematic review, we review the current use of PROMs for patients with CLTI in clinical practice and in research trials and highlight the gaps that need to be addressed to develop a unifying PROM instrument for CLTI.

Published
2022

12. Coronary computed tomography angiography derived fractional flow reserve and risk of recurrent angina: A 3-year follow-up study

Author

Madsen, Kristian Tækker, Nørgaard, Bjarne Linde, Øvrehus, Kristian Altern, Jensen, Jesper Møller, Parner, Erik, Grove, Erik Lerkevang, Mortensen, Martin B., Fairbairn, Timothy A., Nieman, Koen, Patel, Manesh R., Rogers, Campbell, Mullen, Sarah, Mickley, Hans, Thomsen, Kristian Korsgaard, Bøtker, Hans Erik, Leipsic, Jonathon, and Sand, Niels Peter Rønnow

Published
2024
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14. 2024 ACC/AHA Clinical Performance and Quality Measures for Adults With Valvular and Structural Heart Disease: A Report of the American Heart Association/American College of Cardiology Joint Committee on Performance Measures

Author

Jneid, Hani, Chikwe, Joanna, Arnold, Suzanne V., Bonow, Robert O., Bradley, Steven M., Chen, Edward P., Diekemper, Rebecca L., Fugar, Setri, Johnston, Douglas R., Kumbhani, Dharam J., Mehran, Roxana, Misra, Arunima, Patel, Manesh R., Sweis, Ranya N., and Szerlip, Molly

Published
2024
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16. Low-Dose Rivaroxaban Plus Aspirin in Patients With Peripheral Artery Disease Undergoing Lower Extremity Revascularization With and Without Concomitant Coronary Artery Disease: Insights From VOYAGER PAD

Author

Morrison, Justin T., Canonico, Mario Enrico, Anand, Sonia S., Patel, Manesh R., Debus, Eike Sebastian, Nehler, Mark R., Hess, Connie N., Hsia, Judith, Capell, Warren H., Muehlhofer, Eva, Haskell, Lloyd P., Berkowitz, Scott D., Bauersachs, Rupert M., and Bonaca, Marc P.

Published
2024
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18. Efficacy and Safety of Non–Vitamin-K Antagonist Oral Anticoagulants Versus Warfarin Across the Spectrum of Body Mass Index and Body Weight: An Individual Patient Data Meta-Analysis of 4 Randomized Clinical Trials of Patients With Atrial Fibrillation

Author

Patel, Siddharth M., Braunwald, Eugene, Steffel, Jan, Boriani, Giuseppe, Palazzolo, Michael G., Antman, Elliott M., Bohula, Erin A., Carnicelli, Anthony P., Connolly, Stuart J., Eikelboom, John W., Gencer, Baris, Granger, Christopher B., Morrow, David A., Patel, Manesh R., Wallentin, Lars, Ruff, Christian T., and Giugliano, Robert P.

Published
2024
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19. Interaction of AI-Enabled Quantitative Coronary Plaque Volumes on Coronary CT Angiography, FFRCT, and Clinical Outcomes: A Retrospective Analysis of the ADVANCE Registry

Author

Dundas, James, Leipsic, Jonathon, Fairbairn, Timothy, Ng, Nicholas, Sussman, Vida, Guez, Ilana, Rosenblatt, Rachael, Hurwitz Koweek, Lynne M., Douglas, Pamela S., Rabbat, Mark, Pontone, Gianluca, Chinnaiyan, Kavitha, de Bruyne, Bernard, Bax, Jeroen J., Amano, Tetsuya, Nieman, Koen, Rogers, Campbell, Kitabata, Hironori, Sand, Niels P.R., Kawasaki, Tomohiro, Mullen, Sarah, Huey, Whitney, Matsuo, Hitoshi, Patel, Manesh R., Norgaard, Bjarne L., Ahmadi, Amir, and Tzimas, Georgios

Published
2024
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23. SARS-CoV-2 Cardiac Involvement in Young Competitive Athletes.

Author

Moulson, Nathaniel, Petek, Bradley J, Drezner, Jonathan A, Harmon, Kimberly G, Kliethermes, Stephanie A, Patel, Manesh R, Baggish, Aaron L, and Outcomes Registry for Cardiac Conditions in Athletes Investigators

Subjects
Outcomes Registry for Cardiac Conditions in Athletes Investigators, Myocardium, Heart, Humans, Myocarditis, Troponin T, Magnetic Resonance Imaging, Echocardiography, Hospitalization, Registries, Prevalence, Risk, Cohort Studies, Prospective Studies, Female, Male, Young Adult, Athletes, COVID-19, SARS-CoV-2, athletes, myocarditis, return to sport, Lung, Prevention, Cardiovascular, Heart Disease, Emerging Infectious Diseases, Clinical Research, Infectious Diseases, 4.2 Evaluation of markers and technologies, Detection, screening and diagnosis, Good Health and Well Being, Cardiorespiratory Medicine and Haematology, Clinical Sciences, Public Health and Health Services, Cardiovascular System & Hematology
Abstract

BackgroundCardiac involvement among hospitalized patients with severe coronavirus disease 2019 (COVID-19) is common and associated with adverse outcomes. This study aimed to determine the prevalence and clinical implications of COVID-19 cardiac involvement in young competitive athletes.MethodsIn this prospective, multicenter, observational cohort study with data from 42 colleges and universities, we assessed the prevalence, clinical characteristics, and outcomes of COVID-19 cardiac involvement among collegiate athletes in the United States. Data were collected from September 1, 2020, to December 31, 2020. The primary outcome was the prevalence of definite, probable, or possible COVID-19 cardiac involvement based on imaging definitions adapted from the Updated Lake Louise Imaging Criteria. Secondary outcomes included the diagnostic yield of cardiac testing, predictors for cardiac involvement, and adverse cardiovascular events or hospitalizations.ResultsAmong 19 378 athletes tested for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection, 3018 (mean age, 20 years [SD, 1 year]; 32% female) tested positive and underwent cardiac evaluation. A total of 2820 athletes underwent at least 1 element of cardiac triad testing (12-lead ECG, troponin, transthoracic echocardiography) followed by cardiac magnetic resonance imaging (CMR) if clinically indicated. In contrast, primary screening CMR was performed in 198 athletes. Abnormal findings suggestive of SARS-CoV-2 cardiac involvement were detected by ECG (21 of 2999 [0.7%]), cardiac troponin (24 of 2719 [0.9%]), and transthoracic echocardiography (24 of 2556 [0.9%]). Definite, probable, or possible SARS-CoV-2 cardiac involvement was identified in 21 of 3018 (0.7%) athletes, including 15 of 2820 (0.5%) who underwent clinically indicated CMR (n=119) and 6 of 198 (3.0%) who underwent primary screening CMR. Accordingly, the diagnostic yield of CMR for SARS-CoV-2 cardiac involvement was 4.2 times higher for a clinically indicated CMR (15 of 119 [12.6%]) versus a primary screening CMR (6 of 198 [3.0%]). After adjustment for race and sex, predictors of SARS-CoV-2 cardiac involvement included cardiopulmonary symptoms (odds ratio, 3.1 [95% CI, 1.2, 7.7]) or at least 1 abnormal triad test result (odds ratio, 37.4 [95% CI, 13.3, 105.3]). Five (0.2%) athletes required hospitalization for noncardiac complications of COVID-19. During clinical surveillance (median follow-up, 113 days [interquartile range=90 146]), there was 1 (0.03%) adverse cardiac event, likely unrelated to SARS-CoV-2 infection.ConclusionsSARS-CoV-2 infection among young competitive athletes is associated with a low prevalence of cardiac involvement and a low risk of clinical events in short-term follow-up.

Published
2021

28. Coronary Volume to Left Ventricular Mass Ratio in Patients With Hypertension

Author

van Rosendael, Sophie E., van Rosendael, Alexander R., Kuneman, Jurrien H., Patel, Manesh R., Nørgaard, Bjarne Linde, Fairbairn, Timothy A., Nieman, Koen, Akasaka, Takashi, Berman, Daniel S., Koweek, Lynne M. Hurwitz, Pontone, Gianluca, Kawasaki, Tomohiro, Sand, Niels Peter Rønnow, Jensen, Jesper M., Amano, Tetsuya, Poon, Michael, Øvrehus, Kristian A., Sonck, Jeroen, Rabbat, Mark G., Rogers, Campbell, Matsuo, Hitoshi, Leipsic, Jonathon A., Marsan, Nina Ajmone, Jukema, J. Wouter, Bax, Jeroen J., Saraste, Antti, and Knuuti, Juhani

Published
2023
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29. Association of Health Status Scores With Cardiovascular and Limb Outcomes in Patients With Symptomatic Peripheral Artery Disease: Insights From the EUCLID (Examining Use of Ticagrelor in Symptomatic Peripheral Artery Disease) Trial

Author

Rymer, Jennifer A, Mulder, Hillary, Smolderen, Kim G, Hiatt, William R, Conte, Michael S, Berger, Jeffrey S, Norgren, Lars, Mahaffey, Kenneth W, Baumgartner, Iris, Fowkes, F Gerry, Katona, Brian G, Rockhold, Frank, Jones, W Schuyler, and Patel, Manesh R

Subjects
Biomedical and Clinical Sciences, Cardiovascular Medicine and Haematology, Clinical Trials and Supportive Activities, Cardiovascular, Clinical Research, Good Health and Well Being, Cardiovascular Diseases, Double-Blind Method, Female, Health Status Indicators, Humans, Lower Extremity, Male, Middle Aged, Outcome Assessment, Health Care, Peripheral Arterial Disease, Platelet Aggregation Inhibitors, Quality of Life, Surveys and Questionnaires, Symptom Assessment, Ticagrelor, Vascular Surgical Procedures, Visual Analog Scale, health status instruments, peripheral artery disease, quality of life, Cardiorespiratory Medicine and Haematology, Cardiovascular medicine and haematology
Abstract

Background There are limited data on health status instruments in patients with peripheral artery disease and cardiovascular and limb events. We evaluated the relationship between health status changes and cardiovascular and limb events. Methods and Results In an analysis of the EUCLID (Examining Use of Ticagrelor in Symptomatic Peripheral Artery Disease) trial, we examined the characteristics of 13 801 patients by tertile of health status instrument scores collected in the trial (EuroQol 5-Dimensions [EQ-5D], EQ visual analog scale [VAS], and peripheral artery questionnaire). We assessed the association between the baseline health status measurements and major adverse cardiovascular events, major adverse limb events, and lower-extremity revascularization procedures during trial follow-up and the association between 12-month health status change scores and subsequent end points during follow-up. There were 13 217 (95%) patients with EQ-5D scores, 13 533 (98%) with VAS scores, and 4431 (32%) with peripheral artery questionnaire scores. Patients in the lowest baseline EQ-5D tertile (0 to

Published
2020

30. Patient-Reported Satisfaction and Study Drug Discontinuation: Post-Hoc Analysis of Findings from ROCKET AF

Author

Ungar, Leo, Rodriguez, Fatima, Hellkamp, Anne S, Becker, Richard C, Berkowitz, Scott D, Breithardt, Guenter, Fox, Keith AA, Hacke, Werner, Halperin, Jonathan L, Hankey, Graeme J, Nessel, Christopher C, Singer, Daniel E, Patel, Manesh R, Piccini, Jonathan P, and Mahaffey, Kenneth W

Subjects
Pharmacology and Pharmaceutical Sciences, Biomedical and Clinical Sciences, Clinical Research, 6.1 Pharmaceuticals, Evaluation of treatments and therapeutic interventions, Good Health and Well Being, Anticoagulant, Atrial fibrillation, Drug discontinuation, Patient-reported outcomes, Patient satisfaction endpoints, Rivaroxaban, Warfarin
Abstract

IntroductionPatient-reported outcomes (PROs) and satisfaction endpoints are increasingly important in clinical trials and may be associated with treatment adherence. In this post hoc substudy from ROCKET AF, we examined whether patient-reported satisfaction was associated with study drug discontinuation.MethodsROCKET AF (n = 14,264) compared rivaroxaban with warfarin for prevention of stroke and systemic embolism in patients with atrial fibrillation. We analyzed treatment satisfaction scores: the Anti-Clot Treatment Scale (ACTS) and Treatment Satisfaction Questionnaire for Medication version II (TSQM II). We compared satisfaction with study drug between the two treatment arms, and examined the association between satisfaction and patient-driven study drug discontinuation (stopping study drug due to withdrawal of consent, noncompliance, or loss to follow-up).ResultsA total of 1577 (11%) patients participated in the Patient Satisfaction substudy; 1181 (8.3%) completed both the ACTS and TSQM II 4 weeks after starting study drug. Patients receiving rivaroxaban did not experience significant differences in satisfaction compared with those receiving warfarin. During a median follow-up of 1.6 years, 448 premature study drug discontinuations occurred (213 rivaroxaban group; 235 warfarin group), of which 116 (26%) were patient-driven (52 [24%] rivaroxaban group; 64 [27%] warfarin group). No significant differences were observed between satisfaction level and rates of patient-driven study drug discontinuation.ConclusionsStudy drug satisfaction did not predict rate of study drug discontinuation. No significant difference was observed between satisfaction with warfarin and rivaroxaban, as expected given the double-blind trial design. Although these results are negative, the importance of PRO data will only increase, and these analyses may inform future studies that explore the relationship between drug-satisfaction PROs, adherence, and clinical outcomes. CLINICALTRIALS.GOV: NCT00403767.FundingThe ROCKET AF trial was funded by Johnson & Johnson and Bayer.

Published
2019

33. Abstract 17494: The Incremental Risk Prediction of Cardiac CTA-Derived Quantitative Atherosclerosis in the International Advance Registry

Author

Chinnaiyan, Kavitha M, Guez, Ilana, Sussman, Vida, Patel, Manesh R, Norgaard, Bjarne L, Fairbairn, Timothy, Koen, Nieman, koweek, lynne, Pontone, Gianluca, Sand, Neils P, Sonck, Jeroen, Rabbat, Mark, Mullen, Sarah, Ng, Nicholas, De Bruyne, Bernard, Rogers, Campbell, Matsuo, Hitoshi, Bax, Jeroen J, and Leipsic, Jonathon

Published
2023
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35. Abstract 16428: Impact of Low-Dose Rivaroxaban Plus Aspirin on Myocardial Infarction in Patients With Peripheral Artery Disease With and Without Concomitant Coronary Artery Disease: Insights From VOYAGER PAD

Author

Canonico, Mario Enrico, Morrison, Justin, Anand, Sonia S, Patel, Manesh R, Debus, Sebastian, Nehler, Mark, Hess, Connie N, Hsia, Judith A, Capell, Warren, Muehlhofer, Eva, Haskell, Lloyd P, Berkowitz, Scott D, Bauersachs, Rupert, and Bonaca, Marc P

Published
2023
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44. Clinical Events After Deferral of LAD Revascularization Following Physiological Coronary Assessment

Author

Sen, Sayan, Ahmad, Yousif, Dehbi, Hakim-Moulay, Howard, James P, Iglesias, Juan F, Al-Lamee, Rasha, Petraco, Ricardo, Nijjer, Sukhjinder, Bhindi, Ravinay, Lehman, Sam, Walters, Darren, Sapontis, James, Janssens, Luc, Vrints, Christiaan J, Khashaba, Ahmed, Laine, Mika, Van Belle, Eric, Krackhardt, Florian, Bojara, Waldemar, Going, Olaf, Härle, Tobias, Indolfi, Ciro, Niccoli, Giampaolo, Ribichini, Flavio, Tanaka, Nobuhiro, Yokoi, Hiroyoshi, Takashima, Hiroaki, Kikuta, Yuetsu, Erglis, Andrejs, Vinhas, Hugo, Silva, Pedro Canas, Baptista, Sérgio B, Alghamdi, Ali, Hellig, Farrel, Koo, Bon-Kwon, Nam, Chang-Wook, Shin, Eun-Seok, Doh, Joon-Hyung, Brugaletta, Salvatore, Alegria-Barrero, Eduardo, Meuwissen, Martijin, Piek, Jan J, van Royen, Niels, Sezer, Murat, Di Mario, Carlo, Gerber, Robert T, Malik, Iqbal S, Sharp, Andrew SP, Talwar, Suneel, Tang, Kare, Samady, Habib, Altman, John, Seto, Arnold H, Singh, Jasvindar, Jeremias, Allen, Matsuo, Hitoshi, Kharbanda, Rajesh K, Patel, Manesh R, Serruys, Patrick, Escaned, Javier, and Davies, Justin E

Subjects
Biomedical and Clinical Sciences, Clinical Sciences, Heart Disease - Coronary Heart Disease, Heart Disease, Clinical Research, Cardiovascular, Good Health and Well Being, Aged, Coronary Angiography, Coronary Stenosis, Coronary Vessels, Female, Fractional Flow Reserve, Myocardial, Humans, Male, Middle Aged, Myocardial Revascularization, coronary stenosis, fractional flow reserve, instantaneous wave-free ratio, Cardiorespiratory Medicine and Haematology, Public Health and Health Services, Cardiovascular System & Hematology, Cardiovascular medicine and haematology
Abstract

BackgroundPhysicians are not always comfortable deferring treatment of a stenosis in the left anterior descending (LAD) artery because of the perception that there is a high risk of major adverse cardiac events (MACE). The authors describe, using the DEFINE-FLAIR (Functional Lesion Assessment of Intermediate Stenosis to Guide Revascularisation) trial, MACE rates when LAD lesions are deferred, guided by physiological assessment using fractional flow reserve (FFR) or the instantaneous wave-free ratio (iFR).ObjectivesThe purpose of this study was to establish the safety of deferring treatment in the LAD using FFR or iFR within the DEFINE-FLAIR trial.MethodsMACE rates at 1 year were compared between groups (iFR and FFR) in patients whose physiological assessment led to LAD lesions being deferred. MACE was defined as a composite of cardiovascular death, myocardial infarction (MI), and unplanned revascularization at 1 year. Patients, and staff performing follow-up, were blinded to whether the decision was made with FFR or iFR. Outcomes were adjusted for age and sex.ResultsA total of 872 patients had lesions deferred in the LAD (421 guided by FFR, 451 guided by iFR). The event rate with iFR was significantly lower than with FFR (2.44% vs. 5.26%; adjusted HR: 0.46; 95% confidence interval [CI]: 0.22 to 0.95; p = 0.04). This was driven by significantly lower unplanned revascularization with iFR and numerically lower MI (unplanned revascularization: 2.22% iFR vs. 4.99% FFR; adjusted HR: 0.44; 95% CI: 0.21 to 0.93; p = 0.03; MI: 0.44% iFR vs. 2.14% FFR; adjusted HR: 0.23; 95% CI: 0.05 to 1.07; p = 0.06).ConclusionsiFR-guided deferral appears to be safe for patients with LAD lesions. Patients in whom iFR-guided deferral was performed had statistically significantly lower event rates than those with FFR-guided deferral.

Published
2019

48. Coronary volume to left ventricular mass ratio in patients with diabetes mellitus

Author

Kuneman, Jurrien H., El Mahdiui, Mohammed, van Rosendael, Alexander R., van den Hoogen, Inge J., Patel, Manesh R., Nørgaard, Bjarne Linde, Fairbairn, Timothy A., Nieman, Koen, Akasaka, Takashi, Berman, Daniel S., Hurwitz Koweek, Lynne M., Pontone, Gianluca, Kawasaki, Tomohiro, Rønnow Sand, Niels Peter, Jensen, Jesper M., Amano, Tetsuya, Poon, Michael, Øvrehus, Kristian A., Sonck, Jeroen, Rabbat, Mark G., De Bruyne, Bernard, Rogers, Campbell, Matsuo, Hitoshi, Bax, Jeroen J., Leipsic, Jonathon A., and Knuuti, Juhani

Published
2022
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49. Prevention of arterial and venous thrombotic events in symptomatic peripheral arterial disease patients after lower extremity revascularization in the VOYAGER PAD trial: Dual anticoagulant/antiplatelet regimen vs antiplatelet therapy alone

Author

Berkowitz, Scott D., Bauersachs, Rupert M., Szarek, Michael, Nehler, Mark R., Debus, E. Sebastian, Patel, Manesh R., Anand, Sonia S., Capell, Warren H., Hess, Connie N., Hsia, Judy, Leeper, Nicholas J., Brasil, David, Mátyás, Lajos, Diaz, Rafael, Brodmann, Marianne, Muehlhofer, Eva, Haskell, Lloyd P., and Bonaca, Marc P.

Published
2022
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50. Safety of the oral factor XIa inhibitor asundexian compared with apixaban in patients with atrial fibrillation (PACIFIC-AF): a multicentre, randomised, double-blind, double-dummy, dose-finding phase 2 study

Author

Auer, Johann, Hubauer, Martin, Pandzic, Sead, Preishuber, Eva, Primus-Grabscheit, Carina, Reitgruber, Dietmar, Schmalzer, Florian, Adlbrecht, Christopher, Schober, Andreas, Hajos, Johannes, Keil, Christoph, Schratter, Alexandra, Frick, Matthias, Benda, Magdalena Anna, Mächler, Maximilian, Mutschlechner, Beatrix, Saely, Christoph, Sprenger, Lukas, Lichtenauer, Michael, Eber, Miriam, Hoppe, Uta, Kolbitsch, Tobias, Jirak, Peter Michael, Mirna, Moritz, Schönbauer, Robert, Bergler-Klein, Jutta, Hengstenberg, Christian, Stojkovic, Stefan, Scherr, Daniel, Manninger-Wünscher, Martin, Rohrer, Ursula, Stühlinger, Markus, Schgoer, Wilfried, Schwarzl, Jana, Pürerfellner, Helmut, Derndorfer, Michael, Ebner, Christian, Eder, Veronika, Kollias, Georgios, Sturmberger, Thomas, Sieghartsleitner, Stefan, Vijgen, Johan, Koopman, Peter, Dujardin, Karl, Anné, Wim, De Ceuninck, Michel, Tavernier, Rene, Duytschaever, Mattias, Knecht, Sébastien, Missault, Luc, Vandekerckhove, Yves, Rossenbacker, Tom, Ector, Bavo, Charlier, Filip, Debruyne, Philippe, Dewilde, Willem, Janssens, Luc, Roosen, John, Vankelecom, Bart, Heidbuchel, Hein, Delesie, Michiel, Vervoort, Gert, Rombouts, Hans, Vanassche, Thomas, Engelen, Matthias, Verhamme, Peter, Willems, Rik, Constance, Christian, Pranno, Nicolas, Cox, Jafna, Bata, Iqbal, Macle, Laurent, Aguilar, Martin, Tourigny, Julia Cadrin, Dubuc, Marc, Dyrda, Katia, Guerra, Peter, Khairy, Paul, Mondésert, Blandine, Rivard, Léna, Roy, Denis, Tadros, Rafik, Talajic, Mario, Thibault, Bernard, Nault, Isabelle, Blier, Louis, Champagne, Jean, Molin, Franck, O'Hara, Gilles, Philippon, François, Plourde, Benoit, Sarrazin, Jean-François, Steinberg, Christian, Coufal, Zdenek, Balazsik, David, Mikulica, Michal, Zapeca, Jakub, Cermak, Ondrej, Drasnar, Tomas, Falc, Matej, Hornof, Josef, Racz, Blazej, Weissova, Danica, Linkova, Hana, Paskova, Eva, Petr, Robert, Sirakova, Andrea, Kettner, Jiri, Benak, Ales, Holek, Martin, Podpera, Ivo, Podperova, Monika, Vancura, Vlastimil, Jandik, Tomas, Smid, Jiri, Dedek, Vratislav, Banik, Jan, Durdil, Vaclav, Hnat, Tomas, Lellouche, Nicolas, Rouffiac, Ségolène, Taldir, Guillaume, Bridonneau, Valentin, Couffon, Philippe, Daudin, Magalie, Hamon, Cécile, Lacaze, Jonathan, Quentin, Anne, Thebault, Christophe, Boiffard, Emmanuel, Billon, Olivier, Miette, Fabien, Pouliquen, Hervé, Turlotte, Guillaume, Gorka, Hervé, Albert, Franck, Bayle, Sandrine, Bensaid, Reda, Dasoveanu, Madalina, Demichili, Thibaud, Dutoiu, Teodora, Khalil, Cliff, Loghin, Caterina, Range, Grégoire, Roussel, Laurent, Socié, Pierre, Thuaire, Christophe, Extramiana, Fabrice, Algalarrondo, Vincent, Boughanmi, Haten, El Mansour, Noreddine, Mohammad, Usman, Sellier, Romain, Elbaz, Meyer, Laperche, Clémence, Maury, Philippe, Kiss, Robert, Borsanyi, Tunde, Gingl, Zoltan, Polgar, Balaza, Benczur, Bela, Bodor, Alexandra, Hepp, Tamas, Malati, Eva, Nagy, Laszlo, Erdei, Norbert, Kapus, Jozsef, Kapus, Katalin, Toth, Brigitta, Matoltsy, Andras, Kiss, Tunde, Merkely, Bela, Herczeg, Szilvia, Kiss, Orsolya, Sallo, Zoltan, Toth, Kalman, Habon, Tamas, Rabai, Miklos, Totsimon, Kinga, Zilahi, Zsolt, Bencze, Gabriella, Santa, Janos, Aradi, Daniel, Kelemen, Barbara, Bolognese, Leonardo, Nesti, Martina, Notarstefano, Pasquale Giovanni, D'Orazio, Simona, Cosmi, Franco, Becattini, Cecilia, Agnelli, Giancarlo, Broccatelli, Belinda, Mosconi, Maria Giulia, Paciaroni, Maurizio, Urbini, Chiara, Parato, Vito Maurizio, Notaristefani, Camilla, Scarano, Michele, Ameri, Pietro, Ghigliotti, Giorgio, Guglielmi, Giulia, Lotti, Roberta, Merlo, Andrea Carlo, Muiesan, Maria Lorenza, Abondio, Andrea, Berasi, Caterina, Mattiuzzo, Elena, Mutti, Claudio, Salvetti, Massimo, Pignatelli, Pasquale, Menichelli, Danilo, Pastori, Daniele, Tamiya, Eiji, Matsumoto, Takahiro, Takabe, Tomosato, Yamamoto, Shoichi, Yamashita, Haruyo, Higashiue, Shinichi, Furuya, Onichi, Hiramatsu, Norihiko, Kasuga, Kensuke, Kojima, Saburo, Komooka, Masatoshi, Kuroyanagi, Satoshi, Matsuura, Makoto, Takemoto, Tetsushi, Yamamoto, Shuji, Saito, Katusmi, Abe, Takuro, Ishida, Issei, Iwanami, Yuji, Kataoka, Shohei, Moriyama, Tetsu, Murohashi, Akira, Sasaki, Akihito, Nakamura, Yuichiro, Ueno, Tetsuya, Shimane, Akira, Hamana, Tomoyo, Ichibori, Hirotoshi, Inoue, Tomohiro, Itoh, Mitsuaki, Iwane, Seigo, Kawai, Hiroya, Kokawa, Tatsuya, Masumoto, Akiko, Matsuo, Koki, Miyata, Taishi, Nakano, Shinsuke, Oishi, Shogo, Onishi, Tetsuari, Sawada, Takahiro, Saito, Takayuki, Shoda, Mitsuhiko, Takahashi, Nobuyuki, Takaya, Tomofumi, Taniguchi, Yasuyo, Tsukamoto, Shota, Tsukishiro, Yasue, Tsukiyama, Yoshiro, Tsunamoto, Hiroshi, Uzu, Kenzo, Yamamoto, Hiroyuki, Yamamoto, Tetsuya, Yokoi, Kiminobu, Yoshida, Chiaki, Watanabe, Nobuhiro, Betsuyaku, Tetsuo, Adachi, Kumiko, Awane, Kouichi, Goto, Daisuke, Sakakibara, Mamoru, Watanabe, Masashi, Ueno, Hideki, Hiroe, Yoshitaka, Matsuo, Koshi, Ayata, Kenji, Fukuda, Ko, Hata, Yoshiki, Hashimoto, Katsushi, Matsumi, Hiroaki, Nikaido, Akira, Okamoto, Shuichi, Sime, Iveta, Stirna, Valters, Reinholde, Ilze, Hansone, Silvija, Kozlovska, Anita, Romanova, Janina, Klincare, Dace, Pontaga, Natalja, Dirmans, Igors, Kalnins, Artis, Upite, Dana, Gersamija, Arcils, Teleznikovs, Arturs, Rozkova, Nadezda, Safro, Jelena, Anguera Camós, Ignasi, Domenico Dallaglio, Paolo, Salguero Bodes, Rafael, Arnbas, Fernando, Borrego, Luis, Marco, Alvaro, Jimenez, Javier Ramos, Gómez-Doblas, Juan José, Pérez Cabeza, Alejandro, Ferreira Gonzålez, Ignacio, Limeres Freire, Javier, Lopez Grau, Merce, Viñolas Prat, Xavier, Moreno Weidmann, Zoraida, Guerra Ramos, Jose Maria, Alonso Martin, Maria Concepcion, Campos Garcia, Bieito, Mogro Carranza, Javier Mauricio, Mendez Zurita, Francisco Javier, Rodriguez Font, Enrique, Gonzales Matos, Carlos Eduardo, García Hernando, Víctor, Lindholm, Carl-Johan, Thulin, Jörgen, Wallén, Håkan, Hagwall, Kristina, Eliasson, Ken, Lundvall, Martin, Olsson, Jens, Kjellman, Björn, Lind, Markus, Johansson, Lars, Svedberg, Niclas, Berglund, Stefan, Söderberg, Julia, Zedigh, Christer, Mooe, Thomas, Axelsson, Mattias, Binsell, Emil, Huber, Daniel, Müller, Christian, Danier, Isabelle, Kühne, Michael, Okamura, Bernhard, Schoepfer, Hadrien, Simmen, Cornelia, Reichlin, Tobias, Chollet, Laurève, Lam, Anna, Wittmer, Severin, Rickli, Hans, Gall, Christian, Hametner, Greta, Intorp, Stephanie, Luescher, Daniel, Haegeli, Laurent, Berg, Jan Christopher, Ebrahimi, Ramin, Auricchio, Angelo, Crljenica, Carmela, Moccetti, Tizziano, Monti, Cristina, Pasotti, Elena, Petrova, Iveta, Rossi, Mariagrazia, Mach, François, Namdar, Mehdi, de Groot, Joris, Proost, Virginnio, Neefs, Joline, Linz, Dominik, van Stipdonk, Twan, den Uijl, Dennis, Alings, Marco, Schaap, Jeroen, Segers, Dolf, Wouters, Noemi, Bartels, Louis, Tieleman, Robert, Pisters, Ron, de Vries, Tim, Selig, Jaap, Kuijper, Aaf, Bot, Pieter, Keijzers, Mitran, Verdel, Gerardus, Tukkie, Raymond, van den Bos, Ewout, Kauer, Floris, Oemrawsingh, Rohit, Stevenhagen, Jeroen, van Es, Jan, Lip, Gregory, Gupta, Dhiraj, Kotalczyk, Agnieszka, Gunstone, Anthony, Brixey, Richard David, Gorog, Diana, Dinarvand, Danial, Gue, Ying, Kanji, Rahim, Memtsas, Vassilios, Senior, Roxy, Bioh, Gabriel, Wong, Yuk-Ki, Child, Nick, Piccini, Jonathan P, Caso, Valeria, Connolly, Stuart J, Fox, Keith A A, Oldgren, Jonas, Jones, W Schuyler, Gorog, Diana A, Durdil, Václav, Viethen, Thomas, Neumann, Christoph, Mundl, Hardi, and Patel, Manesh R

Published
2022
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