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3. Effect of Torsemide Versus Furosemide on Symptoms and Quality of Life Among Patients Hospitalized for Heart Failure: The TRANSFORM-HF Randomized Clinical Trial

Author

Greene, Stephen J., Velazquez, Eric J., Anstrom, Kevin J., Clare, Robert M., DeWald, Tracy A., Psotka, Mitchell A., Ambrosy, Andrew P., Stevens, Gerin R., Rommel, John J., Alexy, Tamas, Ketema, Fassil, Kim, Dong-Yun, Desvigne-Nickens, Patrice, Pitt, Bertram, Eisenstein, Eric L., and Mentz, Robert J.

Published
2023
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6. Implications of trial eligibility in patients with heart failure with mildly reduced or preserved ejection fraction.

Author

Peters, Anthony E., Clare, Robert M., Chiswell, Karen, Harrington, Josephine, Kelsey, Anita, Hernandez, Adrian, Felker, Gary Michael, Mentz, Robert J., and DeVore, Adam D.

Subjects
GLOBAL longitudinal strain, TRANSIENT ischemic attack, HEART failure patients, PERIPHERAL vascular diseases, NATRIURETIC peptides
Abstract

Aims: Clinical trials in heart failure with mildly reduced or preserved ejection fraction (HFmrEF/HFpEF) commonly have detailed eligibility criteria. This may contribute to challenges with efficient enrolment and questions regarding the generalizability of trial findings. Methods and results: Patients with HFmrEF/HFpEF from a large US healthcare system were identified through a computable phenotype applied in linked imaging and electronic health record databases. We evaluated shared eligibility criteria from five recent/ongoing HFmrEF/HFpEF trials (PARAGON‐HF, EMPEROR‐Preserved, DELIVER, FINE‐ARTS, and SPIRRIT‐HFpEF) and compared clinical and echocardiographic features as well as outcomes between trial‐eligible and trial‐ineligible patients. Among 5552 patients with HFpEF/HFmrEF, 792 (14%) were eligible for trial consideration, having met all criteria assessed. Causes of ineligibility included lack of recent loop diuretics (37%), significant pulmonary disease (24%), reduced estimated glomerular filtration rate (17%), recent stroke/transient ischaemic attack (13%), or low natriuretic peptides (12%); 53% of ineligible patients had >1 reason for exclusion. Compared with eligible patients, ineligible patients were younger (age 71 vs. 75 years, P < 0.001) with higher rates of coronary artery disease (66% vs. 59%, P < 0.001) and peripheral vascular disease (40% vs. 33%, P < 0.001), but less mitral regurgitation, lower E/e′ ratio, and smaller left atrial sizes. Both eligible and ineligible patients demonstrated high rates of structural heart disease consistent with HFpEF [elevated left atrial size or left ventricular (LV) hypertrophy/increased LV mass], although this was slightly higher among eligible patients (95% vs. 92%, P = 0.001). The two cohorts demonstrated similar LV global longitudinal strain along with a similar prevalence of atrial fibrillation/flutter, hypertension, and obesity. Ineligible patients had similar all‐cause mortality (33% vs. 33% at 3 years) to those eligible but lower rates of heart failure hospitalization (20% vs. 28% at 3 years, P < 0.001). Conclusions: Among patients with HFmrEF/HFpEF from a large health system, approximately one in seven were eligible for major trials based on key criteria applied through a clinical computable phenotype. These findings highlight the large proportion of patients with HFmrEF/HFpEF ineligible for contemporary trials for whom the generalizability of trial findings may be questioned and further investigation would be beneficial. [ABSTRACT FROM AUTHOR]

Published
2024
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7. On‐treatment analysis of torsemide versus furosemide for patients hospitalized for heart failure: A post‐hoc analysis of TRANSFORM‐HF

Author

Kittipibul, Veraprapas, primary, Mentz, Robert J., additional, Clare, Robert M., additional, Wojdyla, Daniel M., additional, Anstrom, Kevin J., additional, Eisenstein, Eric L., additional, Ambrosy, Andrew P., additional, Goyal, Parag, additional, Skopicki, Hal A., additional, Ketema, Fassil, additional, Kim, Dong‐Yun, additional, Desvigne‐Nickens, Patrice, additional, Pitt, Bertram, additional, Velazquez, Eric J., additional, and Greene, Stephen J., additional

Published
2024
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11. Prognostic and Practical Validation of Current Definitions of Myocardial Infarction Associated With Percutaneous Coronary Intervention

Author

Tricoci, Pierluigi, Newby, L. Kristin, Clare, Robert M., Leonardi, Sergio, Gibson, C. Michael, Giugliano, Robert P., Armstrong, Paul W., Van de Werf, Frans, Montalescot, Gilles, Moliterno, David J., Held, Claes, Aylward, Philip E., Wallentin, Lars, Harrington, Robert A., Braunwald, Eugene, Mahaffey, Kenneth W., and White, Harvey D.

Published
2018
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12. Association of Acute Kidney Injury and Cardiovascular Disease Following Percutaneous Coronary Intervention: Assessment of Interactions by Race, Diabetes, and Kidney Function

Author

Lunyera, Joseph, primary, Clare, Robert M., additional, Chiswell, Karen, additional, Scialla, Julia J., additional, Pun, Patrick H., additional, Thomas, Kevin L., additional, Starks, Monique A., additional, Mohottige, Dinushika, additional, Boulware, L. Ebony, additional, and Diamantidis, Clarissa J., additional

Published
2023
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17. Deferred testing in stable outpatients with suspected coronary artery disease: a prespecified secondary analysis of the PRECISE randomized clinical trial

Author

Udelson, James E., Kelsey, Michelle D., Nanna, Michael G., Fordyce, Christopher B., Yow, Eric, Clare, Robert M., Mark, Daniel B., Patel, Manesh R., Rogers, Campbell, Curzen, Nicholas, Pontone, Gianluca, Maurovich-Horvat, Pal, De Bruyne, Bernard, Greenwood, John P., Marinescu, Victor, Leipsic, Jonathon, Stone, Gregg W., Ben-Yehuda, Ori, Berry, Colin, Hogan, Shea E., Redfors, Bjorn, Ali, Ziad A., Byrne, Robert A., Kramer, Christopher M., Yeh, Robert W., Martinez, Beth, Mullen, Sarah, Huey, Whitney, Anstrom, Kevin J., Al-Khalidi, Hussein R., Chiswell, Karen, Vemulapalli, Sreekanth, and Douglas, Pamela S.

Abstract

Importance: guidelines recommend deferral of testing for symptomatic people with suspected coronary disease (CAD) and low pretest probability. No randomized trial has prospectively evaluated such a strategy.Objective: to assess process of care and health outcomes in people identified as minimal risk for CAD when testing is deferred.Design: randomized, pragmatic effectiveness trial.Setting: prespecified subgroup analysis of the PRECISE trial, at 65 North American and European sites. Participants: identified as minimal risk by the validated PROMISE Minimal Risk Score (PMRS).Intervention: randomization to a precision strategy using the PMRS to assign those with minimal risk to deferred testing and others to coronary CTA with selective CT-derived fractional flow reserve, or to usual testing (stress testing or catheterization, with PMRS blinded). Randomization was stratified by PMRS risk.Main outcome: composite of all-cause death, nonfatal myocardial infarction (MI), or catheterization without obstructive CAD through 12 months.Results: among 2103 participants, 422 (20%) were identified as minimal risk and randomized to deferred testing (n=214) or usual testing (n=208). Mean age (SD) was 46 (8.6) years; 72% were women. During follow-up, 138 (64%) of those randomized to deferred testing never had testing,whereas 76 (36%) had a downstream test (at median [IQR] 48 [15, 78] days) for worsening (30%), uncontrolled (10%), or new (6%) symptoms or changing provider (19%) or participant (10%) preference. Results were normal for 96% of these tests. The primary endpoint occurred in 2 (0.9%) deferred testing and 13 (6.3%) usual testing participants, HR (95% CI) 0.15 (0.03, 60.66), p=0.012. No death or MI was observed in the deferred testing participants, while 1noncardiovascular death and 1 MI occurred in the usual testing group. Two participants hadcatheterizations without obstructive CAD in the deferred testing group and 12 with usual testing (p=0.016). At baseline, 70% of participants had frequent angina, and there was similar reduction of frequent angina to Conclusion and relevance: in symptomatic participants with suspected CAD, identification of minimal risk by the PMRS guided a strategy of initially deferred testing. The strategy was safe with no observed adverse outcome events, fewer catheterizations without obstructive CAD, and similar symptom relief compared with usual testing.Trial registration: ClinicalTrials.Gov NCT03702244.

Published
2023

22. Frequency, clinical and angiographic characteristics, and outcomes of high-risk non-ST-segment elevation acute coronary syndromes patients with left circumflex culprit lesions

Author

Halim, Sharif A., Clare, Robert M., Newby, L. Kristin, Lokhnygina, Yuliya, Schweiger, Marc J., Hof, Arnoud W., Hochman, Judith S., James, Stefan K., White, Harvey D., Widimsky, Petr, Betriu, Amadeo, Bode, Christoph, Giugliano, Robert P., Harrington, Robert A., and Zeymer, Uwe

Published
2016
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23. Glycoprotein IIb/IIIa Receptor Inhibitors in Combination With Vorapaxar, a Platelet Thrombin Receptor Antagonist, Among Patients With Non–ST-Segment Elevation Acute Coronary Syndromes (from the TRACER Trial)

Author

Cornel, Jan H., Tricoci, Pierluigi, Lokhnygina, Yuliya, Moliterno, David J., Wallentin, Lars, Armstrong, Paul W., Aylward, Philip E., Clare, Robert M., Chen, Edmond, Leonardi, Sergio, Van de Werf, Frans, White, Harvey D., Held, Claes, Strony, John, Mahaffey, Kenneth W., and Harrington, Robert A.

Published
2015
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25. UNDERSTANDING THE IMPORTANCE OF AGE IN SELECTING A TESTING STRATEGY FOR STABLE SYMPTOMATIC PATIENTS WITH SUSPECTED CORONARY ARTERY DISEASE: A PRESPECIFIED ANALYSIS FROM THE PRECISE RANDOMIZED TRIAL

Author

Vemmou, Evangelia, Kelsey, Michelle, Vemulapalli, Sreekanth, Mark, Daniel B., Rogers, Campbell D.K., Mullen, Sarah, Huey, Whitney, Chiswell, Karen E., Clare, Robert M., Caune, Aija, Yow, Eric, Leipsic, Jonathon, Byrne, Robert A., Ng, Nicholas, Pier, Kit, Udelson, James E., Douglas, Pamela S., and Nanna, Michael

Published
2024
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28. Abstract 10426: Worse Clinical Outcomes in Patients with Acute Coronary Syndrome and Prior or New Onset Heart Failure: Insights from 47,474 Patients in a Pooled Analysis of Randomized Clinical Trials

Author

Goodwin, Nathan, primary, Clare, Robert M, additional, Wojdyla, Daniel, additional, Harrington, Josephine, additional, Badjatiya, Anish, additional, Udell, Jacob A, additional, Butler, Javed, additional, Januzzi, James L, additional, Parikh, Puja, additional, James, Stefan K, additional, Alexander, John H, additional, Lopes, Renato D, additional, Wallentin, Lars C, additional, Ohman, E Magnus M, additional, Hernandez, Adrian F, additional, and Jones, William S, additional

Published
2021
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29. Polypharmacy in Palliative Care for Advanced Heart Failure: The PAL-HF Experience

Author

Granger, Bradi B., primary, Tulsky, James A., additional, Kaufman, Brystana G., additional, Clare, Robert M., additional, Anstrom, Kevin, additional, Mark, Daniel B., additional, Johnson, Kimberly A., additional, Patel, Chetan B., additional, Fiuzat, Mona, additional, Steinhauser, Karen, additional, O'Connor, Christopher, additional, Rogers, Joseph G., additional, and Mentz, Robert J., additional

Published
2021
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32. Predicting major adverse limb events in individuals with type 2 diabetes: Insights from the EXSCEL trial

Author

Weissler, E. Hope, primary, Clare, Robert M., additional, Lokhnygina, Yuliya, additional, Buse, John B., additional, Goodman, Shaun G., additional, Katona, Brian, additional, Iqbal, Nayyar, additional, Pagidipati, Neha J., additional, Sattar, Naveed, additional, Holman, Rury R., additional, Hernandez, Adrian F., additional, Mentz, Robert J., additional, Patel, Manesh R., additional, and Jones, W. Schuyler, additional

Published
2021
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34. Predictors of contemporary coronary artery bypass grafting outcomes

Author

Weisel, Richard D., Nussmeier, Nancy, Newman, Mark F., Pearl, Ronald G., Wechsler, Andrew S., Ambrosio, Giuseppe, Pitt, Bertram, Clare, Robert M., Pieper, Karen S., Mongero, Linda, Reece, Tammy L., Yau, Terrence M., Fremes, Stephen, Menasché, Philippe, Lira, Armando, Harrington, Robert A., and Ferguson, Bruce T.

Published
2014
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39. Claims-based cardiovascular outcome identification for clinical research: Results from 7 large randomized cardiovascular clinical trials

Author

Brennan, J. Matthew, primary, Wruck, Lisa, additional, Pencina, Michael J., additional, Clare, Robert M., additional, Lopes, Renato D., additional, Alexander, John H., additional, O'Brien, Sean, additional, Krucoff, Mitchell, additional, Rao, Sunil V., additional, Wang, Tracy Y., additional, Curtis, Lesley H., additional, Newby, L. Kristin, additional, Granger, Christopher B., additional, Patel, Manesh, additional, Mahaffey, Kenneth, additional, Ross, Joseph S., additional, Normand, Sharon-Lise, additional, Eloff, Benjamin C., additional, Caños, Daniel A., additional, Lokhnygina, Yuliya V., additional, Roe, Matthew T., additional, Califf, Robert M., additional, Marinac-Dabic, Danica, additional, and Peterson, Eric D., additional

Published
2019
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42. Stroke Outcomes With Vorapaxar Versus Placebo in Patients With Acute Coronary Syndromes: Insights From the TRACER Trial

Author

Ungar, Leo, primary, Clare, Robert M., additional, Rodriguez, Fatima, additional, Kolls, Bradley J., additional, Armstrong, Paul W., additional, Aylward, Philip, additional, Held, Claes, additional, Moliterno, David J., additional, Strony, John, additional, Van de Werf, Frans, additional, Wallentin, Lars, additional, White, Harvey D., additional, Tricoci, Pierluigi, additional, Harrington, Robert A., additional, Mahaffey, Kenneth W., additional, and Melloni, Chiara, additional

Published
2018
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43. Stroke Outcomes With Vorapaxar Versus Placebo in Patients With Acute Coronary Syndromes : Insights From the TRACER Trial

Author

Ungar, Leo, Clare, Robert M., Rodriguez, Fatima, Kolls, Bradley J., Armstrong, Paul W., Aylward, Philip, Held, Claes, Moliterno, David J., Strony, John, Van de Werf, Frans, Wallentin, Lars, White, Harvey D., Tricoci, Pierluigi, Harrington, Robert A., Mahaffey, Kenneth W., Melloni, Chiara, Ungar, Leo, Clare, Robert M., Rodriguez, Fatima, Kolls, Bradley J., Armstrong, Paul W., Aylward, Philip, Held, Claes, Moliterno, David J., Strony, John, Van de Werf, Frans, Wallentin, Lars, White, Harvey D., Tricoci, Pierluigi, Harrington, Robert A., Mahaffey, Kenneth W., and Melloni, Chiara

Abstract

Background Vorapaxar, a protease‐activated receptor‐1 antagonist, is approved for secondary prevention of cardiovascular events but is associated with increased intracranial hemorrhage. Methods and Results TRACER (Thrombin Receptor Antagonist for Clinical Event Reduction in Acute Coronary Syndrome) was a trial of vorapaxar versus placebo among patients with acute coronary syndrome. Strokes were adjudicated by a central events committee. Of 12 944 patients, 199 (1.5%) had ≥1 stroke during the study period (median follow‐up, 477 days). Four patients had a single stroke of unknown type; 195 patients had ≥1 stroke classified as hemorrhagic or nonhemorrhagic (165 nonhemorrhagic, 28 hemorrhagic, and 2 both). Strokes occurred in 96 of 6473 patients (1.5%) assigned vorapaxar and 103 of 6471 patients (1.6%) assigned placebo. Kaplan‐Meier incidence of stroke for vorapaxar versus placebo was higher for hemorrhagic stroke (0.45% versus 0.14% [hazard ratio, 2.74; 95% confidence interval, 1.22–6.15]), lower but not significantly different for nonhemorrhagic stroke (1.53% versus 1.98% at 2 years [hazard ratio, 0.79; 95% confidence interval, 0.58–1.07]), and similar for stroke overall (1.93% versus 2.13% at 2 years [hazard ratio, 0.94; 95% confidence interval, 0.71–1.24]). Conclusions Stroke occurred in <2% of patients. Vorapaxar‐assigned patients had increased hemorrhagic stroke but a nonsignificant trend toward lower nonhemorrhagic stroke. Overall stroke frequency was similar with vorapaxar versus placebo.

Published
2018
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44. Safety of ticagrelor in patients with baseline conduction abnormalities : A PLATO (Study of Platelet Inhibition and Patient Outcomes) analysis

Author

Scirica, Benjamin M., Bansilal, Sameer, Davoudi, Farideh, Armstrong, Paul W., Clare, Robert M., Schulte, Phillip J., Pieper, Karen S., Becker, Richard C., James, Stefan K, Storey, Robert F., Steg, Philippe Gabriel, Held, Claes, Himmelmann, Anders, Mahaffey, Kenneth W., Wallentin, Lars, Cannon, Christopher P., Scirica, Benjamin M., Bansilal, Sameer, Davoudi, Farideh, Armstrong, Paul W., Clare, Robert M., Schulte, Phillip J., Pieper, Karen S., Becker, Richard C., James, Stefan K, Storey, Robert F., Steg, Philippe Gabriel, Held, Claes, Himmelmann, Anders, Mahaffey, Kenneth W., Wallentin, Lars, and Cannon, Christopher P.

Abstract

Background: Although bradyarrhythmias have been observed with ticagrelor and its use with advanced atrioventricular block is not recommended, questions arise regarding its use in patients with mild conduction abnormalities. The objectives were to compare rates of clinically relevant arrhythmias in relation to any mild baseline conduction abnormality in patients with acute coronary syndrome randomized to ticagrelor versus clopidogrel. Methods: We included all subjects in the electrocardiographic (ECG) substudy of the Platelet Inhibition and Patient Outcomes trial, excluding those with missing baseline ECG or with a pacemaker at baseline (N = 15,460). Conduction abnormality was defined as sinus bradycardia, first-degree atrioventricular block, hemiblock, or bundle-branch block. The primary arrhythmic outcome was the composite of any symptomatic brady-or tachyarrhythmia, permanent pacemaker placement, or cardiac arrest through 12 months. Results: Patients with baseline conduction abnormalities (n = 4,256, 27.5%) were older and more likely to experience the primary arrhythmic outcome. There were no differences by ticagrelor versus clopidogrel in the composite arrhythmic end point in those with baseline conduction disease (1-year cumulative incidence rate: 17% for both study arms; hazard ratio: 0.99 [0.86-1.15]) or without baseline conduction disease (1-year cumulative incidence rate: clopidogrel 12.8% vs ticagrelor 12.4%; hazard ratio: 0.98 (0.88-1.09). There were also no statistically significant differences between ticagrelor and clopidogrel in the rates of bradycardic (or any individual arrhythmic) events in patients with baseline conduction abnormalities. Conclusions: Ticagrelor compared to clopidogrel did not increase arrhythmic events even in subjects with acute coronary syndrome who present with mild conduction abnormalities on their baseline ECG. (C) 2018 Published by Elsevier Inc.

Published
2018
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47. Safety of ticagrelor in patients with baseline conduction abnormalities: A PLATO (Study of Platelet Inhibition and Patient Outcomes) analysis

Author

Scirica, Benjamin M., primary, Bansilal, Sameer, additional, Davoudi, Farideh, additional, Armstrong, Paul W., additional, Clare, Robert M., additional, Schulte, Phillip J., additional, Pieper, Karen S., additional, Becker, Richard C., additional, James, Stefan K., additional, Storey, Robert F., additional, Steg, Philippe Gabriel, additional, Held, Claes, additional, Himmelmann, Anders, additional, Mahaffey, Kenneth W., additional, Wallentin, Lars, additional, and Cannon, Christopher P., additional

Published
2018
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48. Discharge timing and outcomes after uncomplicated non–ST-segment elevation acute myocardial infarction

Author

Rymer, Jennifer A., primary, Tempelhof, Michael W., additional, Clare, Robert M., additional, Pieper, Karen S., additional, Granger, Christopher B., additional, Van de Werf, Frans, additional, Moliterno, David J., additional, Harrington, Robert A., additional, White, Harvey D., additional, Armstrong, Paul W., additional, Lopes, Renato D., additional, Mahaffey, Kenneth W., additional, and Newby, L. Kristin, additional

Published
2018
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49. Interaction of Body Mass Index on the Association Between N‐Terminal‐Pro‐b‐Type Natriuretic Peptide and Morbidity and Mortality in Patients With Acute Heart Failure: Findings From ASCEND‐HF (Acute Study of Clinical Effectiveness of Nesiritide in Decompensated Heart Failure)

Author

Bhatt, Ankeet S., primary, Cooper, Lauren B., additional, Ambrosy, Andrew P., additional, Clare, Robert M., additional, Coles, Adrian, additional, Joyce, Emer, additional, Krishnamoorthy, Arun, additional, Butler, Javed, additional, Felker, G. Michael, additional, Ezekowitz, Justin A., additional, Armstrong, Paul W., additional, Hernandez, Adrian F., additional, O'Connor, Christopher M., additional, and Mentz, Robert J., additional

Published
2018
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50. Use of thienopyridine prior to presentation with non-ST-segment elevation acute coronary syndrome and association with safety and efficacy of vorapaxar : insights from the TRACER trial

Author

Harskamp, Ralf E., Clare, Robert M., Ambrosio, Giuseppe, Held, Claes, Lokhnygina, Yuliya, Moliterno, David J., White, Harvey D., Aylward, Philip E., Armstrong, Paul W., Mahaffey, Kenneth W., Harrington, Robert A., Van de Werf, Frans, Wallentin, Lars, Strony, John, Tricoci, Pierluigi, Harskamp, Ralf E., Clare, Robert M., Ambrosio, Giuseppe, Held, Claes, Lokhnygina, Yuliya, Moliterno, David J., White, Harvey D., Aylward, Philip E., Armstrong, Paul W., Mahaffey, Kenneth W., Harrington, Robert A., Van de Werf, Frans, Wallentin, Lars, Strony, John, and Tricoci, Pierluigi

Abstract

Background: Vorapaxar is effective in the prevention of secondary atherothrombotic events, although the efficacy/safety balance appears less favorable in the treatment of patients with non-ST-segment elevation (NSTE) acute coronary syndrome (ACS). We hypothesized that patients with NSTE ACS already receiving thienopyridine prior to the ACS event may show differential efficacy/safety effects with vorapaxar vs. placebo added to their standard care. Methods: We studied 12,944 patients from the Thrombin Receptor Antagonist for Clinical Event Reduction in Acute Coronary Syndrome (TRACER) trial with respect to thienopyridine use before admission for the index NSTE ACS event. The primary endpoint was a composite of cardiovascular death, myocardial infarction, stroke, rehospitalization for ischemia, and urgent revascularization. The key secondary endpoint was a composite of cardiovascular death, myocardial infarction, and stroke. Safety endpoints were bleeding complications. Results: Only 1513 patients (11.7%) were receiving thienopyridine before admission for the index NSTE ACS event. In these patients, Global Use of Strategies to Open Occluded Coronary Arteries (GUSTO) moderate/severe bleeding occurred in 5.7% treated with vorapaxar and 5.3% treated with a placebo (hazards ratio (HR) 1.10, 95% confidence interval (CI) 0.70-1.71); in thienopyridine-naive patients, the rates were 5.7% and 4.1%, respectively (HR 1.32, 95% CI 1.11-1.57; P-int=0.45). GUSTO severe bleeding in the prior thienopyridine group occurred in 0.5% of patients treated with vorapaxar and 1.3% of patients treated with placebo (HR 0.34, 95% CI 0.09-1.30); in thienopyridine-naive patients, the rates were 2.0% and 1.0%, respectively (HR 1.89, 95% CI 1.36-2.62; P-int=0.01). No interaction was observed between vorapaxar efficacy and prior thienopyridine use on the primary (adjusted P-int=0.53) or key secondary endpoints (P-int=0.61). Conclusions: TRACER was largely conducted in thienopyridine-naive patients wi

Published
2017
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