ENGAGE AF-TIMI 48

The purpose of this study was to demonstrate the safety and efficacy profile, in two different dose regimens of DU-176b, (an investigational new drug being tested for the prevention of stroke/systemic embolic events (SEE)), in individuals with atrial fibrillation. Patients were randomized to one of three treatment groups: High Dose Regimen, Low Dose Regimen, & Warfarin.

MAIN RESULTS:
Edoxaban versus warfarin in patients with atrial fibrillation

N Engl J Med. 2013 Nov 28;369(22):2093-104.

PRESENTATIONS

TIMI 48 Slides
Relationship Between Edoxaban Dose, Concentration, Anti-Factor Xa Activity, and Outcomes in the ENGAGE AF-TIMI 48 Trial (Ruff, ESC 2014)
Biomarkers for the Assessment of Stroke-Systemic Embolism and Bleeding Risk in Patients with AF in ENGAGE (Berg, AHA 2018)
HF Hospitalization and Mortality in Non-Valvular AF (Inciardi, ESC 2019)
Edoxaban versus Warfarin in Atrial Fibrillation Patients with Low, Mid and High Body Weight in ENGAGE (Boriani, ESC 2019)
ENGAGE Genetics (Marston, AHA 2019)
A Targeted Proteomic Approach Identifies Novel Biomarkers of Arterial Thromboembolic Risk in ENGAGE AF-TIMI 48 (Berg, ACC 2021)
Epistaxis in Anticoagulated Patients with Atrial Fibrillation in the ENGAGE AF-TIMI 48 Trial (Semco, ESC 2021)
Effectiveness and Safety of Edoxaban in Atrial Fibrillation Patients from the ETNA-AF Global Registry (de Caterina, ESC 2021)
Evaluation of the ABC Pathway for Comprehensive Management of Atrial Fibrillation in 20,933 Patients from the ENGAGE AF-TIMI 48 Trial (Patel, AHA 2021)
A Genetic Risk Score to Predict Peripheral Artery Disease and Acute Limb Ischemia in Patients With Cardiometabolic Disease (Patel, AHA 2021)
Neutrophil-Lymphocyte Ratio and Outcomes in Patients with AF-Analyses from ENGAGE AF-TIMI 48 (Fagundes, ACC 2022)
Serial Assessment of Biomarkers and the Risk of Heart Failure in Patients (Oyama, ACC 2022) (with audio)

Safety and Efficacy of Non-Vitamin K Antagonist Oral Anticoagulants vs. Warfarin Across Body Mass Index and Body Weight – Insights from COMBINE-AF (Patel, AHA 2022)
Development of a Novel Polygenic Risk Score to Predict Risk of Aortic Stenosis Events (Small, AHA 2022)
Edoxaban 30mg vs Warfarin in 2,406 Patients Age 80 or Greater: A Randomized Analysis from ENGAGE-TIMI 48 (Zimerman, ACC 2023)
Development and Validation of the DOAC Score – A Novel Bleeding Risk Prediction Tool for Patients with Atrial Fibrillation on Direct-Acting Oral Anticoagulants (Aggarwal, ESC 2023)
Efficacy and Safety of DOACs vs. Warfarin by Background Antiplatelet Therapy in 57,598 Patients With Atrial Fibrillation (Patel, ESC 2023)
Performance of a Polygenic Risk Score for CAD Across the Spectrum of ASCVD-An Analysis of 60k Patients from 6 TIMI Randomized Trials (Zimerman, AHA 2023)
Identification Of Atrial Fibrillation Patients With Favorable Outcomes On Warfarin: An Individual Patient-Level Analysis Of 29,272 Warfarin Patients From The COMBINE-AF Study (Al Said, ACC 2024).
Should Frail Elderly AF Patients On VKA Switch To A DOAC? A Randomized Comparison From COMBINE-AF, A Patient-Level Metanalysis Of The 4 Large RCTS Of DOACs VS Warfarin (Giugliano, ACC 2024)
Frailty Status And Outcomes In 58,634 Patients With Atrial Fibrillation Randomized To DOAC VS Warfarin (Nicolau, ACC 2024)
Effect Of DOACs Versus Warfarin By ASCVD Status In 58,634 Patients With Atrial Fibrillation: A Pooled Analysis Of 4 Randomized Trials (Zimerman, ACC 2024)
Extracranial systemic embolic events in patients with atrial fibrillation-an individual patient-level meta-analysis of 71 683 patients randomized to NOAC vs warfarin (Al Said, ESC 2024)
Clinical outcomes in 10,000 Asian vs 61,000 Non-Asian race patients with AF randomized to Warfarin vs DOACs-a patient-level meta-analyses from COMBINE AF (Chao, ESC 2024)
Paul Haller – Heart failure risk assessment using biomarkers in patients with atrial fibrillation – Analysis of 32,041 patients from the COMBINE study
Evaluation of the biomarker-based ABC-AF-bleeding risk score and clinically based bleeding scores in 31,605 patients with atrial fibrillation treated with oral anticoagulation (Hijazi, ESC 2024)
Pathogenic cardiomyopathy gene variants inform prognosis in atrial fibrillation-results from exome sequencing in over 17,000 patients in TIMI trials (Jurgens, ESC 2024)
Exome sequencing in over 63,000 patients in TIMI trials uncovers pathogenic cardiomyopathy variant carriers with high risk for heart failure and cardiovascular death (Kany, ESC 2024)
Intracranial Hemorrhage in Patients with Atrial Fibrillation-Insights from COMBINE-AF (Tannu, ESC 2024)
Polygenic Risk in Heart Failure (Haller, AHA 2024)
Risk of myocardial infarction in paroxysmal vs. non-paroxysmal atrial fibrillation-an individual patient-level data analysis of 71,466 patients from COMBINE-AF Goette, AHA 2024)
Low-dose edoxaban in patients 80 years and older with atrial fibrillation and dose-reduction criteria-randomized analysis between edoxaban 15 mg and 30 mg (Zimerman, ESC 2025)
The association between sex and body size and stroke risk and survival in patients with atrial fibrillation an analysis of 71,589 patients from the COMBINE AF study (Aulin, ESC 2025)
Validation of the DOAC Score among Patients on Vitamin K Antagonists (Aggarwal, ESC 2025)
Polygenic Risk Score for Abdominal Aortic Aneurysm in Patients with Cardiometabolic Disease: Analysis of 40,000 Patients from 3 TIMI Trials (Lai, AHA 2025)
Guiding iterative decision-making in anticoagulant dosing including patient preferences of stroke vs bleeding avoidance (Gibson, CVCT 2025)
Patient-Centered Evaluation of DOACs versus Warfarin in Atrial Fibrillation (Shoji, CVCT 2025)

OTHER PUBLICATIONS

Evaluation of the novel factor Xa inhibitor edoxaban compared with warfarin in patients with atrial fibrillation: design and rationale for the Effective aNticoaGulation with factor xA next GEneration in Atrial Fibrillation-Thrombolysis In Myocardial Infarction study 48 (ENGAGE AF-TIMI 48). Am Heart J. 2010 Oct;160(4):635-41.

Novel oral anticoagulants in atrial fibrillation: a meta-analysis of large, randomized, controlled trials vs warfarin. Clin Cardiol. 2013 Feb;36(2):61-7. 

Current and new oral antithrombotics in non-valvular atrial fibrillation: a network meta-analysis of 79 808 patients. Heart. 2014 Mar;100(5):396-405.

Left atrial structure and function in atrial fibrillation: ENGAGE AF-TIMI 48. Eur Heart J. 2014 Jun 7;35(22):1457-65.

Comparison of the efficacy and safety of new oral anticoagulants with warfarin in patients with atrial fibrillation: a meta-analysis of randomised trials. Lancet. 2014 Mar 15;383(9921):955-62.

Cerebrovascular events in 21 105 patients with atrial fibrillation randomized to edoxaban versus warfarin: Effective Anticoagulation with Factor Xa Next Generation in Atrial Fibrillation-Thrombolysis in Myocardial Infarction 48. Stroke. 2014 Aug;45(8):2372-8.

Transition of patients from blinded study drug to open-label anticoagulation: the ENGAGE AF-TIMI 48 trial. J Am Coll Cardiol. 2014 Aug 12;64(6):576-84.

Edoxaban vs. warfarin in vitamin K antagonist experienced and naive patients with atrial fibrillation. Eur Heart J. 2015 Jun 14;36(23):1470-7.

Genetics and the clinical response to warfarin and edoxaban: findings from the randomised, double-blind ENGAGE AF-TIMI 48 trial. Lancet. 2015 Jun 6;385(9984):2280-7.

Association between edoxaban dose, concentration, anti-Factor Xa activity, and outcomes: an analysis of data from the randomised, double-blind ENGAGE AF-TIMI 48 trial. Lancet. 2015 Jun 6;385(9984):2288-95.

Edoxaban vs. warfarin in patients with atrial fibrillation on amiodarone: a subgroup analysis of the ENGAGE AF-TIMI 48 trial. Eur Heart J. 2015 Sep 1;36(33):2239-45.

Systemic, Non-cerebral, Arterial Embolism in 21,105 Patients with Atrial Fibrillation Randomized to Edoxaban or Warfarin: Results from the ENGAGE AF-TIMI 48 Trial. Am Heart J. 2015 Oct;170(4):669-74.

Cost-effectiveness of edoxaban vs warfarin in patients with atrial fibrillation based on results of the ENGAGE AF–TIMI 48 trial. Am Heart J. 2015 Dec;170(6):1140-50.

Effects of Regional Differences in Asia on Efficacy and Safety of Edoxaban Compared With Warfarin- Insights From the ENGAGE AF-TIMI 48 Trial. Circ J. 2015;79(12):2560-7.

Edoxaban vs warfarin in patients with nonvalvular atrial fibrillation in the US Food and Drug Administration approval population: An analysis from the Effective Anticoagulation with Factor Xa Next Generation in Atrial Fibrillation-Thrombolysis in Myocardial Infarction 48 (ENGAGE AF-TIMI 48) trial. Am Heart J. 2016 Feb;172:144-51.

Edoxaban vs. Warfarin in East Asian Patients With Atrial Fibrillation- An ENGAGE AF-TIMI 48 Subanalysis. Circ J. 2016;80(4):860-9.

Concomitant Use of Single Antiplatelet Therapy With Edoxaban or Warfarin in Patients With Atrial Fibrillation: Analysis From the ENGAGE AF-TIMI 48 Trial. J Am Heart Assoc. 2016 Feb 23;5(2):e002587.

Mortality in Patients With Atrial Fibrillation Randomized to Edoxaban or Warfarin: Insights from the ENGAGE AF-TIMI 48 Trial. Am J Med. 2016 Aug;129(8):850-857.e2.

Cardioversion of Atrial Fibrillation in ENGAGE AF-TIMI 48. Clin Cardiol. 2016 Jun;39(6):345-6.

The Prognostic Significance of Cardiac Structure and Function in Atrial Fibrillation: The ENGAGE AF-TIMI 48 Echocardiographic Substudy. J Am Soc Echocardiogr. 2016 Jun;29(6): 537–544.

Efficacy and Safety of Edoxaban in Elderly Patients With Atrial Fibrillation in the ENGAGE AF-TIMI 48 Trial. J Am Heart Assoc. 2016 May 20;5(5):e003432.

Efficacy and Safety of Non-Vitamin K Antagonist Oral Anticoagulants After Cardioversion for Nonvalvular Atrial Fibrillation. Am J Med. 2016 Oct;129(10):1117-1123.e2.

Efficacy and safety of edoxaban compared with warfarin in patients with atrial fibrillation and heart failure: insights from ENGAGE AF-TIMI 48. Eur J Heart Fail. 2016 Sep;18(9):1153-61.

The Impact of Renal Function on Outcomes With Edoxaban in the ENGAGE AF-TIMI 48 Trial. Circulation. 2016 Jul 5;134(1):24-36.

Outcomes With Edoxaban Versus Warfarin in Patients With Previous Cerebrovascular Events: Findings From ENGAGE AF-TIMI 48 (Effective Anticoagulation With Factor Xa Next Generation in Atrial Fibrillation-Thrombolysis in Myocardial Infarction 48). Stroke. 2016 Aug;47(8):2075-82.

Sudden Cardiac Death in Patients With Atrial Fibrillation: Insights From the ENGAGE AF-TIMI 48 Trial. J Am Heart Assoc. 2016 Jul 8;5(7):e003735.

Management of Bleeding With Non-Vitamin K Antagonist Oral Anticoagulants in the Era of Specific Reversal Agents. Circulation. 2016 Jul 19;134(3):248-61.

Population Pharmacokinetics of Edoxaban in Patients with Non-Valvular Atrial Fibrillation in the ENGAGE AF-TIMI 48 Study, a Phase III Clinical Trial. Clin Pharmacokinet. 2016 Sep;55(9):1079-90.

Standard dose versus low dose non-vitamin K antagonist oral anticoagulants in Asian patients with atrial fibrillation: A meta-analysis of contemporary randomized controlled trials. Heart Rhythm. 2016 Dec;13(12):2340-2347.

Edoxaban Versus Warfarin in Atrial Fibrillation Patients at Risk of Falling: ENGAGE AF-TIMI 48 Analysis. J Am Coll Cardiol. 2016 Sep 13;68(11):1169-1178.

Non-Vitamin K Antagonist Oral Anticoagulants in Atrial Fibrillation. Hematol Oncol Clin North Am. 2016 Oct;30(5):1019-34.

Efficacy and Safety of Novel Oral Anticoagulants in Patients With Atrial Fibrillation and Heart Failure: A Meta-Analysis. JACC Heart Fail. 2016 Nov;4(11):870-880.

Cardiovascular Biomarker Score and Clinical Outcomes in Patients With Atrial Fibrillation: A Subanalysis of the ENGAGE AF-TIMI 48 Randomized Clinical Trial. JAMA Cardiol. 2016 Dec 1;1(9):999-1006.

Stroke and Mortality Risk in Patients With Various Patterns of Atrial Fibrillation: Results From the ENGAGE AF-TIMI 48 Trial (Effective Anticoagulation With Factor Xa Next Generation in Atrial Fibrillation-Thrombolysis in Myocardial Infarction 48). Circ Arrhythm Electrophysiol. 2017 Jan;10(1):e004267.

Edoxaban for the Prevention of Thromboembolism in Patients With Atrial Fibrillation and Bioprosthetic Valves. Circulation. March 28, 2017. Vol 135, Issue 13.

Valvular Heart Disease Patients on Edoxaban or Warfarin in the ENGAGE AF-TIMI 48 Trial. J Am Coll Cardiol. 2017 Mar 21;69(11):1372-1382.

A novel risk prediction score in atrial fibrillation for a net clinical outcome from the ENGAGE AF-TIMI 48 randomized clinical trial. Eur Heart J. 2017 Mar 21;38(12):888-896.

Non-Vitamin K Antagonist Oral Anticoagulants in Patients With Atrial Fibrillation and Valvular Heart Disease. J Am Coll Cardiol. 2017 Mar 21;69(11):1363-1371.

Extracranial arterial and venous thromboembolism in patients with atrial fibrillation: A meta-analysis of randomized controlled trials. Heart Rhythm. 2017 Apr;14(4):599-605.

Cost-Effectiveness of Edoxaban vs. Warfarin in Patients with Atrial Fibrillation Based on Results of the ENGAGE AF – TIMI 48 Trial: Taiwanese Perspective. Value Health Reg Issues. 2017 May;12:74-83.

Digoxin Use and Subsequent Clinical Outcomes in Patients With Atrial Fibrillation With or Without Heart Failure in the ENGAGE AF-TIMI 48 Trial. J Am Heart Assoc. 2017 Jun 30;6(7):e006035.

Impact of Spontaneous Extracranial Bleeding Events on Health State Utility in Patients with Atrial Fibrillation: Results from the ENGAGE AF-TIMI 48 Trial. J Am Heart Assoc. 2017 Aug 11;6(8):e006703.

Once- or twice-daily non-vitamin K antagonist oral anticoagulants in Asian patients with atrial fibrillation: A meta-analysis of randomized controlled trials. J Formos Med Assoc. 2017 Aug;116(8):591-598. 

First experience with edoxaban and atrial fibrillation ablation – Insights from the ENGAGE AF-TIMI 48 trial. Int J Cardiol. 2017 Oct 1;244:192-195.

Drug Class, Renal Elimination, and Outcomes of Direct Oral Anticoagulants in Asian Patients: A Meta-Analysis. J Stroke Cerebrovasc Dis. 2018 Apr;27(4):857-864.

Clinical events after interruption of anticoagulation in patients with atrial fibrillation: a subgroup analysis from ENGAGE AF-TIMI 48 trial. Int J Cardiol. 2018 Apr 15;257:102-107.

Gastrointestinal Bleeding With Edoxaban versus Warfarin: Results From the ENGAGE AF-TIMI 48 Trial. Circ Cardiovasc Qual Outcomes. 2018 May;11(5):e003998.

Peri-operative Adverse Outcomes in Patients with Atrial Fibrillation Taking Warfarin or Edoxaban: Analysis of the ENGAGE AF-TIMI 48 Trial. Thromb Haemost. 2018 Jun;118(6):1001-1008.

Edoxaban in atrial fibrillation patients with established coronary artery disease: Insights from ENGAGE AF-TIMI 48. Eur Heart J Acute Cardiovasc Care. 2019 Mar;8(2):176-185.

Efficacy And Safety Of Edoxaban In Patients With Atrial Fibrillation And Active Malignancy: An Analysis Of ENGAGE AF – TIMI 48 Randomized Clinical Trial. J Am Heart Assoc. 2018 Aug 21;7(16):e008987.

Edoxaban Versus Warfarin in Latin American Patients With Atrial Fibrillation: The ENGAGE AF-TIMI 48 Trial. J Am Coll Cardiol. 2018 Sep 25;72(13):1466-1475.

The efficacy and safety of non-vitamin K antagonist oral anticoagulants in patients with atrial fibrillation and coronary artery disease: A meta-analysis of randomized trials. Eur Heart J Acute Cardiovasc Care. 2019 Sep;8(6):554-561.

Linking endogenous factor X activity, a biologically relevant pharmacodynamic marker, to edoxaban plasma concentration and clinical outcomes in the ENGAGE AF-TIMI 48 trial. Circulation. 2018 Oct 30;138(18):1963-1973.

Edoxaban and implantable cardiac device interventions: insights from the ENGAGE AF-TIMI 48 triaEuropace. 2019 Feb 1;21(2):306-312.

Performance of the ABC Scores for Assessing the Risk of Stroke or Systemic Embolism and Bleeding in Patients With Atrial Fibrillation in ENGAGE AF-TIMI 48. Circulation. 2019 Feb 5;139(6):760-771.

Efficacy and safety of reduced-dose non-vitamin K antagonist oral anticoagulants in patients with atrial fibrillation: a meta-analysis of randomized controlled trials. Eur Heart J. 2019 May 14;40(19):1492-1500.

Relationship between body mass index and outcomes in patients with atrial fibrillation treated with edoxaban or warfarin in the ENGAGE AF-TIMI 48 trial. Eur Heart J. 2019 May 14;40(19):1541-1550.

Clinical outcomes, edoxaban concentration, and anti-factor Xa activity of Asian patients with atrial fibrillation compared with non-Asians in the ENGAGE AF-TIMI 48 trial. Eur Heart J. 2019 May 14;40(19):1518-1527.

Edoxaban Versus Warfarin in Patients With Atrial Fibrillation and History of Liver Disease. J Am Coll Cardiol. 2019 Jul 16;74(2):179-189.

Edoxaban Versus Warfarin Stratified by Average Blood Pressure in 19 679 Patients With Atrial Fibrillation and a History of Hypertension in the ENGAGE AF-TIMI 48 Trial. Hypertension. 2019 Sep;74(3):597-605.

Comparison of Events Across Definitions of Major Bleeding in the Engage AF-TIMI 48 Trial. Circulation. 2019 Nov 26;140(22):1792-1801.

Left atrial structure and function and the risk of death or heart failure in atrial fibrillation. Eur J Heart Fail. 2019 Dec;21(12):1571-1579.

Pharmacogenetic-guided and clinical warfarin dosing algorithm assessments with bleeding outcomes risk-stratified by genetic and covariate subgroups. Int J Cardiol. 2020 Oct 15;317:159-166.

Efficacy and safety of edoxaban in patients with diabetes mellitus in the ENGAGE AF-TIMI 48 trial. Int J Cardiol. 2020 Apr 1;304:185-191.

Efficacy and safety of edoxaban compared with warfarin according to the burden of diseases in patients with atrial fibrillation: insights from the ENGAGE AF-TIMI 48 trial. Eur Heart J Cardiovasc Pharmacother. 2020 Jul 1;6(3):167-175.

Edoxaban versus Warfarin in Patients with Atrial Fibrillation at the Extremes of Body Weight: An Analysis from the ENGAGE AF-TIMI 48 Trial. Thromb Haemost. 2021 Feb;121(2):140-149.

Cardiovascular- and Bleeding-Related Hospitalization Rates With Edoxaban Versus Warfarin in Patients With Atrial Fibrillation Based on Results of the ENGAGE AF-TIMI 48 Trial. Circ Cardiovasc Qual Outcomes. 2020 Nov;13(11):e006511.

Clinical Application of a Novel Genetic Risk Score for Ischemic Stroke in Patients with Cardiometabolic Disease. Circulation. 2021 Feb 2;143(5):470-478.

Individual Patient Data from the Pivotal Randomized Controlled Trials of Non-Vitamin K Antagonist Oral Anticoagulants in Patients with Atrial Fibrillation (COMBINE AF): Design and Rationale: From the COMBINE AF (A COllaboration between Multiple institutions to Better Investigate Non-vitamin K antagonist oral anticoagulant usE in Atrial Fibrillation) Investigators. Am Heart J. 2020 Dec 6;233:48-58.

Intracranial hemorrhage in patients with atrial fibrillation receiving anticoagulation with warfarin or edoxaban: An in-depth analysis from the ENGAGE AF-TIMI 48 randomized trial. J Clin Neurosci. 2021 Apr;86:294-300.

Edoxaban versus Warfarin in Patients with Atrial Fibrillation in Relation to the Risk of Stroke: A Secondary Analysis of the ENGAGE AF-TIMI 48 Study. Am Heart J. 2021 Jan 22;235:132-139.

Comparison of the Efficacy and Safety Outcomes of Edoxaban in 8040 Women Versus 13 065 Men With Atrial Fibrillation in the ENGAGE AF-TIMI 48 Trial. Circulation. 2021 Feb 16;143(7):673-684.

Randomized, Double-Blind Comparison of Half-Dose Versus Full-Dose Edoxaban in 14,014 Patients With Atrial Fibrillation. J Am Coll Cardiol. 2021 Mar 9;77(9):1197-1207.

Serial assessment of biomarkers and the risk of stroke or systemic embolism and bleeding in patients with atrial fibrillation in the ENGAGE AF-TIMI 48 trial. Eur Heart J. 2021 May 1;42(17):1698-1706.

Reply: Do We Need to Define Therapeutic Ranges for Edoxaban Plasma Concentration? J Am Coll Cardiol. 2021 Jun 29;77(25):3232-3233.

A Targeted Proteomic Approach Identifies Novel Biomarkers of Arterial Thromboembolic Risk in ENGAGE AF-TIMI 48. J Am Coll Cardiol. 2021 Aug 10;78(6):634-636.

Ischemic and bleeding risk in atrial fibrillation with and without peripheral artery disease and efficacy and safety of full and half-dose Edoxaban vs. Warfarin: insights from ENGAGE AF-TIMI 48. Eur Heart J Cardiovasc Pharmacother. 2022 Sep 29;8(7):695-706.

Edoxaban vs. Warfarin in High-risk Patients with Atrial Fibrillation: A Comprehensive Analysis of High-Risk Subgroups. Am Heart J. 2022 May;247:24-32.

Direct Oral Anticoagulants versus Warfarin in Patients with Atrial Fibrillation: Patient-Level Network Meta-Analyses of Randomized Clinical Trials with Interaction Testing by Age and Sex. Circulation. 2022 Jan 25;145(4):242-255.

Evaluation of the atrial fibrillation better care pathway in the ENGAGE AF-TIMI 48 trial. Europace. 2022 Nov 22;24(11):1730-1738.

Serial assessment of biomarkers and heart failure outcomes in patients with atrial fibrillation. Eur J Heart Fail. 2023 Mar 29. doi: 10.1002/ejhf.2844.

Direct Oral Anticoagulants Versus Warfarin Across the Spectrum of Kidney Function: Patient-Level Network Meta-Analyses From COMBINE AF. Circulation. 2023 Jun 6;147(23):1748-1757.

Risks of Heart Failure, Stroke, and Bleeding in Atrial Fibrillation According to Heart Failure Phenotypes. JACC Clin Electrophysiol. 2023 Apr;9(4):569-580.

Neutrophil-lymphocyte ratio and clinical outcomes in 19,697 patients with atrial fibrillation: Analyses from ENGAGE AF- TIMI 48 trial. Int J Cardiol. 2023 Sep 1;386:118-124.

Development and Validation of the DOAC Score: A Novel Bleeding Risk Prediction Tool for Patients With Atrial Fibrillation on Direct-Acting Oral Anticoagulants. Circulation. 2023 Sep 19;148(12):936-946.

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 Four Randomized Clinical Trials of 58 464 Patients With Atrial Fibrillation. Circulation. 2024 Mar 19;149(12):932-943.

Optimizing warfarin dosing for patients with atrial fibrillation using machine learning. Sci Rep. 2024 Feb 24;14(1):4516.

Novel Polygenic Risk Score and Established Clinical Risk Factors for Risk Estimation of Aortic Stenosis. JAMA Cardiol. 2024 Apr 1;9(4):357-366.

Response by Aggarwal et al to Letter Regarding Article, “Development and Validation of the DOAC Score: A Novel Bleeding Risk Prediction Tool for Patients With Atrial Fibrillation on Direct-Acting Oral Anticoagulants”. Circulation. 2024 Apr 16;149(16):e1111-e1112.

Application of the Win Ratio Method in the ENGAGE AF-TIMI 48 Trial Comparing Edoxaban With Warfarin in Patients With Atrial Fibrillation. Circ Cardiovasc Qual Outcomes. 2024 Jun 3:e010561.

Dose Reduction of Edoxaban in Patients 80 Years and Older With Atrial Fibrillation: Post Hoc Analysis of the ENGAGE AF-TIMI 48 Randomized Clinical Trial. JAMA Cardiol. 2024 Sep 1;9(9):817-825.

Clonal hematopoiesis, cardiovascular events and treatment benefit in 63,700 individuals from five TIMI randomized trials. Nat Med. 2024 Sep;30(9):2641-2647.

Residual Stroke Risk Among Patients With Atrial Fibrillation Prescribed Oral Anticoagulants: A Patient-Level Meta-Analysis From COMBINE AF. J Am Heart Assoc. 2024 Sep 3;13(17):e034758.

Heart Failure Risk Assessment Using Biomarkers in Patients With Atrial Fibrillation: Analysis From COMBINE-AF.J Am Coll Cardiol. 2024 Oct 15;84(16):1528-1540.

Epistaxis Versus Nonepistaxis Bleeding in Anticoagulated Patients With Atrial Fibrillation: Results From the ENGAGE AF-TIMI 48 Trial. J Am Heart Assoc. 2025 Jan 21;14(2):e031434.

Long-term visit-to-visit blood pressure variability and risk of cardiovascular and bleeding events: insights from the ENGAGE AF-TIMI 48 trial. Hypertens Res. 2025 Apr;48(4):1613-1618.

Biomarker-Based Model for Prediction of Ischemic Stroke in Patients With Atrial Fibrillation. J Am Coll Cardiol. 2025 Mar 25;85(11):1173-1185.

Outcomes in Older Patients After Switching to a Newer Anticoagulant or Remaining on Warfarin: The COMBINE-AF Substudy. J Am Coll Cardiol. 2025 Aug 12;86(6):426-439.

A Polygenic Risk Score to Predict Incident Heart Failure Across the Spectrum of Cardiovascular Risk. J Am Coll Cardiol. 2025 2025 Sep 23;86(12):860-873.

Pathogenic Cardiomyopathy-Associated Gene Variants and Prognosis in Atrial Fibrillation: Results in 18,000 Clinical Trial Participants. J Am Coll Cardiol. 2025 Sep 9;86(10):738-753.

Polygenic Risk Score for Coronary Artery Disease Across the Spectrum of Atherosclerotic Disease. Eur J Prev Cardiol. 2025 Oct 28:zwaf693. doi: 10.1093/eurjpc/zwaf693. 

A polygenic risk score for peripheral artery disease and major adverse limb events. Eur Heart J. 2025 Nov 28:ehaf891. doi: 10.1093/eurheartj/ehaf891.

Response by Patel and Giugliano to Letter Regarding Article, “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”. Patel SM, Giugliano RP. Circulation. 2025 Dec 2;152(22):e425-e426.

REPLY: Is Switching From VKA to DOAC Universally Safe in Frail Elderly Patients With Atrial Fibrillation? J Am Coll Cardiol. 2025 Nov 19:S0735-1097(25)09863-8. doi: 10.1016/j.jacc.2025.09.1606.

Genomic and transcriptomic analyses of aortic stenosis enhance therapeutic target discovery and disease prediction. Nat Genet. 2025 Dec 19. doi: 10.1038/s41588-025-02417-6.

Systemic Embolic Events in Atrial Fibrillation: An Individual Patient Data Meta-analysis of 71 683 Participants Randomized to NOAC Versus Warfarin. Circulation. 2026 Jan 30. doi: 10.1161/CIRCULATIONAHA.125.075275.

fibrillation treated with a direct oral anticoagulant or warfarin. J Thromb Haemost. 2026 Feb;24(2):399-407. doi: 10.1016/j.jtha.2025.09.032.