Randomized Controlled Trial

. 2024 Mar 4;20(5):e322-e328.

doi: 10.4244/EIJ-D-23-00699.

One-month DAPT with ticagrelor and aspirin for patients undergoing coronary artery bypass grafting: rationale and design of the randomised, multicentre, double-blind, placebo-controlled ODIN trial

Sigrid Sandner¹, Mario Gaudino², Bjorn Redfors^{3

4}, Dominick J Angiolillo⁵, Ori Ben-Yehuda⁶, Deepak L Bhatt⁷, Stephen E Fremes⁸, Andre Lamy⁹, Riccardo Marano¹⁰, Roxana Mehran¹¹, Stuart Pocock¹², Sunil V Rao¹³, John A Spertus¹⁴, Jonathan W Weinsaft¹⁵, George Wells¹⁶, Marc Ruel¹⁷

Affiliations

¹ Department of Cardiac Surgery, Medical University of Vienna, Vienna, Austria.
² Department of Cardiothoracic Surgery, Weill Cornell Medicine, New York, NY, USA.
³ Department of Cardiology, Sahlgrenska University Hospital, Gothenburg, Sweden.
⁴ Department of Molecular and Clinical Medicine, Institute of Medicine, Gothenburg University, Gothenburg, Sweden.
⁵ Division of Cardiology, University of Florida College of Medicine, Jacksonville, FL, USA.
⁶ University of California San Diego, San Diego, CA, USA.
⁷ Mount Sinai Heart, Icahn School of Medicine at Mount Sinai, New York, NY, USA.
⁸ Division of Cardiac Surgery, Schulich Heart Centre, Sunnybrook Health Sciences Centre, University of Toronto, Toronto, ON, Canada.
⁹ Division of Cardiac Surgery and Population Health Research Institute, McMaster University, Hamilton, ON, Canada.
¹⁰ Department of Radiological and Hematological Sciences, Section of Radiology, Fondazione Policlinico Universitario Agostino Gemelli IRCCS, Università Cattolica del Sacro Cuore, Rome, Italy.
¹¹ The Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of Medicine at Mount Sinai, New York, NY, USA.
¹² Department of Medical Statistics, London School of Hygiene and Tropical Medicine, London, United Kingdom.
¹³ New York University Langone Health System, New York, NY, USA.
¹⁴ University of Missouri-Kansas City's Healthcare Institute for Innovations in Quality, Kansas City, MO, USA and Saint Luke's Mid America Heart Institute, Kansas City, MO, USA.
¹⁵ Department of Medicine, Greenberg Cardiology Division, Weill Cornell Medical College, New York, NY, USA.
¹⁶ Heart Institute, School of Epidemiology and Public Health, University of Ottawa, Ottawa, ON, Canada.
¹⁷ Division of Cardiac Surgery, University of Ottawa Heart Institute, Ottawa, ON, Canada.

PMID: 38436365
PMCID: PMC10905196
DOI: 10.4244/EIJ-D-23-00699

Randomized Controlled Trial

One-month DAPT with ticagrelor and aspirin for patients undergoing coronary artery bypass grafting: rationale and design of the randomised, multicentre, double-blind, placebo-controlled ODIN trial

Sigrid Sandner et al. EuroIntervention. 2024.

. 2024 Mar 4;20(5):e322-e328.

doi: 10.4244/EIJ-D-23-00699.

Authors

Affiliations

¹ Department of Cardiac Surgery, Medical University of Vienna, Vienna, Austria.
² Department of Cardiothoracic Surgery, Weill Cornell Medicine, New York, NY, USA.
³ Department of Cardiology, Sahlgrenska University Hospital, Gothenburg, Sweden.
⁴ Department of Molecular and Clinical Medicine, Institute of Medicine, Gothenburg University, Gothenburg, Sweden.
⁵ Division of Cardiology, University of Florida College of Medicine, Jacksonville, FL, USA.
⁶ University of California San Diego, San Diego, CA, USA.
⁷ Mount Sinai Heart, Icahn School of Medicine at Mount Sinai, New York, NY, USA.
⁸ Division of Cardiac Surgery, Schulich Heart Centre, Sunnybrook Health Sciences Centre, University of Toronto, Toronto, ON, Canada.
⁹ Division of Cardiac Surgery and Population Health Research Institute, McMaster University, Hamilton, ON, Canada.
¹⁰ Department of Radiological and Hematological Sciences, Section of Radiology, Fondazione Policlinico Universitario Agostino Gemelli IRCCS, Università Cattolica del Sacro Cuore, Rome, Italy.
¹¹ The Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of Medicine at Mount Sinai, New York, NY, USA.
¹² Department of Medical Statistics, London School of Hygiene and Tropical Medicine, London, United Kingdom.
¹³ New York University Langone Health System, New York, NY, USA.
¹⁴ University of Missouri-Kansas City's Healthcare Institute for Innovations in Quality, Kansas City, MO, USA and Saint Luke's Mid America Heart Institute, Kansas City, MO, USA.
¹⁵ Department of Medicine, Greenberg Cardiology Division, Weill Cornell Medical College, New York, NY, USA.
¹⁶ Heart Institute, School of Epidemiology and Public Health, University of Ottawa, Ottawa, ON, Canada.
¹⁷ Division of Cardiac Surgery, University of Ottawa Heart Institute, Ottawa, ON, Canada.

PMID: 38436365
PMCID: PMC10905196
DOI: 10.4244/EIJ-D-23-00699

Abstract

The optimal antiplatelet strategy after coronary artery bypass graft (CABG) surgery in patients with chronic coronary syndromes (CCS) is unclear. Adding the P2Y₁₂ inhibitor, ticagrelor, to low-dose aspirin for 1 year is associated with a reduction in graft failure, particularly saphenous vein grafts, at the expense of an increased risk of clinically important bleeding. As the risk of thrombotic graft failure and ischaemic events is highest early after CABG surgery, a better risk-to-benefit profile may be attained with short-term dual antiplatelet therapy followed by single antiplatelet therapy. The One Month Dual Antiplatelet Therapy With Ticagrelor in Coronary Artery Bypass Graft Patients (ODIN) trial is a prospective, randomised, double-blind, placebo-controlled, international, multicentre study of 700 subjects that will evaluate the effect of short-term dual antiplatelet therapy with ticagrelor plus low-dose aspirin after CABG in patients with CCS. Patients will be randomised 1:1 to ticagrelor 90 mg twice daily or matching placebo, in addition to aspirin 75-150 mg once daily for 1 month; after the first month, antiplatelet therapy will be continued with aspirin alone. The primary endpoint is a hierarchical composite of all-cause death, stroke, myocardial infarction, revascularisation and graft failure at 1 year. The key secondary endpoint is a hierarchical composite of all-cause death, stroke, myocardial infarction, Bleeding Academic Research Consortium (BARC) type 3 bleeding, revascularisation and graft failure at 1 year (net clinical benefit). ODIN will report whether the addition of ticagrelor to low-dose aspirin for 1 month after CABG reduces ischaemic events and provides a net clinical benefit in patients with CCS. (ClinicalTrials.gov: NCT05997693).

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Conflict of interest statement

D.J. Angiolillo has received consulting fees or honoraria from Abbott, Amgen, AstraZeneca, Bayer, Biosensors, Boehringer Ingelheim, Bristol-Myers Squibb, Chiesi, CSL Behring, Daiichi Sankyo, Eli Lilly, Haemonetics, Janssen, Merck, Novartis, PhaseBio, PLx Pharma, Pfizer, Sanofi, and Vectura; his institution has received research grants from Amgen, AstraZeneca, Bayer, Biosensors, CeloNova (now Alta Biomaterials), CSL Behring, Daiichi Sankyo, Eisai, Eli Lilly, Gilead Sciences, Idorsia, Janssen, Matsutani Chemical Industry Co., Merck, Novartis, and the Scott R. MacKenzie Foundation. D.L. Bhatt has had advisory board roles with ANGIOWave, Bayer, Boehringer Ingelheim, Cardax, CellProthera, Cereno Scientific, Elsevier, High Enroll, Janssen, Level Ex, McKinsey & Company, Medscape Cardiology, Merck, MyoKardia, NirvaMed, Novo Nordisk, PhaseBio, PLx Pharma, Regado Biosciences, and Stasys; he has held board of directors’ positions with ANGIOWave (stock options), Boston VA Research Institute, Bristol-Myers Squibb (stock), DRS.LINQ (stock options), High Enroll (stock), Society of Cardiovascular Patient Care, and TobeSoft; he has held Chair roles including inaugural Chair for American Heart Association Quality Oversight Committee; he has held consultant roles with Broadview Ventures, and Hims; and has been on data monitoring committees, including for Acesion Pharma, Assistance Publique-Hôpitaux de Paris, Baim Institute for Clinical Research, Boston Scientific, Cleveland Clinic, Contego Medical, Duke Clinical Research Institute, Mayo Clinic, Mount Sinai School of Medicine, Novartis, Population Health Research Institute, and Rutgers University; and has received honoraria from various organisations; he has also held other roles with Clinical Cardiology, NCDR-ACTION Registry Steering Committee, and VA CART Research and Publications Committee; he has held a patent for Sotagliflozin; he has received research funding from numerous entities, including AstraZeneca; he has received royalties from Elsevier; he has been a site co-investigator for multiple companies; he has been a trustee for the American College of Cardiology; and he has carried out unfunded research with FlowCo and Takeda. S.E. Fremes has received grant support from CIHR, NIH, Medtronic, Boston Scientific, and Amgen. S.V. Rao has received research funding from NHLBI. J.A. Spertus has provided consultancy services to Alnylam, AstraZeneca, Bayer, Merck, Janssen, Bristol-Myers Squibb, Edwards Lifesciences, Kineksia, 4D Medical, Terumo, Cytokinetics, Imbria, and UnitedHealthcare; he has received research grants from Bristol-Myers Squibb, Abbott, and Janssen; he has held ownership of copyrights to the Seattle Angina Questionnaire, Kansas City Cardiomyopathy Questionnaire, and Peripheral Artery Questionnaire; and he has been on the board of directors for Blue Cross Blue Shield of Kansas City. The other authors have no conflicts of interest to declare.

Figures

**Figure 1. Study flowchart.**
BARC: Bleeding Academic Research Consortium; bd: twice daily; CABG: coronary artery bypass grafting; CCTA: coronary computed tomography angiography; MI: myocardial infarction

See this image and copyright information in PMC

References

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1. Mehran R, Rao SV, Bhatt DL, Gibson CM, Caixeta A, Eikelboom J, Kaul S, Wiviott SD, Menon V, Nikolsky E, Serebruany V, Valgimigli M, Vranckx P, Taggart D, Sabik JF, Cutlip DE, Krucoff MW, Ohman EM, Steg PG, White H. Standardized bleeding definitions for cardiovascular clinical trials: a consensus report from the Bleeding Academic Research Consortium. Circulation. 2011;123:2736–47. - PubMed

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One-month DAPT with ticagrelor and aspirin for patients undergoing coronary artery bypass grafting: rationale and design of the randomised, multicentre, double-blind, placebo-controlled ODIN trial

Affiliations

One-month DAPT with ticagrelor and aspirin for patients undergoing coronary artery bypass grafting: rationale and design of the randomised, multicentre, double-blind, placebo-controlled ODIN trial

Authors

Affiliations

Abstract

Conflict of interest statement

Figures

References

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Associated data

LinkOut - more resources

Full Text Sources

Medical

Research Materials