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The purpose of this study is to compare the presence of graft patency in single aspirin vs dual anti platelet therapy (DAPT) treatment including ticagrelor in patients with acute coronary syndrome (ACS) treated with coronary artery bypass surgery (CABG). Follow up time is 12-36 months postoperatively and the patency will be evaluated with coronary computed tomography angiography (CCTA)
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| Measure | Description | Time Frame |
|---|---|---|
| Graft patency after CABG | Defined as patency on CCTA (FitzGibbon A) without previous graft failure identified on CCTA and/or invasive coronary angio (ICA) since CABG, intention to treat (ITT) analysis. | 12-36 months |
| Measure | Description | Time Frame |
|---|---|---|
| Graft patency after CABG - PP analysis | Defined as patency on CCTA (FitzGibbon A) without previous graft failure identified on CCTA and/or ICA since CABG, per protocol (PP) analysis. | 12-36 months |
| Graft patency after CABG |
| Measure | Description | Time Frame |
|---|---|---|
| Subgroup analyses | Possible interactions in response to study treatment, with special focus on the following factors; age, gender, renal function, diabetes, oral anticoagulant therapy, adherence to study treatment and time from end of study medication. | 12-36 months |
| Explorative analyses |
Inclusion Criteria:
Exclusion Criteria:
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This study will include patients previously included in the TACSI-trial (Dual antiplatelet therapy with ticagrelor and ASA vs. ASA alone after coronary artery bypass grafting in patients with acute coronary syndrome) . This means patients with age ≥18 years that has undergone for the first time an isolated CABG due to an episode of an acute coronary syndrome (ACS) event within 6 weeks before CABG. The randomized, controlled trial TACSI (ClinicalTrials.gov NCT03560310) offers a unique possibility to address the issue of graft patency based on antiplatelet strategy in patients with acute coronary syndromes.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jonas Holm, MD, PhD | Contact | +46101034498 | jonas.holm@regionostergotland.se | |
| Sofia Sederholm Lawesson, MD, PhD | Contact | +461037472 | sofia.sederholm.lawesson@regionostergotland.se |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Heart Disease, Haukeland University Hospital | Enrolling by invitation | Bergen | Norway | |||
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| ID | Term |
|---|---|
| D054058 | Acute Coronary Syndrome |
| ID | Term |
|---|---|
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular Diseases |
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Defined as non-occlusion on CCTA (FitzGibbon A+B) without previous graft occlusion identified on CCTA and/or ICA since CABG, ITT analysis.
| 12-36 months |
| Graft patency after CABG | Defined as non-occlusion on CCTA (FitzGibbon A+B) without previous graft occlusion identified on CCTA and/or ICA since CABG, PP analysis. | 12-36 months |
| Graft patency after CABG | Defined as patency on CCTA (FitzGibbon A) without graft failure identified on CCTA and/or ICA since CABG, patients on oral anticoagulants excluded, ITT (sensitivity analysis). | 12-36 months |
| Graft patency after CABG | Defined as non-occlusion on CCTA (FitzGibbon A) without previous graft failure identified on CCTA and/or ICA since CABG, patients on oral anticoagulants excluded, PP (sensitivity analysis). | 12-36 months |
Performed on the graft patency of internal mammary artery (IMA) in the two treatment groups, as well as if there are any differences in graft patency between different anastomoses and grafting techniques. Possible predictors of graft failure in general, with age, gender, diabetes, obesity, renal failure, urgency level and length of surgery, per-operative complications, number and type of graft as well as pre-operative fractional flow reserve as variables to explore. Gender analysis will be performed, analyzing if female gender is associated with worse prognosis post CABG, adjusting for their higher age and burden of co-morbidities. |
| 12-36 months |
| St Olavs University Hospital |
| Not yet recruiting |
| Trondheim |
| Norway |
|
| Department of Molecular and Clinical Medicine, Wallenberg Laboratory, Institute of Medicine | Enrolling by invitation | Gothenburg | Sweden |
| Dep of Vascular and Thoracic Surgery | Active, not recruiting | Örebro | Sweden |
| Department of Cardiothoracic Surgery Karolinska University Hospital | Enrolling by invitation | Stockholm | Sweden |
| University Hospital Linköping | Recruiting | Linköping | Östergötland County | 58185 | Sweden |
|