Safety and Feasibility Evaluation of Planning and Execution of Surgical Revascularization Solely Based on Coronary Computed Tomography Angiogram, (CTA) and Fractional Flow Reserve – derived by Computed Tomography (FFRCT) in Patients with Complex Coronary Artery Disease: The FAST TRACK CABG Study
The primary objective of the trial is to assess the capability of CTA to replace conventional cine-angiography as guidance for surgeons in the execution of Coronary Artery Bypass Graft (CABG) in patients with established 3-vessel disease with or without left-main.
- Patient referred to CABG treatment (as assessed by ‘conventional Heart Team’);
- Patients with at least 1 stenosis (visually determined de novo lesions with ≥50% DS) in all 3 major epicardial territories (LAD and/or side branch, CX and/or side branch, RCA and/or side branch) supplying viable myocardium with or without left main involvement;
- Patients with hypoplastic RCA with absence of descending posterior and presence of a lesion in the LAD and CX territories may be included in the trial as a 3VD equivalent. Ostial LAD plus ostial LCX may be included in the trial as a Left Main equivalent;
- Distal vessel size should be at least 1.5 mm in diameter as visually assessed in diagnostic angiogram;
- Patient with silent ischemia, chronic stable angina or stabilized acute coronary syndromes with normalized (stable or decreasing) cardiac biomarker values
- Note: For patients showing elevated Troponin (cTn) (e.g. non-STEMI patients) at baseline (within 24h pre-CABG) an additional blood sample must be collected prior to the CABG procedure to confirm that:
- - Hs-cTn or Troponin I or T levels are stable, i.e. the value should be within 20% range of the value found in the first sample at baseline, or have dropped
- - CK-MB and CK levels are within normal range
- - If Hs-cTn or Troponin I or T levels are stable or have dropped, or the CK-MB and CK levels are within normal ranges, and the ECG is normal, the patient may be included in the study
- All anatomical SYNTAX Scores are eligible;
- Patient amenable to a CTA coronary angiography (e.g. no claustrophobia, high heartrate not amenable to beta-blockers, poor renal function, etc., up to discretion of investigator);
- Patient has been informed of the nature of the study and agrees to its provisions and has provided written informed consent as approved by the Ethical Committee or IRB of the respective clinical site;
- The patient agrees to the 1-month follow-up visit including a CTA coronary angiography.