Thrombelastographic haemostatic status and antiplatelet therapy after coronary artery bypass surgery (TEG-CABG trial): assessing and monitoring the antithrombotic effect of clopidogrel and aspirin versus aspirin alone in hypercoagulable patients: study protocol for a randomized controlled trial

Abstract

BackgroundHypercoagulability, assessed by the thrombelastography (TEG) assay, has in several observational studies been associated with an increased risk of post-procedural thromboembolic complications. We hypothesize that intensified antiplatelet therapy with clopidogrel and aspirin, as compared to aspirin alone, will improve saphenous vein graft patency in preoperatively TEG-Hypercoagulable coronary artery bypass surgery (CABG) patients and reduce their risk for thromboembolic complications and death postoperatively.Methods/DesignThis is a prospective randomized clinical trial, with an open-label design with blinded evaluation of graft patency. TEG-Hypercoagulability is defined as a TEG maximum amplitude above 69 mm. Two hundred and fifty TEG-Hypercoagulable patients will be randomized to either an interventional group receiving clopidogrel 75 mg daily for three months (after initial oral bolus of 300 mg) together with aspirin 75 mg or a control group receiving aspirin 75 mg daily alone. Monitoring of antiplatelet efficacy and on-treatment platelet reactivity to clopidogrel and aspirin will be conducted with Multiplate aggregometry. Graft patency will be assessed with Multislice computed tomography (MSCT) at three months after surgery.ConclusionsThe present trial is the first randomized clinical trial to evaluate whether TEG-Hypercoagulable CABG patients will benefit from intensified antiplatelet therapy after surgery. Monitoring of platelet inhibition from instituted antithrombotic therapy will elucidate platelet resistance patterns after CABG surgery. The results could be helpful in redefining how clinicians can evaluate patients preoperatively for their postoperative thromboembolic risk and tailor individualized postoperative antiplatelet therapy.Trial registrationClinicaltrials.gov Identifier NCT01046942

Left Atrial Appendage Closure Reduces the Incidence of Postoperative Cerebrovascular Accident in Patients Undergoing Cardiac Surgery

“…In the present study, we did not perform independent analysis of patients undergoing cardiac surgery with and without cardiopulmonary bypass, although several previous studies discussed the relationship between hypercoagulability and off-pump bypass surgery. 29, 30 Nevertheless, this is the preliminary report on the possible beneficial effect of LAAC/A, which we believe is worth reporting. Postoperative AF as well as CVA can occur in various time frames.…”

Impact and Diagnosis of Antiplatelet Therapy Resistance in Patients Undergoing Cardiac Surgery

“…chemotherapy or antibiotic regimes), remains to be seen. At least two currently ongoing prospective randomized studies aim to place aspirin resistance post‐CABG in a clinical perspective [Gasparovic et al., 2012a; Rafiq et al., ]. The first is randomizing aspirin‐resistant patients into either a group that will receive an upgrade to dAPT or a control group with continuation on the current aspirin regimen [Gasparovic et al., 2012b].…”

Role of Thrombelastography (TEG) in Risk Assessment and Guidance of Antithrombotic Therapy in Patients with Coronary Artery Disease

“…The role of dual antiplatelet therapy after CABG surgery is currently unknown. The TEG‐CABG (thrombelastography haemostatic status and antiplatelet therapy after coronary artery bypass surgery) trial is the first to assess the role of dual antiplatelet therapy in reducing thromboembolic events and graft patency post‐CABG in a group of patients with TEG‐hypercoagulable state [Rafiq et al., 2012b].…”