Colchicine in Patients at Cardiac Risk Undergoing Major Non-Cardiac Surgery: Prospective, Randomized, Double-blinded, Placebo-controlled, Multi-centre Study
Perioperative myocardial injury and major adverse cardiovascular events (MACE) are common causes of morbidity and mortality in patients at increased cardiovascular risk undergoing non-cardiac surgery. However, research in recent years has yielded limited preventive and therapeutic measures for myocardial injury/MACE. Recent studies in patients with chronic and acute coronary artery disease have shown that colchicine administration can reduce the risk of cardiovascular events. These encouraging results in non-surgical patients ask for a similar investigation in patients undergoing major non-cardiac surgery. The aim of the proposed study is to investigate the effects of perioperative colchicine administration on the incidence of myocardial injury/MACE.
⁃ undergoing major non-cardiac surgery in general anaesthesia will be included. Major non-cardiac surgery is defined as:
• vascular surgery (with the exception of arteriovenous shunt, vein stripping procedures and carotid endarterectomies)
• intraperitoneal surgery
• intrathoracic surgery
• major orthopaedic surgery (spinal surgery or joint replacement surgery)
• at cardiovascular risk, defined as meeting at least 1 of the following 6 criteria:
‣ preoperative n-terminal pro brain natriuretic peptide (NT-proBNP) ≥ 200 ng/l
⁃ history of coronary artery disease
⁃ history of peripheral vascular disease
⁃ history of stroke
⁃ undergoing major vascular surgery, with the exception of arteriovenous shunt, vein stripping procedures and carotid endarterectomies
⁃ fulfilment of any 3 of the 8 following criteria:
• undergoing major surgery (intrathoracic, intraperitoneal or supra-inguinal vascular surgery)
∙ any history of congestive heart failure or history of pulmonary oedema
∙ anamnestic transient ischemic attack (TIA)
∙ diabetes under treatment with either oral antidiabetic agent or insulin
∙ age \> 70 years
∙ history of hypertension
∙ serum creatinine \> 175 mumol/l or calculated creatinine clearance \< 60 ml/min/1.73m2 (cockcroft gault)
∙ history of smoking within 2 years of surgery
∙ planned surgical time ≥ 90 minutes
∙ planned postoperative hospital stay at least 1 night