Amal Bessissow1, John Agzarian2, Yaron Shargall2, Sadeesh Srinathan3, John Neary4, Vikas Tandon5, Christian Finley2, Jeff S Healey6, David Conen6, Reitze Rodseth7, Shirley Pettit8, William Dechert9, Otto Regalado10, Chinthanie Ramasundarahettige8, Saleh Alshalash10, P J Devereaux6. 1. Department of Medicine, McGill University Health Centre, Montreal, QC, Canada. 2. Department of Thoracic Surgery, St. Joseph's Healthcare Hamilton, Hamilton, ON, Canada. 3. Department of Thoracic Surgery, Health Sciences Centre, Winnipeg, MB, Canada. 4. Department of Medicine, St. Joseph's Healthcare Hamilton, Hamilton, ON, Canada. 5. Department of Medicine, Hamilton General Hospital, Hamilton, ON, Canada. 6. Department of Medicine, Hamilton General Hospital, Population Health Research Institute, Hamilton, ON, Canada. 7. Nelson R. Mandela School of Medicine, University of KwaZulu-Natal, Pietermaritzburg, South Africa. 8. Population Health Research Institute, Hamilton, ON, Canada. 9. Population Health Research Institute, St. Joseph's Healthcare Hamilton, Hamilton, ON, Canada. 10. McMaster University, Hamilton, ON, Canada.
Abstract
OBJECTIVES: We carried out a pilot randomized controlled study to determine the feasibility of a large trial evaluating the impact of colchicine versus placebo on postoperative atrial fibrillation or atrial flutter (POAF) among patients undergoing lung resection surgery. METHODS:Patients ≥55 years of age undergoing lung resection surgery were randomly assigned to receive colchicine 0.6 mg or placebo starting a few hours before surgery. Postoperatively, patients received colchicine 0.6 mg or placebo twice daily for an additional 9 days. Our feasibility outcomes included the period of time required to recruit 100 patients, the completeness of follow-up and compliance with the study drug. The primary efficacy outcome was POAF within 30 days of randomization. RESULTS:One hundred patients were randomized (49 to colchicine and 51 to placebo) over a period of 12 months at 2 centres in Canada. All patients completed the 30-day follow-up. The mean staff time required to recruit and to follow-up each patient was 165 min. In all, 71% of patients completed the study drug course without interruption. Patient refusal to continuing taking the study drug was the main reason for permanent drug discontinuation. New POAF occurred in 5 (10.2%) patients in the colchicine group and 7 (13.7%) patients in the placebo group (adjusted hazard ratio 0.69, 95% confidence interval 0.20-2.34). CONCLUSIONS: These results show the feasibility of a trial evaluating Colchicine for the prevention of perioperative Atrial Fibrillation in patients undergoing lung resection surgery. This pilot study will serve as the foundation for the large multicentre COP-AF trial.
RCT Entities:
OBJECTIVES: We carried out a pilot randomized controlled study to determine the feasibility of a large trial evaluating the impact of colchicine versus placebo on postoperative atrial fibrillation or atrial flutter (POAF) among patients undergoing lung resection surgery. METHODS:Patients ≥55 years of age undergoing lung resection surgery were randomly assigned to receive colchicine 0.6 mg or placebo starting a few hours before surgery. Postoperatively, patients received colchicine 0.6 mg or placebo twice daily for an additional 9 days. Our feasibility outcomes included the period of time required to recruit 100 patients, the completeness of follow-up and compliance with the study drug. The primary efficacy outcome was POAF within 30 days of randomization. RESULTS: One hundred patients were randomized (49 to colchicine and 51 to placebo) over a period of 12 months at 2 centres in Canada. All patients completed the 30-day follow-up. The mean staff time required to recruit and to follow-up each patient was 165 min. In all, 71% of patients completed the study drug course without interruption. Patient refusal to continuing taking the study drug was the main reason for permanent drug discontinuation. New POAF occurred in 5 (10.2%) patients in the colchicine group and 7 (13.7%) patients in the placebo group (adjusted hazard ratio 0.69, 95% confidence interval 0.20-2.34). CONCLUSIONS: These results show the feasibility of a trial evaluating Colchicine for the prevention of perioperative Atrial Fibrillation in patients undergoing lung resection surgery. This pilot study will serve as the foundation for the large multicentre COP-AF trial.
Authors: Sarah Stewart; Kevin Chih Kai Yang; Kate Atkins; Nicola Dalbeth; Philip C Robinson Journal: Arthritis Res Ther Date: 2020-02-13 Impact factor: 5.156