Colchicine for Prevention of Perioperative Atrial Fibrillation in patients undergoing lung resection surgery: a pilot randomized controlled study
| Autor: | Saleh Alshalash, Chinthanie Ramasundarahettige, John Agzarian, William Dechert, Otto Regalado, Philip J. Devereaux, John Neary, David Conen, Vikas Tandon, Amal Bessissow, Sadeesh Srinathan, Christian Finley, Shirley Pettit, Jeff S. Healey, Yaron Shargall, Reitze N. Rodseth |
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| Rok vydání: | 2017 |
| Předmět: |
Male
Pulmonary and Respiratory Medicine Canada medicine.medical_specialty Randomization Pilot Projects Kaplan-Meier Estimate 030204 cardiovascular system & hematology Placebo law.invention 03 medical and health sciences Postoperative Complications 0302 clinical medicine Randomized controlled trial law Atrial Fibrillation medicine Humans 030212 general & internal medicine Pneumonectomy Aged business.industry Hazard ratio Cardiovascular Agents Atrial fibrillation General Medicine Perioperative Middle Aged medicine.disease Confidence interval Surgery Female Colchicine Cardiology and Cardiovascular Medicine business Atrial flutter |
| Zdroj: | European Journal of Cardio-Thoracic Surgery. 53:945-951 |
| ISSN: | 1873-734X 1010-7940 |
| DOI: | 10.1093/ejcts/ezx422 |
| Popis: | 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. |
| Databáze: | OpenAIRE |
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