TY - JOUR
T1 - Colchicine in Patients With Acute Coronary Syndrome
T2 - The Australian COPS Randomized Clinical Trial
AU - Tong, David C.
AU - Quinn, Stephen
AU - Nasis, Arthur
AU - Hiew, Chin
AU - Roberts-Thomson, Philip
AU - Adams, Heath
AU - Sriamareswaran, Rumes
AU - Htun, Nay M.
AU - Wilson, William
AU - Stub, Dion
AU - van Gaal, William
AU - Howes, Laurie
AU - Collins, Nicholas
AU - Yong, Andy
AU - Bhindi, Ravinay
AU - Whitbourn, Robert
AU - Lee, Astin
AU - Hengel, Chris
AU - Asrress, Kaleab
AU - Freeman, Melanie
AU - Amerena, John
AU - Wilson, Andrew
AU - Layland, Jamie
N1 - Funding Information:
The study was supported by the Cardiology Department of Peninsula Health and St Vincent’s Hospital Melbourne, and received philanthropic support from the CASS Foundation (Contributing to Australian Scholarship and Science). Additional funding support was obtained from Peninsula Health and Faculty of Medicine, Nursing and Health Sciences, Monash University. The funders of the study had no role in study design, data collection, data analysis, data interpretation, or writing of the report. The corresponding author had full access to all the data in the study and had final responsibility for the decision to submit for publication. Dr Stub’s research is supported by a National Heart Foundation Future Leader Fellowship (grant 101908). Dr Yong received honoraria from Abbott Vascular and Philips.
Funding Information:
The study was supported by the Cardiology Department of Peninsula Health and St Vincent's Hospital Melbourne, and received philanthropic support from the CASS Foundation (Contributing to Australian Scholarship and Science). Additional funding support was obtained from Peninsula Health and Faculty of Medicine, Nursing and Health Sciences, Monash University. The funders of the study had no role in study design, data collection, data analysis, data interpretation, or writing of the report. The corresponding author had full access to all the data in the study and had final responsibility for the decision to submit for publication. Dr Stub's research is supported by a National Heart Foundation Future Leader Fellowship (grant 101908). Dr Yong received honoraria from Abbott Vascular and Philips.
Publisher Copyright:
© 2020 American Heart Association, Inc.
PY - 2020/11/17
Y1 - 2020/11/17
N2 - BACKGROUND: Inflammation plays a crucial role in clinical manifestations and complications of acute coronary syndromes (ACS). Colchicine, a commonly used treatment for gout, has recently emerged as a novel therapeutic option in cardiovascular medicine owing to its anti-inflammatory properties. We sought to determine the potential usefulness of colchicine treatment in patients with ACS. METHODS: This was a multicenter, randomized, double-blind, placebo-controlled trial involving 17 hospitals in Australia that provide acute cardiac care service. Eligible participants were adults (18-85 years) who presented with ACS and had evidence of coronary artery disease on coronary angiography managed with either percutaneous coronary intervention or medical therapy. Patients were assigned to receive either colchicine (0.5 mg twice daily for the first month, then 0.5 mg daily for 11 months) or placebo, in addition to standard secondary prevention pharmacotherapy, and were followed up for a minimum of 12 months. The primary outcome was a composite of all-cause mortality, ACS, ischemia-driven (unplanned) urgent revascularization, and noncardioembolic ischemic stroke in a time to event analysis. RESULTS: A total of 795 patients were recruited between December 2015 and September 2018 (mean age, 59.8±10.3 years; 21% female), with 396 assigned to the colchicine group and 399 to the placebo group. Over the 12-month follow-up, there were 24 events in the colchicine group compared with 38 events in the placebo group (P=0.09, log-rank). There was a higher rate of total death (8 versus 1; P=0.017, log-rank) and, in particular, noncardiovascular death in the colchicine group (5 versus 0; P=0.024, log-rank). The rates of reported adverse effects were not different (colchicine 23.0% versus placebo 24.3%), and they were predominantly gastrointestinal symptoms (colchicine, 23.0% versus placebo, 20.8%). CONCLUSIONS: The addition of colchicine to standard medical therapy did not significantly affect cardiovascular outcomes at 12 months in patients with ACS and was associated with a higher rate of mortality.
AB - BACKGROUND: Inflammation plays a crucial role in clinical manifestations and complications of acute coronary syndromes (ACS). Colchicine, a commonly used treatment for gout, has recently emerged as a novel therapeutic option in cardiovascular medicine owing to its anti-inflammatory properties. We sought to determine the potential usefulness of colchicine treatment in patients with ACS. METHODS: This was a multicenter, randomized, double-blind, placebo-controlled trial involving 17 hospitals in Australia that provide acute cardiac care service. Eligible participants were adults (18-85 years) who presented with ACS and had evidence of coronary artery disease on coronary angiography managed with either percutaneous coronary intervention or medical therapy. Patients were assigned to receive either colchicine (0.5 mg twice daily for the first month, then 0.5 mg daily for 11 months) or placebo, in addition to standard secondary prevention pharmacotherapy, and were followed up for a minimum of 12 months. The primary outcome was a composite of all-cause mortality, ACS, ischemia-driven (unplanned) urgent revascularization, and noncardioembolic ischemic stroke in a time to event analysis. RESULTS: A total of 795 patients were recruited between December 2015 and September 2018 (mean age, 59.8±10.3 years; 21% female), with 396 assigned to the colchicine group and 399 to the placebo group. Over the 12-month follow-up, there were 24 events in the colchicine group compared with 38 events in the placebo group (P=0.09, log-rank). There was a higher rate of total death (8 versus 1; P=0.017, log-rank) and, in particular, noncardiovascular death in the colchicine group (5 versus 0; P=0.024, log-rank). The rates of reported adverse effects were not different (colchicine 23.0% versus placebo 24.3%), and they were predominantly gastrointestinal symptoms (colchicine, 23.0% versus placebo, 20.8%). CONCLUSIONS: The addition of colchicine to standard medical therapy did not significantly affect cardiovascular outcomes at 12 months in patients with ACS and was associated with a higher rate of mortality.
KW - acute coronary syndrome
KW - colchicine
KW - coronary artery disease
KW - inflammation
UR - https://www.scopus.com/pages/publications/85092799883
U2 - 10.1161/CIRCULATIONAHA.120.050771
DO - 10.1161/CIRCULATIONAHA.120.050771
M3 - Article
C2 - 32862667
AN - SCOPUS:85092799883
SN - 0009-7322
VL - 142
SP - 1890
EP - 1900
JO - Circulation
JF - Circulation
IS - 20
ER -