Effects of colchicine on major adverse cardiac events in next 6-month period after acute coronary syndrome occurrence; a randomized placebo-control trial.
Acute Coronary Syndrome
/ diagnostic imaging
Adult
Aged
Anti-Inflammatory Agents
/ adverse effects
Colchicine
/ adverse effects
Double-Blind Method
Female
Humans
Iran
Male
Middle Aged
Non-ST Elevated Myocardial Infarction
/ diagnostic imaging
Percutaneous Coronary Intervention
/ adverse effects
Prospective Studies
ST Elevation Myocardial Infarction
/ diagnostic imaging
Time Factors
Treatment Outcome
Acute coronary syndrome
Colchicine
Coronary artery disease
Inflammation
Journal
BMC cardiovascular disorders
ISSN: 1471-2261
Titre abrégé: BMC Cardiovasc Disord
Pays: England
ID NLM: 100968539
Informations de publication
Date de publication:
07 12 2021
07 12 2021
Historique:
received:
28
07
2021
accepted:
22
11
2021
entrez:
8
12
2021
pubmed:
9
12
2021
medline:
1
2
2022
Statut:
epublish
Résumé
Cardiovascular disease in particular acute coronary syndrome (ACS) is remained one of the most cause of morbidity and mortality, annually. Considering inflammatory pathway of atherosclerosis, colchicine as an anti-inflammatory drug is introduced to be effective in pathogenesis, prognosis and mortality rate of these patients. So in order to find out the effects of this drug we conducted this trial to know whether it reduces major adverse cardiac events (MACE) in ACS patients or not. In a prospective randomized double-blinded placebo-controlled trial, we enrolled ACS patients (40-70 years) with recent ST-segment elevation myocardial infarction (STEMI) or NSTE-ACS diagnosed by coronary angiography and managed with either medical therapy or percutaneous coronary intervention. Patients were assigned to two groups either receiving colchicine 0.5 mg daily or placebo for 6 months. Both groups simultaneously received standard medical therapy as accessible guidelines. MACE occurrence consists of decompensated heart failure, ACS, stroke and survival rate compared between two groups. A total of 249 patients were recruited between October 2019-March 2020 with mean age of 56.89 ± 7.54, 69.5% males; 120 assigned to the colchicine group and 129 assigned to the placebo group. Over the 6 months' period, 36 MACE occurred that were 8 events in the colchicine group compared with 28 events in the placebo group experiencing the event (P = 0.001). All of four deaths in the colchicine group and two in the placebo group were due to cardiovascular events. Evaluating adverse effects, gastrointestinal symptom was the most with the rate of 15 (12.5%) in the colchicine group and 3 (2.5%) in the controls. (P = 0.002). The addition of colchicine to standard medical therapy in ACS patients significantly reduces MACE occurrence and improves survival rate over the time.
Sections du résumé
BACKGROUND
Cardiovascular disease in particular acute coronary syndrome (ACS) is remained one of the most cause of morbidity and mortality, annually. Considering inflammatory pathway of atherosclerosis, colchicine as an anti-inflammatory drug is introduced to be effective in pathogenesis, prognosis and mortality rate of these patients. So in order to find out the effects of this drug we conducted this trial to know whether it reduces major adverse cardiac events (MACE) in ACS patients or not.
METHODS
In a prospective randomized double-blinded placebo-controlled trial, we enrolled ACS patients (40-70 years) with recent ST-segment elevation myocardial infarction (STEMI) or NSTE-ACS diagnosed by coronary angiography and managed with either medical therapy or percutaneous coronary intervention. Patients were assigned to two groups either receiving colchicine 0.5 mg daily or placebo for 6 months. Both groups simultaneously received standard medical therapy as accessible guidelines. MACE occurrence consists of decompensated heart failure, ACS, stroke and survival rate compared between two groups.
RESULTS
A total of 249 patients were recruited between October 2019-March 2020 with mean age of 56.89 ± 7.54, 69.5% males; 120 assigned to the colchicine group and 129 assigned to the placebo group. Over the 6 months' period, 36 MACE occurred that were 8 events in the colchicine group compared with 28 events in the placebo group experiencing the event (P = 0.001). All of four deaths in the colchicine group and two in the placebo group were due to cardiovascular events. Evaluating adverse effects, gastrointestinal symptom was the most with the rate of 15 (12.5%) in the colchicine group and 3 (2.5%) in the controls. (P = 0.002).
CONCLUSION
The addition of colchicine to standard medical therapy in ACS patients significantly reduces MACE occurrence and improves survival rate over the time.
Identifiants
pubmed: 34876021
doi: 10.1186/s12872-021-02393-9
pii: 10.1186/s12872-021-02393-9
pmc: PMC8650300
doi:
Substances chimiques
Anti-Inflammatory Agents
0
Colchicine
SML2Y3J35T
Types de publication
Journal Article
Randomized Controlled Trial
Research Support, Non-U.S. Gov't
Langues
eng
Sous-ensembles de citation
IM
Pagination
583Informations de copyright
© 2021. The Author(s).
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