Abstract
BackgroundCardiovascular 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.MethodsIn 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.ResultsA 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).ConclusionThe addition of colchicine to standard medical therapy in ACS patients significantly reduces MACE occurrence and improves survival rate over the time.
Highlights
In spite of multilateral attempts managing primary and secondary preventive strategies, cardiovascular diseases have been the main cause of mortality in recent decades [1, 2]
A total of 249 patients were selected through randomization (122 and 129 subjects were assigned to colchicine and the placebo groups, respectively) and were kept under study for a 6-month period
It was found that at the end of the enrollment, 15 (12.5%) patients had a history of gastrointestinal adverse effects caused by colchicine use in compare with 3 (2.5%) in placebo group
Summary
In spite of multilateral attempts managing primary and secondary preventive strategies, cardiovascular diseases have been the main cause of mortality in recent decades [1, 2]. An inflammatory response is triggered, thereby contributing to the release of cytokines and other inflammatory mediators which trigger further destruction [6, 7] Likewise, it was Canakinumab Anti-inflammatory Thrombosis Outcome Study (CANTOS) trial that revealed the inhibition of interleukin (IL)-1β, as an important inflammatory cytokine, by Canakinumab and its association with reduced cardiovascular events [8]. Considering inflammatory pathway of atherosclerosis, colchicine as an antiinflammatory drug is introduced to be effective in pathogenesis, prognosis and mortality rate of these patients. 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
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