Aernoud Fiolet

126 Chapter 5 diabetes. Most patients (4658 [84.4%]) had a history of acute coronary syndrome; in 68.2% of the patients, the acute event had occurred more than 24 months before randomization. At baseline, the patients were well treated with respect to chronic coronary disease, with 99.7% taking an antiplatelet agent or an anticoagulant, 96.6% a lipid-lowering agent, 62.1% a beta-blocker, and 71.7% an inhibitor of the renin–angiotensin system. Distribution of baseline characteristics according to country is provided in Table S4. Adherence and follow-up The date of the last follow-up contact with a patient was February 17, 2020. The database was locked on May 22, 2020. The primary end-point status was available for all but one patient. The median duration of follow-up was 28.6 months (interquartile range, 20.5 to 44.4). In each trial group, 10.5% of the patients permanently discontinued colchicine or placebo prematurely (Figure 1). Primary and secondary end points The primary composite end-point event of cardiovascular death, spontaneous myocardial infarction, ischemic stroke, or ischemia-driven coronary revascularization occurred in 187 patients (6.8%) in the colchicine group and in 264 patients (9.6%) in the placebo group, with incidence rates of 2.5 and 3.6 events, respectively, per 100 person-years (hazard ratio, 0.69; 95% confidence interval [CI], 0.57 to 0.83; P<0.001) (Figure 2 and Figure 3). This treatment effect was consistent in the on-treatment analysis (Fig. S1 and Table S5). A key secondary composite end-point event of cardiovascular death, spontaneous myocardial infarction, or ischemic stroke occurred in 115 patients (4.2%) in the colchicine group and in 157 patients (5.7%) in the placebo group, with incidence rates of 1.5 and 2.1 events, respectively, per 100 person-years (hazard ratio, 0.72; 95% CI, 0.57 to 0.92; P=0.007) (Figures 2 and Figure 3). In the prespecified hierarchical testing of the ranked secondary end points, the rates of the first five secondary end points, including spontaneous myocardial infarction, were significantly lower in the colchicine group than in the placebo group (Figure 3). Colchicine did not result in a lower incidence of death from any cause than placebo (73 vs. 60 fatalities; incidence, 0.9 vs. 0.8 events, respectively, per 100 person- years; hazard ratio, 1.21; 95% CI, 0.86 to 1.71). Fine and Gray subdistribution hazard ratios were virtually identical to the cause-specific hazard ratios (Table S6).