Abstract
Abstract Background ST-segment elevation myocardial infarction (STEMI) is associated with an intense acute inflammatory response and an increased risk of recurrent ischemic events. Prior studies of IL-1 blockade have shown conflicting results regarding the risk of future events. Methods We enrolled patients with STEMI within 12 hours of presentation at 3 sites in the United States of America. After revascularization, patients were randomly assigned to receive anakinra 100 mg twice daily, anakinra 100 mg once daily (standard dose) alternated with placebo once daily every 12 hours, or placebo every 12 hours for 14 days in 1:1:1 ratio. Prespecified exploratory endpoints for recurrent ischemic events, adjudicated by an independent committee, evaluated the composite risk of subsequent acute myocardial infarction (AMI, World Health Organization classification Type 1), unstable angina, or urgent revascularization. Data are expressed as median and interquartile range or number and percentage. Cox regression analysis was used to generate unadjusted hazard ratios and confidence intervals. (ClinicalTrials.gov number, NCT01950299) Results Of 311 patients screened, 99 subjects (81% males, 58% Caucasians, 55 [49–62] years of age) were randomly assigned to anakinra twice daily (N=31), anakinra once daily (N=33) or placebo (N=35). The cohort included patients with hypertension (57%), tobacco use (55%), diabetes mellitus (30%), and prior diagnosis of coronary artery disease (21%) without statistically significant imbalances in the demographic characteristics between groups (all P>0.05). Discharge medications for the index STEMI admission, in addition to the study medication, included aspirin (100%), statins (100%), P2Y12 inhibitors (100%), beta-blockers (90%), and angiotensin converting enzyme inhibitor/angiotensin receptor blocker (84%), without statistically significant imbalances between the 3 groups. Over the 1-year follow-up, recurrent ischemic events occurred in 5/35 (14.3%) patients treated with placebo and 6/64 (9.1%) patients treated with anakinra (hazard ratio = 0.68 [0.20–2.24], P=0.53). No differences were observed between high- and low-dose anakinra treatment groups. Conclusions A two week treatment with IL-1 receptor antagonist, anakinra, did not significantly decrease or increase recurrent ischemic events over the course of a 1-year follow-up in patients with STEMI. Acknowledgement/Funding Funded by NHLBI 1R34HL121402; Drug supply by Swedish Orphan Biovitrum
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