Randomized trial of interleukin-6 receptor inhibition in patients with acute ST-segment elevation myocardial infarction

K Broch, AK Anstensrud, S Woxholt, K Sharma… - Journal of the American …, 2021 - jacc.org
K Broch, AK Anstensrud, S Woxholt, K Sharma, IM Tøllefsen, B Bendz, S Aakhus, T Ueland…
Journal of the American College of Cardiology, 2021jacc.org
Background Prompt myocardial revascularization with percutaneous coronary intervention
(PCI) reduces infarct size and improves outcomes in patients with ST-segment elevation
myocardial infarction (STEMI). However, as much as 50% of the loss of viable myocardium
may be attributed to the reperfusion injury and the associated inflammatory response.
Objectives This study sought to evaluate the effect of the interleukin-6 receptor inhibitor
tocilizumab on myocardial salvage in acute STEMI. Methods The ASSAIL-MI trial was a …
Background
Prompt myocardial revascularization with percutaneous coronary intervention (PCI) reduces infarct size and improves outcomes in patients with ST-segment elevation myocardial infarction (STEMI). However, as much as 50% of the loss of viable myocardium may be attributed to the reperfusion injury and the associated inflammatory response.
Objectives
This study sought to evaluate the effect of the interleukin-6 receptor inhibitor tocilizumab on myocardial salvage in acute STEMI.
Methods
The ASSAIL-MI trial was a randomized, double-blind, placebo-controlled trial conducted at 3 high-volume PCI centers in Norway. Patients admitted with STEMI within 6 h of symptom onset were eligible. Consenting patients were randomized in a 1:1 fashion to promptly receive a single infusion of 280 mg tocilizumab or placebo. The primary endpoint was the myocardial salvage index as measured by magnetic resonance imaging after 3 to 7 days.
Results
We randomized 101 patients to tocilizumab and 98 patients to placebo. The myocardial salvage index was larger in the tocilizumab group than in the placebo group (adjusted between-group difference 5.6 [95% confidence interval: 0.2 to 11.3] percentage points, p = 0.04). Microvascular obstruction was less extensive in the tocilizumab arm, but there was no significant difference in the final infarct size between the tocilizumab arm and the placebo arm (7.2% vs. 9.1% of myocardial volume, p = 0.08). Adverse events were evenly distributed across the treatment groups.
Conclusions
Tocilizumab increased myocardial salvage in patients with acute STEMI. (ASSessing the effect of Anti-IL-6 treatment in Myocardial Infarction [ASSAIL-MI]; NCT03004703)
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