Intensive glucose regulation does not reduce enzymatic infarct size in hyperglycemic acute coronary syndromes: results of the randomized BIOMArCS-2 glucose trial

Abstract

Background: Elevated admission plasma glucose (APG) in acute coronary syndrome (ACS) patients is associated with increased mortality. Clinical trials of glucose regulation provided inconsistent results with respect to cardiovascular outcomes. Target glucose levels might have been suboptimal. Aim: To study the effectiveness and safety of intensive glucose management in ACS patients with hyperglycemia, aiming at a strict blood glucose normalization. Methods: BIOMArCS-2 Glucose is a single-centre, prospective, open-label, randomized, clinical trial that enrolled 294 ACS patients with an APG 7.8-16 mmol/l. Patients were randomized to an intensive glucose management strategy, aiming at a plasma glucose 4.7-6.1 mmol/l by using intravenous insulin, or conventional expectative glucose management. Endpoints were high sensitivity Troponin T 72 hours after admission (hsTropT72) (primary), the area under the curve (AUC) of CKMB release, and myocardial perfusion scintigraphy (MPS) parameters at 6 weeks follow-up. Results: In the intensive arm hsTropT72 was 1197 ng/L (541-2296) vs. 1354 ng/L (530-3057) in the conventional arm, p-value 0.41. Median AUC-CKMB was 2372 U/L (1242 – 5004) vs. 3171 U/L (1620 – 5337), p-value 0.18. The median extent of myocardial injury measured by MPS was comparable (2% vs. 4%, p value 0.07). Severe hypoglycemia (<2.8 mmol/l) was rare and occurred in 13 patients. Before discharge, death or spontaneous recurrent MI occurred in 8 (5.7%) vs. 1 patients, p-value 0.04. ![Figure][1] Treatment effect for subgroups Conclusion: Intensive glucose regulation did not reduce enzymatic infarct size in troponin positive ACS patients treated with PCI. The benefit of a possible smaller infarct size needs to be carefully weighed against the risk of death or recurrent myocardial infarction. [1]: pending:yes