European heart journal · 2026
Intravenous dexrazoxane for haemorrhagic myocardial infarction: the SHIELD-MI study.
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Vora Keyur P, Bhatt Kinjal, Doshi Shrenik, Poptani Vishal, Kumar Andreas, Finney Robert, Taub Cynthia, Reed Grant, Puri Rishi, Tamarappoo Balaji, Fry Edward, Henry Timothy, Traverse Jay, Kalra Ankur, Dharmakumar Rohan
Аннотация
BACKGROUND AND AIMS: Intramyocardial hemorrhage (IMH) after reperfused ST-elevation myocardial infarction (STEMI) is associated with adverse outcomes, yet no therapy specifically targets it. Dexrazoxane (DXZ) may mitigate iron-mediated injury from IMH.
METHODS: SHIELD-MI was a single-center, non-randomized, placebo-controlled, sequential-cohort phase IIa study with participants and the cardiac MRI (CMR) core laboratory blinded to treatment. Twenty-five patients received intravenous DXZ 250 mg before primary PCI and at 4, 8, and 12 h thereafter. Twenty-five comparators, selected from 78 placebo-treated patients, were matched on total ischemic time, culprit territory, and pre-PCI occlusion status. Primary endpoints were left ventricular ejection fraction (LVEF) and IMH volume on CMR at 48-72 h, evaluating early ventricular function and hemorrhagic myocardial injury after reperfusion.
RESULTS: In the matched analytic cohort (n=50), LVEF was higher in patients receiving DXZ (39.8±7.7% vs. 34.7±10.1%; P=0.048), permitting formal testing of IMH volume, which was lower with DXZ (2.0±3.4% LV vs. 6.3±6.0% LV; P=0.004). The prespecified fixed-sequence criterion was therefore met at both steps. Infarct size was lower with DXZ (29.1±13.1% LV vs. 43.8±18.6% LV; P=0.002). Hemorrhagic MI occurred in 6/25 (24%) versus 16/25 (64%) participants (P=0.010). No drug-related serious adverse events were observed.
CONCLUSIONS: Peri-procedural intravenous DXZ was associated with lower IMH and infarct size and higher LVEF, without safety concerns. These exploratory findings identify IMH as a candidate therapeutic target warranting a randomized trial.
METHODS: SHIELD-MI was a single-center, non-randomized, placebo-controlled, sequential-cohort phase IIa study with participants and the cardiac MRI (CMR) core laboratory blinded to treatment. Twenty-five patients received intravenous DXZ 250 mg before primary PCI and at 4, 8, and 12 h thereafter. Twenty-five comparators, selected from 78 placebo-treated patients, were matched on total ischemic time, culprit territory, and pre-PCI occlusion status. Primary endpoints were left ventricular ejection fraction (LVEF) and IMH volume on CMR at 48-72 h, evaluating early ventricular function and hemorrhagic myocardial injury after reperfusion.
RESULTS: In the matched analytic cohort (n=50), LVEF was higher in patients receiving DXZ (39.8±7.7% vs. 34.7±10.1%; P=0.048), permitting formal testing of IMH volume, which was lower with DXZ (2.0±3.4% LV vs. 6.3±6.0% LV; P=0.004). The prespecified fixed-sequence criterion was therefore met at both steps. Infarct size was lower with DXZ (29.1±13.1% LV vs. 43.8±18.6% LV; P=0.002). Hemorrhagic MI occurred in 6/25 (24%) versus 16/25 (64%) participants (P=0.010). No drug-related serious adverse events were observed.
CONCLUSIONS: Peri-procedural intravenous DXZ was associated with lower IMH and infarct size and higher LVEF, without safety concerns. These exploratory findings identify IMH as a candidate therapeutic target warranting a randomized trial.