Dexrazoxane at primary PCI and intramyocardial haemorrhage

Design

Single-centre, non-randomised, sequential-cohort phase IIa

Population

50 patients with STEMI undergoing primary PCI

Primary outcome

LVEF and intramyocardial haemorrhage volume on CMR at 48–72 h

Effect

LVEF 39.8% vs 34.7%; haemorrhage 2.0% vs 6.3% of LV

SHIELD-MI was a single-centre, non-randomised, sequential-cohort phase IIa study. Twenty-five STEMI patients received intravenous dexrazoxane 250 mg before primary PCI and at 4, 8 and 12 hours, compared with 25 matched placebo-treated patients. Participants and the CMR core laboratory were blinded. It was published in the European Heart Journal in August.

At 48 to 72 hours, LVEF was 39.8% versus 34.7%, intramyocardial haemorrhage volume 2.0% versus 6.3% of the left ventricle, and infarct size 29.1% versus 43.8%. Haemorrhagic infarction occurred in 24% versus 64%. No drug-related serious adverse events were seen.

This identifies intramyocardial haemorrhage as a treatable target, which is new. It is not a reason to use dexrazoxane in STEMI outside a trial.

• Do not use dexrazoxane for STEMI outside a trial.
• Note intramyocardial haemorrhage on post-STEMI CMR reports; it carries prognostic weight.
• Watch for a randomised trial.

Why it matters

Intramyocardial haemorrhage may be a therapeutic target, not just a marker of poor outcome.

Don't overread it

A non-randomised phase IIa study of 50 patients cannot show that the drug improves outcomes.

The statistics, in plain English

With 25 patients per group, non-random allocation and comparators selected from a larger placebo cohort, these differences could reflect how the groups were chosen. The LVEF P value of 0.048 is borderline. The end points are imaging surrogates at 72 hours.

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