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NIAMI: STEMI patients did not benefit from sodium nitrite before PCI
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DALLAS — New data from the NIAMI study demonstrate that administration of sodium nitrite immediately before PCI did not reduce infarct size in patients with ST-elevation MI.
Nishat Siddiqi
Previous experimental animal studies have shown that nitrite protects against ischemia reperfusion injury in the heart and other organs, but it had not been tested in humans, Nishat Siddiqi, MBBCh, a cardiology clinical research fellow at University of Aberdeen in the United Kingdom, said during a press conference.
Therefore, Siddiqi and colleagues conducted the phase 2, double blind NIAMI trial at three centers in the United Kingdom and one in Australia. They randomly assigned 280 patients with first acute STEMI and TIMI 0 or 1 flow to IV sodium nitrite 70 micromoles in 5 mL of saline (n=146) or matching placebo (n=134) for 5 minutes immediately before angioplasty.
A total of 229 patients were included in the final analyses. Results showed that, at 6 to 8 days post-procedure, patients in the sodium nitrite group experienced only a 0.7% reduction (95% CI, –2.2 to 0.7) in infarct size, as measured by CV MRI (CMR), which was not significantly different from that observed in the placebo group.
The researchers also found no significant differences between the sodium nitrite and placebo groups in secondary endpoints, including infarct size at 6 months (13.3% and 15%, respectively), plasma creatinine kinase and troponin I, left ventricular ejection fraction and LV end-systolic volume index, as measured by CMR, at 6 to 8 days and 6 months post-procedure.
No treatment effect was observed in patients without diabetes, but patients with diabetes in the sodium nitrite group experienced a 4.5% reduction in infarct size (95% CI, –8.8 to –0.2). However, the interaction was not significant (P=.067).
“A 5-minute intravenous infusion of sodium nitrite administered immediately prior to primary PCI does not reduce myocardial infarct size,” Siddiqi concluded at the presentation.
For more information:
Siddiqi N. Late-breaking clinical trials I: Acute cardiovascular and cerebrovascular care. Presented at: the American Heart Association Scientific Sessions; Nov. 16-20, 2013; Dallas.
Disclosure: Siddiqi reports no relevant financial disclosures.