• Cardiology Clinical Trials
• Cardiology
• Interventional Techniques & Devices
• Myocardial Infarction

• Cardiology Clinical Trials
• Interventional Techniques & Devices
• Myocardial Infarction

Inhaled nitric oxide (NO) did not reduce infarct size (IS) in patients who experienced STEMI and underwent percutaneous coronary intervention (PCI). Stefan P. Janssens, MD, PhD, University of Leuven, Leuven, Belgium, presented data from the Effects of Nitric Oxide for Inhalation in Myocardial Infarction Size study [NOMI; NCT01398384].

In animal models, inhalation of 40 to 80 ppm of NO decreased IS and area at risk and improved functional recovery [Liu X et al. J Am Coll Cardiol. 2007; Hataishi R et al. Am J Physiol Heart Circ Physiol. 2006]. The hypothesis of the NOMI study was that inhaled NO would decrease IS and improve left ventricular (LV) function in patients with STEMI who underwent primary PCI.

The NOMI trial was a multicenter double-blind phase 2 trial that randomized 248 patients with STEMI undergoing PCI within 12 hours to either inhaled NO (80 ppm) or placebo. All patients underwent magnetic resonance imaging to evaluate IS, LV function, and remodeling at 48 to 72 hours and again at 4 months. The primary end point was IS and secondary end points included myocardial salvage index, myocardial hemorrhage, LV remodeling at 48 to 72 hours, and LV remodeling at 4 months. The trial also examined the effects on prespecified subgroups, including TIMI flow grade, culprit artery, time between symptom onset and PCI, and troponin levels upon admission.

Inhaled NO failed to significantly reduce IS, and the IS/LV mass ratio was 19.4% in the control arm and 18% in the inhaled NO arm (estimate R effect, −1.48; 95% CI, −5.25 to 2.29; P = .44). There were no differences in the composite end point of death, recurrent ischemia, stroke, and rehospitalization at 150 days (log-rank P = .1022). NO treatment resulted in a significant improvement in LV remodeling at 4 months (OR, 0.90; 95% CI, 0.81 to 0.999; P = .048) compared with control. There were no significant differences in the other secondary end points.

Prof Janssens stated that the data from the NOMI trial show that inhaled NO is safe but did not decrease the IS, as measured by percentage LV mass. However, there were improvements in LV remodeling at 4 months.

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