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SELECT-ACS: Inclacumab reduced myocardial damage after PCI for non-STEMI
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SAN FRANCISCO — A single dose of inclacumab, an investigational anti-inflammatory drug, reduced myocardial damage during PCI in patients with non-STEMI, according to late-breaking clinical trial data presented here.
“There's a lot of excitement around the role of inflammation in CAD and potentially the role of anti-inflammatory agents, and this is one of the largest studies in humans to show the potential benefits of blocking inflammation and, specifically, the P-selectin pathways,” Jean-Claude Tardif, MD, director of the Research Center at Montreal Heart Institute, University of Montreal, told Cardiology Today’s Intervention. “We think it’s an important piece of information that is going to fuel the concept of blocking inflammation in patients with CAD undergoing PCI.”
Tardif and colleagues of the phase 2, double blind, randomized SELECT-ACS trial compared the effects of a single dose of inclacumab by measuring patients’ levels of troponin I and CK-MB. They found that inclacumab 5 mg/kg did not change efficacy endpoints. However, the placebo-adjusted change in troponin I with inclacumab 20 mg/kg was –24.4% at 24 hours (P=.05) and –22.4% at16 hours (P=.066). Additionally, peak troponin I levels were reduced by 23.8% (P=.054) and area under the curve during 24 hours was lower by 33.9% (P=.075).
Results were similar with CK-MB (–17.4% at 24 hours, P=.055; –16.3% at 16 hours, P=.088). No significant differences in adverse events were observed between treatment groups.
Jean-Claude Tardif
“These data support the role of inflammation in patients with recent non-STEMI undergoing PCI, but we will need additional studies to show that the broader populations of patients presenting with STEMI or non-STEMI who receive angioplasty or not will benefit from blocking inflammation through P-selectin antagonism,” Tardif said.
The SELECT-ACS trial involved 530 patients with non-STEMI (median age, 61 years; 79% men) scheduled for coronary angiography and ad hoc PCI. Patients were randomly assigned to inclacumab infusion at 20 mg/kg, inclacumab at 5 mg/kg or placebo 1 to 24 hours before angioplasty. Troponin I and CK-MB were then measured at 8, 16 and 24 hours after angioplasty. – by Katie Kalvaitis and Brian Ellis
For more information:
Tardif JC. Late-breaking clinical trials III: Chronic CAD/stable ischemic heart disease and acute coronary syndromes. Presented at: American College of Cardiology Scientific Sessions; March 9-11, 2013; San Francisco.
Disclosure: Tardif reports no relevant financial disclosures. The trial was supported by Roche.