SELECT-ACS Trial Shows Inclacumab May Reduce PCI Damage After NSTEMI

Early clinical data suggest that inclacumab, a recombinant monoclonal antibody to P-selectin, may help protect patients undergoing percutaneous coronary intervention (PCI) from myocardial damage. The SELECT-ACS trial was presented during the third ACC.13 Late Breaking Clinical Trial session on March 10, and was published simultaneously in the Journal of the American College of Cardiology.

"Myocardial damage is common after PCI," said Jean-Claude Tardiff, MD, Montreal Heart Institute of the University of Montreal, presenting on behalf of the SELECT-ACS steering committee. "Preclinical models suggest that inhibition of P-selectin decreases neutrophil and platelet adhesion, macrophage accumulation and neointimal formation after this injury."

Inclacumab is a highly selective P-selectin inhibitor, he said. There have been no adverse safety findings in preclinical studies and suggestions that it has potent anti-inflammatory and antithrombotic effects. SELECT was designed to assess the efficacy of inclacumab in reducing myocardial damage during PCI in patients with non-ST elevation MI (NSTEMI).

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A total of 530 NSTEMI patients who were scheduled for coronary angiography and ad hoc PCI were randomized to one of three groups: placebo, inclacumab 5 mg/kg or inclacumab 20 mg/kg. Patients continued to angiography as scheduled and PCI as indicated. Troponin I and CK-MB were measured at eight, 16 and 24 hours post-PCI. Patients also returned for safety visits 30 and 120 days after PCI.

A total of 322 patients underwent PCI and constituted the efficacy population. The primary endpoint was change in troponin I at 16 and 24 hours post-PCI. Secondary endpoints included peak troponin I post PCI, area under the curve for troponin I over 24 hours, change in troponin I at eight hours and changes in CK-MB at eight, 16, and 24 hours post-PCI.

The 5 mg/kg dose did not show any significant change, Tardiff reported. But the 20 mg/kg dose showed a 24.4 percent reduction at troponin I at 24 hours (p=0.05) and a 23.8 percent decrease in peak troponin I (p=0.05). The percent change in both troponin I and CK-MB showed similar and consistent reductions compared to placebo at eight, 16 and 24 hours post-PCI. There were no significant differences in adverse events between the three groups.

The study was not powered to evaluate the potential clinical value of inclacumab, Tardiff added, but results showed both safety and efficacy in NSTEMI patients.

"The consistency of our data suggest that inclacumab reduces myocardial damage after PCI," he concluded. "Further investigation is needed to determine the clinical value of inclacumab in patients who present with MI whether or not they have PCI."

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