Effects of the P-Selectin Antagonist Inclacumab on Myocardial Damage After Percutaneous Coronary Intervention for Non-ST-Elevation Myocardial Infarction - SELECT-ACS
The goal of the trial was to evaluate treatment with the P-selectin antagonist inclacumab compared with placebo among patients undergoing percutaneous coronary intervention (PCI) for non–ST-segment elevation myocardial infarction (NSTEMI).
Inclacumab will reduce ischemic events.
- Placebo Controlled
- Patients 18-85 years of age with NSTEMI, scheduled for coronary angiography and possible PCI
Number of enrollees: 322
Duration of follow-up: 120 days
Mean patient age: 61 years
Percentage female: 21%
- PCI in the last 72 hours
- Recent fibrinolytic therapy
- Recent stroke or cerebrovascular disease
- Bleeding disorder
- Uncontrolled hypertension
- Prior coronary artery bypass graft
- Active infection
- Uncontrolled diabetes
- Severe renal or liver disease
- Inflammatory or immune-mediated disease
- Change in troponin I from baseline to 16-24 hours post-PCI
- Peak troponin I post-PCI
- Area under the curve for troponin I
- Change in troponin I from baseline to 8 hours post-PCI
- Change in CK-MB from baseline to 8, 16, and 24 hours post-PCI
Patients with NSTEMI were randomized to receive pre-PCI inclacumab 5 mg/kg (n = 95), inclacumab 20 mg/kg (n = 112), versus placebo (n = 115).
Overall, 322 patients were randomized. The median age was 61 years, 21% were women, 23% had diabetes, and 58% received a drug-eluting stent.
The percent change in troponin I from baseline to 16 hours (adjusted for placebo) was -3.4% with inclacumab 5 mg/kg (p = 0.81) and -22.4% with inclacumab 20 mg/kg (p = 0.07).
The percent change in troponin I from baseline to 24 hours (adjusted for placebo) was -1.4% with inclacumab 5 mg/kg (p = 0.93) and -24.4% with inclacumab 20 mg/kg (p = 0.05). The results were similar in patients with/without diabetes.
The percent change in creatine kinase-myocardial band (CK-MB) from baseline to 24 hours (adjusted for placebo) was -4.7% with inclacumab 5 mg/kg (p = 0.64) and -17.4% with inclacumab 20 mg/kg (p = 0.06).
Serious adverse events were observed in 24.0% of the inclacumab 5 mg/kg group, 25.6% of the inclacumab 20 mg/kg, and 18.3% of the placebo group, which were mostly mild or moderate severity.
Infection: 10.6%, 10.8%, and 12%, respectively for inclacumab 5 mg/kg, inclacumab 20 mg/kg, and placebo.
Among NSTEMI patients undergoing PCI, the preprocedure use of inclacumab resulted in a modest reduction in post-PCI cardiac enzyme elevation. This was observed with the 20 mg/kg, but not the 5 mg/kg dose. Serious adverse events and infections appeared similar between treatment groups. Further study will need to evaluate the 20 mg/kg dose powered for clinical outcomes.
Tardif JC, Tanguay JF, Wright SS, et al. Effects of the P-selectin antagonist inclacumab on myocardial damage after percutaneous coronary intervention for non-ST elevation myocardial infarction: results of the SELECT-ACS trial. J Am Coll Cardiol 2013;Mar 10:[Epub ahead of print].
Presented by Dr. Jean-Claude Tardif at ACC.13, San Francisco, March 10, 2013.
Clinical Topics: Heart Failure and Cardiomyopathies, Invasive Cardiovascular Angiography and Intervention, Noninvasive Imaging, Heart Failure and Cardiac Biomarkers, Interventions and Imaging, Angiography, Nuclear Imaging
Keywords: Menopause, Myocardial Infarction, P-Selectin, Follow-Up Studies, Coronary Angiography, Drug-Eluting Stents, Troponin I, Creatine Kinase, MB Form, Diabetes Mellitus, Percutaneous Coronary Intervention
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