Effects of the P-Selectin Antagonist Inclacumab on Myocardial Damage After Percutaneous Coronary Intervention for Non-ST-Elevation Myocardial Infarction - SELECT-ACS

Mar 10, 2013
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Author/Summarized by Author:
Anthony A. Bavry, MD, MPH, FACC
Summary Reviewer:
Deepak L. Bhatt, MD, MPH, MBA, FACC
Trial Sponsor:
F. Hoffmann-La Roche
Date Presented:
01/01/2013
Date Published:
01/01/2013
Date Updated:
03/10/2013
Original Posted Date:
03/10/2013
References

Description:

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).

Hypothesis:

Inclacumab will reduce ischemic events.

Study Design

  • Placebo Controlled
  • Blinded
  • Randomized
  • Parallel

Patient Populations:

  • 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%

Exclusions:

  • 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
  • Pregnancy

Primary Endpoints:

  • Change in troponin I from baseline to 16-24 hours post-PCI

Secondary Endpoints:

  • 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

Drug/Procedures Used:

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).

Principal Findings:

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.

Interpretation:

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.

References:

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.

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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