Zalunfiban at First Medical Contact for ST-Elevation Myocardial Infarction - CELEBRATE

Nov 10, 2025

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Author/Summarized by Author:
Abdullah Al-Abcha, MD
Summary Reviewer:
Abdallah El Sabbagh, MD, FACC; Fred M. Kusumoto, MD, FACC
Original Posted Date:
11/10/2025
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Contribution To Literature:

The CELEBRATE trial demonstrated that a single injection of zalunfiban administered at first medical contact in patients with suspected STEMI significantly improved patency of the infarct-related artery at index angiography and reduced the likelihood of a composite of all-cause death, stroke, recurrent myocardial infarction (MI), stent thrombosis, heart failure, and larger MI at 30 days.

Study Design:

Zalunfiban is a glycoprotein (GP) IIb/IIIa (integrin αIIbβ3) inhibitor designed for subcutaneous administration in patients with suspected STEMI. CELEBRATE was an international, double-blind, randomized controlled trial in which patients were assigned in a 1:1:1 ratio to receive a single subcutaneous injection of zalunfiban (n=853 to 0.11 mg/kg and n=818 to 0.13 mg/kg) or matching placebo (n=796) at first medical contact.

  • Total number of enrollees: 2,467
  • Duration of follow-up: 30 days
  • Mean patient age: 63 years
  • Demographics: 21% women; 95% White

Principal Findings:

Primary efficacy outcome:
The primary 30-day hierarchical composite outcome (death, stroke, recurrent MI, acute stent thrombosis, heart failure, larger MI, or none of the above) was significantly improved with pooled zalunfiban compared with placebo (adjusted odds ratio, 0.79; 95% CI, 0.65–0.98; p=0.028).

Individual components (nonhierarchical rates):

  • Death: zalunfiban 2.3% vs. placebo 2.2%
  • Stroke: zalunfiban 0.7% vs. placebo 0.8%
  • Recurrent MI: zalunfiban 1.9% vs. placebo 1.2%
  • Acute stent thrombosis: zalunfiban 0.2% vs. placebo 1.0%
  • New/recurrent heart failure: zalunfiban 6.5% vs. placebo 8.1%
  • Large MI (high-sensitivity cardiac troponin T ≥30× upper limit of normal): zalunfiban 85.4% vs. placebo 88.5%
  • No major adverse clinical endpoint: zalunfiban 13.3% vs. placebo 9.8%

Primary safety outcome:

  • No difference in GUSTO severe/life-threatening bleeding: zalunfiban 1.2% vs. placebo 0.8% (difference, 0.4; 95% CI, −0.4 to 1.2; p=0.40).

Secondary outcomes:

  • Improved infarct-related artery flow at index angiography; median corrected TIMI frame count: 109 frames in the zalunfiban arm vs. 176 frames in the placebo arm (difference, −66; 95% CI, −93 to −39; p=0.012).
  • No significant difference in post-PCI ST-segment resolution at 1 hour: zalunfiban 52.1% vs. placebo 50.7% (difference, 1.4; 95% CI, −2.1 to 5.0; p=0.42).
  • No significant difference in bailout IV GP inhibitor/P2Y12 use: zalunfiban 8.6% vs. placebo 9.5% (difference, −0.9; 95% CI, −3.5 to 1.5).
  • Increased likelihood of having TIMI 2 or 3 flow at index angiography: zalunfiban 52.0% vs. placebo 45.1% (difference, 6.8; 95% CI, 2.5 to 11.2).
  • Greater resolution of ST-segment deviation shortly before angiography: zalunfiban 6.4% vs. placebo 0.1% (difference, 6.3; 95% CI, 1.3 to 11.4).

Interpretation:

In early-presenting patients with STEMI, subcutaneous zalunfiban administered at first medical contact reduced the likelihood of a worse 30-day hierarchical composite clinical outcome, without increasing severe or life-threatening bleeding. Benefits were observed despite contemporary background therapy, including aspirin, heparin, and P2Y12 inhibitors (predominantly ticagrelor), and in the context of very short symptom-to-needle and drug-to-PCI times, demonstrating that rapid upstream platelet inhibition can still provide incremental value.

References

Van't Hof AWJ, Gibson CM, Rikken SAOF, et al. Zalunfiban at first medical contact for ST-Elevation myocardial infarction. NEJM Evidence. Published online November 10, 2025:EVIDoa2500268. doi:10.1056/evidoa2500268.

Presented by Arnoud Willem van't Hof, MD, PhD, at the American Heart Association Scientific Sessions (AHA 2025), New Orleans, LA, Nov. 10, 2025.

Resources

Clinical Topics: Acute Coronary Syndromes, Anticoagulation Management, Invasive Cardiovascular Angiography and Intervention, Anticoagulation Management and ACS, Interventions and ACS, Interventions and Imaging, Angiography, Nuclear Imaging

Keywords: AHA Annual Scientific Sessions, AHA25, Acute Coronary Syndrome, Angiography, Anticoagulants