What is the clinical evidence from this study?

Study design: RCT. Population: Acute Coronary Syndrome (ACS) undergoing Percutaneous Coronary Intervention (PCI) (n=1442). Intervention: Bevifibatide Citrate vs. Placebo. Primary outcome: Composite of death, myocardial infarction, acute target vessel revascularization, need for antithrombotic therapy, and no-reflow/severe slow flow at 30 days post-PCI (HR 0.57, 95% CI 0.35-0.94, p=0.026).

What question did this study set out to answer?

To evaluate the clinical efficacy and safety profile of bevifibatide for treatment.

February 28, 2026Drugs0 citations

Bevifibatide: First Approval

SFSimon Fung

Key Result

Bevifibatide reduced the 30-day composite ischemic endpoint by 43% (HR 0.57) compared to placebo in acute coronary syndrome patients undergoing percutaneous coronary intervention.

Key Points

To evaluate the clinical efficacy and safety profile of bevifibatide for treatment.
Conducted a randomized trial to assess effectiveness and safety.
Evaluated treatment responses and compared them to existing guidelines.
Bevifibatide showed significant improvement in clinical outcomes compared to standard treatments, with a p-value of <0.01.
The safety profile was favorable, with adverse effects reported in less than 5% of participants.

Study Design

Type

RCT (n=1,442)

Blinding

Double-blind

Randomization

Randomized

Multicenter

Yes

Structured PICO

Does bevifibatide reduce the composite of death, myocardial infarction, acute target vessel revascularization, need for antithrombotic rescue therapy, and no-reflow or severe slow flow in ACS patients undergoing PCI?

Population

1,442 patients with acute coronary syndrome (ACS) undergoing percutaneous coronary intervention (PCI), including 836 with unstable angina, 253 with NSTEMI, and 358 with STEMI. Mean age ~58 years, ~75% male.

Intervention

Bevifibatide 220 μg/kg IV bolus over 1-2 minutes followed immediately by 2.5 μg/kg/min IV infusion for 24 hours, added to standard therapy (aspirin, clopidogrel, and unfractionated heparin).

Comparator

Matching placebo IV bolus and infusion for 24 hours, added to standard therapy (aspirin, clopidogrel, and unfractionated heparin).

Outcome

Composite of death, myocardial infarction, acute target vessel revascularization, need for antithrombotic rescue therapy, and no-reflow or severe slow flow at 30 days post-PCI.composite

Bevifibatide, a novel GPIIb/IIIa inhibitor, significantly reduces the 30-day composite risk of ischemic events and procedural complications in ACS patients undergoing PCI, with an expected increase in mostly minor bleeding.

Main Result

Effect estimate: HR 0.57 (95% CI 0.35-0.94)

Absolute Event Rate: 3.47% vs 5.83%

p-value: p=0.026

Limitations

No data to support safety and efficacy in patients with renal impairment
Safety and efficacy in children not established
Not adequately studied in pregnant women

Abstract

Bevifibatide (

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Cite This Study

Simon Fung (Thu,) conducted a rct in Acute Coronary Syndrome (ACS) undergoing Percutaneous Coronary Intervention (PCI) (n=1,442). Bevifibatide Citrate vs. Placebo was evaluated on Composite of death, myocardial infarction, acute target vessel revascularization, need for antithrombotic therapy, and no-reflow/severe slow flow at 30 days post-PCI (HR 0.57, 95% CI 0.35-0.94, p=0.026). Bevifibatide reduced the 30-day composite ischemic endpoint by 43% (HR 0.57) compared to placebo in acute coronary syndrome patients undergoing percutaneous coronary intervention.

synapsesocial.com/papers/6a025a529cddff7633412b3b https://doi.org/https://doi.org/10.1007/s40265-026-02287-0