BioNIR Ridaforolimus Eluting Coronary Stent System in Coronary Stenosis - BIONICS

Aug 21, 2017
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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:
Medinol Ltd., Tel Aviv, Israel
Date Published:
08/09/2017
Date Updated:
08/21/2017
Original Posted Date:
08/21/2017
References

Contribution To Literature:

The BIONICS trial showed that a ridaforolimus-eluting stent was noninferior to a zotarolimus-eluting stent.

Description:

The goal of the trial was to evaluate a ridaforolimus-eluting stent compared with a zotarolimus-eluting stent among patients undergoing percutaneous coronary intervention (PCI).

Study Design

  • Randomized
  • Parallel
  • Blinded
  • Stratified

Patients undergoing PCI were randomized to a ridaforolimus-eluting stent (n = 958) versus a zotarolimus-eluting stent (n = 961). Dual antiplatelet therapy was mandated for 6 months.

  • Total number of enrollees: 1,919
  • Duration of follow-up: 12 months
  • Mean patient age: 64 years
  • Percentage female: 22%
  • Percentage with diabetes: 33%
  • Percentage with acute coronary syndrome: 40%

Inclusion criteria:

  • Patients ≥18 years of age undergoing PCI
  • Reference vessel diameter 2.5-4.25 mm
  • Recent myocardial infarction (MI)
  • Chronic total occlusion
  • Bifurcation lesions
  • Calcified lesions
  • Bypass graft stenosis
  • Bare-metal in-stent restenosis

Exclusion criteria:

  • ST-segment elevation  MI within 24 hours
  • Left ventricular ejection fraction <30%
  • Acute stent thrombosis
  • Renal dysfunction (creatinine clearance <30 ml/min)
  • Prior PCI within 12 months

Principal Findings:

The primary outcome, incidence of target lesion failure at 12 months, occurred in 5.4% of the ridaforolimus-eluting stent group versus 5.4% of the zotarolimus-eluting stent group (p for noninferiority = 0.001).

Secondary outcomes:

  • Death: 1.2% vs. 1.0% (p = 0.82); respectively, for ridaforolimus vs. zotarolimus
  • Definite/probable stent thrombosis: 0.4% vs. 0.6% (p = 0.53); respectively, for ridaforolimus vs. zotarolimus

Interpretation:

Among patients undergoing PCI, the novel ridaforolimus-eluting stent was noninferior to the zotarolimus-eluting stent. The ridaforolimus-eluting stent was associated with a similar incidence of target vessel failure compared with the zotarolimus-eluting stent. Mortality and stent thrombosis were also similar between treatment arms. Further study of the ridaforolimus-eluting stent is warranted.

References:

Kandzari DE, Smits PC, Love MP, et al. Randomized Comparison of Ridaforolimus-Eluting and Zotarolimus-Eluting Coronary Stents in Patients With Coronary Artery Disease: Primary Results From the BIONICS Trial. Circulation 2017;Aug 9:[Epub ahead of print].

Keywords: Acute Coronary Syndrome, Constriction, Pathologic, Coronary Artery Disease, Drug-Eluting Stents, Myocardial Infarction, Percutaneous Coronary Intervention, Platelet Aggregation Inhibitors, Secondary Prevention, Sirolimus, Stents, Thrombosis


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