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Drug-Coated Balloon

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Watch Drs. Robert Yeh and Ajay Kirtane discuss the AGENT IDE trial results, presented at TCT 2023.

Data from the first coronary drug-coated balloon (DCB) study in U.S. met the 1-year primary endpoint and demonstrated low adverse event rates. The AGENT IDE Clinical Trial showed that AGENT DCB is superior to conventional balloon angioplasty in reducing target lesion failure for the treatment of coronary in-stent restenosis (ISR).

CAUTION: Investigational Device. Limited by Federal (or US) law to investigational use only. Not available for sale.

AGENT IDE Clinical Trial

AGENT Investigational Device Exemption (IDE) is a prospective, multicenter, randomized controlled trial in the United States to evaluate the safety and effectiveness of the AGENT™ Drug-Coated Balloon compared to balloon angioplasty in patients with ISR.¹ 
AGENT IDE Study Design

Primary Endpoint²

AGENT DCB showed statistically superior outcomes compared to balloon angioplasty for TLF at 1-year. (17.9% versus 28.7%, P=0.0063). 
Primary Endpoint
The TLF relative risk reduction from using AGENT DCB was approximately 38%.

Additional Endpoints²

At 1-year, AGENT DCB also demonstrated statistically lower event rates:

  • 51% risk reduction in TLR (12.4% vs. 24.0%, P=0.002)
  • 49% risk reduction in TV-MI (6.4% vs 12.3%, P=0.03)
  • Zero definite/probable ST (0.0% vs. 3.9%, P=0.001)

Antiplatelet Therapy

DAPT with aspirin and a P2Y12 inhibitor was required for at least 1-month post-procedure. Antiplatelet monotherapy was continued thereafter for the entire duration of the study.