Primary Outcomes of a Pivotal Multicenter Randomized Trial Comparing the AGENT Paclitaxel-Coated Balloon With Conventional Balloon Angioplasty for In-Stent Restenosis—Coverage of TCT 2023 | SCAI

Why is this study important? 

  • Despite advances in coronary stent technology, the incidence of coronary artery in-stent restenosis (ISR) remains significant (about 10% of all PCI’s performed). 
  • Traditionally, ISR is treated by conventional balloon angioplasty using compliant, non-compliant, or cutting balloons, laser therapy, and/or implanting an additional layer of drug-coated stent. 
  • Drug-coated balloons (DCBs) are angioplasty balloons that can deliver drugs that inhibit growth of tissue and prevent ISR without leaving additional layers of metal behind. 
  • The US Food and Drug Administration has not yet approved the use of coronary DCB’s in the US. 

What question was this study supposed to answer? 

  • AGENT IDE is a prospective, randomized, multicenter, superiority trial comparing the safety and efficacy of the AGENT DCB to conventional balloon angioplasty in patients with ISR. 

What did the study show? 

  • The trial was conducted across 40 US sites, enrolling 480 patients (mean age of 68 years) with ISR. 
  • A 2:1 randomization was performed after successful pre-dilation of target lesion ISR. 
  • Primary endpoint was target lesion failure at 1 year (a composite of recurrent ISR, Myocardial Infarction involving the treated vessel, or Cardiac Death). 
  • AGENT DCB demonstrated superior primary outcome as compared to conventional balloon angioplasty (target lesion failure of 17.9% with AGENT-treated patients vs. 28.7% in controls, P=0.0063). 
  • There was no stent thrombosis seen in the AGENT DCB arm as compared to the control arm, which had six stent thrombosis events following conventional balloon angioplasty(P=0.001). 


  • In summary, the AGENT IDE trial shows that the use of AGENT drug-coated balloon angioplasty is safe and is clinically superior to conventional balloon angioplasty in treatment of coronary artery In-Stent Restenosis (ISR). 

All authors: Sanjeev Nair, MD, FSCAI

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