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). 

Conclusion: 

• 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