AGENT ISR is the first DCB study to randomize 1:1 two different drug formulations.
The AGENT In-Stent Restenosis study compares the novel AGENT DCB to the commercially-available SeQuent® Please DCB. This is the first head-to-head clinical study of two DCBs with different drug formulations
- AGENT Drug-Coated Balloon met its primary endpoint of non-inferiority of in-stent late loss compared to the SeQuent Please DCB.
- At six months the AGENT DCB showed lower event rates and 25% lower TLF (6.2% vs. 8.3%).
- In addition, the AGENT DCB was numerically better in all clinical endpoints including TVF and ST.