The United States has been way behind other nations in using drug-coated balloons (DCB) to treat coronary in-stent restenosis (ISR), but that might change soon thanks to the results from the AGENT IDE Trial.
- Although drug-eluting stents have been used for years, a significant number of stents still experience reblockage, and US clinicians have been limited to less-effective ISR treatments like repeat balloon angioplasty.
- Boston Scientific’s AGENT DCB is a paclitaxel-coated balloon catheter, designed to re-open ISR vessels and then transfer the drug to the vessel wall to help prevent ISR reoccurrence.
- AGENT DCB already has regulatory approval in Europe and Japan, and has been used to treat 100k global patients, but it hasn’t gained FDA approval (yet).
A packed TCT 2023 assembly hall greeted the AGENT IDE Trial results with applause, after showing perhaps the strongest evidence yet that DCBs are safe, effective, and superior to balloon angioplasty.
The study included 480 patients with ISR from 40 sites (44% w/ multiple stent layers, 51% diabetic), and showed that after one year Boston Scientific’s AGENT DCB was far superior to balloon angioplasty for…
- Target lesion failure (17.9% vs. 28.7%, the primary endpoint)
- Target lesion revascularization (12.4% vs. 24.0%)
- Target vessel myocardial infarction (6.4% vs 12.3%)
- Stent thrombosis (0.0% vs. 3.9%)
Those results were enough for the study presenter, discussion participants, and online commenters to widely support AGENT DCB as a primary option for ISR in the US.
Although some questioned why AGENT DCB wasn’t compared against drug-eluting stents, the study authors decided against adding a third or fourth stent to these patients, and believed AGENT DCB would show similar advantages versus an additional DES.
The Takeaway
Based on reactions from the TCT audience and social media, it seems like these were the results that interventional cardiologists have been hoping for (and largely expecting), suggesting that AGENT DCB should become a go-to ISR treatment in the US once it gains FDA approval.
