Full Results Following FDA Approval of AGENT Drug-Coated Balloon

The first coronary drug-coated balloon (DCB) has been approved by the U.S Food and Drug Administration (FDA) for the treatment of coronary in-stent restenosis following initial results of the AGENT IDE trial. 

The AGENT Drug-Coated Balloon ™ (Boston Scientific ™)  is used during percutaneous coronary intervention (PCI) to prevent the recurrence of in-stent restenosis (ISR). 

In October 2023, the initial findings from a prespecified interim analysis of the first 480 patients enrolled in the AGENT trial were released. The results from the full study were released on March 9th at the Cardiovascular Research Technologies (CRT) conference 2024 with simultaneous full publication in JAMA.



  • AGENT IDE was a prospective, randomized multicenter trial that aimed to assess the safety and effectiveness of the AGENT paclitaxel-coated balloon ™ to plain-old balloon angioplasty (POBA) in a cohort of patients with in-stent restenosis (ISR) P600 patients across 40 US centers were enrolled in the study and were randomized in a 2:1 fashion.
  • The primary outcomes were a composite endpoint of target lesion failure at one year, which was a combination of ischemia-driven target vessel revascularisation, target vessel myocardial infarction or cardiac death. 
  • Previously treated lesions of up to 26mm in length in a native coronary artery 2.0mm to 4.0 mm in diameter were evaluated.



  • Amongst the 600 patients enrolled in the trial, 574 completed the 1-year follow-up.
  • The primary endpoint at one year occurred in 17.9% of the paclitaxel-coated AGENT ™ DCB as compared to 28.6% in the POBA group. This met the criteria for superiority (HR 0.59 [95% CI, 0.42-0.84]; 2-sided P=0.001). 
  • Target lesion revascularization (13.0% vs 24.7%; HR, 0.50 [95% CI, 0.34-0.74]; P = 0.001)  and target-vessel-related myocardial infarction (5.8% vs 11.1%; HR, 0.51 [95% CI, 0.28-0.92]; P = 0.02) happened less frequently in the patients treated with the AGENT ™ DCB. 
  • Cardiac death rates were 2.9% as compared to 1.6% (HR, 1.75 [95% CI, 0.49-6.28]; P = .38) in the coated vs uncoated balloon groups. 
  • Overall, procedural success rate (92.1% for DCB compared to 88.7% for POBA) and technical success rates (93.4% for DCB compared to 89.7% for POBA) were similar. 


On March 1st 2024, the FDA announced its approval of the AGENT drug-coated balloon for the treatment of coronary in-stent restenosis (ISR) in patients with coronary artery disease. 

Discussing the next steps of the AGENT study in October 2023, principal investigator, Dr Robert Yeh commented on the future of the AGENT DCB; “Well, I think the real take-home message is that we now have a device, […] which will be able to be an excellent alternative to placement of an additional drug-eluting balloon. […] In the United States, this trial enrolled much faster than anticipated. That's rare even during a post-COVID period where we were enrolling patients so quickly. And that reflects really the enthusiasm and the clinical need for a device for practitioners in the United States who have not had a coronary eluting balloon at their disposal”.

The AGENT DCB is available in Europe, parts of the Asia Pacific region and Latin America for the treatment of patients with ISR and untreated small vessel disease. The technology is planned for release in the U.S. in the coming months. 



Yeh, R, Shlofmitz, R, Moses, J, Et Al. Paclitaxel-Coated Balloon vs Uncoated Balloon for Coronary In-Stent Restenosis: The AGENT IDE Randomized Clinical Trial. JAMA. Published Online March 9, 2024. https://jamanetwork.com/journals/jama/fullarticle/2816073 [Accessed 19th March 2024.]

Yeh, R, TCT 23: AGENT IDE: AGENT Paclitaxel Coated Balloon Angioplasty for In-Stent Restenosis, Radcliffe Cardiology, 2023. https://www.icrjournal.com/video-index/tct-23-agent-ide-agent-paclitaxel-coated-balloon-angioplasty-stent-restenosis [Accessed 19th March, 2024]

A Clinical Trial to Assess the Agent Paclitaxel Coated PTCA Balloon Catheter for the Treatment of Subjects With In-Stent Restenosis (ISR) (AGENT IDE). ClinicalTrials.gov. https://clinicaltrials.gov/study/NCT04647253 [Accessed 19th March, 2024].