A Clinical Trial to Assess the Agent Paclitaxel Coated PTCA Balloon Catheter for the Treatment of Subjects With In-Stent Restenosis - AGENT IDE

Contribution To Literature:

Highlighted text has been updated as of March 20, 2024.

The AGENT IDE trial showed that the Agent DCB is superior to conventional balloon angioplasty in reducing target lesion failure for the treatment of coronary ISR.


The goal of the trial was to assess the safety and efficacy of a paclitaxel-coated balloon (drug-coated balloon; DCB) to conventional balloon angioplasty among patients with coronary in-stent restenosis (ISR).

Study Design

Eligible patients were randomized in a 2:1 fashion to either DCB (n = 406) or balloon angioplasty (n = 194).

  • Total number of enrollees: 600
  • Duration of follow-up: 12 months
  • Mean patient age: 68 years
  • Percentage female: 27%

Inclusion criteria:

  • Patients with ISR of a lesion previously treated with bare-metal stent or drug-eluting stent (DES)
  • Lesion length <26 mm
  • Reference vessel diameter >2.0 to ≤4.0 mm, and % diameter stenosis (DS) >70 to <100% (asymptomatic) or % DS >50 to <100% (symptomatic)

Exclusion criteria:

  • Recent ST-segment elevation myocardial infarction; bifurcation, left main, saphenous vein graft, or arterial graft; thrombus in target vessel
  • Ejection fraction <25%

Other salient features/characteristics:

  • Prior coronary artery bypass grafting: 30%
  • Multivessel disease: 78%
  • Single stent layer: 56%
  • Lesion length: 12 mm, reference vessel diameter: 2.7 mm
  • Use of intravascular imaging: 74%
  • Total occlusion: 1%

Principal Findings:

The primary outcome, target lesion failure at 1 year, for DCB vs. balloon angioplasty, was: 17.9% vs. 28.7% (hazard ratio 0.59, 95% confidence interval 0.42-0.84,  (p for superiority = 0.003).

Secondary outcomes for DCB vs. balloon angioplasty:

  • Cumulative target lesion revascularization: 13.0% vs. 24.7% (p = 0.001)
  • Target vessel myocardial infarction (MI): 5.8% vs. 11.1% (p = 0.02)
  • Definite/probable stent thrombosis: 0% vs. 3.2% (p < 0.001)
  • All-cause mortality: 4.1% vs. 3.7% (p = 0.85)


The results of this trial indicate that the Agent DCB is superior to conventional balloon angioplasty in reducing target lesion failure at 12 months for the treatment of coronary ISR (44% were due to multiple stent layers). Reductions were noted in the need for repeat revascularization, target vessel MI, and stent thrombosis.

This is an important study and resulted in recent FDA approval for use in the United States. The DCB studied in this trial, Agent, has a lower dose of paclitaxel (2 mcg/mm2) compared with others such as SeQuent Please (3 mcg/mm2). One limitation of this trial was the absence of a DES arm, which could be the preferred modality for patients with ISR with one layer of stent; a subsequent head-to-head comparison will be important.


Yeh RW, Shlofmitz R, Moses J, et al. Paclitaxel-Coated Balloon vs Uncoated Balloon for Coronary In-Stent Restenosis: The AGENT IDE Randomized Clinical Trial. JAMA 2024;Mar 9:[Epub ahead of print].

Editorial Comment: Kundu A, Moliterno DJ. Drug-Coated Balloons for In-Stent Restenosis—Finally Leaving Nothing Behind for US Patients. JAMA 2024;Mar 9:[Epub ahead of print].

Presented by Dr. Robert W. Yeh at the Transcatheter Cardiovascular Therapeutics meeting (TCT 2023), San Francisco, CA, October 25, 2023.

Clinical Topics: Invasive Cardiovascular Angiography and Intervention, Acute Coronary Syndromes

Keywords: Coronary Artery Stenosis, Percutaneous Coronary Intervention, TCT23

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