Why is the study important?

• The AGENT drug-coated balloon (DCB) is designed to deliver paclitaxel directly to the diseased artery without the use of a permanent metal implant.
• AGENT IDE is the first randomized controlled trial (RCT) conducted in the US examining the efficacy and safety of DCB in patients with coronary in-stent restenosis (ISR).
• Based on primary data from this trial, the AGENT device was approved by the FDA for use in ISR patients.

What question was the study supposed to answer?

• AGENT IDE is a multicenter, randomized controlled trial comparing the safety and efficacy of the AGENT DCB versus balloon angioplasty in patients with ISR.
• Patients presenting with ISR in a previously stented lesion of length <26 mm and reference vessel diameter (RVD) >2.0 to ≤4.0 mm were randomly assigned in a 2:1 ratio to receive treatment with AGENT (N=406) or an uncoated balloon (N=194) following successful lesion preparation.
• Key clinical exclusion criteria were recent ST-elevation or Q-wave myocardial infarction, left ventricular ejection fraction <25%, and chronic kidney disease. Angiographic exclusion included unprotected left main stenosis (>50%), target lesion in a graft, and thrombus in the target vessel.
• The primary endpoint was target lesion failure (TLF), defined as the composite occurrence of target lesion revascularization, target vessel-related myocardial infarction (MI), or cardiac death.

What did the study show?

• AGENT DCB was superior to conventional balloon angioplasty for 1-year target lesion failure (18.2% vs. 29.0%; p=0.0025), meeting the primary endpoint.
• Results were consistent through 3 years of follow-up after treatment with AGENT DCB compared with balloon angioplasty:
  • 28% reduction in TLF, with 35% reduction in first TLR and 42% reduction in first TV-MI
  • Recurrent TLR analysis: More repeat events per patient with BA, including multiple TLRs
  • One definite/probable ST with AGENT vs 7 in the BA arm (0.3% vs. 3.8%; p=0.001)
• These data support the use of AGENT DCB for the treatment of coronary ISR.