Paclitaxel-Coated Balloon vs Uncoated Balloon for Coronary In-Stent Restenosis: The AGENT IDE Randomized Clinical...

Area of Science:

• Cardiovascular Medicine
• Interventional Cardiology
• Medical Devices

Background:

• Drug-coated balloons (DCBs) present a potential treatment for coronary in-stent restenosis.
• No DCBs were previously approved for coronary use in the United States.

Purpose of the Study:

• To assess the superiority of a paclitaxel-coated balloon versus an uncoated balloon in patients with in-stent restenosis undergoing percutaneous coronary intervention.

Main Methods:

• The AGENT IDE trial randomized 600 patients with in-stent restenosis to receive either a paclitaxel-coated balloon (n=406) or an uncoated balloon (n=194).
• The primary endpoint was target lesion failure at one year, defined as a composite of ischemia-driven target lesion revascularization, target vessel-related myocardial infarction, or cardiac death.

Main Results:

• At one year, target lesion failure occurred in 17.9% of the paclitaxel-coated balloon group versus 28.6% in the uncoated balloon group (Hazard Ratio [HR], 0.59; P=.003), demonstrating superiority.
• Paclitaxel-coated balloon use was associated with significantly lower rates of target lesion revascularization (13.0% vs 24.7%; P=.001) and target vessel-related myocardial infarction (5.8% vs 11.1%; P=.02).

Conclusions:

• A paclitaxel-coated balloon is superior to an uncoated balloon for managing coronary in-stent restenosis.
• Paclitaxel-coated balloons represent an effective treatment strategy for patients with coronary in-stent restenosis.