Weekly Journal Scan: Drug-coated balloon for the treatment of in-stent restenosis - the AGENT IDE trial

The AGENT IDE (A Clinical Trial to Assess the Agent Paclitaxel Coated PTCA Balloon Catheter for the Treatment of Subjects With In-Stent Restenosis) is an industry-funded, multi-centre, single-blind, superiority, randomized controlled trial (RCT), aimed at comparing percutaneous coronary intervention (PCI) with the AGENT paclitaxel-coated balloon vs. an uncoated balloon in patients with coronary in-stent restenosis. 1 • A total of 600 patients (mean age, 68 years; 26% female) with in-stent restenosis were enrolled at 40 sites in the USA between May 2021 and August 2022, and randomized, in a 2:1 fashion, to undergo PCI with a paclitaxel-coated (n = 406) or an uncoated balloon (n = 194) after successful pre-dilation of the target stenosis.In-stent restenosis was defined as stenosis of less than 100% but greater than 50% in symptomatic patients, or greater than 70%, in asymptomatic patients, with visually estimated reference vessel diameter greater than 2.0 to up to 4.0 mm, and a lesion length less than 26 mm.Only one target lesion was eligible for randomization for each patient.Successful pre-dilation was defined as no residual stenosis greater than 50% (after dilation with a balloon, or pre-treatment with rotational coronary atherectomy, laser, or cutting/scoring balloon).Operators were not blinded due to the different packaging of the balloons.Exclusion criteria included left main disease, graft disease, thrombus in the target vessel, recent ST-elevation or Q-wave myocardial infarction (MI), and left ventricular ejection fraction less than 25%.• The primary endpoint was the 1-year rate of target lesion failure, defined as the composite of ischaemia-driven target-lesion revascularization, target vessel-related MI or cardiac death.Additional pre-specified endpoints included the individual components of the primary endpoint and all-cause death.• The indication for the procedure was stable angina in 53% of patients, with a balanced distribution of the target vessels (37% right coronary artery, 35% left anterior descending artery, 24% left circumflex artery, and 4% left main coronary artery).The mean reference vessel diameter was 2.7 mm and was similar in the two groups, and the mean lesion length was 12.8 and 11.8 mm in the paclitaxel-coated balloon and uncoated balloon groups, respectively.Intravascular imaging was performed in 74% of cases, 43% of patients had multiple-layer in-stent restenosis, and 1% had total occlusion.• The primary outcome occurred in 71 patients (18%) in the paclitaxel-coated balloon group and 54 patients (29%) in the uncoated balloon group [hazard ratio (HR), 0.59; 95% confidence interval (CI), 0.42-0.84;P = .003).Patients undergoing PCI with paclitaxel-coated balloon experienced less frequent target lesion revascularization (13% vs. 25%; HR, 0.50; 95% CI, 0.34-0.74;P = .001)and target vessel-related MI (6% vs. 11%; HR, 0.51; 95% CI, 0.28-0.92;P = .02).Cardiac death was non-significantly higher in the paclitaxel-coated balloon group than in the uncoated balloon group (2.9% vs. 1.6%;HR 1.75; 95% CI, 0.49-6.28;P = .38).The results of the primary endpoint were consistent across pre-specified subgroups.