TCT-182 Impact of Lesion Preparation Strategy on the Efficacy of Paclitaxel Coated Balloon for Coronary In-stent Restenosis: A Subgroup Analysis of the AGENT IDE Randomized Trial
Recommended Citation
Mantha A, Krishnaswamy A, Grantham J, Zidar F, Tremmel J, Grines C, Ahmed M, Latib A, Tehrani B, Alaswad K, Kimmelstiel C, Cavalcante R, Yeh R, Kirtane A. TCT-182 Impact of Lesion Preparation Strategy on the Efficacy of Paclitaxel Coated Balloon for Coronary In-stent Restenosis: A Subgroup Analysis of the AGENT IDE Randomized Trial. J Am Coll Cardiol 2025; 86(17):B82-B83.
Document Type
Conference Proceeding
Publication Date
10-28-2025
Publication Title
J Am Coll Cardiol
Abstract
Background: Prior evidence suggests that complex lesion preparation (CLP) with scoring balloon and atherectomy before treatment with a drug-coated balloon (DCB) may offer potential clinical benefits. AGENT IDE trial demonstrated superiority of AGENT paclitaxel-coated balloon over balloon angioplasty (BA) for treating in-stent restenosis (ISR). This post-hoc analysis evaluates whether pre-treatment with CLP vs. typical balloons (TB) modified the ISR treatment effect. Methods: The study randomized 600 ISR patients in a 2:1 allocation to AGENT DCB or BA. Entry into the trial required successful lesion preparation defined angiographically as TIMI grade flow >2, with no greater than 50% residual stenosis and no dissection greater than National Heart, Lung, Blood Institute type C. Primary endpoint was 12-month target lesion failure (TLF) rate (composite of target lesion revascularization [TLR], myocardial infarction [MI], or cardiac death). Results: A total of 326 patients (54.3%) achieved successful lesion preparation using CLP (specialty balloon, atherectomy, or combination therapy) prior to randomization; 274 (45.7%) underwent pre-treatment with TB. Patient demographics, comorbidities and lesion characteristics were similar between CLP and TB groups. One-year outcomes are shown in the Table. The reduction in TLF with DCB vs. BA was consistent for patients treated with CLP tools (18.3% vs 32.6%, HR 0.53, 95% CI [0.33-0.84]) and those treated with TB (17.5% vs 24.3%, HR 0.68, 95% CI [0.39-1.18], interaction P = 0.48), driven by reduced TLR and target vessel MI. [Formula presented] Conclusion: Lesion optimization is critically important when treating patients with ISR. AGENT DCB is a more effective therapeutic option than conventional BA, irrespective of ISR lesion preparation strategies. Categories: CORONARY: Drug-Coated Balloons and Local Drug Delivery
Volume
86
Issue
17
First Page
B82
Last Page
B83
