TCT-492 One-Year Clinical Outcomes After PCI With Agent Paclitaxel-Coated Balloon Among Underrepresented Racial and Ethnic Subgroups With In-Stent Restenosis: Analysis of the AGENT IDE Trial
Recommended Citation
Batchelor W, Kirtane A, Shlofmitz R, Moses J, Bachinsky W, Dohad S, Rudick S, Stoler R, Jefferson B, Nicholson W, Altman J, Bateman C, Krishnaswamy A, Alaswad K, Kimmelstiel C, Dixon W, Reitman A, Bhatt P, Song S, Yeh R. TCT-492 One-Year Clinical Outcomes After PCI With Agent Paclitaxel-Coated Balloon Among Underrepresented Racial and Ethnic Subgroups With In-Stent Restenosis: Analysis of the AGENT IDE Trial. J Am Coll Cardiol 2024; 84(18):B162.
Document Type
Conference Proceeding
Publication Date
10-29-2024
Publication Title
J Am Coll Cardiol
Abstract
Background: Minorities bear a higher risk of adverse ischemic events following coronary stenting. The efficacy of drug-coated balloon (DCB) angioplasty for in-stent restenosis (ISR) has not been studied in this underrepresented population. Methods: AGENT IDE is a prospective multicenter trial that randomized ISR patients (2:1) with reference vessel diameter [RVD] >2.0 to ≤4.0 mm and lesion length <26 mm to receive treatment with AGENT (n = 406) or conventional balloon angioplasty (BA; n = 194). A prespecified analysis comparing outcomes of underrepresented racial and ethnic minorities (non-White race/Hispanic ethnicity) with those of White patients was performed using Cox regression. Results: Mean age was 68 years and 27% of patients were women. A total of 148 patients from underrepresented minorities were available for analysis, including 15 Asian, 33 Hispanic or Latino, and 41 Black patients. More minority than White patients were diabetic (61% vs 48%; P = 0.006). Single and multiple layer ISR occurred in 57% and 43% patients, respectively. Angiographic core lab reported mean RVD was 2.7 mm in both groups, and lesion length was 12.4 mm vs 12.5 mm (P = 0.84). One-year outcomes are shown in Table 1. Compared with Whites, minority patients had similar restenosis rates and relative risk reductions in ischemic events with AGENT. TLR rates were significantly reduced with AGENT vs BA in minority patients (11.3% vs 26.7%; P = 0.01), consistent with results observed in White patients (P interaction = 0.38). There was no definite/probable ST with AGENT. Additional data on risk adjusted outcomes and interactions between race/ethnicity and treatment will be available at the time of presentation. [Formula presented] Conclusions: In the only DCB study evaluating underrepresented minorities, AGENT paclitaxel-coated balloon appeared safe and was associated with similar relative risk reductions in 1-year ischemic events vs BA as noted for White patients within the trial. Categories: CORONARY: Drug-Eluting Balloons and Local Drug Delivery.
Volume
84
Issue
18
First Page
B162
