Trial reportJournal of the American Heart Association2026
Paclitaxel-Coated Balloon for Treating In-Stent Restenosis in Racial and Ethnic Minority Patients: A Subanalysis From the AGENT IDE Trial.
Trial report in Journal of the American Heart Association, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04647253 (AGENT IDE), which is not on this map. Not yet cited in PubMed.
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
AGENT IDE: A Prospective, Randomized (2:1), Multicenter Trial to Assess the Safety and Effectiveness of the AgentTM Paclitaxel Coated PTCA Balloon Catheter for the Treatment of Subjects With In-Stent Restenosis (ISR)
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Authors and funding
19 authors.
Funding
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Abstract
backgroundRacial and ethnic minority patients have higher rates of adverse ischemic events following percutaneous coronary intervention. The impact of these disparities on the efficacy of drug-coated balloon (DCB) angioplasty for in-stent restenosis is unclear. We aimed to evaluate the comparative efficacy of DCB angioplasty among racial and ethnic minority patients presenting with in-stent restenosis.
methodsThis was a prespecified analysis of the AGENT IDE (A Clinical Trial to Assess the Agent Paclitaxel Coated PTCA [Percutaneous Transluminal Coronary Angioplasty] Balloon Catheter for the Treatment of Subjects With In-Stent Restenosis) trial which randomized patients with in-stent restenosis (2:1) to treatment with AGENT paclitaxel-coated balloon or conventional balloon angioplasty. The primary outcome was 1-year target lesion failure (composite of ischemia-driven target lesion revascularization, target vessel myocardial infarction, and cardiac death). Baseline clinical characteristics and outcomes were compared in minority patients versus non-Hispanic White patients and interaction terms used to determine if DCB efficacy was influenced by race or ethnicity.
resultsOf the 406 patients treated with DCB, 103 (25%) self-identified as minority patients (30.1% Black, 25.2% Hispanic/Latino, 8.7% Asian), and 303 (75%) as non-Hispanic White patients. Minority patients were younger (66 versus 69 years,
conclusionsIn this prespecified analysis of the AGENT IDE trial, 1-year outcomes following DCB angioplasty were comparable between minority and non-Hispanic White patients. Although wide CIs limited the exclusion of clinically meaningful differences in outcomes between these groups, the relative efficacy of DCB versus balloon angioplasty was consistent across race and ethnicity. Registration: ClinicalTrials.gov; Identifier: NCT04647253. URL: https://www.clinicaltrials.gov/study/NCT04647253.
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