Predictors of Target Lesion Failure in Patients With In-Stent Restenosis: Insights From the AGENT IDE Trial
J. Dawn Abbott, Nicholas Kassis, Azeem Latib, Richard A. Shlofmitz, Jeffrey W. Moses, William B. Bachinsky, Suhail Dohad, Steven G. Rudick, Robert C. Stoler, Brian K. Jefferson, William J. Nicholson, John D. Altman, Cinthia T. Bateman, Amar Krishnaswamy, Rafael Cavalcante, Robert W. Yeh, Ajay J. KirtaneBACKGROUND:
Predictors of target lesion failure (TLF) after percutaneous coronary intervention with drug-coated balloon therapy in patients with in-stent restenosis, as opposed to de novo disease, are limited. This post hoc analysis of the AGENT IDE trial (Agent Paclitaxel-Coated PTCA Balloon Catheter for the Treatment of Subjects With In-Stent Restenosis) aimed to identify predictors of TLF in patients with in-stent restenosis treated with a paclitaxel-coated balloon.
METHODS:
Of the 600 patients with in-stent restenosis in the AGENT IDE trial, 406 were randomized to treatment with the paclitaxel-coated balloon. Among this cohort, demographic, clinical, and core laboratory angiographic data were assessed using a Cox proportional hazards model to identify independent predictors of TLF, defined as the composite occurrence of ischemia-driven target lesion revascularization, target vessel-related myocardial infarction, or cardiac death, at 2-year follow-up.
RESULTS:
Independent risk factors for 2-year TLF, which occurred in 106 (27.0%) of patients, included multiple stent layers (hazard ratio, 1.80 [95% CI, 1.23–2.65]), White race (hazard ratio, 1.71 [95% CI, 1.03–2.85]), and postlesion preparation in-lesion % diameter stenosis (per 10% increment; hazard ratio, 1.16 [95% CI, 1.03–1.31]). The presence of the target lesion in the left anterior descending artery was associated with a reduced risk of 2-year TLF (hazard ratio, 0.56 [95% CI, 0.36–0.87]).
CONCLUSIONS:
Our findings highlight the variable risk of in-stent restenosis governed by relatively few patient and lesion factors and underscore the significance of optimal lesion preparation before drug-coated balloon therapy as a potentially modifiable factor.
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