Jinnette Dawn Abbott

BACKGROUND: 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. REGISTRATION: URL: https://www.clinicaltrials.gov ; Unique identifier: NCT04647253.

BACKGROUND: Drug-coated balloons (DCB) are superior to conventional balloon angioplasty in coronary in-stent restenosis. The influence of chronic kidney disease (CKD) on outcomes after DCB for in-stent restenosis is not well described. METHODS: A post hoc analysis of the AGENT IDE trial was performed to compare the efficacy and safety of DCB versus balloon angioplasty in patients with CKD (estimated glomerular filtration rate 2 ) and those without renal impairment. The primary outcome was target lesion failure, a composite of ischemia-driven target lesion revascularization (TLR), target vessel myocardial infarction, or cardiac death. The 2 cohorts were compared using time-to-first-event and recurrent event methods through 2 years. RESULTS: Of the 406 patients randomized to DCB, 149 (25%) had CKD (mean estimated glomerular filtration rate 47.3±9.2). They were older and had greater multivessel disease and congestive heart failure than those without CKD. There were no differences in clinical presentation, Mehran in-stent restenosis patterns or technical success. The effect of DCB versus balloon angioplasty on 2-year target lesion failure was similar in patients with CKD (23.6% versus 30.0%; hazard ratio, 0.70 [95% CI, 0.35–1.39]) compared with those without CKD (28.1% versus 34.9%; hazard ratio, 0.74 [95% CI, 0.52–1.05]; P _Int =0.90). Similarly, the effect of DCB on outcomes in the recurrent events analysis was not influenced by baseline renal function. CONCLUSIONS: Among patients undergoing intervention for in-stent restenosis, the benefit of DCB versus balloon angioplasty was consistent irrespective of baseline CKD status. Baseline renal function also did not influence outcomes in the recurrent event analysis. REGISTRATION: URL: https://www.clinicaltrials.gov ; Unique identifier: NCT04647253.