Influence of Chronic Kidney Disease on Outcomes After Paclitaxel-Coated Balloon Angioplasty for Coronary In-Stent Restenosis

Abstract

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 <60 mL/min per 1.73 m 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.