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

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 m2) 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]; PInt=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.