Polymer-free biolimus-A9-eluting stent performance according to renal impairment: insights from the RUDI-FREE registry.

Abstract

AIMS\nPatients with chronic kidney disease (CKD) are at increased risk of cardiovascular disease and have a worse prognosis after percutaneous coronary interventions (PCI). The BioFreedom polymer-free biolimus-A9-eluting stent (PF-BES) has shown promising results in patients at high bleeding risk; however, its performance in CKD patients has yet to be analyzed.\n\n\nMETHODS\nThe all-comers RUDI-FREE registry documented patients undergoing PCI with PF-BES in routine clinical practice. Patients were stratified into three groups according to their estimated glomerular filtration rate (eGFR): preserved renal function, mild renal insufficiency (RI), and with moderate to severe RI (eGFR ≥ 90, between 90 and 45, and <45\u200aml/min/1.73\u200am2, respectively). The primary safety end point was a patient-oriented composite end point of cardiovascular death, myocardial infarction (MI), and definite or probable stent thrombosis (ST). The primary efficacy end point was target lesion revascularization (TLR).\n\n\nRESULTS\nThe registry documented 1,104 consecutive patients treated with PF-BES: 258 (23.4%) with preserved renal function, whereas 712 (64.7%) and 131 (11.9%) had mild and moderate to severe RI, respectively. At 1\u200ayear, the primary safety end point was significantly higher in patients with moderate to severe RI (3.5% vs. 2.8% vs. 11.5%; P\u200a<\u200a0.001). Conversely, TLR proved similar among groups (0.4% vs. 1.8% vs. 0.8%; P\u200a=\u200a0.235).\n\n\nCONCLUSIONS\nPatients with worse renal function had increased risk of the composite of cardiovascular deaths, MI, and definite or probable ST. However, the PF-BES showed similar efficacy despite differences in renal function. These findings need to be confirmed in large-scale randomized trials.