Drug-coated balloons for small coronary artery disease in patients with chronic kidney disease: a pre-specified analysis of the BASKET-SMALL 2 trial

Abstract

Background Data on the safety and efcacy of drug-coated balloon (DCB) compared to drug-eluting stent (DES) in patients with chronic kidney disease (CKD) are scarce, particularly at long term. This pre-specifed analysis aimed to investigate the 3-year efcacy and safety of DCB versus DES for small coronary artery disease (<3 mm) according to renal function at baseline. Methods BASKET-SMALL-2 was a large multi-center, randomized, controlled trial that tested the efcacy and safety of DCBs (n=382) against DESs (n=376) in small vessel disease. CKD was defned as eGFR<60 ml/min/1.73m2 . The primary endpoint was the composite of cardiac death, non-fatal myocardial infarction, and target vessel revascularization (MACE) during 3 years. Results A total of 174/758 (23%) patients had CKD, out of which 91 were randomized to DCB and 83 to DES implantation. The primary efcacy outcome during 3 years was similar in both, DCB and DES patients (HR 0.98; 95%-CI 0.67–1.44; p=0.937) and patients with and without CKD (HR 1.18; 95%-CI 0.76–1.83; p=0.462), respectively. Rates of cardiac death and all-cause death were signifcantly higher among patients with CKD but not afected by treatment with DCB or DES. Major bleeding events were lower in the DCB when compared to the DES group (12 vs. 3, HR 0.26; 95%-CI 0.07–0.92; p=0.037) and not infuenced by presence of CKD. Conclusions The long-term efcacy and safety of DCB was similar in patients with and without CKD. The use of DCB was associated with signifcantly fewer major bleeding events (NCT 01574534).