Abstract
BackgroundData on the safety and efficacy 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-specified analysis aimed to investigate the 3-year efficacy and safety of DCB versus DES for small coronary artery disease (< 3 mm) according to renal function at baseline.MethodsBASKET-SMALL-2 was a large multi-center, randomized, controlled trial that tested the efficacy and safety of DCBs (n = 382) against DESs (n = 376) in small vessel disease. CKD was defined 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.ResultsA total of 174/758 (23%) patients had CKD, out of which 91 were randomized to DCB and 83 to DES implantation. The primary efficacy 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 significantly higher among patients with CKD but not affected 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 influenced by presence of CKD.ConclusionsThe long-term efficacy and safety of DCB was similar in patients with and without CKD. The use of DCB was associated with significantly fewer major bleeding events (NCT 01574534).Graphical Central Illustration. Drug-coated balloon versus drug-eluting stents in small coronary artery disease with and without chronic kidney disease, a prespecified subgroup analysis of the BASKET-SMALL 2 trial
Highlights
Chronic kidney disease (CKD) and coronary artery disease (CAD) frequently coexist [1]
The present pre-specified subgroup analysis aimed at investigating the long-term efficacy and safety of drug-coated balloon (DCB) versus drug-eluting stent (DES) for small coronary artery disease using the dataset of a large, randomized trial according to renal function at baseline
174 (23%) patients had an estimated GFR at baseline < 60 ml/min/1.73m2, and 584 (77%) had an eGFR > 60 ml/min/1.73m2. For those with an impaired eGFR, baseline characteristics differed from patients with a normal renal function, including older age, higher body mass index, and a greater prevalence of hypercholesterolemia, hypertension, diabetes, heart failure, and stroke/TIA, but the rates of prior MI were similar
Summary
Chronic kidney disease (CKD) and coronary artery disease (CAD) frequently coexist [1]. The present pre-specified subgroup analysis aimed at investigating the long-term efficacy and safety of DCB versus DES for small coronary artery disease using the dataset of a large, randomized trial according to renal function at baseline. Data on the safety and efficacy of drug-coated balloon (DCB) compared to drug-eluting stent (DES) in patients with chronic kidney disease (CKD) are scarce, at long term. This pre-specified analysis aimed to investigate the 3-year efficacy and safety of DCB versus DES for small coronary artery disease (< 3 mm) according to renal function at baseline. The use of DCB was associated with significantly fewer major bleeding events (NCT 01574534)
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