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Randomized Controlled Trial
. 2022 Jul;111(7):806-815.
doi: 10.1007/s00392-022-01995-3. Epub 2022 Feb 27.

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

Felix Mahfoud  1 , Ahmed Farah  2 , Marc-Alexander Ohlow  3 , Norman Mangner  4 , Jochen Wöhrle  5 , Sven Möbius-Winkler  6 , Daniel Weilenmann  7 , Gregor Leibundgut  8 , Florim Cuculi  9 , Nicole Gilgen  10 , Christoph Kaiser  10 , Marco Cattaneo  10 , Bruno Scheller  11 , Raban V Jeger  10
Affiliations
Randomized Controlled Trial

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

Felix Mahfoud et al. Clin Res Cardiol. 2022 Jul.

Abstract

Background: 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, 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.

Methods: BASKET-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.

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 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.

Conclusions: The 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 (NCT01574534). 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.

Keywords: Drug-coated balloon; Renal insufficiency; Revascularization strategies.

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Conflict of interest statement

FM is supported by Deutsche Gesellschaft für Kardiologie (DGK), and Deutsche Forschungsgemeinschaft (SFB TRR219) and has received scientific support and speaker honoraria from Astra-Zeneca, Bayer, Boehringer Ingelheim, Medtronic, Merck and ReCor Medical. NM reports personal fees from Edwards Lifesciences, Medtronic, Biotronik, Novartis, Sanofi Genzyme, AstraZeneca, Pfizer, Bayer, Abbott, Abiomed, and Boston Scientific outside the submitted work. BS is a shareholder of InnoRa GmbH and was named as co-inventor on patent applications submitted by Charité University Hospital, Berlin, Germany. RVJ received research support from B.Braun Melsungen AG, and received honoraria and consultation fees from B. Braun Melsungen AG, Cardionovum and Nipro.

Figures

None
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
Fig. 1
Fig. 1
Kaplan–Meier estimates of the cumulative probabilities of MACE during 3 years in the four combinations of subgroups and study arms
Fig. 2
Fig. 2
Kaplan–Meier estimates of the cumulative probabilities of major bleeding during 3 years in the four combinations of subgroups and study arms
See this image and copyright information in PMC

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