{"id":"321f0d912f87","type":"article","url":"https://hartvaat.nl/2018/09/08/drug-coated-balloons-bij-kleine-coronairarterien-lancet-basket-small-2/","title":"Drug-coated balloons bij kleine coronairarteriën: Lancet BASKET-SMALL 2","title_en":"Drug-coated balloons for small coronary artery disease (BASKET-SMALL 2): an open-label randomised non-inferiority trial.","category":"algemeen","category_label":"Algemeen","professions":["cardioloog"],"tags":[],"journal":"Lancet (London, England)","doi":"10.1016/S0140-6736(18)31719-7","source_url":"https://doi.org/10.1016/S0140-6736(18)31719-7","authors":["Raban V Jeger","Ahmed Farah","Marc-Alexander Ohlow","Norman Mangner","Sven Möbius-Winkler","Gregor Leibundgut","Daniel Weilenmann","Jochen Wöhrle","Stefan Richter","Matthias Schreiber","Felix Mahfoud","Axel Linke","Frank-Peter Stephan","Christian Mueller","Peter Rickenbacher","Michael Coslovsky","Nicole Gilgen","Stefan Osswald","Christoph Kaiser","Bruno Scheller"],"significance":7,"published":"2018-09-08","source_date":"2018-09-08","image":"","kennis":[],"congress":"","summary_en":"The BASKET-SMALL 2 trial demonstrated that drug-coated balloons are noninferior to drug-eluting stents for treating small coronary arteries, establishing a leave-nothing-behind strategy as a viable option in small vessel disease.","created":"2026-07-03T10:27:28Z","updated":"2026-07-03T13:26:43Z","licence":"Citeer vrij, met bronvermelding en een link naar hartvaat.nl (de url van het record). Samenvattingen zijn redactioneel werk van HartVaat; de oorspronkelijke publicaties blijven van hun uitgevers (doi). Geen medisch advies.","body_markdown":"Lancet BASKET-SMALL 2 non-inferioriteitstrial die drug-coated balloons vergeleek met drug-eluting stents bij kleine coronairarteriën. Stentloos alternatief.","abstract_original":"BACKGROUND: Drug-coated balloons (DCB) are a novel therapeutic strategy for small native coronary artery disease. However, their safety and efficacy is poorly defined in comparison with drug-eluting stents (DES). METHODS: BASKET-SMALL 2 was a multicentre, open-label, randomised non-inferiority trial. 758 patients with de-novo lesions (<3 mm in diameter) in coronary vessels and an indication for percutaneous coronary intervention were randomly allocated (1:1) to receive angioplasty with DCB versus implantation of a second-generation DES after successful predilatation via an interactive internet-based response system. Dual antiplatelet therapy was given according to current guidelines. The primary objective was to show non-inferiority of DCB versus DES regarding major adverse cardiac events (MACE; ie, cardiac death, non-fatal myocardial infarction, and target-vessel revascularisation) after 12 months. The non-inferiority margin was an absolute difference of 4% in MACE. This trial is registered with ClinicalTrials.gov, number NCT01574534. FINDINGS: Between April 10, 2012, and February 1, 2017, 382 patients were randomly assigned to the DCB group and 376 to DES group. Non-inferiority of DCB versus DES was shown because the 95% CI of the absolute difference in MACE in the per-protocol population was below the predefined margin (-3·83 to 3·93%, p=0·0217). After 12 months, the proportions of MACE were similar in both groups of the full-analysis population (MACE was 7·5% for the DCB group vs 7·3% for the DES group; hazard ratio [HR] 0·97 [95% CI 0·58-1·64], p=0·9180). There were five (1·3%) cardiac-related deaths in the DES group and 12 (3·1%) in the DCB group (full analysis population). Probable or definite stent thrombosis (three [0·8%] in the DCB group vs four [1·1%] in the DES group; HR 0·73 [0·16-3·26]) and major bleeding (four [1·1%] in the DCB group vs nine [2·4%] in the DES group; HR 0·45 [0·14-1·46]) were the most common adverse events. INTERPRETATION: In small native coronary artery disease, DCB was non-inferior to DES regarding MACE up to 12 months, with similar event rates for both treatment groups. FUNDING: Schweizerischer Nationalfonds zur Förderung der Wissenschaftlichen Forschung, Basel Cardiovascular Research Foundation, and B Braun Medical AG."}