Efficacy and safety of drug-coated balloons according to coronary vessel size. A report from the BASKET-SMALL 2 trial

• Published in: Postępy w kardiologii interwencyjnej 2022-01, Vol.18 (2), p.122-130
• Main Authors: Farah, Ahmed, Elgarhy, Mohamed, Ohlow, Marc-Alexander, Wohrle, Jochen, Mangner, Norman, Möbius-Winkler, Sven, Cattaneo, Marco, Gilgen, Nicole, Scheller, Bruno, Jeger, Raban
• Format: Article
• Language: English
• Subjects: Coronary vessels; drug-coated balloon; drug-eluting stent; Heart attacks; Original Paper; paclitaxel; small vessel disease; Stents; Veins & arteries; vessel size
• ISSN: 1734-9338; 1897-4295
• DOI: 10.5114/aic.2022.118528

Introduction In BASKET-SMALL 2, drug-coated balloons (DCB) were non-inferior to drug-eluting stents (DES) in de-novo stenosis of small coronary vessels (≤ 2.75 mm) regarding clinical endpoints up to 36 months. Aim: In the present subgroup analysis, we aimed to analyze the effect of the two treatment strategies in different vessel sizes. Material and methods Patients were analyzed according to the size of the device used (small > 2.5 mm vs. very small ≤ 2.5 mm). The primary endpoint was major adverse cardiac events (MACE), while secondary endpoints were target vessel revascularization (TVR), non-fatal myocardial infarction, cardiac death, and all-cause mortality, all at 36 months. Interactions for the different groups were assessed with Cox regression analysis. Results Overall, 758 patients were enrolled in this analysis, of which 437 (58%) had very small vessel disease. There were similar results in both treatment groups for the primary endpoint in both small and very small vessels (DCB vs DES, MACE at 3 years in small vessels HR = 1.31, 95% CI: 0.74–2.32, p = 0.355, and very small vessels HR = 0.82, 95% CI: 0.49–1.39, p = 0.468). Second generation paclitaxel-eluting stents showed significantly higher rates for MACE (p = 0.041), TVR (p = 0.004) and non-fatal myocardial infarction (p = 0.036) compared to DCB in very small coronary arteries at 3 years, while results were similar in small coronary arteries. Conclusions Efficacy and safety of DCB are similar irrespective of vessel size. However, there is a beneficial effect of DCB over paclitaxel-eluting stents regarding TVR, non-fatal myocardial infarction and MACE that is most pronounced in very small coronary arteries.