Efficacy and safety of drug-coated balloons according to coronary vessel size. A report from the BASKET-SMALL 2 trial
Ahmed Farah, Mohammed Elgarhy, Marc‐Alexander Ohlow, Jochen Wöhrle, Norman Mangner, Sven Möbius‐Winkler, Marco Cattaneo, Nicole Gilgen, Bruno Scheller, Raban Jeger
Abstract
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: = 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.