Postępy w Kardiologii Interwencyjnej

Abstract

2/2022 vol. 18
Original paper

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

Ahmed Farah 1
,
Mohamed Elgarhy 2
,
Marc-Alexander Ohlow 3
,
Jochen Wohrle 4
,
Norman Mangner 5
,
Sven Möbius-Winkler 6
,
Marco Cattaneo 7
,
Nicole Gilgen 7
,
Bruno Scheller 8
,
Raban Jeger 7, 9
  1. Knappschaftskrankenhaus, Westfalen-Clinic, Dortmund, Germany
  2. Central Hospital, Bad Berka, Germany
  3. SRH, Wald-Clinic, Gera, Germany
  4. Medical Campus Lake Constance, Friedrichshafen, Germany
  5. Herzzentrum Dresden, Technische Universität Dresden, Dresden, Germany
  6. University Hospital Jena, Jena, Germany
  7. University Hospital Basel, University of Basel, Basel, Switzerland
  8. University Hospital Saarland, Homburg, Germany
  9. Triemli Hospital Zürich, Switzerland
Adv Interv Cardiol 2022; 18, 2 (68): 122–130
DOI: https://doi.org/10.5114/aic.2022.118528
Online publish date: 2022/08/19
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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.

Keywords

small vessel disease, drug-coated balloon, drug-eluting stent, vessel size, paclitaxel

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