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. 2022 Jun;18(2):122-130.
doi: 10.5114/aic.2022.118528. Epub 2022 Aug 19.

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
Affiliations

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

Ahmed Farah et al. Postepy Kardiol Interwencyjnej. 2022 Jun.

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: 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: drug-coated balloon; drug-eluting stent; paclitaxel; small vessel disease; vessel size.

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Conflict of interest statement

The authors declare no conflict of interest.

Figures

Figure 1
Figure 1
Kaplan-Meier estimates of the cumulative probabilities of MACE during 3 years in the 4 combinations of subgroups and study arms
Figure 2
Figure 2
Kaplan-Meier estimates of the cumulative probabilities of TVR during 3 years in the 4 combinations of subgroups and study arms
Figure 3
Figure 3
Kaplan-Meier estimates of the cumulative probabilities of MACE during 3 years in the 6 combinations of subgroups and devices
Figure 4
Figure 4
Kaplan-Meier estimates of the cumulative probabilities of TVR during 3 years in the 6 combinations of subgroups and devices
Figure 5
Figure 5
Kaplan-Meier estimates of the cumulative probabilities of non-fatal MI during 3 years in the 6 combinations of subgroups and devices
See this image and copyright information in PMC

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