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Drug-coated balloon versus drug-eluting stent in small coronary artery lesions: angiographic analysis from the BASKET-SMALL 2 trial

Abstract

Background

The randomized BASKET-SMALL 2 trial showed non-inferiority for treatment with drug-coated balloon (DCB) compared with drug-eluting stents (DES) in patients undergoing percutaneous coronary intervention (PCI) for de novo lesions in small coronary arteries regarding clinical endpoints at 1 year. In this predefined substudy, we investigated the angiographic findings in patients undergoing a clinically indicated follow-up angiography during the study phase.

Methods

Eight-hundred and eighty-three patients underwent PCI with either DES or DCB in a culprit vessel < 3 mm in diameter for stable coronary artery disease or acute coronary syndrome. Event-driven re-angiographies and the corresponding images at baseline were analyzed for angiographic endpoints.

Results

One-hundred and eleven patients (117 lesions, 66 DES versus 51 DCB) presented for an unscheduled re-angiography at median 5.7 months after the index procedure. At baseline, mean reference vessel diameter was 2.05 mm and the residual in-segment stenosis after the index procedure was less in DES compared to DCB (23.7% vs 33.8%, p = 0.001). At follow-up angiography, diameter stenosis in the DES group (29.0%) was still somewhat smaller than after DCB angioplasty (35.8%) when adjusting for time since PCI (p = 0.047), whereas lumen loss (LL) did not differ between the two treatment arms (LL-DES 0.06 mm vs LL-DCB 0.10 mm, p = 0.20). Eight patients following DES implantation presented with a complete occlusion of the target lesion compared to no occlusion in the DCB group (p = 0.009).

Conclusions

The clinically indicated follow-up angiography within 1 year showed no difference in LL. Complete thrombotic vessel occlusions were found only in the DES group.

Clinical Trial Registration

www.clinicaltrials.gov; number, NCT01574534

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Abbreviations

DES:

Drug-eluting stent

DCB:

Drug-coated balloon

SVD:

Small vessel disease

PCI:

Percutaneous coronary intervention

ACS:

Acute coronary syndrome

DAPT:

Dual antiplatelet therapy

QCA:

Quantitative coronary angiography

LL:

Lumen loss

MLD:

Minimal lumen diameter

RVD:

Reference vessel diameter

DS:

Diameter stenosis

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Funding

This work was supported by the Swiss National Science Foundation, the Basel Cardiovascular Research Foundation, and B. Braun Medical AG, Switzerland.

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Correspondence to Raban Jeger.

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Conflict of interest

Dr. Jeger reports Grants from Swiss National Foundation, Grants from Basel Cardiovascular Research Foundation, Grants, personal fees and non-financial support from B. Braun Medical AG, Sempach, Switzerland during the conduct of the study; Dr. Mangner reports personal fees from Edwards Lifesciences, personal fees from Medtronic, personal fees from Biotronik, personal fees from Sanofi Genzyme, personal fees from Astra Zeneca and personal fees from Novartis outside the submitted work; Dr. Scheller reports other support from B.Braun, InnoRa GmbH and Charite University Hospital outside the submitted work; Dr. Twerenbold reports personal fees from Abbott, Roche, Siemens, Brahms, Singulex and Amgen, Grants from Swiss National Science Foundation, Swiss Heart Foundation, Swiss Society of Cardiology, University of Basel and Cardiovascular Research Foundation Basel outside the submitted work; all the other authors have nothing to disclose.

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Fahrni, G., Scheller, B., Coslovsky, M. et al. Drug-coated balloon versus drug-eluting stent in small coronary artery lesions: angiographic analysis from the BASKET-SMALL 2 trial. Clin Res Cardiol 109, 1114–1124 (2020). https://doi.org/10.1007/s00392-020-01603-2

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Keywords

  • Percutaneous coronary intervention
  • Small vessel disease
  • De novo
  • Drug-eluting balloon
  • Drug-coated balloon
  • Quantitative coronary analysis