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Observational Study
. 2025 Aug;48(8):e70189.
doi: 10.1002/clc.70189.

Long-Term Effectiveness of a Stent-Less Strategy With Drug Coated Balloon in Coronary Artery Disease: 3-Year Follow-Up of a Prospective All-Comers Observational Study

Ludovic Meunier  1 , Simon Eccleshall  2 , Ronan Bakdi  1 , Matthieu Godin  3 , Géraud Souteyrand  4 , Benoît Mottin  1 , Yann Valy  1 , Christian Benoit  1 , Vincent Lordet  1 , Virginie Laurençon  5 , Antoine Milhem  1 , Matthias Waliszewski  6 , Caroline Allix-Béguec  5
Affiliations
Observational Study

Long-Term Effectiveness of a Stent-Less Strategy With Drug Coated Balloon in Coronary Artery Disease: 3-Year Follow-Up of a Prospective All-Comers Observational Study

Ludovic Meunier et al. Clin Cardiol. 2025 Aug.

Abstract

Introduction: Drug-eluting stent (DES) angioplasty is the gold standard treatment for coronary lesions. Drug-coated balloon (DCB) is an option for in-stent restenosis, and has also shown promise for small-calibre coronary artery disease. We evaluated the 3-year effectiveness of a decision algorithm for percutaneous coronary intervention (PCI) that favoured a stent-less strategy (SLS) in primary angioplasty.

Methods: All patients who underwent angioplasty during 1 year were included in a prospective observational study. Patients eligible for SLS first underwent scoring balloon followed by DCB angioplasty or DES in case of mandatory bailout. Patients not eligible for SLS were unstable patients who underwent conventional drug-eluting stenting. The metal index, stent burden, was calculated by stent length divided by the total lesion length. A 36-month follow-up recorded target lesion revascularization (TLR).

Results: Patients eligible for SLS represented 85% (n = 840) of patients who underwent PCI. TLR was required in 2.6% and 6% of patients in the DCB-only and bailout-DES groups, respectively. Median metal index was 0.25 (IQR: 0.5) in patients with TLR. There was a difference between TLR-free survival distributions in the DCB-only and bailout-DES groups (p = 0.016).

Conclusions: The SLS based on a combination of scoring balloon and DCB was effective at 3 years with a low rate of TLR. This rate was higher in patients with stent burden.

Trial registration: This study was registered with clinicaltrials. gov (NCT03893396, first posted on March 28, 2019).

Keywords: DCB‐based strategy; angioplasty; coronary artery disease; drug‐coated balloon; drug‐eluting stent; patient outcome assessment; percutaneous coronary intervention.

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Conflict of interest statement

Ludovic Meunier reports grants and personal honoraria payment from B Braun. Virginie Laurençon and Caroline Allix‐Béguec reports grants from B Braun. Matthias Waliszewski is an employee of B Braun. The other authors declare no conflicts of interest.

Figures

Figure 1
Figure 1
Flow diagram. DCB, Drug Coated Balloon; DES, Drug Eluting Stent; PCI, percutaneous coronary intervention.
Figure 2
Figure 2
Histogram of patient outcomes by type of lesion treated.
See this image and copyright information in PMC

References

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