The role of drug-coated balloons for coronary bifurcation management: results from the prospective EASTBOURNE-BIF study.

Abstract

Background: Coronary bifurcation lesions are associated with less favourable outcome as compared to other lesion subsets. The role of drug-coated balloons (DCB) for bifurcation lesions has been only investigated in small studies so far, which reported encouraging results. We here describe the results of EASTBOURNE-BIF prospective registry, in which a sirolimus-DCB was used for the treatment of bifurcation lesions.

Methods: Overall, 194 patients with bifurcations lesions identified in the EASTBOURNE study (Medina 1.1.1/1.1.0/1.0.1/0.1.1/0.1.0) were compared with 1049 patients with de-novo lesions from the same registry. Both a blended-strategy using a drug-eluting stent in the main branch and a DCB in the side branch as well as a full-DCB approach were used in the treatment of bifurcation lesions.

Results: At one year of follow-up the study primary endpoint, target-lesion revascularization occurred at a similar rate in the bifurcation group versus the de-novo group (4.2 vs. 2%, P=0.28). Similar outcomes were observed in terms of all-cause death (3.3 vs. 1.4%, P=0.138), major adverse cardiovascular events (8.8 vs. 5.2%, P=0.081) and the rate of spontaneous myocardial infarction (2.8 vs. 1.0%, P=0.117).

Conclusions: The results of EASTBOURNE-BIF study show how the use of this DCB alone or in combination with drug eluting stents could represent a safe and effective alternative to stents for the treatment of bifurcations.