Clin Res Cardiol (2021). 10.1007/s00392-021-01933-9

Safety and Feasibility of Drug Eluting Balloons in the Main Vessel for Treatment of Bifurcation Lesions – Results from DEBIFU Registry (Drug Eluting Balloons for the Treatment of Bifurcation Lesions)
P. Swojanowsky1, H. U. Hink2, T. Gori3, B. Hügl4, B. Buchter4, R. Zotz5, E. Friedrich6, H. von Korn1, für die Studiengruppe: DEBIFU
1Medizinische Klinik I, Marienhaus Klinikum Hetzelstift, Neustadt a. d. Weinstraße; 2Klinik für Innere Medizin 1 - Kardiologie, Klinikum Frankfurt Höchst GmbH, Frankfurt am Main; 3Zentrum für Kardiologie, Universitätsmedizin der Johannes Gutenberg-Universität Mainz, Mainz; 4Klinik für Kardiologie/Rhythmologie, Marienhaus Klinikum St. Elisabeth Neuwied, Neuwied; 5Marienhaus Klinikum Eifel-Bitburg, Bitburg; 6Praxis für Kardiologie und Angiologie, St. Wendel;

Objectives: Treating the main vessel with drug eluting balloon is safe and feasible in bifurcation lesions.

Background: Treatment for bifurcation lesions developed over recent years and different techniques evolved. There is still debate about the optimal treatment of these lesions. Provisional stenting is a safe and simple technique and recommended by the European Bifurcation Club in most cases. Treating the MV with DEB may add further benefit to this strategy.

Methods: The DEBIFU registry consists of 98 patients with coronary bifurcation lesions. Indication for coronary angiography was CCS or ACS (unstable Angina or NSTE-ACS). Patients with STEMI or relevant LMS stenosis, CTO and cardiogenic shock were excluded. We further selected 85 patients with relevant MV stenosis and divided in two groups, one treated with DEB (DEB group, n=57), one without (non DEB group, n=28). QCA was performed by a blinded core lab. Postinterventional antiplatelet therapy was according to current guidelines. Follow-up was performed after 9 months.

Results: Baseline characteristics did not differ between groups. Numerically, patients in the DEB group had more advanced CAD with 60% three vessel disease and the lesion was significantly more often located in the RCX compared to the MV non DEB group where the LAD was significantly more often treated. Lumen gain after dilatation was comparable between groups. There was a significant decrease in stent implantation in patients treated with DEB (50% vs 84,2%; p<0,001). MACE rates were low in both groups and without relevant difference. Two cardiac death occurred, one in each group.  TLR was performed in both groups once. Stent thrombosis was observed in only one patient in the non DEB group.

Conclusion: Treating the MV with a DEB instead of just a plain balloon is safe and feasible. Mace rates were similar in both groups and comparable to previously published data. According to our findings, this strategy may prevent the need for stent implantation in a quarter of patients. This may translate to a decrease in stent thrombosis because it is proven that risk for stent thrombosis increases with stent length. So no stent may be the best stent. This has to be evaluated in further studies.


https://dgk.org/kongress_programme/ht2021/P757.htm