Coronary bifurcation lesions treated with the drug-eluting balloon: a preliminary insight from the DEBIUT study

Abstract

Coronary bifurcation lesions, which account for 15-20% of all lesions treated percutaneously, remain hampered by procedural difficulties, post-procedural complications and suboptimal long-term results, even with the introduction of the drug-eluting stent (DES). Side branch (SB) restenosis rates remain a drawback even in the provisional T-stenting technique with final kissing balloons. The introduction of drug-eluting balloons (DEB) creates a new hope for this technique by maintaining the relatively easy provisional T-technique but promising better long term outcomes for the SB treated with DEB. The DEB delivers locally a high concentration of an anti-restenotic drug, paclitaxel, thereby potentially reducing restenosis rates as compared to a regular balloon. However little is still known on the optimal use and long-term outcomes of DEB in bifurcations. First results of the DEBIUT study will help to understand future directions in development of this new and promising device.

Opportunities and limitations of drug-coated balloons in interventional therapies

“…Primary endpoints were angiographic late lumen loss in the main branch and the side branch after 6 months. However, in this trial the primary endpoint was not reached [35].…”

Drug‐coated balloon treatment of coronary artery disease: A position paper of the Italian Society of Interventional Cardiology

“…The interventional strategy consisted in main vessel stenting followed by final kissing balloon and, in the case of the DCB group, sequential predilation of both bifurcation branches with the DCB. At six months follow‐up, the LLL was not significantly different among patients treated by BMS only and those treated by BMS plus DCB .…”

Provisional main branch stenting with drug-eluting stents after drug-eluting balloon treatment of the side branch: A simple and durable technique for treating bifurcation lesions

“…Although DEBs are well-recognized for the treatment of in-stent restenosis [5], very little is known about the optimal use and long-term outcomes of DEB/DCBs in bifurcation lesions. To date most studies on DEB utilization in bifurcation lesions have been performed with a combination of DEB and bare metal stents [3,4,6]. However, it was common practice in these trials to employ a kissing balloon (KB) inflation of the treated bifurcation, which, theoretically, leads to damage to the MB stent struts with an increased risk for MB complications such as in-stent restenosis [7] and stent thrombosis and to increased costs related to additional wires and non-coated balloon use in the SB.…”

“…However, there is a risk of side branch (SB) occlusion at the time of PCI and a risk of MB complications related to stent distortion when, for example, a kissing technique is employed. Furthermore, complex dual-stent techniques are associated with a poor outcome compared to provisional stenting [2].Recent development of the drug-eluting balloon (DEB) or drugcoated balloon (DCB) has led to experimentation with its successful use in bifurcation lesions [3,4]. Although DEBs are well-recognized for the treatment of in-stent restenosis [5], very little is known about the optimal use and long-term outcomes of DEB/DCBs in bifurcation lesions.…”

“…Recent development of the drug-eluting balloon (DEB) or drugcoated balloon (DCB) has led to experimentation with its successful use in bifurcation lesions [3,4]. Although DEBs are well-recognized for the treatment of in-stent restenosis [5], very little is known about the optimal use and long-term outcomes of DEB/DCBs in bifurcation lesions.…”