Safety and efficacy of drug-eluting balloons in percutaneous treatment of bifurcation lesions: the DEBIUT (drug-eluting balloon in bifurcation Utrecht) registry.

OBJECTIVES: To evaluate outcomes after percutaneous coronary intervention (PCI) with a drug-eluting balloon catheter (paclitaxel-coated) in patients with coronary artery bifurcation lesions.

BACKGROUND: The current practice of provisional stenting of the main branch (MB) is reasonable; however, long-term results of side-branch (SB) treatment are suboptimal. The use of drug-eluting stents has not improved these results, regardless of the implantation technique, and could potentially lead to a significant increase in (late) thrombotic events. To evaluate short-term safety and efficacy of a drug-eluting balloon (DEB) in patients with bifurcation lesions followed by provisional stenting of the main branch, we set up the DEBIUT Registry.

METHODS: This registry enrolled 20 eligible patients with coronary artery bifurcation lesions. Patients received a PCI with a paclitaxel-coated balloon catheter, followed by provisional stenting of the MB with a bare-metal stent. Acute angiographic and clinical follow-up were performed after 1 and 4 months.

RESULTS: The procedure was successful in all patients. The use of sequential predilatation with DEB was safe and well tolerated. No acute or subacute closure of side branches occurred after treating with DEB. All patients were treated according to the provisional stenting technique; no stents were placed in the SB. At 4-month follow-up no major acute coronary events and no subacute vessel closure were reported.

CONCLUSION: The use of a drug-eluting balloon in patients with bifurcation lesions was effective and safe up to 4 months following PCI in patients with coronary artery bifurcation lesions.