Safety and Efficacy of a Hybrid Approach Combining a Paclitaxel-Coated Balloon With a New Generation Drug-Eluting Stent in Patients With De Novo True Coronary Bifurcation Lesions

The use of drug-coated balloon in the management of true bifurcation lesions appears to be an attractive option to reduce the rate of stent thrombosis and restenosis particularly at the level of the side branch ostium. We aim to assess the safety and the efficacy of a hybrid approach combining a drug-eluting stent in the main branch and a drug-coated balloon to treat the side branch ostium in patients with de novo true bifurcation. From September 2020 to March 2022, 45 patients with a de novo true bifurcation lesion Medina (1.1.1) or Medina (0.1.1) were enrolled. All patients underwent a percutaneous coronary intervention with the hybrid approach. Clinical assessment with functional stress imaging test was scheduled at 6 months. In case of documented ischemia, coronary angiography was performed. The primary endpoint was the composite of target lesion failure at 6 months including cardiac death, target vessel MI or ischemia-driven target lesion revascularization. The secondary endpoints were technical success, defined by performing the percutaneous coronary intervention without an additional drug-eluting stent at the level of the side branch ostium, and clinical success, defined by a technical success associated with the absence of severe complications during in-hospital phase. The immediate results show a technical success of the procedure in the majority of cases (88.9 %) with a low rate of bailout side branch stenting (11.1 %). The clinical success was obtained in 86.7 % and only one patient experienced a severe in-hospital complication. A side branch ostial lesion length > 10 mm was the only independent predictor of clinical failure of the procedure (OR 12.49, 95 % CI 1.17–133.6; p = 0.037). At 6 months, the TLF was low and occurred in 1 patient (2.2 %). No cardiac death was observed. No TVMI was observed. Importantly, at 6 months, no side branch thrombosis was observed. The use of a hybrid approach combining a drug-eluting stent in the main branch and a drug-coated balloon in the side branch to treat true bifurcation lesions appears to be safe and efficient with few immediate complications and with satisfactory results at mid-term follow up.