Treatment of bifurcation lesions with a drug-eluting balloon: the PEPCAD V (Paclitaxel Eluting PTCA Balloon in Coronary Artery Disease) trial

Abstract

AIMS: Percutaneous coronary interventions for bifurcation lesions are often complex and associated with an unsatisfactory result. The aim of this first-in-man, observational study was to investigate the efficacy and safety of a paclitaxel-eluting balloon in these lesions. METHODS AND RESULTS: Twenty-eight patients presenting significant coronary bifurcational lesions of the left coronary artery were studied. The main branch (MB) and the side branch (SB) were dilated with a drug-eluting balloon (DEB; SeQuent Please balloon catheter , 3 µg paclitaxel/mm2 balloon surface). An open-cell bare-metal stent (BMS; Coroflex) was then deployed in the MB. Only if the SB had a TIMI flow <III and/or a residual stenosis of ≥ 50%, a BMS was implanted in the SB. The procedure was successful in all patients. At nine months, the late lumen loss (LLL) in the MB was 0.38 ± 0.46 mm and 0.21 ± 0.48 mm in the SB resulting in an MLD of 2.2 ± 0.60 mm in the MB and 1.7 ± 0.44 mm in the SB. Three patients had angiographic restenosis and in one a target lesion revascularisation (TLR) was performed. Two patients experienced a late stent thrombosis at six and eight months. No patient died. CONCLUSIONS: Percutaneous treatment of bifurcation lesions with a drug-eluting balloon resulted in a procedural success of 100%. Follow-up angiography at nine months showed DES-like results in MB and SB. However, when the DEB was used in combination with a BMS (MB), the possibility of late stent thrombosis cannot be ruled out.