Drug Coated Balloon Compared to Bare Metal Stent for de Novo Coronary Artery Lesions
Condition: Stable Angina; Unstable Angina
MeSH terms: Angina Pectoris; Angina, Stable; Angina, Unstable
Study type: Interventional

Summary: 
      This randomized trial will assess the efficacy of Drug Coated Balloon (DCB) compared to Bare
      Metal Stent (BMS) using Fractional Flow Reserve (FFR) guidance for de novo coronary artery
      lesions in patients unable to tolerate dual antiplatelet therapy and at high risk of
      bleeding. Patients will be randomized after balloon angioplasty to receive either DCB or BMS.
      Endpoints are late luminal loss at 9 months, and major adverse cardiac events including
      arterial thrombosis at 1, 9 and 12 months.
    

Detailed description: 
      Although the use of drug-eluting stents (DES) has reduced in-stent restenosis when compared
      to bare metal stents (BMS) and decreased the incidence of adverse clinical events (1-2), DES
      therapy is limited by delayed arterial healing, late acquired malapposition and
      neo-atherosclerosis leading to an increased risk of late stent thrombosis and late restenosis
      (3-4). Conceptually, a permanent stent inhibits advantageous vascular remodeling and durable
      polymer provokes excessive inflammation (5). Non-stent based local drug delivery using
      paclitaxel-coated balloon has emerged as a new clinical treatment alternative by maintaining
      the anti-proliferative properties of DES (6). There is limited data on the efficacy of Drug
      Coated Balloon (DCB) treatment for de novo coronary lesions when compared to BMS. To avoid
      the risk of abrupt closure of target lesion after balloon angioplasty, a reliable predictor
      of coronary flow is necessary especially in de novo lesions of major coronary arteries.
      Therefore, using fractional flow reserve (FFR) after angioplasty as a good indicator of
      immediate functional improvement and reduced restenosis (7), the aim of this study is to
      assess the efficacy of DCB treatment compared to BMS in patients with de novo coronary artery
      lesions.

      Patients with de novo coronary artery lesions with > 50% stenosis in a single vessel and at
      high risk of bleeding with the inability to tolerate dual antiplatelet therapy (DAPT) will be
      included in this trial. Patients will undergo balloon angioplasty and if the FFR post balloon
      angioplasty is > 0.80, they will be randomized to receive either DCB or BMS. Patients will
      receive Quantitative Coronary Angiography (QCA) analysis at 9 months follow-up. Endpoints are
      late luminal loss at 9 months and major adverse events including arterial thrombosis at 1, 9
      and 12 months and these endpoints will be compared between DCB and BMS groups.
    

Intervention name(s): Drug Coated Balloon; Bare Metal Stent
Intervention type(s): Device; Device
Intervention description(s): If post balloon angioplasty FFR is more than 0.80, either DCB treatment or BMS implantation will be carried out based on randomization of 1:1. DCB (SeQuent Please paclitaxel-coated balloon catheter, B. Braun, Melsungen, Germany) will be applied at the predilated lesions. PCB will be delivered rapidly and inflated for 60 seconds with nominal pressure.; BMS (Vision®) will be applied at the predilated lesions after angiographic confirmation of the target lesion.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment