Drug-Coated Balloon in Patients With High Bleeding Risk — DCB-HBR  

Coronary Artery Disease Clinical Trial

Official title: Drug-Coated Balloon Versus Drug-Eluting Stent for Treatment of De-Novo Coronary Lesions in Patients With High Bleeding Risk (DCB-HBR Trial)

Status Recruiting

Clinical Trial Summary

DCB-HBR trial is prospective, multi-center, open-label, randomized controlled, noninferiority trial. The aim of the study is to compare clinical outcomes of drug-coated balloon (DCB) with drug-eluting stent (DES) for treatment of de-novo coronary lesion under intravascular imaging-guided optimization in patients with high bleeding risk (HBR).

Clinical Trial Description

Second-generation drug-eluting stent (DES) is the standard of care for patients with coronary artery disease who are deemed eligible for percutaneous coronary intervention (PCI). Despite many advantages, DES inevitably accompanies disadvantages such as the occurrence of late stent thrombosis and the need for maintaining dual antiplatelet (DAPT) for certain period due to permanent vascular implant, which leads to both increased ischemic and bleeding events. As an alternative to DES, drug-coated balloon (DCB), a novel treatment strategy, which has benefit of having shorter DAPT maintenance duration due to the absence of scaffolds and polymers, has been introduced. Based on meta-analysis based on many randomized clinical trials (RCT), its use has been established in in-stent restenosis of bare-metal stents (BMS) and DES. Furthermore, recently published RCTs demonstrated efficacy and safety of DCB in de-novo coronary lesions in small vessels. However, studies exploring the feasibility of DCB in de-novo coronary lesions are limited. In particular, there are scarce data comparing DCB with DES in patients with high bleeding risk (HBR), a situation in which long-term maintenance of DAPT is a clinical dilemma. In the previous two RCTs, DCB showed noninferiority to DES in lesions in large vessels. Nevertheless, these studies were conducted in non-HBR patients and the number of participated patients was insufficient. In another RCT, only patients with HBR were included, but the efficacy of DCB was compared with BMS not DES. Recently, studies have proved short term (1-3 months) DAPT has comparable efficacy to longer DAPT in HBR patients using latest second-generation DES. On this background, this trial aims to compare clinical outcomes between DCB and DES in de-novo coronary lesions in large vessels in patients with HBR receiving short term DAPT. ;

Related Conditions & MeSH terms

• Coronary Artery Disease
• Hemorrhage

• NCT number: NCT05221931
• Study type: Interventional
• Source: Samsung Medical Center
• Contact: Joo Myung Lee, MD, PhD
• Phone: 82-2-3410-3391
• Email: drone80@hanmail.net
• Status: Recruiting
• Phase: N/A
• Start date: July 29, 2022
• Completion date: December 2028