Late-lumen Changes After Drug-Coated Balloon Angioplasty Versus Drug-Eluting Stents in De Novo Coronary Lesions

Overview

This study aims to compare late-lumen loss (LLL) between DCB and DES to treat de novo coronary artery stenosis by intravascular ultrasound (IVUS).

Drug-eluting stent (DES) is the standard of care for patients with coronary artery disease who are eligible for percutaneous coronary intervention (PCI).1 During long-term follow-up, remained metallic stent strut continuously related with stent-related cardiovascular events.2 As an alternative option to DES, drug-coated balloon (DCB) which has benefit of having shorter DAPT maintenance duration due to the absence of metallic scaffolds and polymers, has been introduced. Based on meta-analysis based on many randomized clinical trials (RCT),3,4 its use has been established in in-stent restenosis of bare-metal stents and DES.5 Furthermore, recent RCTs demonstrated efficacy and safety of DCB in de novo coronary lesions in small vessels with reference vessel size \<3.0mm.6,7 For the patients with de novo, non-complex coronary artery lesions, REC-CAGEFREE I tested the non-inferiority of DCB angioplasty with DES implantation, irrespective of vessel diameter.8 Overall, 2272 patients were randomly assigned to the DCB or the DES group. At 2 years, adverse events occurred in 6.4% of DCB group and 3.4% of DES group and failed to prove the non-inferiority of DCB angioplasty (P for non-inferiority=0.65). Regarding the heterogenous results, it is questionable that DCB angioplasty for large de novo lesions is safe and effective compared with DES implantation. On this background, the current study aims to compare late-lumen loss (LLL) between DCB and DES to treat de novo coronary artery stenosis by intravascular ultrasound (IVUS).

Conditions

Interventions

Eligibility

Locations (8)

Outcomes

Central Contacts