Paclitaxel-Coated Balloon Versus Zotarolimus-Eluting Stent for Treatment of De Novo Coronary Artery Lesions
Status:
Recruiting
Trial end date:
2025-02-01
Target enrollment:
Participant gender:
Summary
Coronary restenosis has been one of the main reasons affecting the prognosis of patients with
coronary artery disease (CAD) after percutaneous coronary intervention (PCI). With
drug-eluting stents (DES), which elutes an antiproliferative drug to the vessel wall and
reduces the restenosis rate; however, the incidence of restenosis is still about 10%. The
late stent thrombosis and restenosis, with a hazard of nearly 2% per year after implantation,
remained a concern and motivated the development of drug-coated balloons (DCB).
DCB angioplasty has the following advantages compared with DES implantation: Firstly, the
drug in DCB is uniformly distributed and released; whereas the drug release of DES via stent
platform is uneven -85% of the vascular wall is not covered by the stent strut. Secondly,
there is no alloy in the vessel after DCB angioplasty, while the coronary stent platform and
polymer might cause temporal or persistent inflammatory response leading to intimal
hyperplasia. Finally, there is no metal cage restraining vessel motion after DCB, the
physiological function of coronary arteries would be maintained.
Studies with the strategy of DCB angioplasty with bailout stenting have demonstrated safety
and efficacy for the small-vessel disease. The application of DCB in large vessels with de
novo lesions is still to be investigated. The DEBUT study showed that in high bleeding risk
patients aimed using only 1-month DAPT, DCB was superior to BMS in terms of MACE [MACE
(cardiovascular mortality, nonfatal myocardial infarction or revascularization of
ischemia-reperfusion target lesions)] at 9-month follow-up.
However, there is still a lack of evidence comparing the DCB versus DES in large vessels with
de novo lesions. The current study aims to investigate if in patients undergoing PCI for de
novo stenoses in large vessels, DCB is non-inferior to DES.