Paclitaxel-coated Balloon for Treatment of De-novo Non-complex Coronary Artery Lesions
Status:
Recruiting
Trial end date:
2028-04-01
Target enrollment:
Participant gender:
Summary
The introduction of Bare-metal stents (BMS) since 1986 has alleviated the limitations of
plain old balloon angioplasty (POBA) related elastic recoil and flow-limiting dissections.
Later on, higher restenosis rates due to exaggerated neointimal growth in BMS has led to the
development of drug-eluting stents (DES), which elutes an antiproliferative drug to the
vessel wall and reduce the restenosis rate. However, 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).
The advantages of DCB are that leaving no metal in the blood vessel and respect the vessel
anatomy.
Recently, studies with the strategy of DCB angioplasty with bailout stenting have
demonstrated safety and efficacy for the small-vessel disease. In the BASKET-SMALL 2 trial,
which compared SeQuent Please DCB with EES or Taxus DES in the vessels that have reference
diameter<3mm, showed that at 12-month follow-up, DCB was non-inferior to DES (MACE [cardiac
death, non-fatal myocardial infarction, and target-vessel revascularisation] rates: 8% vs.
9%).
Although some small-scale RCT using surrogate endpoints have reported that no significant
difference in MLD or late lumen loss between the two groups in large vessels, up to now,
there is no large-scale RCT comparing the clinical outcomes of DCB versus DES in large
vessels with de novo lesions.
Therefore, the investigators hypothesized that in patients undergoing non-complex
percutaneous coronary intervention (PCI) for de-novo stenoses, drug-coated balloon (DCB) is
non-inferior to drug-eluting stents (DES).
Besides the ischemic events to be observed, there might be also a potential benefit of the
DCB strategy by reducing the bleeding events. Although there is scarce evidence showing the
optimal DAPT duration for DCB, in the current study, according to our empirical clinical
experiences and previous expert consensus, the investigators chose aspirin +
Ticagrelor/Clopidogrel for 3-month followed by Ticagrelor/Clopidogrel monotherapy for 3-month
to be the antiplatelet regimen in DCB arm. In contrast to the antiplatelet regimen for the
DES arm used in the current trial, which is aspirin + Ticagrelor/Clopidogrel for 3-month
followed by Ticagrelor/Clopidogrel monotherapy for 9-month, the DCB and its antiplatelet
strategy is estimated to reduce the bleeding events during follow-up.