Aspirin-free strategy within 1 month after PCI does not reduce major bleeding
STOPDAPT-3: An Aspirin-Free antiplatelet strategy for percutaneous coronary intervention
Presented at the ESC congress 2023 by: Masahiro Natsuaki, MD, PhD- Saga, Japan
Introduction and methods
Dual-antiplatelet therapy (DAPT) is the standard strategy after percutaneous coronary intervention (PCI) to prevent ischemic events, especially stent thrombosis. DAPT is prescribed at least 1 month after stent implantation. However, the incidence of major bleeding within this 1-month mandatory DAPT period is high, in particular in patients with ACS or high bleeding risk.
Therefore, it was investigated whether removing aspirin from the DAPT regimen after PCI would reduce major bleeding events without increasing ischemic events in patients with ACS or high bleeding risk.
The STOPDAPT-3 was a multicenter randomized open-label trial in which 6000 patients were randomized to an aspirin-free strategy or DAPT strategy in 1:1 ratio. The aspirin-free group received a prasugrel loading dose of 20 mg before PCI and a maintenance dose of 3.75 mg/day during 1 month. The DAPT group received a loading dose of 20 mg prasugrel and 162-200 mg aspirin (if aspirin naïve) and a maintenance dose of 3.75 mg/day prasugrel and 81-100 mg/day aspirin for 1 month.
The co-primary bleeding endpoint was BARC 3 or 5 bleeding (superiority) at 1 month and the co-primary CV endpoint was a composite of CV death, MI, definite stent thrombosis or ischemic stroke (non-inferiority) at 1 month.
- These was no difference in the bleeding endpoint between the 2 groups (HR 0.95, 95%CI: 0.75-1.20, Psuperiority=0.66).
- The rate of the CV endpoint was 4.12% in the no-aspirin group vs. 3.65% in the DAPT group (HR 1,12, 95%CI: 0.87-1.45, Pnoninferiority=0.01).
- There was no difference in the individual endpoints, with the exception of higher rates in the no-aspirin group of sub-acute definite or probable stent thrombosis (HR 3.40, 95%CI: 1.26-9.23) and any unplanned coronary revascularization (HR 1.83, 95%CI: 1.01-3.30).
There was no reduction in major bleeding with the aspirin-free strategy compared to DAPT at 1 month after PCI. Also, there was no difference in the composite CV endpoint between the 2 groups, but there were some signals suggesting an increase in coronary events.
Masahiro Natsuaki concluded: “Dual-antiplatelet therapy should remain the standard strategy within 1 month after coronary stent implantation”.
- Our reporting is based on the information provided at the ESC Congress -