Can aspirin be omitted after PCI in patients with high bleeding risk?

An aspirin-free strategy did not reduce major bleeding risk compared with a dual antiplatelet (DAPT) strategy, including aspirin, in the first month after patients with high bleeding risk underwent a percutaneous coronary intervention (PCI). However, the STOPDAPT-3 trial results suggested there may be an increased risk for coronary events in patients not receiving aspirin. The authors concluded that a DAPT strategy with aspirin and a P2Y₁₂ inhibitor remains the standard-of-care in the first month after PCI.

In the first month following a PCI, the risk for major bleeding events with DAPT remains high in clinical practice, especially in patients with acute coronary syndrome (ACS) or a high bleeding risk [1]. To tackle this matter, Dr Masahiro Natsuaki (Saga University, Japan) and colleagues investigated the role of aspirin in this context. They hypothesised that omitting aspirin from a DAPT strategy could reduce the risk of bleeding in the first month after PCI in patients with ACS or patients with high bleeding risk without increasing the risk for cardiovascular events.

To test this hypothesis, the phase 4 STOPDAPT-3 study (NCT04609111) enrolled 6,002 patients with ACS or high bleeding risk undergoing PCI with an everolimus-eluting stent from 72 centres in Japan (mean age 71.6 years; 23% women) [2]. The participants were randomised to prasugrel (20 mg loading dose followed by 3.75 mg per day) plus aspirin (81–100 mg per day) or prasugrel monotherapy. Co-primary endpoints were BARC type 3, 4, or 5 bleeding and a composite of cardiovascular death, myocardial infarction (MI), definite stent thrombosis, or ischaemic stroke at 1 month.

Major bleeding occurred in 4.71% of the participants in the DAPT arm and 4.47% in the no-aspirin arm (HR 0.95; 95% CI 0.75–1.20; P=0.66), demonstrating that the omission of aspirin was not superior to a DAPT strategy in terms of bleeding risk. Next, the no-aspirin arm was non-inferior to the DAPT arm with regard to the composite outcome of cardiovascular events (4.12% vs 3.69%; HR 1.12; 95% CI 0.87–1.45; P_{non-inferiority}=0.01). “However, the risk for sub-acute stent thrombosis appeared to be higher in the no-aspirin arm (HR 3.40; 95% CI 1.26–9.23; P<0.05),” added Dr Natsuaki. Similarly, the risk for unplanned coronary revascularisation may be higher in the no-aspirin group (HR 1.83; 95% CI 1.01–3.30; P<0.05).

“The use of aspirin as a component of DAPT may have an additional protective effect on the vulnerable coronary lesions in the first month after PCI, without increasing the risk for major bleeding,” argued Dr Natsuaki. “The DAPT approach remains the standard-of-care in the first month after PCI.”

Prof. Marco Valgimigli (Cardiocentro Ticino Institute, Switzerland) commented that some questions remain to be answered. “For example, what is the role of intravascular imaging guidance, which was routine in this study. And importantly, what is the role of peri-procedural versus post-procedural aspirin administration, an issue that was not resolved by the current trial.” Finally, it should be mentioned that this study utilised an ad hoc dose of prasugrel for the Asian study population.

1. 
   
   1. Natsuaki M, et al. Circ J. 2021;85:1928–1941.
   2. Natsuaki M, et al. Short and optimal duration of dual antiplatelet therapy study after everolimus-eluting cobalt-chromium stent. Hot Line Session 3, ESC Congress 2023, 25–28 August, Amsterdam, the Netherlands.

 

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Posted on 30 October 202313 June 2024