Is it Time to Give Up Aspirin after PCI in High Bleeding Risk Patients? A Critical Analysis of STOPDAPT-3

Short dual antiplatelet treatment (DAPT) has been adopted in high bleeding risk patients to minimize bleeding complications after percutaneous coronary intervention (PCI). However, the effectiveness of completely eliminating the use of aspirin in this population, opting for post PCI prasugrel monotherapy instead, remains unclear. 

This subanalysis of the STOPDAPT-3 assessed 3,258 patients at high risk of bleeding and compared prasugrel monotherapy (no aspirin) against DAPT for one month. Participants were subdivided according to clinical presentation: 1,803 patients with acute coronary syndrome (ACS) (915 in the prasugrel monotherapy group and 888 treated with DAPT) and 1,455 non-ACS patients (723 treated with prasugrel monotherapy and 732 with DAPT). Prasugrel loading dose was 20 mg, with 3.75 mg maintenance dose (Japan approval). No P2Y12 receptor inhibitors were used, such as Clopidogrel or Ticagrelor. 

Mean patient age was 77.6 ± 8.8, and 71.2% were men. Of ACS patients, 53% presented ST elevation MI (STEMI). In both subgroups, 78% of procedures were transradial. Adherence to treatment was high and similar between the groups (ACS: 88.2% with Prasugrel vs. 86.1% with DAPT; non-ACS: 87.2% vs. 86.8%).

Primary end point was major bleeding (BARC 3 or 5), while efficacy end point was a composite of cardiovascular death, acute MI, stent thrombosis or ischemic stroke, both assessed at 30 days after PCI with everolimus eluting stents. 

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There were no significant differences in major bleeding between aspirin-free and DAPT patients, regardless clinical subgroup (SCA: 7.3% vs. 7.9%; non-ACS: 3.1% vs. 2.9%; p for interaction = 0.66). As regards cardiovascular events (death, AMI, stent thrombosis or stroke) ACS patients showed a non-significant trend towards higher risk with the aspirin-free strategy (7.9% vs. 5.8%; HR 1.39). In contrast, non-ACS patients showed no increased risk (2.4% vs. 3.0%; HR 0.78). However, AMI risk showed significant interaction by subgroup (SCA: 1.6% vs. 0.3%; HR 4.57; non-ACS: 1.4% vs. 1.8%; HR 0.78; p for interaction = 0.02).

Conclusion

The aspirin-free strategy (post PCI prasugrel monotherapy) did not reduce major bleeding events in high bleeding risk patients, regardless of ACS presence. In ACS patients, this strategy was associated to higher risk of cardiovascular events, especially AMI. In non-ACS patients, this strategy could be considered as an alternative after PCI. 

Original Title: Aspirin-Free Strategy for PCI in Patients With High Bleeding Risk With or Without Acute Coronary Syndrome: A Subgroup Analysis From the STOPDAPT-3 Trial.

Reference: Tetsuya Ishikawa et al. Circulation: Cardiovascular Interventions, Volumen 18, e015197, julio 2025.