Prasugrel monotherapy after PCI with drug-eluting stents was not superior to dual-antiplatelet therapy (DAPT) for major bleeding but was non-inferior for cardiovascular events in patients with acute coronary syndrome (ACS) or high bleeding risk (HBR), according to findings from the STOPDAPT-3 trial presented at ESC Congress 2023.

Researchers randomized 5,966 patients with ACS or HBR from 72 centers in Japan to receive either prasugrel (3.75 mg/day) monotherapy or DAPT with aspirin (81-100 mg/day) and prasugrel, right before PCI. Both groups received a loading dose of prasugrel (20 mg). The average age was 71.6 years and 23.4% were women. Primary endpoints were major bleeding events at one month for superiority, as well as cardiovascular events at one month for non-inferiority. The major secondary endpoint was a composite of the co-primary bleeding and cardiovascular endpoints at one month representing net clinical benefit.

Results at one month found that prasugrel monotherapy was not superior to DAPT for the co-primary bleeding endpoint (4.47% vs. 4.71%). Researchers also noted that prasugrel monotherapy was non-inferior to DAPT with a relative 50% margin for the co-primary cardiovascular endpoint (4.12% vs. 3.69%). No between-group difference was observed in the incidence of all-cause death, while the major secondary endpoint occurred in 7.14% patients in the prasugrel monotherapy group and 7.38% patients in the DAPT group.

In other findings, there was an excess of any coronary revascularization (1.15% vs. 0.57%) and definite or probable stent thrombosis (0.71% vs. 0.44) in the prasugrel monotherapy group compared with the DAPT group. A subgroup analysis stratified by patients with ACS and without ACS, indicated an excess risk of cardiovascular events among patients with ACS in the prasugrel monotherapy group compared with the DAPT group was seen in patients with ACS. Similar risk was not observed in patients without ACS.

"The aspirin-free strategy compared with the DAPT strategy failed to reduce major bleeding within one month after PCI, but it was non-inferior for the co-primary cardiovascular endpoint with a relative 50% margin," said Masahiro Natsuaki, MD, PhD, FACC, of Saga University, Japan. "Aspirin used for a limited period of one month after PCI as a component of DAPT might have exerted a protective effect on vulnerable coronary lesions, particularly in patients with ACS, without a large increase in major bleeding. DAPT should remain the standard strategy for PCI even in the new-generation drug-eluting stent era."

Clinical Topics: Invasive Cardiovascular Angiography and Intervention

Keywords: ESC Congress, ESC23, ACC International, Percutaneous Coronary Intervention

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