STOPDAPT-3: Skipping aspirin after PCI does not reduce bleeding, may raise CV risk
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Key takeaways:
- Compared with dual antiplatelet therapy, a prasugrel-only strategy did not reduce major bleeding 1 month after PCI.
- Skipping aspirin was also associated with a signal for excess coronary events.
In the STOPDAPT-3 trial, an aspirin-free strategy after PCI did not reduce major bleeding event risk compared with dual antiplatelet therapy, with data also suggesting a signal for excess coronary events, a speaker reported.
DAPT with a P2Y12 inhibitor on top of aspirin therapy is the established treatment to prevent ischemic CV events, in particular stent thrombosis, at least 1 month after PCI; however, the role of aspirin as a component of DAPT has not been established in clinical trials, Masahiro Natsuaki, MD, from the department of cardiovascular medicine at Saga University in Japan, said during a press conference at the European Society of Cardiology Congress. The incidence of major bleeding events within the 1-month mandatory DAPT period after PCI remains high in real clinical practice, particularly among patients with ACS or high bleeding risk, Natsuaki said.
“Removing aspirin from the DAPT regimen in high-bleeding-risk patients early after PCI, such as ACS patients, could reduce major bleeding events without compromising CV events,” Natsuaki said during the press conference.
Higher stent thrombosis seen without aspirin
In the randomized, open-label trial, Natsuaki and colleagues analyzed data from 6,002 patients with ACS or at high bleeding risk who underwent PCI with an everolimus-eluting stent, randomly assigned after coronary angiography to DAPT therapy (prasugrel 3.75 mg daily plus aspirin) or prasugrel monotherapy without aspirin for up to 1 month. The mean age of patients was 72 years; 76% were men; 75% had ACS and 54% were at high bleeding risk.
The coprimary endpoints were Bleeding Academic Research Consortium (BARC) type 3 or 5 bleeding events (for superiority) and a composite CV endpoint of CV death, MI, stent thrombosis or ischemic stroke (for noninferiority), both at 1 month.
The cumulative incidence of major bleeding was 4.47% in the no-aspirin group and 4.71% in the DAPT group, for an HR of 0.95 (95% CI, 0.75-1.2; P for superiority = .66). Cumulative incidence of the composite CV endpoint was 4.12% in the no-aspirin group and 3.69% in the DAPT group; for an HR of 1.12 (95% CI, 0.87-1.45; P for noninferiority = .01).
There was no between-group difference in mortality; however, rates of subacute and definite or probable stent thrombosis and any unplanned coronary revascularization were higher in the no-aspirin group than in the DAPT group, Natsuaki said. The cumulative rates of acute and subacute stent thrombosis were 0.71% in the no-aspirin group and 0.44% in the DAPT group, for an HR of 1.62 (95% CI, 0.81-3.23); however, rates of subacute stent thrombosis were 0.58% in the no-aspirin group and 0.17% in the DAPT group (HR = 3.4; 95% CI, 1.26-9.23).
The failure of an aspirin-free strategy to reduce bleeding events observed in STOPDAPT-3 is perhaps due to differences in the types of bleeding observed in the acute setting vs. previous clinical trials in the chronic phase after PCI, Natsuaki said. Natsuaki also cited bleeding benefits “drowning in the extensive antithrombotic management before and during PCI” and more of an impact of anticoagulation than antiplatelet treatment on bleeding risk.
“Dual antiplatelet therapy should remain the standard strategy within 1 month of a coronary stent implant,” Natsuaki said during the press conference.
Aspirin remains ‘cornerstone treatment’
Discussing the STOPDAPT-3 findings after the Hot Line presentation, Marco Valgimigli, MD, FESC, deputy chief of interventional cardiology at Cardiocentro Ticino Institute in Lugano, Switzerland, said the STOPDAPT-3 data demonstrate there is no benefit for major bleeding events and a signal for possible harm with respect to subacute stent thrombosis when skipping aspirin therapy after PCI.
“The absolute event rates were extremely low; 0.2% vs. 0.6%; yet, unquestionably higher in the no-aspirin group,” Valgimigli said during the presentation. “The implication for clinical practice is very clear. Aspirin remains a cornerstone in the periprocedural and acute phase of PCI in patients without indication for oral anticoagulation.”
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Natsuaki M, et al. Hot line 3. Presented at: European Society of Cardiology Congress; Aug. 25-28, 2023; Amsterdam (hybrid meeting).
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