Background: Bleeding rates on dual antiplatelet therapy (DAPT) within 1 month after percutaneous coronary intervention (PCI) remain high in clinical practice, particularly in patients with acute coronary syndrome or high bleeding risk. Aspirin-free strategy might result in lower bleeding early after PCI without increasing cardiovascular events, but its efficacy and safety have not yet been proven in randomized trials.
Methods: We randomly assigned 6002 patients with acute coronary syndrome or high bleeding risk just before PCI either to prasugrel (3.75 mg/day) monotherapy or to DAPT with aspirin (81-100 mg/day) and prasugrel (3.75 mg/day) after loading of 20 mg of prasugrel in both groups. The coprimary end points were major bleeding (Bleeding Academic Research Consortium 3 or 5) for superiority and cardiovascular events (a composite of cardiovascular death, myocardial infarction, definite stent thrombosis, or ischemic stroke) for noninferiority with a relative 50% margin.
Results: The full analysis set population consisted of 5966 patients (no-aspirin group, 2984 patients; DAPT group, 2982 patients; age, 71.6±11.7 years; men, 76.6%; acute coronary syndrome, 75.0%). Within 7 days before randomization, aspirin alone, aspirin with P2Y12 inhibitor, oral anticoagulants, and intravenous heparin infusion were given in 21.3%, 6.4%, 8.9%, and 24.5%, respectively. Adherence to the protocol-specified antiplatelet therapy was 88% in both groups at 1 month. At 1 month, the no-aspirin group was not superior to the DAPT group for the coprimary bleeding end point (4.47% and 4.71%; hazard ratio, 0.95 [95% CI, 0.75-1.20]; =0.66). The no-aspirin group was noninferior to the DAPT group for the coprimary cardiovascular end point (4.12% and 3.69%; hazard ratio, 1.12 [95% CI, 0.87-1.45]; =0.01). There was no difference in net adverse clinical outcomes and each component of coprimary cardiovascular end point. There was an excess of any unplanned coronary revascularization (1.05% and 0.57%; hazard ratio, 1.83 [95%CI, 1.01-3.30]) and subacute definite or probable stent thrombosis (0.58% and 0.17%; hazard ratio, 3.40 [95% CI, 1.26-9.23]) in the no-aspirin group compared with the DAPT group.
Conclusions: The aspirin-free strategy using low-dose prasugrel compared with the DAPT strategy failed to attest superiority for major bleeding within 1 month after PCI but was noninferior for cardiovascular events within 1 month after PCI. However, the aspirin-free strategy was associated with a signal suggesting an excess of coronary events.
Registration: URL: https://www.clinicaltrials.gov; Unique identifier: NCT04609111.
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http://dx.doi.org/10.1161/CIRCULATIONAHA.123.066720 | DOI Listing |
Am J Obstet Gynecol
January 2025
Department of Obstetrics and Gynecology, University Hospital Brugmann, Université Libre de Bruxelles, Brussels, Belgium. Electronic address:
Background: Aspirin has proved its efficacy in reducing the rate of preeclampsia in singleton pregnancy, however, there is discrepancy about the efficient dosage that should be used. While some societies recommend daily 75-81mg, others recommend higher dosage (160mg). This discrepancy is due to the lack of randomized controlled studies that compare these two dosages.
View Article and Find Full Text PDFEur Heart J Cardiovasc Pharmacother
October 2024
Department of Cardiology, Hirakata Kohsai Hospital, Hirakata, Japan.
Aims: Safety of aspirin-free strategy immediately after percutaneous coronary intervention (PCI) for cardiovascular events in patients with diabetes was unknown.
Methods And Results: We conducted the prespecified subgroup analysis on diabetes in the STOPDAPT-3 trial, which randomly compared prasugrel (3.75 mg/day) monotherapy (2984 patients) to dual antiplatelet therapy (DAPT) with prasugrel and aspirin (2982 patients) in patients with acute coronary syndrome or high bleeding risk.
Am J Cardiovasc Drugs
September 2024
Department of Data Science, Hyogo Medical University, 1-1 Mukogawa, Nishinomiya, Hyogo, 663-8501, Japan.
Sci Rep
September 2024
Department of Geriatrics, First Hospital of Lanzhou University, Lanzhou, 730000, China.
To investigate the relationship between long-term use of low-dose aspirin and Helicobacter pylori (HP) infection, and its effect on eradication and recurrence of HP. According to the results of C-Urea Breath Test (C-UBT), 3256 patients with cardiovascular and cerebrovascular diseases from March 2019 to December 2020, were divided into HP infection group and non-infection group. Univariate and multivariate was used to investigate the relationship between Low-dose aspirin use and HP infection.
View Article and Find Full Text PDFHeliyon
August 2024
Department of Radiology, the Affiliated Panyu Central Hospital of Guangzhou Medical University, Guangzhou, China.
Background: A modified antiplatelet therapy approach after percutaneous coronary intervention (PCI), specifically reducing dual antiplatelet therapy (DAPT) duration and transitioning to P2Y12 inhibitor monotherapy, may offer advantages in terms of bleeding risk reduction. However, the impact of initiating aspirin-free P2Y12 inhibitor monotherapy immediately after PCI is not yet fully understood.
Methods: We systematically searched the PubMed and Embase databases until January 2024 for studies that examined the use of P2Y12 inhibitor monotherapy as a treatment approach without initial DAPT following PCI.
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