Single antiplatelet therapy directly after percutaneous coronary intervention in non-ST-segment elevation acute coronary syndrome patients: the OPTICA study

Sangen, Niels M R van der; Claessen, Bimmer E.; Küçük, I Tarik; Hartog, Alexander W. den; Baan, Jan; Beijk, Marcel A.M.; Delewi, Ronak; Hoef, Tim P. van de; Knaapen, Paul; Lemkes, Jorrit S.; Marques, Koen; Verouden, Niels; Vis, Marije M.; Winter, Robbert J. de; Kikkert, Wouter J.; Appelman, Yolande; Henriques, José P.S.

doi:10.4244/eij-d-22-00886

Cited by 23 publications

(6 citation statements)

References 32 publications

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“…13,14 In several recent single-arm studies, an aspirin-free prasugrel or ticagrelor monotherapy after successful new-generation drug-eluting stent implantation was not associated with any stent thrombosis in selected low-risk patients with non-ACS, and ACS, as well. [15][16][17] Removing aspirin from the DAPT regimen might result in reducing bleeding events early after PCI without compromising the risk of cardiovascular events, but its efficacy and safety have not been yet proven in randomized trials.…”

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confidence: 99%

An Aspirin-Free Versus Dual Antiplatelet Strategy for Coronary Stenting: STOPDAPT-3 Randomized Trial

Natsuaki,

Watanabe,

Morimoto

et al. 2024

Circulation

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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 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]; P superiority =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]; P non inferiority =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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confidence: 99%

An Aspirin-Free Versus Dual Antiplatelet Strategy for Coronary Stenting: STOPDAPT-3 Randomized Trial

Natsuaki,

Watanabe,

Morimoto

et al. 2024

Circulation

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“…Our seminal observations and exploratory findings need to be confirmed in future randomized trials in patients with acute coronary syndrome and HBR. In 2023, the OPTICA (Optical Coherence Tomography-Guided PCI with Single Antiplatelet Therapy) trial assessed using ticagrelor or prasugrel monotherapy in 70 patients with non–ST-segment elevation acute coronary syndrome, 28 with the results demonstrating the feasibility and safety of this regimen with a primary ischemic endpoint, defined as the composite of all-cause mortality, MI, definite or probable ST, or stroke, occurring in 3 (4.0%) patients at 6-month follow-up. Currently, 4 ongoing RCTs (LEGACY [Less Bleeding by Omitting Aspirin in non-ST-segment Elevation Acute Coronary Syndrome Patients], STOPDAPT-3 [Short and Optimal Duration of Dual Antiplatelet Therapy After Everolimus-Eluting Cobalt-Chromium Stent-3], NEOMINDSET [PercutaNEOus coronary intervention followed by Monotherapy INstead of Dual antiplatelet therapy in the SETting of acute coronary syndromes], and PREMIUM [PRasugrel Monotherapy Following prImary percUtaneous Coronary Intervention for ST-elevation Myocardial Infarction]), which will enroll a total of 15,000 patients, are exploring novel strategies of monotherapy using P2Y 12 receptor inhibitors in patients with ACS and HBR.…”

Section: Discussionmentioning

confidence: 99%

Prasugrel Monotherapy After Percutaneous Coronary Intervention for Chronic Coronary Syndrome

Masuda,

Tanabe,

Guimarães

et al. 2024

JACC: Asia

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“…This strategy was also recently studied in ACS patients in the OPTICA and MACT trial, which resembled the study design of the ASET [123,124]. In this latter trial, which was also the only one to include STEMI patients, two ST were observed, all in this higher risk group, which raises concerns regarding early de-escalation of treatment in patients at particularly high ischemic risk such as STEMI patients [123,125].…”

Section: Immediate Dapt Discontinuation After Pci the No Dapt Strategymentioning

confidence: 99%

Individualization of Duration of Dual Antiplatelet Therapy after Coronary Stenting: A Comprehensive, Evidence-Based Review

Carciotto,

Costa,

Garcia-Ruiz

et al. 2023

JCM

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Dual antiplatelet therapy (DAPT), comprising aspirin and a P2Y12 receptor inhibitor, is the cornerstone of post-percutaneous coronary intervention treatment to prevent stent thrombosis and reduce the risk of adverse cardiovascular events. The selection of an optimal DAPT regimen, considering the interplay of various antiplatelet agents, patient profiles, and procedural characteristics, remains an evolving challenge. Traditionally, a standard duration of 12 months has been recommended for DAPT in most patients. While contemporary guidelines provide general frameworks, DAPT modulation with longer or shorter treatment courses followed by aspirin or P2Y12 inhibitor monotherapy are evolving towards an individualized strategy to optimize the balance between efficacy and safety. This review comprehensively examines the current landscape of DAPT strategies after coronary stenting, with a focus on emerging evidence for treatment individualization.

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Single antiplatelet therapy directly after percutaneous coronary intervention in non-ST-segment elevation acute coronary syndrome patients: the OPTICA study

Cited by 23 publications

References 32 publications

An Aspirin-Free Versus Dual Antiplatelet Strategy for Coronary Stenting: STOPDAPT-3 Randomized Trial

An Aspirin-Free Versus Dual Antiplatelet Strategy for Coronary Stenting: STOPDAPT-3 Randomized Trial

Prasugrel Monotherapy After Percutaneous Coronary Intervention for Chronic Coronary Syndrome

Individualization of Duration of Dual Antiplatelet Therapy after Coronary Stenting: A Comprehensive, Evidence-Based Review

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