Potent P2Y12 inhibitor monotherapy versus dual antiplatelet therapy in patients with ST-segment elevation myocardial infarction undergoing primary percutaneous coronary intervention: Rationale and design of the STARS DAPT randomized pilot trial
Key result
Ongoing STARS DAPT trial evaluates early P2Y12 monotherapy versus standard DAPT in STEMI.
- n=350
Why the study?
Although potent oral P2Y12 inhibitor-based single antiplatelet therapy after 1 to 3 months of DAPT reduces major bleeding in acute coronary syndrome, the optimal timing of aspirin discontinuation in STEMI patients undergoing primary PCI remains uncertain.
Does potent oral P2Y12 inhibitor-based single antiplatelet therapy (with aspirin discontinued before hospital discharge) reduce major adverse cardiac and cerebrovascular events and major bleeding compared to standard 12-month dual antiplatelet therapy in STEMI patients undergoing primary PCI with a polymer-free DES?
Study Design
Type
RCT (n=350)
Blinding
Open-label with blinded outcome assessment
Randomization
1:1 ratio
Multicenter
Yes
Structured PICO
Does potent oral P2Y12 inhibitor-based single antiplatelet therapy (with aspirin discontinued before hospital discharge) reduce major adverse cardiac and cerebrovascular events and major bleeding compared to standard 12-month dual antiplatelet therapy in STEMI patients undergoing primary PCI with a polymer-free DES?
P
Population
Planned recruitment of 350 patients with STEMI undergoing successful primary PCI of the culprit lesion with a newer-generation polymer-free DES, followed for 12 months.
I
Intervention
Potent oral P2Y12 inhibitor-based single antiplatelet therapy (SAPT) for 12 months, with aspirin discontinued after an initial period of dual antiplatelet therapy (DAPT) during the index hospitalization and before hospital discharge
C
Comparator
Standard dual antiplatelet therapy (DAPT) for 12 months
O
Outcome
Primary efficacy endpoint: rate of major adverse cardiac and cerebrovascular events (MACCE), defined as the composite of all-cause death, non-fatal myocardial re-infarction, non-fatal stroke, urgent target vessel revascularization, or definite/probable stent thrombosis, at 12 months. Primary safety endpoint: Bleeding Academic Research Consortium (BARC) class 3 or 5 major bleeding at 12 monthscomposite
This randomized pilot trial will provide preliminary safety and efficacy estimates for very early aspirin discontinuation (prior to hospital discharge) in STEMI patients treated with potent P2Y12 inhibitor monotherapy following primary PCI with a polymer-free DES.
Limitations
- Pilot trial designed to provide estimates of treatment effects to inform a larger randomized trial
- Open-label design
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Key expert perspectives
Captured external expert commentary on this paper, strongest first. Original sources are linked where available.
“Patients with acute STEMI represent a particularly challenging population, characterized by a dual risk profile: a high risk of ischemic events driven by a heightened prothrombotic and proinflammatory state, and an increased risk of bleeding complications associated with the use of potent antithrombotic therapies during management. Achieving an optimal balance between preventing acute thrombotic events and minimizing major bleeding remains a persistent challenge and an important unmet need in routine clinical practice. Recent advances in polymer-free DES technology may facilitate the adoption of novel antiplatelet strategies aimed at reducing bleeding risk while preserving ischemic protection after primary PCI. STARS DAPT is the first RCT designed to evaluate the non-inferiority of a P2Y12 inhibitor–based SAPT strategy following a very short course of DAPT, compared with the current standard of care of 12-month DAPT, with respect to both major ischemic and bleeding outcomes at one year after primary PCI using the Abluminus np DES. The results of the STARS DAPT trial are expected to provide important insights into the optimal antiplatelet regimen after primary PCI and have the potential to meaningfully improve STEMI care”
MDManish DoshiFounder and Managing Director, Concept Medical Group
“The initiation of patient enrolment in the STARS DAPT trial marks an important milestone for Abluminus np. While contemporary drug-eluting stents have achieved excellent outcomes, challenges such as polymer-related inflammation, late catch-up, and the need for prolonged dual antiplatelet therapy persist. Abluminus np was designed as a polymer-free, sub-micron sirolimus delivery platform to enable more uniform drug distribution across the diseased vessel, extending beyond the stent struts to the stent edges and adjacent vessel segments. The STARS DAPT trial is designed to evaluate whether this approach can support safe and effective reduction in DAPT duration, particularly for patients at increased bleeding risk.”
Implication
Tests early aspirin discontinuation post-STEMI PCI in pilot; leaves open bleeding-ischemic tradeoffs for phase 3.
Abstract
Background Dual antiplatelet therapy (DAPT) for 12 months is the current standard of care for patients with ST-segment elevation myocardial infarction (STEMI) undergoing primary percutaneous coronary intervention (PCI). Recent evidence indicates that potent oral P2Y 12 inhibitor-based single antiplatelet therapy (SAPT) after 1 to 3 months of DAPT following drug-eluting-stent (DES) implantation reduces major bleeding events without increasing the risk of major ischemic outcomes in patients with acute coronary syndrome. However, the optimal timing of aspirin discontinuation in STEMI patients treated with P2Y 12 inhibitor-based SAPT remains uncertain. Design STARS DAPT is an investigator-initiated, prospective, multicenter, open-label, precision-based, randomized controlled pilot trial with a blinded outcome assessment. Patients with STEMI who underwent successful primary PCI of the culprit lesion with a newer-generation polymer-free DES will be randomized in a 1:1 ratio to potent P2Y 12 inhibitor-based SAPT (with aspirin discontinued after an initial period of DAPT during the index hospitalization and before hospital discharge) for 12 months vs. standard DAPT for 12 months. The primary efficacy endpoint is the rate of major adverse cardiac and cerebrovascular events (MACCE), defined as the composite of all-cause death, non-fatal myocardial re-infarction, non-fatal stroke, urgent target vessel revascularization, or definite/probable stent thrombosis, at 12 months. The primary safety endpoint is Bleeding Academic Research Consortium (BARC) class 3 or 5 major bleeding at 12 months. The study is designed to provide estimates of treatment effects and their precision to inform the design of a subsequent larger randomized trial. Enrolment status The trial aims to recruit a total of 350 patients. The first patient was enrolled on December 1, 2025. Conclusion STARS DAPT is a randomized pilot study assessing the safety and efficacy of a potent oral P2Y 12 inhibitor-based SAPT strategy, with aspirin discontinued after an initial period of DAPT during the index hospitalization and before hospital discharge, following primary PCI with a newer-generation polymer-free DES in patients with STEMI. The findings will inform future large-scale trial design and may help optimize antiplatelet strategies and guide clinical decision-making after primary PCI. Trial Registration Clinicaltrials.gov: Identifier, NCT05785897. Funding source Unrestricted research grant from Concept Medical (Tampa, FL, USA) to Geneva University Hospitals, Switzerland.
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Cite This Study
Iglesias et al. (2026) conducted an RCT in ST-segment elevation myocardial infarction (STEMI) undergoing primary percutaneous coronary intervention (n=350). Potent P2Y12 inhibitor-based single antiplatelet therapy (SAPT) with aspirin discontinued before hospital discharge vs. Standard dual antiplatelet therapy (DAPT) for 12 months was evaluated on Major adverse cardiac and cerebrovascular events (MACCE: all-cause death, non-fatal myocardial re-infarction, non-fatal stroke, urgent target vessel revascularization, or definite/probable stent thrombosis) and BARC class 3 or 5 major bleeding at 12 months. Potent P2Y12 inhibitor monotherapy vs 12-month DAPT after primary PCI in 350 STEMI patients is being evaluated in the ongoing STARS DAPT pilot trial (no results yet).