STEMI Treated With a Polymer-free Sirolimus-coated Stent and P2Y12 Inhibitor-based SAPT Versus Conventional DAPT
ST-segment Elevation Myocardial infArction Treated With a Polymer-free Sirolimus-based nanocarrieR Eluting Stent and a P2Y12 Inhibitor-based Aspirin-free Single Antiplatelet Strategy Versus Conventional Dual AntiPlatelet Therapy
IGLESIAS Juan Fernando
350 participants
Nov 1, 2025
INTERVENTIONAL
Conditions
Summary
Primary percutaneous coronary intervention (PCI) is the preferred revascularization strategy for patients with acute ST-segment elevation myocardial infarction (STEMI). Compared with bare-metal stents (BMS) and early-generation thick-strut polymer-based drug-eluting stents (DES), newer-generation DES with thinner strut stent platforms and durable or biodegradable polymers have been shown to improve long-term safety and efficacy outcomes among patients with STEMI. Accordingly, the use of newer-generation DES over BMS is currently recommended by the most recent guidelines. Vessel healing at the culprit site after DES implantation is however substantially delayed in patients with acute STEMI as compared to those with chronic coronary syndromes and is associated with a long-term risk for recurrent stent-related adverse clinical outcomes. These findings highlight the need for future iterations in modern DES technology to further improve clinical outcomes following PCI in this highest-risk patient subset. Current guidelines recommend dual antiplatelet therapy (DAPT) consisting of aspirin and a potent P2Y12 receptor inhibitor for 12 months after primary PCI for STEMI, unless there are contraindications such as excessive risk of bleeding. A recent meta-analysis of five large-scale randomized clinical trials including a total of 32'145 patients, of whom 4,070 (12.7%) patients were treated for STEMI, indicated that 1-3 months of DAPT followed by P2Y12 inhibitor-based single antiplatelet therapy (SAPT) after second-generation DES implantation in patients with chronic and acute coronary syndromes was associated with lower risk for major bleeding and similar risk for stent thrombosis, all-cause death, myocardial infarction, and stroke compared with conventional DAPT. These findings suggest that a potent P2Y12 inhibitor-based SAPT following a short DAPT course (1-3 months) may represent a preferable treatment option, which is associated with similar ischemic, but lower bleeding risk, for patients undergoing PCI with newer-generation DES compared to standard conventional 12 months DAPT. The question of whether SAPT using a potent oral P2Y12 inhibitor (ticagrelor or prasugrel) without aspirin (aspirin-free strategy) after primary PCI with a newest-generation thin-strut polymer-free drug-eluting stent is safe and effective compared to a conventional guideline-recommended 6- to 12-month DAPT course among patients with STEMI remains uncertain.
Eligibility
Inclusion Criteria4
- Age ≥18 years.
- Subjects who have received DAPT consisting of aspirin and any of the commercially available P2Y12 receptor inhibitors (ticagrelor, prasugrel, or clopidogrel) at the time of STEMI diagnosis, or at the very latest at the time of primary PCI.
- Subjects with ≥1 acute infarct artery target vessel with ≥1 coronary artery stenosis in a native coronary artery with diameter from 2.25 to 4.0 mm who underwent successful primary PCI, defined as primary PCI with ≥1 Abluminus NP polymer-free sirolimus-based nanocarrier eluting stent (Concept Medical Inc., India) implantation, and final residual stenosis \<30% by visual estimation or 20% by quantitative coronary angiography (QCA) \[38\].
- Subject willing to participate and able to understand, read and sign the informed consent form.
Exclusion Criteria11
- Known allergy or intolerance to aspirin, ticagrelor, prasugrel, or sirolimus.
- Inability to adhere to DAPT for at least 6 months.
- Patient already on DAPT at index presentation due to recent PCI for chronic coronary syndrome (\<6 months) or ACS (\<12 months).
- Patient on chronic oral anticoagulation at index presentation.
- Patient with mechanical complication of STEMI.
- Patient with STEMI due to stent thrombosis.
- Planned non-cardiac surgery that cannot be postponed for at least 6 months.
- Participation or planned participation in another interventional clinical trial.
- Life expectancy \<1 years.
- Pregnancy.
- Unwillingness or inability (e.g. physical or cognitive) to comply with study procedure, medication adherence and schedule.
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Interventions
'All-comer' subjects with acute STEMI undergoing primary PCI according to current ESC guidelines will be eligible. Eligible subjects will be pre-treated with DAPT consisting of aspirin (loading dose: 150-300 mg orally or 80-500 mg intravenously, maintenance dose: 75-100 mg daily orally) and a potent P2Y12 receptor inhibitor, either ticagrelor (loading dose: 180 mg orally, maintenance dose: 90 mg bd orally) or prasugrel (loading dose: 60 mg orally, maintenance dose: 10 mg od orally or 5 mg od orally if age \>75 years or weight \<60 kg) at the time of STEMI diagnosis, or at the very latest at the time of primary PCI. Successful primary PCI, defined as primary PCI of the culprit lesion with ≥1 Abluminus NP polymer-free sirolimus-based nanocarrier eluting stent (Concept Medical Inc., India) implantation and final residual stenosis \<30% by visual estimation or 20% by QCA.
Locations(2)
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NCT05785897