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Randomized Controlled Trial
. 2025 May 16;21(10):571-580.
doi: 10.4244/EIJ-D-24-00829.

Prasugrel monotherapy versus standard DAPT in STEMI patients with OCT-guided or angio-guided complete revascularisation: design and rationale of the randomised, multifactorial COMPARE STEMI ONE trial

Valeria Paradies  1   2 , Nicolas M Van Mieghem  2 , Rohit M Oemrawsingh  3 , Gert Richardt  4 , Giovanni Esposito  5 , Gianluca Campo  6 , Francesco Burzotta  7 , Paolo Canova  8 , Axel Linke  9 , Italo Porto  10 , Daniela Trabattoni  11 , Koen Teeuwen  12 , Tom Adriaenssens  13 , Petr Kala  14 , Goran Stankovic  15 , Ria van Vliet  1 , Daniele Giacoppo  16   17   18 , Joost Daemen  2 , Pieter C Smits  1
Affiliations
Randomized Controlled Trial

Prasugrel monotherapy versus standard DAPT in STEMI patients with OCT-guided or angio-guided complete revascularisation: design and rationale of the randomised, multifactorial COMPARE STEMI ONE trial

Valeria Paradies et al. EuroIntervention. .

Abstract

Monotherapy with a potent P2Y12 receptor antagonist after 1 month of dual antiplatelet therapy (DAPT) may reduce bleeding in the absence of increased ischaemic events compared to 12-month DAPT in patients with acute coronary syndrome undergoing percutaneous coronary intervention (PCI). PCI guidance with optical coherence tomography (OCT) may enhance stent expansion. COMPARE STEMI ONE is an international, multicentre, open-label, randomised controlled trial. In 1,656 ST-segment elevation myocardial infarction (STEMI) patients, prasugrel monotherapy after 1 month of DAPT, as compared to standard 12-month prasugrel-based DAPT, will be tested for non-inferiority for the primary composite endpoint of net adverse clinical events - defined as all-cause death, myocardial infarction, stroke, or Bleeding Academic Research Consortium Type 3 or 5 bleeding events - at 11 months after randomisation. Furthermore, an ancillary substudy will test the superiority of OCT-guided versus angiography-guided staged complete revascularisation in achieving a larger minimal stent area (MSA) in non-culprit lesions during staged procedures. COMPARE STEMI ONE is the first randomised controlled trial assessing an abbreviated 1-month DAPT regimen followed by prasugrel monotherapy in the context of STEMI. The trial will also study the value of OCT-guided PCI in terms of the MSA of non-culprit lesions and may elucidate potential synergies between intravascular imaging-guided PCI and abbreviated DAPT regimens. (ClinicalTrials.gov: NCT05491200).

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Conflict of interest statement

V. Paradies declares a research grant from Abbott Vascular via the institution; speaker fees from Abbott Vascular, Boston Scientific, and Elixir; and an educational grant from Terumo via the institution. P.C. Smits has received consultancy fees and institutional research grants from Abbott Vascular. R. M. Oemrawsingh declares speaker fees from Abbott Vascular and an educational grant from Terumo. F. Burzotta declares speakers' fees from Abbott, Abiomed, Medtronic, Edwards Lifesciences, and Terumo. The other authors have no conflicts of interest relevant to the contents of this paper to declare.

References

    1. Capodanno D, Angiolillo DJ. Timing, Selection, Modulation, and Duration of P2Y12 Inhibitors for Patients With Acute Coronary Syndromes Undergoing PCI. JACC Cardiovasc Interv. 2023;16:1–18. - PubMed
    1. Angiolillo DJ, Galli M, Collet JP, Kastrati A, O’Donoghue ML. Antiplatelet therapy after percutaneous coronary intervention. EuroIntervention. 2022;17:e1371–96. - PMC - PubMed
    1. Giustino G, Baber U, Sartori S, Mehran R, Mastoris I, Kini AS, Sharma SK, Pocock SJ, Dangas GD. Duration of dual antiplatelet therapy after drug-eluting stent implantation: a systematic review and meta-analysis of randomized controlled trials. J Am Coll Cardiol. 2015;65:1298–310. - PubMed
    1. Stone GW. Intravascular Imaging Guidance for PCI: A “Real-Time” Updated Network Meta-analysis. Intravascular Imaging Guidance for PCI: A “Real-Time” Updated Network Meta-analysis; ESC 2023; 28 August 2023; Amsterdam, the Netherlands.
    1. Baber U, Dangas G, Angiolillo DJ, Cohen DJ, Sharma SK, Nicolas J, Briguori C, Cha JY, Collier T, Dudek D, Džavik V, Escaned J, Gil R, Gurbel P, Hamm CW, Henry T, Huber K, Kastrati A, Kaul U, Kornowski R, Krucoff M, Kunadian V, Marx SO, Mehta S, Moliterno D, Ohman EM, Oldroyd K, Sardella G, Sartori S, Shlofmitz R, Steg PG, Weisz G, Witzenbichler B, Han YL, Pocock S, Gibson CM, Mehran R. Ticagrelor alone vs. ticagrelor plus aspirin following percutaneous coronary intervention in patients with non-ST-segment elevation acute coronary syndromes: TWILIGHT-ACS. Eur Heart J. 2020;41:3533–45. - PubMed

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