Drug-Eluting Balloon or Drug-Eluting Stent in Acute Myocardial Infarction: A Randomized Controlled Trial

Официальное название

A Prospective, Randomized, Multicenter, International, Open-Label Clinical Trial Comparing Drug-Coated Balloon and Drug-Eluting Stent for the Treatment of Acute ST-Elevation Myocardial Infarction.

Обзор

The objective of the study is to compare drug-coated balloon (DCB) with the gold standard drug-eluting stent (DES) in percutaneous coronary intervention (PCI) for patients presenting with ST-elevation myocardial infarction (STEMI). Randomization will be performed after successful culprit-lesion preparation and confirmation that all angiographic entry criteria are met. Patients will be randomly assigned in a 1:1 fashion to receive either treatment with a Paclitaxel-coated balloon alone or second or third-generation DES.

Вмешательства

• Устройство Drug (paclitaxel) coated balloon (DCB)
  In the experimental arm, a paclitaxel-coated balloon (DCB) delivering 3.0-3.5 µg/mm² will be used in STEMI patients after successful lesion preparation (defined as residual stenosis ≤30%, TIMI flow grade 2-3, and absence of flow-limiting dissection). If the result after DCB treatment is unsatisfactory, bailout implantation of a drug-eluting stent (DES) will be performed at the operator's discretion.
• Устройство Second-generation Drug Eluting Stent (DES)
  In the control arm, patients randomized to the DES treatment group will undergo implantation of a second-generation drug-eluting stent (DES) using standard techniques, according to current practice guidelines

Первичные конечные точки

• DoCE (Device-oriented composite endpoint) [Срок оценки: 1 year and 2 years]

Вторичные конечные точки (5)

• Individual components of the primary endpoint (DoCE) [Срок оценки: 1 year and 2 years]
• Patient-oriented composite endpoint (PoCE) [Срок оценки: 1 year and 2 years]
• Target vessel revascularization (TVR) [Срок оценки: 1 year and 2 years]
• Target vessel failure (TVF) [Срок оценки: 1 year and 2 years]
• BARC (Bleeding Academic Research Consortium) type 3 and 5 bleeding complications. [Срок оценки: 1 year and 2 years]

Критерии участия

Критерии включения

• Age >18 years with a life expectancy of >1 year;
• Patients fulfilling criteria for STEMI (>20 min of chest-pain; At least 1 mm ST-elevation in at least two contiguous leads, a new left bundle branch block or a true posterior myocardial infarction confirmed by ECG or echocardiography; Reperfusion is expected to be feasible within 12 h after onset of symptoms)
• Infarct related artery eligible for primary PCI (De novo lesion in a native coronary artery; Reference-vessel diameter ≥2.5 mm and ≤ 4 mm; Absence of severe calcification; Residual diameter stenosis of ≤30% (by visual assessment) after lesion preparation after lesion preparation; Absence of coronary dissection type ≥C.

Критерии исключения

• Killip class>II on admission
• Known contraindication for aspirin, clopidogrel, ticagrelor, heparin or GP IIb/IIIa inhibitor
• Previous myocardial infarction
• Previous PCI in the territory of the infarct-related artery (IRA)
• Previous CABG
• 3-vessel disease requiring revascularization
• Left-main disease
• Extremely angulated or severely calcified vessels
• History of ischemic stroke within the past 6 months or hemorrhagic stroke
• Planned CABG for a non-culprit vessel
• Participation in another investigational trial that has not completed its primary endpoint or could interfere with the endpoints of this study

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Сербия · 4 центра

• University Clinical Centre of Nis — Niš
• University Clinical Center of Serbia — Belgrade
• Institute of Cardiovascular Diseases of Vojvodina — Kamenitz
• University Clinical Center of Kragujevac — Kragujevac

Bosnia and Herzegovina · 1 центр

• University Clinical Centre of the Republic of Srpska — Banja Luka

Публикации

• Scheller B, Eccleshall S. Drug-coated balloons for acute coronary syndromes. EuroIntervention. 2024 Jul 1;20(13):e791-e792. doi: 10.4244/EIJ-E-24-00019. No abstract available. PMID 38949238
• Byrne RA, Rossello X, Coughlan JJ, Barbato E, Berry C, Chieffo A, Claeys MJ, Dan GA, Dweck MR, Galbraith M, Gilard M, Hinterbuchner L, Jankowska EA, Juni P, Kimura T, Kunadian V, Leosdottir M, Lorusso R, Pedretti RFE, Rigopoulos AG, Rubini Gimenez M, Thiele H, Vranckx P, Wassmann S, Wenger NK, Ibanez B; ESC Scientific Document Group. 2023 ESC Guidelines for the management of acute coronary syndrom PMID 37740496
• Merinopoulos I, Gunawardena T, Corballis N, Bhalraam U, Reinhold J, Wickramarachchi U, Maart C, Gilbert T, Richardson P, Sulfi S, Sarev T, Sawh C, Wistow T, Ryding A, Mohamed MO, Perperoglou A, Mamas MA, Vassiliou VS, Eccleshall SC. Assessment of Paclitaxel Drug-Coated Balloon Only Angioplasty in STEMI. JACC Cardiovasc Interv. 2023 Apr 10;16(7):771-779. doi: 10.1016/j.jcin.2023.01.380. PMID 37045498
• Fang Z, Ji J, He S, Liu N, Xu B. Drug-Coated Balloon vs. Drug-Eluting Stent in Acute Myocardial Infarction: A Systematic Review and Updated Meta-Analysis. Anatol J Cardiol. 2023 Jul 1;27(8):444-452. doi: 10.14744/AnatolJCardiol.2023.2953. Epub 2023 Jun 15. PMID 37329115
• Wang Z, Yin Y, Li J, Qi W, Yu B, Xu Z, Zhu W, Yang F, Cao M, Zhang H. New Ultrasound-Controlled Paclitaxel Releasing Balloon vs. Asymmetric Drug-Eluting Stent in Primary ST-Segment Elevation Myocardial Infarction - A Prospective Randomized Trial. Circ J. 2022 Mar 25;86(4):642-650. doi: 10.1253/circj.CJ-21-0315. Epub 2021 Nov 10. PMID 34759131
• Hao X, Huang D, Wang Z, Zhang J, Liu H, Lu Y. Study on the safety and effectiveness of drug-coated balloons in patients with acute myocardial infarction. J Cardiothorac Surg. 2021 Jun 21;16(1):178. doi: 10.1186/s13019-021-01525-8. PMID 34154628
• Vos NS, Fagel ND, Amoroso G, Herrman JR, Patterson MS, Piers LH, van der Schaaf RJ, Slagboom T, Vink MA. Paclitaxel-Coated Balloon Angioplasty Versus Drug-Eluting Stent in Acute Myocardial Infarction: The REVELATION Randomized Trial. JACC Cardiovasc Interv. 2019 Sep 9;12(17):1691-1699. doi: 10.1016/j.jcin.2019.04.016. Epub 2019 May 21. PMID 31126887
• Gobic D, Tomulic V, Lulic D, Zidan D, Brusich S, Jakljevic T, Zaputovic L. Drug-Coated Balloon Versus Drug-Eluting Stent in Primary Percutaneous Coronary Intervention: A Feasibility Study. Am J Med Sci. 2017 Dec;354(6):553-560. doi: 10.1016/j.amjms.2017.07.005. Epub 2017 Jul 19. PMID 29208251

Идентификаторы

NCT: NCT06746233 · ICDVojvodina 1482-1/3

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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