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

NCT06746233 | Recruiting

• 1 other identifier: ICDVojvodina 1482-1/3
• Study Type: interventional
• Target: 598
• Locations: 2 countries
• Sites: 5

Brief Summary

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.

Conditions

ST Elevation Myocardial Infarction (STEMI)

Keywords

STEMI; DES; DCB

Outcome Measures

Primary Outcomes (1)

• DoCE (Device-oriented composite endpoint)

  DoCE: A composite endpoint consisting of cardiac mortality, non-fatal target vessel myocardial infarction (NF-TVMI), and target lesion revascularization (TLR).

  1 year and 2 years

Secondary Outcomes (5)

• Individual components of the primary endpoint (DoCE)

  1 year and 2 years

• Patient-oriented composite endpoint (PoCE)

  1 year and 2 years

• Target vessel revascularization (TVR)

  1 year and 2 years

• Target vessel failure (TVF)

  1 year and 2 years

• BARC (Bleeding Academic Research Consortium) type 3 and 5 bleeding complications.

  1 year and 2 years

Study Arms (2)

Drug coated balloon (DCB)

EXPERIMENTAL

Drug (paclitaxel) coated balloon (DCB) with concentration of 3-3.5 μg Paclitaxel per 1 mm2

Device: Drug (paclitaxel) coated balloon (DCB)

Second generation of drug eluting stents (DES)

ACTIVE COMPARATOR

Drug eluting stent (DES)

Device: Second-generation Drug Eluting Stent (DES)

Interventions

Drug (paclitaxel) coated balloon (DCB) DEVICE

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.

Drug coated balloon (DCB)

Second-generation Drug Eluting Stent (DES) DEVICE

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

Second generation of drug eluting stents (DES)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Institute of Cardiovascular Diseases, Vojvodina: lead

Study Sites (5)

University Clinical Centre of the Republic of Srpska

Banja Luka, 21204, Bosnia and Herzegovina

RECRUITING

University Clinical Centre of Nis

Niš, Serbia, 18105, Serbia

NOT YET RECRUITING

University Clinical Center of Serbia

Belgrade, 11000, Serbia

RECRUITING

Institute of Cardiovascular Diseases of Vojvodina

Kamenitz, 21204, Serbia

RECRUITING

University Clinical Center of Kragujevac

Kragujevac, 34000, Serbia

NOT YET RECRUITING

Related Publications (17)

• 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 RESULT

• 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 syndromes. Eur Heart J Acute Cardiovasc Care. 2024 Feb 9;13(1):55-161. doi: 10.1093/ehjacc/zuad107. No abstract available.

  PMID: 37740496 RESULT

• 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 RESULT

• 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 RESULT

• 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 RESULT

• 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 RESULT

• 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 RESULT

• 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 RESULT

• Jeger RV, Farah A, Ohlow MA, Mangner N, Mobius-Winkler S, Leibundgut G, Weilenmann D, Wohrle J, Richter S, Schreiber M, Mahfoud F, Linke A, Stephan FP, Mueller C, Rickenbacher P, Coslovsky M, Gilgen N, Osswald S, Kaiser C, Scheller B; BASKET-SMALL 2 Investigators. Drug-coated balloons for small coronary artery disease (BASKET-SMALL 2): an open-label randomised non-inferiority trial. Lancet. 2018 Sep 8;392(10150):849-856. doi: 10.1016/S0140-6736(18)31719-7. Epub 2018 Aug 28.

  PMID: 30170854 RESULT

• Tang Y, Qiao S, Su X, Chen Y, Jin Z, Chen H, Xu B, Kong X, Pang W, Liu Y, Yu Z, Li X, Li H, Zhao Y, Wang Y, Li W, Tian J, Guan C, Xu B, Gao R; RESTORE SVD China Investigators. Drug-Coated Balloon Versus Drug-Eluting Stent for Small-Vessel Disease: The RESTORE SVD China Randomized Trial. JACC Cardiovasc Interv. 2018 Dec 10;11(23):2381-2392. doi: 10.1016/j.jcin.2018.09.009.

  PMID: 30522667 RESULT

• Indermuehle A, Bahl R, Lansky AJ, Froehlich GM, Knapp G, Timmis A, Meier P. Drug-eluting balloon angioplasty for in-stent restenosis: a systematic review and meta-analysis of randomised controlled trials. Heart. 2013 Mar;99(5):327-33. doi: 10.1136/heartjnl-2012-302945. Epub 2013 Jan 18.

  PMID: 23335497 RESULT

• Kawai T, Watanabe T, Yamada T, Morita T, Furukawa Y, Tamaki S, Kawasaki M, Kikuchi A, Seo M, Nakamura J, Tachibana K, Kida H, Sotomi Y, Sakata Y, Fukunami M. Coronary vasomotion after treatment with drug-coated balloons or drug-eluting stents: a prospective, open-label, single-centre randomised trial. EuroIntervention. 2022 Jun 3;18(2):e140-e148. doi: 10.4244/EIJ-D-21-00636.

  PMID: 34757917 RESULT

• Kleber FX, Schulz A, Waliszewski M, Hauschild T, Bohm M, Dietz U, Cremers B, Scheller B, Clever YP. Local paclitaxel induces late lumen enlargement in coronary arteries after balloon angioplasty. Clin Res Cardiol. 2015 Mar;104(3):217-25. doi: 10.1007/s00392-014-0775-2. Epub 2014 Oct 28.

  PMID: 25349065 RESULT

• Ann SH, Balbir Singh G, Lim KH, Koo BK, Shin ES. Anatomical and Physiological Changes after Paclitaxel-Coated Balloon for Atherosclerotic De Novo Coronary Lesions: Serial IVUS-VH and FFR Study. PLoS One. 2016 Jan 29;11(1):e0147057. doi: 10.1371/journal.pone.0147057. eCollection 2016.

  PMID: 26824602 RESULT

• Madhavan MV, Kirtane AJ, Redfors B, Genereux P, Ben-Yehuda O, Palmerini T, Benedetto U, Biondi-Zoccai G, Smits PC, von Birgelen C, Mehran R, McAndrew T, Serruys PW, Leon MB, Pocock SJ, Stone GW. Stent-Related Adverse Events >1 Year After Percutaneous Coronary Intervention. J Am Coll Cardiol. 2020 Feb 18;75(6):590-604. doi: 10.1016/j.jacc.2019.11.058.

  PMID: 32057373 RESULT

• De Luca G, Damen SA, Camaro C, Benit E, Verdoia M, Rasoul S, Liew HB, Polad J, Ahmad WA, Zambahari R, Postma S, Kedhi E, Suryapranata H; Collaborators. Final results of the randomised evaluation of short-term dual antiplatelet therapy in patients with acute coronary syndrome treated with a new-generation stent (REDUCE trial). EuroIntervention. 2019 Dec 6;15(11):e990-e998. doi: 10.4244/EIJ-D-19-00539.

  PMID: 31422929 RESULT

• Keeley EC, Boura JA, Grines CL. Primary angioplasty versus intravenous thrombolytic therapy for acute myocardial infarction: a quantitative review of 23 randomised trials. Lancet. 2003 Jan 4;361(9351):13-20. doi: 10.1016/S0140-6736(03)12113-7.

  PMID: 12517460 RESULT

MeSH Terms

Conditions

ST Elevation Myocardial Infarction

Interventions

Dosage Forms

Condition Hierarchy (Ancestors)

Myocardial Infarction; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis

Intervention Hierarchy (Ancestors)

Pharmaceutical Preparations; Technology, Pharmaceutical; Investigative Techniques

Study Officials

• Mila Kovačević, MD, PhD

  Institute of Cardiovascular Diseases of Vojvodina

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mila Kovačević, MD, PhD

CONTACT

+381601594444; milakov979@gmail.com

Branislav Crnomarković, MD

CONTACT

+381642636495; branislavc.89@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor, MD, PhD

Study Record Dates

• First Submitted: December 13, 2024
• First Posted: December 24, 2024
• Study Start: December 25, 2024
• Primary Completion (Estimated): December 1, 2028
• Study Completion (Estimated): December 1, 2028
• Last Updated: March 30, 2026

Record last verified: 2026-03

Locations

BO (1); SE (4)