The Safety and Efficacy of New-Generation BRS vs. DCB for De Novo Large Coronary Artery Lesions: A Prospective RCT

Официальное название

The Safety and Efficacy of New-Generation Bioabsorbable Scaffolds Versus Drug-Coated Balloons in the Treatment of De Novo Lesions in Large Coronary Arteries: A Prospective Randomized Controlled Study

Обзор

This study plans to enroll 150 patients who are candidates for "intervention without implantation" therapy and they will be randomly assigned in a 1:1 ratio to either the new-generation Firesorb scaffold group (BRS group, N=75) or the drug-coated balloon group (DCB group, N=75). All enrolled patients will undergo angiographic follow-up at 1 year post-procedure, and serial follow-up (via telephone or outpatient visit) will be performed at 1 month, 6 months, 1 year, 2 years, 3 years, 4 years, and 5 years post-procedure. The primary study endpoint was percentage diameter stenosis at 1 year post-procedure.

Вмешательства

• Устройство bioresorbable scaffold
  75 subjects with de novo large vessel coronary lesions who met the inclusion/exclusion criteria were enrolled; subjects were assigned to the treatment group of BRS.
• Устройство drug-coated balloon
  75 subjects with de novo large vessel coronary lesions who met the inclusion/exclusion criteria were enrolled; subjects were assigned to the treatment group of DCB.

Первичные конечные точки

• percentage diameter stenosis [Срок оценки: 12 months]

Критерии участия

Критерии включения

• \- Radiography inclusion criteria

• angiographically confirmed de novo coronary artery lesion;
• target lesion stenosis must be ≥70% or ≥50% with clear evidence of myocardial ischaemia (visual assessment);
• target lesion vessel diameter is between 2.75mm and 4.0mm, target lesion length must be ≤25mm (visual assessment);
• either one or two target lesions to be treated; if two target lesions, they must be located in different target vessels;
• successful target lesion preparation: residual stenosis ≤30%, no flow-restricting entrapment, and TIMI grade 3 flow; General inclusion criteria

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• subjects at the age between ≥18 and ≤80 years old;
• patients with symptoms or evidence of myocardial ischaemia;
• subjects are willing to participate in the study, sign informed consent form, and accept clinical follow-up after operation.

Критерии исключения

• 1\. in-stent lesions; 2. For the left main disease, chronic total occlusive lesions; 3. bifurcation lesion (reference vessel diameter of side branch vessels > 2.0 mm); 4. Severely calcified lesions and tortuous lesions; lesions that have failed pretreatment; lesions unsuitable for balloon delivery and dilatation; 5. Previous use of any brand of drug-coated balloon in the target vessel. General inclusion criteria

• Any patient with myocardial infarction within one month;
• Patients with severe congestive heart failure (NYHA Level III severe heart failure) or severe valvular heart disease; or left ventricular ejection fraction of less than 40%;
• Patients with stroke, peptic ulcer or gastrointestinal bleeding within the past 6 months; or patients with bleeding tendency or coagulation disorders;
• Patients with severe liver failure (ALT and AST are larger than 3 times of the upper limit of normal value), who are judged to be not applicable to angiography by investigators;
• Patients with severe renal failure(eGFR<30ml/minute) or such medical history, failure to comply with angiography conditions;
• Subjects who are intolerance or allergic to heparin, contrast agent, polyethylene oxide and polylactic acid - glycolic acid polymer;
• Patients who plans to accept selective operation within 1 year;
• Patients who are participating in the clinical trial of other drug or device without reaching the time limit of primary endpoint;
• Subjects who are considered to be not applicable to be enrolled by investigators due to other reasons.

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

Четверное слепое

Основная цель

Лечение

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Публикации

• Yerasi C, Case BC, Forrestal BJ, Torguson R, Weintraub WS, Garcia-Garcia HM, Waksman R. Drug-Coated Balloon for De Novo Coronary Artery Disease: JACC State-of-the-Art Review. J Am Coll Cardiol. 2020 Mar 10;75(9):1061-1073. doi: 10.1016/j.jacc.2019.12.046. PMID 32138967
• Rissanen TT, Uskela S, Eranen J, Mantyla P, Olli A, Romppanen H, Siljander A, Pietila M, Minkkinen MJ, Tervo J, Karkkainen JM; DEBUT trial investigators. Drug-coated balloon for treatment of de-novo coronary artery lesions in patients with high bleeding risk (DEBUT): a single-blind, randomised, non-inferiority trial. Lancet. 2019 Jul 20;394(10194):230-239. doi: 10.1016/S0140-6736(19)31126-2. Epub PMID 31204115
• 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
• Jiang JL, Huang QJ, Chen MH. Efficacy and safety of drug-coated balloon for de novo lesions of large coronary arteries: Systematic review and meta-analysis of randomized controlled trials. Heliyon. 2024 Jan 30;10(3):e25264. doi: 10.1016/j.heliyon.2024.e25264. eCollection 2024 Feb 15. PMID 38333846
• Yu X, Wang X, Ji F, Zhang W, Yang C, Xu F, Wang F. Correction to: A Non-inferiority, Randomized Clinical Trial Comparing Paclitaxel-Coated Balloon Versus New-Generation Drug-Eluting Stents on Angiographic Outcomes for Coronary De Novo Lesions. Cardiovasc Drugs Ther. 2022 Dec;36(6):1261-1262. doi: 10.1007/s10557-021-07183-1. No abstract available. PMID 33842993
• 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
• Vos NS, Amoroso G, Herrman JR, Patterson MS, van der Schaaf RJ, Slagboom T, Vink MA. Pronounced late acquired focal coronary artery dilatation after paclitaxel-coated balloon angioplasty: observations from the randomized REVascularization With PaclitaxEL-Coated Balloon Angioplasty Versus Drug-Eluting Stenting in Acute Myocardial InfarcTION (REVELATION) trial. Coron Artery Dis. 2022 Mar 1;33(2):151 PMID 35112669
• Shin ES, Lee JM, Her AY, Chung JH, Eun Lee K, Garg S, Nam CW, Doh JH, Koo BK. Prospective randomized trial of paclitaxel-coated balloon versus bare-metal stent in high bleeding risk patients with de novo coronary artery lesions. Coron Artery Dis. 2019 Sep;30(6):425-431. doi: 10.1097/MCA.0000000000000755. PMID 31009399

Идентификаторы

NCT: NCT07162792 · 2025-02-011-H01

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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