Single vs. Dual Antiplatelet Therapy in Patients Undergoing Percutaneous Intervention With DCB-only Strategy (KONG-FREEDOM-I)

Официальное название

An Investigator-initiated, Multicenter, Open-label, Randomized Controlled Non-inferiority Trial to Assess the Single vs. Dual Antiplatelet Therapy in the Chronic Coronary Syndrome (CCS) and Stable Acute Coronary Syndrome (S-ACS) Patients Undergoing Percutaneous Intervention With Drug-coated Balloons (DCB)-Only Strategy (KONG-FREEDOM-I)

Обзор

This investigator-initiated, multicenter, open-label, randomized clinical trial evaluates the safety and efficacy of single antiplatelet therapy (SAPT) utilizing a P2Y12 inhibitor compared to dual antiplatelet therapy (DAPT) in the chronic coronary syndrome (CCS) and stable Acute Coronary Syndrome (S-ACS) patients undergoing percutaneous coronary intervention (PCI) with the latest generation rapamycin drug-coated balloon (DCB) without stent implantation. The study aims to assess rates of ischemic and bleeding adverse events.

Подробное описание

The purpose of the KONG-FREEDOM-I study is to evaluate the efficacy and safety of single antiplatelet therapy (SAPT) utilizing a P2Y12 inhibitor after successful PCI with the Fireliums coronary rapamycin drug-eluting balloon without stent implantation in coronary artery disease in vessels with a diameter between 2.0 and 4.5 mm, compared to routine dual antiplatelet therapy (DAPT). Patients with chronic coronary syndrome (CCS) and stable Acute Coronary Syndrome (S-ACS) will be enrolled and randomized in this study.

Вмешательства

• Устройство Drug-coated balloon
  Fireliums rapamycin eluting coronary balloon dilatation catheter is a rapid exchange catheter, it has a patented microcrystalline coating process to ensure rapid drug delivery to the blood vessel wall and achieve a long-lasting sustained release effect, intended for coronary arteries percutaneous transluminal angioplasties. Patients assigned to this arm will be treated with a Drug-Coated Balloon (DCB) after pre-dilatation, the angiography will be conducted as standard of care.
• Препарат Single antiplatelet therapy (SAPT)
  The antithrombotic regimen is single antiplatelet (P2Y12 inhibitor）therapy (SAPT). The Investigator will decide whether to use ticagrelor first; if ticagrelor is not the first-line recommended drug, then clopidogrel will be considered. The type of agent and treatment duration will be selected according to the clinical characteristics of the patient.
• Препарат Dual antiplatelet therapy (DAPT)
  The antithrombotic regimen will follow the standard of care with a dual antiplatelet regimen (DAPT) per local preferences and international guidelines/ARC consensus paper. The type of agent and treatment duration will be selected according to the patient's clinical characteristics.

Первичные конечные точки

• Rate of Net Adverse Clinical Events (NACE) at 12 months after randomization [Срок оценки: 12 months after randomization]

Вторичные конечные точки (3)

• Rate of Clinically Relevant Bleeding Events (Bleeding Academic Research Consortium [BARC] Scale, Grades 2-5; range 0-5, where higher grades indicate more severe bleeding and worse clinical outcome) [Срок оценки: 1, 3, 6, 12 and 24 months after randomization]
• Patient-oriented composite endpoint (PoCE) [Срок оценки: 1, 3, 6, 12 and 24 months after randomization]
• Device-oriented Composite Endpoint (DoCE) [Срок оценки: 1, 3, 6, 12 and 24 months after randomization]

Критерии участия

Критерии включения

Subjects who successfully underwent percutaneous coronary intervention (PCI) with drug-coated balloon (DCB) treatment without stent implantation are eligible for inclusion in this study if Male and female patients who meet the following criteria：

• Age ≥ 18 years.
• target lesion in vessels with diameter ≥2.0 and ≤4.5 mm (visual estimation).
• the total target vessels ≤2 and a total of target lesions ≤2.
• Total length of DCB used for target lesions <60 mm.
• The subject's indication for PCI is chronic coronary syndrome (CCS) and stable Acute Coronary Syndrome (S-ACS), include Silent Ischemia, stable angina (SA), unstable angina (UA), non-ST-segment elevation myocardial (NSTEMI), or ST-segment elevation acute myocardial infarction (STEMI) with onset >2 weeks.
• All lesions were successfully treated with a drug-eluting balloon during routine clinical practice, i.e., post-procedural angiographic visual diameter stenosis <30%.
• At the operator's discretion, no flow-limiting angiographic complications requiring extension of dual antiplatelet therapy (DAPT)have occurred.
• All PCI stages have been completed (if applicable), and no further PCI procedures are planned.

Inclusion criteria at the randomization visit within 24 hours post-index PCI:

At the time of the randomization visit (within 24 hours after successful drug-eluting balloon treatment during index PCI), the following criteria mustbe met:

The subject must have had an uneventful clinical course within 24 hours post-index PCI, i.e., no myocardial infarction,symptomatic restenosis, device-related thrombus formation, stroke, or any revascularization procedure (coronary or non-coronary)requiring extension of dual antiplatelet therapy.

Критерии исключения

Patients will be ineligible if they meet any of the following criteria:

• Stent implantation within 6 months prior to index percutaneous coronary intervention (PCI).
• Treatment for in-stent thrombosis (IST) at the time of index PCI or within 6 months prior to it.
• Treatment with a bioabsorbable stent at any time prior to index PCI.
• Acute myocardial infarction with ST-segment elevation within the past two weeks.
• True bifurcation lesions requiring treatment with two stents (Medina 1,1,1/1,0,1/0,1,1) with a branch vessel diameter≥2.5 mm (visual estimation).
• Chronic total occlusion of the target lesion (≥3 months).
• Unprotected left main coronary artery.
• Thrombus present in the target lesion (imaging/visual).
• Total length of DCB used in the target lesion ≥60 mm.
• Active bleeding requiring medical intervention (BARC ≥2) at the time of randomization.
• Indications for long-term oral anticoagulation therapy.
• Life expectancy of less than 1 year.
• Known allergy or hypersensitivity to aspirin, clopidogrel, ticagrelor, or sirolimus.
• Currently participating in another trial and has not yet reached the primary endpoint.
• History of asthma induced by salicylates or substances with similar effects (particularly nonsteroidal anti-inflammatory drugs).
• Pregnant or breastfeeding women.
• Inability to understand and follow study-related instructions or to comply with the study protocol.
• Inability to provide written informed consent

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

Простое слепое

Основная цель

Лечение

Центры проведения

Китай · 14 центров

• Beijing Luhe Hospital — Пекин
• The First Affiliated Hospital of Hainan Medical University — Haikou
• The 2nd Affiliated Hospital of Harbin Medical University — Харбин
• The Second Affiliated Hospital of Nanchang University — Nanchang
• Heze Municipal Hospital — Heze
• Shandong Provincial Hospital — Цзинань
• Shandong Provincial Third Hospital — Цзинань
• Affiliated Hospital of Jining Medical University — Jining
• … и ещё 6 центров

Публикации

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• Valgimigli M, Garcia-Garcia HM, Vrijens B, Vranckx P, McFadden EP, Costa F, Pieper K, Vock DM, Zhang M, Van Es GA, Tricoci P, Baber U, Steg G, Montalescot G, Angiolillo DJ, Serruys PW, Farb A, Windecker S, Kastrati A, Colombo A, Feres F, Juni P, Stone GW, Bhatt DL, Mehran R, Tijssen JGP. Standardized classification and framework for reporting, interpreting, and analysing medication non-adherence i PMID 29992264
• Mehran R, Rao SV, Bhatt DL, Gibson CM, Caixeta A, Eikelboom J, Kaul S, Wiviott SD, Menon V, Nikolsky E, Serebruany V, Valgimigli M, Vranckx P, Taggart D, Sabik JF, Cutlip DE, Krucoff MW, Ohman EM, Steg PG, White H. Standardized bleeding definitions for cardiovascular clinical trials: a consensus report from the Bleeding Academic Research Consortium. Circulation. 2011 Jun 14;123(23):2736-47. doi: 1 PMID 21670242
• Sabatine MS, Morrow DA, Giugliano RP, Burton PB, Murphy SA, McCabe CH, Gibson CM, Braunwald E. Association of hemoglobin levels with clinical outcomes in acute coronary syndromes. Circulation. 2005 Apr 26;111(16):2042-9. doi: 10.1161/01.CIR.0000162477.70955.5F. Epub 2005 Apr 11. PMID 15824203
• Wiviott SD, Braunwald E, McCabe CH, Montalescot G, Ruzyllo W, Gottlieb S, Neumann FJ, Ardissino D, De Servi S, Murphy SA, Riesmeyer J, Weerakkody G, Gibson CM, Antman EM; TRITON-TIMI 38 Investigators. Prasugrel versus clopidogrel in patients with acute coronary syndromes. N Engl J Med. 2007 Nov 15;357(20):2001-15. doi: 10.1056/NEJMoa0706482. Epub 2007 Nov 4. PMID 17982182
• Rao SV, O'Grady K, Pieper KS, Granger CB, Newby LK, Van de Werf F, Mahaffey KW, Califf RM, Harrington RA. Impact of bleeding severity on clinical outcomes among patients with acute coronary syndromes. Am J Cardiol. 2005 Nov 1;96(9):1200-6. doi: 10.1016/j.amjcard.2005.06.056. Epub 2005 Sep 12. PMID 16253582
• Lansky AJ, Messe SR, Brickman AM, Dwyer M, van der Worp HB, Lazar RM, Pietras CG, Abrams KJ, McFadden E, Petersen NH, Browndyke J, Prendergast B, Ng VG, Cutlip DE, Kapadia S, Krucoff MW, Linke A, Moy CS, Schofer J, van Es GA, Virmani R, Popma J, Parides MK, Kodali S, Bilello M, Zivadinov R, Akar J, Furie KL, Gress D, Voros S, Moses J, Greer D, Forrest JK, Holmes D, Kappetein AP, Mack M, Baumbach A PMID 28183511
• Thygesen K, Alpert JS, Jaffe AS, Chaitman BR, Bax JJ, Morrow DA, White HD; Executive Group on behalf of the Joint European Society of Cardiology (ESC)/American College of Cardiology (ACC)/American Heart Association (AHA)/World Heart Federation (WHF) Task Force for the Universal Definition of Myocardial Infarction. Fourth Universal Definition of Myocardial Infarction (2018). Circulation. 2018 Nov 1 PMID 30571511

Идентификаторы

NCT: NCT07587099 · JYFY-CV-001

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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