DEBSCAN-IVL. Drug Eluting Balloon or Drug Eluting Stent to Treat CAlcified Nodules After IntraVascular Lithotripsy.

Обзор

International, investigator-driven, multicenter, open-label, prospective randomized controlled trial where patients with de novo lesions due to calcified nodules (CN) were randomized to drug eluting balloon (DEB) or drug eluting stents (DES).

Подробное описание

Regardless some observational data of DEB performance in calcified lesions, there is a lack of data about the safety and efficacy in the setting of calcified nodules. However, a "leave-nothing-behind" PCI strategy is attractive in this scenario in which the probability of non-optimal stent expansion and apposition is higher, hypothesis is, that following optimal plaque modification with IVL, the utilization of a DEB is either non-inferior or possibly superior to DES in terms of late lumen loss and net luminal gain at 6 months follow up.

Вмешательства

• Устройство Percutaneous coronary intervention of a calcified nodule with intravascular lithotripsy followed by drug eluting balloon
  Percutaneous coronary intervention of a calcified nodule with intravascular lithotripsy followed by drug eluting balloon
• Устройство Percutaneous coronary intervention of a calcified nodule with intravascular lithotripsy followed by drug eluting stent
  Percutaneous coronary intervention of a calcified nodule with intravascular lithotripsy followed by drug eluting stent

Первичные конечные точки

• EFFICACY: Late Lumen Loss (LLL) [Срок оценки: 9 Month]
• EFFICACY: Net Lumen Gain (NLG) [Срок оценки: 9 Month]

Вторичные конечные точки (12)

• SAFETY: Dissection [Срок оценки: During Percutaneous Coronary Intervention (PCI)]
• SAFETY: Perforation [Срок оценки: During Percutaneous Coronary Intervention (PCI)]
• SAFETY: Abrupt vessel closure [Срок оценки: During Percutaneous Coronary Intervention (PCI)]
• SAFETY: Slow Flow [Срок оценки: During Percutaneous Coronary Intervention (PCI)]
• SAFETY: No Reflow [Срок оценки: During Percutaneous Coronary Intervention (PCI)]
• SAFETY: Thrombosis [Срок оценки: During Percutaneous Coronary Intervention (PCI)]
• SAFETY: MACE [Срок оценки: Up to 30 days]
• SAFETY: Stent Thrombosis [Срок оценки: During hospitalization]
• SAFETY: Major bleeding event [Срок оценки: During hospitalization]
• SAFETY: Stent Thrombosis [Срок оценки: During hospitalization]
• SAFETY: Hemodynamic stability [Срок оценки: During hospitalization]
• EFFICACY: Minimal Lumen Diameter (MLD) [Срок оценки: Day 0]

Критерии участия

Критерии включения

Patients must meet all inclusion criteria:

• Patients >18 years admitted for stable coronary artery disease or acute coronary syndromes and indication for percutaneous coronary intervention (PCI) and
• Severe coronary lesion with calcified nodule, confirmed with intracoronary imaging (optical coherence tomography or intravascular ultrasound) and;
• Lesion to treat in a vessel between 2.5 and 4 mm.

Критерии исключения

Patients must not meet any criteria

• Inability to provide oral and written informed consent or unwillingness to come back for systematic angiographic follow-up.
• Pregnant or breastfeeding patients.
• Cardiogenic Shock or Cardiac arrest at the moment of the index procedure.
• Impossibility to maintain double antiplatelet treatment during at least 1 month.
• Life expectancy <1 year.
• Index lesion at left main stem.
• Aorto-ostial lesion.
• Target lesion previously treated with stents or DEB.
• High thrombus burden in the target lesion (TIMI thrombus scale≥3).

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

Испания · 13 центров

• Hospital Del Mar — Barcelona
• Hospital Universitario de La Paz — Fuencarral-El Pardo
• Hospital Universitario de Galdakao-Usansolo — Galdakao
• Hospital Universitario de León — León
• Hospital Universitario 12 de Octubre — Madrid
• Hospital Universitario Puerta de Hierro — Madrid
• Hospital Clínico San Carlos — Moncloa-Aravaca
• Hospital Universitario de Navarra — Pamplona
• … и ещё 5 центров

Нидерланды · 1 центр

• Leiden University Medical Center — Leiden

Публикации

• Jurado-Román A, Gómez-Menchero A, Gonzalo N, et al. Plaque modification techniques to treat calcified coronary lesions. Position paper from the ACI-SEC. REC Interv Cardiol Engl Ed. Published online February 7, 2023:9672. doi:10.24875/RECICE.M22000345
• Morofuji T, Kuramitsu S, Shinozaki T, Jinnouchi H, Sonoda S, Domei T, Hyodo M, Shirai S, Ando K. Clinical impact of calcified nodule in patients with heavily calcified lesions requiring rotational atherectomy. Catheter Cardiovasc Interv. 2021 Jan 1;97(1):10-19. doi: 10.1002/ccd.28896. Epub 2020 Apr 7. PMID 32259392
• Lee T, Mintz GS, Matsumura M, Zhang W, Cao Y, Usui E, Kanaji Y, Murai T, Yonetsu T, Kakuta T, Maehara A. Prevalence, Predictors, and Clinical Presentation of a Calcified Nodule as Assessed by Optical Coherence Tomography. JACC Cardiovasc Imaging. 2017 Aug;10(8):883-891. doi: 10.1016/j.jcmg.2017.05.013. PMID 28797410
• Sato T, Matsumura M, Yamamoto K, Shlofmitz E, Moses JW, Khalique OK, Thomas SV, Tsoulios A, Cohen DJ, Mintz GS, Shlofmitz RA, Jeremias A, Ali ZA, Maehara A. Impact of Eruptive vs Noneruptive Calcified Nodule Morphology on Acute and Long-Term Outcomes After Stenting. JACC Cardiovasc Interv. 2023 May 8;16(9):1024-1035. doi: 10.1016/j.jcin.2023.03.009. PMID 37164599
• Ali ZA, Nef H, Escaned J, Werner N, Banning AP, Hill JM, De Bruyne B, Montorfano M, Lefevre T, Stone GW, Crowley A, Matsumura M, Maehara A, Lansky AJ, Fajadet J, Di Mario C. Safety and Effectiveness of Coronary Intravascular Lithotripsy for Treatment of Severely Calcified Coronary Stenoses: The Disrupt CAD II Study. Circ Cardiovasc Interv. 2019 Oct;12(10):e008434. doi: 10.1161/CIRCINTERVENTIONS.11 PMID 31553205
• Ho HH, Lee JH, Khoo DZL, Hpone KKS, Li KFC. Shockwave intravascular lithotripsy and drug-coated balloon angioplasty in calcified coronary arteries: preliminary experience in two cases. J Geriatr Cardiol. 2021 Aug 28;18(8):689-691. doi: 10.11909/j.issn.1671-5411.2021.08.009. No abstract available. PMID 34527034
• Iwasaki Y, Koike J, Ko T, Funatsu A, Kobayashi T, Ikeda T, Nakamura S. Comparison of drug-eluting stents vs. drug-coated balloon after rotational atherectomy for severely calcified lesions of nonsmall vessels. Heart Vessels. 2021 Feb;36(2):189-199. doi: 10.1007/s00380-020-01684-z. Epub 2020 Aug 28. PMID 32857188

Идентификаторы

NCT: NCT06657833 · EPIC40-DEBSCAN-IVL

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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