DCB Angioplasty for Coronary Lesions: an OCT Analysis

Coronary Stenosis Clinical Trial

Official title:

Drug-coated Balloon Angioplasty for De-novo or in-Stent Restenotic Coronary Lesions: an Optical Coherence Tomography Analysis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04984135
• Other study ID #: YJ-KY-FB-2021-09
• Status: Completed
• Start date: December 1, 2020
• Est. completion date: July 20, 2021

Study information

• Verified date: August 2021
• Source: The First Affiliated Hospital of Dalian Medical University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

In this study, the investigators preformed OCT before and after DCB treatment, as well as at 6 months of follow-up, to assess the tissue characterization. The aim of this study was to investigate the relationship between quantitative and qualitative OCT findings, angiographic and clinical outcomes after PCB for coronary lesions.

Description:

The paclitaxel drug-coated balloon (DCB) is an emerging device in percutaneous coronary intervention (PCI); it allows a rapid local release of an anti-restenotic drug without the use of a durable polymer or metal scaffold. The DCB has been proven to be effective with paclitaxel in preclinical trials and in clinical practice for the treatment of coronary lesions such as in-stent restenosis (ISR), de novo and bifurcation lesions. Optical coherence tomography (OCT) is an intravascular imaging modality that has higher resolution than intravascular ultrasound. Excellent contrast among lumen, vessel, and stent in OCT images allows accurate measurement of lumen and lesion. However, only a few studies have investigated the effect of DCB on the intimal lumen in the acute phase and during the follow-up using optical coherence tomography (OCT). In this study, the investigators preformed OCT before and after DCB treatment, as well as at 6 months of follow-up, to assess the tissue characterization. Demographic, angiographic, and procedural data were collected. Participants were followed up with coronary angiography and OCT for at least 6-9 months, combined with OCT to analyze qualitative analysis of changes in plaque characterization, and late lumen loss. The participants were followed up for long-term clinical events (including cardiac death, target vessel myocardial infarction, and clinically driven target lesion revascularization).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: July 20, 2021
• Est. primary completion date: July 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• Coronary angiography shows that at least one coronary artery has a diameter stenosis >70% (left main stem diameter stenosis>50%)
• Stable or unstable angina
• Availability for follow-up for up to 12 months

Exclusion Criteria:

• Acute myocardial infarction within 48 hours
• Severe calcified lesions
• Unable to tolerate dual antiplatelet treatment (DAPT)
• Severe abnormal hematopoietic system, such as platelet count of < 100×109/L or > 700×109/L and white blood cell count of < 3×109/L
• Active bleeding or bleeding tendency
• Severe coexisting conditions, such as severe renal insufficiency (GFR < 60 ml/min•1.73m2), severe hepatic dysfunction [elevated ALT (glutamicpyruvic transaminase) or AST (glutamic-oxal acetic transaminase) level by more than three-fold of the normal limitation], acute or chronic heart failure (NYHA III-IV), acute infectious diseases, immune disorders, malignancy, etc.
• Life expectancy < 12 months
• Pregnancy or planning pregnancy
• Drug allergies or contraindications to aspirin, clopidogrel, ticagrelor, statins, contract, anticoagulant, stent, etc.
• Participation or planning to participate in another clinical trial during the same period
• Refusal to comply with the study protocol

Related Conditions & MeSH terms

• Coronary Stenosis
• Drug-coated Balloon

Intervention

Procedure:
• Percutaneous coronary intervention
All patients were treated with a loading dose of clopidogrel 300 or 600 mg before the procedure followed by maintenance clopidogrel 75 mg daily for 6 months. 100 U/ kg of unfractionated heparin was injected intravenously to maintain an activated clotting time = 250 s during the procedure. For DCB treatment, the patient underwent predilation with an optimal-sized balloon (non-compliant balloon or cutting balloon) based on angiography (balloon-to-vessel ratio of 1.0), with the standard balloon shorter than the intended DCB size. The DCB was sized at 1:1 balloon-to-vessel ratio, delivered rapidly (median of 15 s) and inflated at nominal pressure for 60 s.

Locations

Country	Name	City	State
China	The First Affiliated Hospital of Dalian Medical University	Dalian	Liaoning

Sponsors (1)

Lead Sponsor	Collaborator
The First Affiliated Hospital of Dalian Medical University

Country where clinical trial is conducted

China, 

References & Publications (8)

de la Torre Hernández JM, Garcia Camarero T, Lozano Ruiz-Poveda F, Urbano-Carrillo CA, Sánchez Pérez I, Cano-García M, Saez R, Andrés Morist A, Molina E, Pinar E, Torres A, Lezcano EJ, Gutierrez H, Arnold RJ, Zueco J. Angiography and Optical Coherence Tom — View Citation

Fukushima T, Ashikaga T, Yoshikawa S, Hatano Y, Ueshima D, Yamamoto T, Yasuhiro M, Isobe M. Effect of drug-coated balloon on stent restenosis, neointimal proliferation, and coronary dissection: an optical coherence tomography analysis. Coron Artery Dis. 2 — View Citation

Her AY, Shin ES, Chung JH, Kim YH, Garg S, Lee JM, Doh JH, Nam CW, Koo BK. Plaque modification and stabilization after paclitaxel-coated balloon treatment for de novo coronary lesions. Heart Vessels. 2019 Jul;34(7):1113-1121. doi: 10.1007/s00380-019-01346 — View Citation

Liu Y, Zhang YJ, Deng LX, Yin ZY, Hu T, Wang Q, Li Y, Li JY, Guo WY, Mou FJ, Tao L. 12-Month clinical results of drug-coated balloons for de novo coronary lesion in vessels exceeding 3.0 mm. Int J Cardiovasc Imaging. 2019 Apr;35(4):579-586. doi: 10.1007/s — View Citation

Miura K, Tada T, Habara S, Kuwayama A, Shimada T, Ohya M, Murai R, Amano H, Kubo S, Otsuru S, Tanaka H, Fuku Y, Goto T, Kadota K. Optical Coherence Tomography Predictors for Recurrent Restenosis After Paclitaxel-Coated Balloon Angioplasty for Drug-Eluting — View Citation

Rissanen TT, Uskela S, Eränen J, Mäntylä P, Olli A, Romppanen H, Siljander A, Pietilä M, Minkkinen MJ, Tervo J, Kärkkäinen JM; DEBUT trial investigators. Drug-coated balloon for treatment of de-novo coronary artery lesions in patients with high bleeding r — View Citation

Sogabe K, Koide M, Fukui K, Kato Y, Kitajima H, Akabame S, Zen K, Nakamura T, Matoba S. Optical coherence tomography analysis of late lumen enlargement after paclitaxel-coated balloon angioplasty for de-novo coronary artery disease. Catheter Cardiovasc In — View Citation

Tada T, Kadota K, Hosogi S, Miyake K, Ohya M, Amano H, Izawa Y, Kanazawa T, Kubo S, Ichinohe T, Hyoudou Y, Hayakawa Y, Sabbah MM, Otsuru S, Hasegawa D, Habara S, Tanaka H, Fuku Y, Katoh H, Goto T, Mitsudo K. Association between tissue characteristics asse — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	In-segment late lumen loss	Changes to lumen area assessed with the use of OCT	6 months
Secondary	Target lesion failure	The secondary endpoint was the incidence of target lesion failure (TLF), a composite of cardiac death, target vessel myocardial infarction, and clinically driven target lesion revascularization (TLR) at 6 months.	6 months