OPtical frequency domain imaging vs. INtravascular ultrasound in percutaneous coronary InterventiON in patients with Acute Coronary Syndrome: Study protocol for a randomized controlled trial.
Acute Coronary Syndrome
/ surgery
Aged
Drug-Eluting Stents
Equivalence Trials as Topic
Female
Humans
Japan
Male
Middle Aged
Percutaneous Coronary Intervention
/ methods
Prospective Studies
Randomized Controlled Trials as Topic
Sirolimus
/ administration & dosage
Surgery, Computer-Assisted
/ methods
Tomography, Optical Coherence
/ methods
Treatment Outcome
Ultrasonography, Interventional
/ methods
Intravascular ultrasound
Optical coherence tomography
Optical frequency domain imaging
Journal
Journal of cardiology
ISSN: 1876-4738
Titre abrégé: J Cardiol
Pays: Netherlands
ID NLM: 8804703
Informations de publication
Date de publication:
09 2020
09 2020
Historique:
received:
17
02
2020
revised:
17
03
2020
accepted:
22
03
2020
pubmed:
29
4
2020
medline:
18
5
2021
entrez:
29
4
2020
Statut:
ppublish
Résumé
A recent clinical trial demonstrated that optical frequency domain imaging (OFDI) guidance in percutaneous coronary intervention (PCI) is noninferior to intravascular ultrasound (IVUS) guidance in patients with coronary artery disease with regard to target vessel failure (composed of cardiac death, myocardial infarction attributed to the target vessel, and clinically-driven target vessel revascularization) at 12 months. The impact of OFDI guidance in PCI for patients with acute coronary syndrome (ACS) remains uncertain. OPINION ACS is a multicenter, prospective, randomized, controlled, open-label, parallel group, non-inferiority trial in Japan. Eligible patients will be randomly assigned to receive either OFDI- or IVUS-guided PCI. PCI is performed using the sirolimus-eluting stent in accordance with certain OFDI and IVUS criteria for optimal stent deployment. All patients will undergo follow-up angiography and OFDI imaging at 8 months. The primary endpoint is the minimum lumen area, as measured by OFDI at 8 months. The OPINION ACS trial outcomes will provide insights regarding the impact of OFDI-guided PCI on in-stent restenosis at 8 months in patients with ACS.
Sections du résumé
BACKGROUND
A recent clinical trial demonstrated that optical frequency domain imaging (OFDI) guidance in percutaneous coronary intervention (PCI) is noninferior to intravascular ultrasound (IVUS) guidance in patients with coronary artery disease with regard to target vessel failure (composed of cardiac death, myocardial infarction attributed to the target vessel, and clinically-driven target vessel revascularization) at 12 months. The impact of OFDI guidance in PCI for patients with acute coronary syndrome (ACS) remains uncertain.
METHODS
OPINION ACS is a multicenter, prospective, randomized, controlled, open-label, parallel group, non-inferiority trial in Japan. Eligible patients will be randomly assigned to receive either OFDI- or IVUS-guided PCI. PCI is performed using the sirolimus-eluting stent in accordance with certain OFDI and IVUS criteria for optimal stent deployment. All patients will undergo follow-up angiography and OFDI imaging at 8 months. The primary endpoint is the minimum lumen area, as measured by OFDI at 8 months.
CONCLUSION
The OPINION ACS trial outcomes will provide insights regarding the impact of OFDI-guided PCI on in-stent restenosis at 8 months in patients with ACS.
Identifiants
pubmed: 32340781
pii: S0914-5087(20)30123-4
doi: 10.1016/j.jjcc.2020.03.010
pii:
doi:
Substances chimiques
Sirolimus
W36ZG6FT64
Types de publication
Clinical Trial Protocol
Journal Article
Multicenter Study
Research Support, Non-U.S. Gov't
Langues
eng
Sous-ensembles de citation
IM
Pagination
317-321Informations de copyright
Copyright © 2020 Japanese College of Cardiology. Published by Elsevier Ltd. All rights reserved.