계명대학교 의학도서관 Repository

Preventive PCI or medical therapy alone for vulnerable atherosclerotic coronary plaque: Rationale and design of the randomized, controlled PREVENT trial

Metadata Downloads
Author(s)
Jung-Min AhnDo-Yoon KangPil Hyung LeeYoung-Keun AhnWon-Jang KimChang-Wook NamJin-Ok JeongIn-Ho ChaeHiroki ShiomiPaul Hsien Li KaoJoo-Yong HahnSung-Ho HerBong-Ki LeeTae Hoon AhnKiyuk ChangJei Keon ChaeDavid SmythGregg W StoneDuk-Woo ParkSeung-Jung Park
Keimyung Author(s)
Nam, Chang Wook
Department
Dept. of Internal Medicine (내과학)
Journal Title
Am Heart J
Issued Date
2023
Volume
264
Abstract
Background:
Acute coronary syndromes are commonly caused by the rupture of vulnerable plaque, which often appear angiographically not severe. Although pharmacologic management is considered standard therapy for stabilizing plaque vulnerability, the potential role of preventive local treatment for vulnerable plaque has not yet been determined. The PREVENT trial was designed to compare preventive percutaneous coronary intervention (PCI) plus optimal medical therapy (OMT) with OMT alone in patients with functionally nonsignificant high-risk vulnerable plaques.

Methods:
The PREVENT trial is a multinational, multicenter, prospective, open-label, active-treatment-controlled randomized trial. Eligible patients have at least 1 angiographically significant stenosis (diameter stenosis >50% by visual estimation) without functional significance (fractional flow reserve [FFR] >0.80). Target lesions are assessed by intracoronary imaging and must meet at least 2 imaging criteria for vulnerable plaque; (1) minimal lumen area <4.0 mm2; (2) plaque burden >70%; (3) maximal lipid core burden index in a 4 mm segment >315 by near infrared spectroscopy; and (4) thin cap fibroatheroma as determined by virtual histology or optical coherence tomography. Enrolled patients are randomly assigned in a 1:1 ratio to either preventive PCI with either bioabsorbable vascular scaffolds or metallic everolimus-eluting stents plus OMT or OMT alone. The primary endpoint is target-vessel failure, defined as the composite of death from cardiac causes, target-vessel myocardial infarction, ischemic-driven target-vessel revascularization, or hospitalization for unstable or progressive angina, at 2 years after randomization.

Results:
Enrollment of a total of 1,608 patients has been completed. Follow-up of the last enrolled patient will be completed in September 2023 and primary results are expected to be available in early 2024.

Conclusions:
The PREVENT trial is the first large-scale, randomized trial to evaluate the effect of preventive PCI on non-flow-limiting vulnerable plaques containing multiple high-risk features that is appropriately powered for clinical outcomes. PREVENT will provide compelling evidence as to whether preventive PCI of vulnerable plaques plus OMT improves patient outcomes compared with OMT alone.

Clinical trial registration:
URL: https://www.clinicaltrials.gov . Unique identifier: NCT02316886.

Clinicaltrials: gov. Unique identifier: NCT02316886.

Key points:
The PREVENT trial is the first, large-scale randomized clinical trial to evaluate the effect of preventive PCI on non-flow-limiting vulnerable plaque with high-risk features. It will provide compelling evidence to determine whether PCI of focal vulnerable plaques on top of OMT improves patient outcomes.
Keimyung Author(s)(Kor)
남창욱
Publisher
School of Medicine (의과대학)
Type
Article
ISSN
1097-6744
Source
https://www.clinicalkey.com/#!/content/playContent/1-s2.0-S0002870323001345
DOI
10.1016/j.ahj.2023.05.017
URI
https://kumel.medlib.dsmc.or.kr/handle/2015.oak/45163
Appears in Collections:
1. School of Medicine (의과대학) > Dept. of Internal Medicine (내과학)
공개 및 라이선스
  • 공개 구분공개
  • 엠바고Forever
파일 목록
  • 관련 파일이 존재하지 않습니다.

Items in Repository are protected by copyright, with all rights reserved, unless otherwise indicated.