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

被引:21
作者
Ahn, Jung -Min [1 ]
Kang, Do-Yoon [1 ]
Lee, Pil Hyung [1 ]
Ahn, Young-Keun [2 ]
Kim, Won-Jang [3 ]
Nam, Chang-Wook [4 ]
Jeong, Jin-Ok [5 ]
Chae, In -Ho [6 ]
Shiomi, Hiroki [7 ]
Kao, Paul Hsien Li [8 ]
Hahn, Joo-Yong [9 ]
Her, Sung -Ho [10 ]
Lee, Bong-Ki [11 ]
Ahn, Tae Hoon [12 ]
Chang, Kiyuk [13 ]
Chae, Jei Keon [14 ]
Smyth, David [15 ]
Stone, Gregg W. [16 ]
Park, Duk-Woo [1 ]
Park, Seung-Jung [1 ]
机构
[1] Univ Ulsan, Coll Med, Asan Med Ctr, Div Cardiol, 388-1 Poongnap Dong, Seoul 138736, South Korea
[2] Chonnam Natl Univ Hosp, Div Cardiol, Gwangju, South Korea
[3] CHA Univ, Ilsan Med Ctr, Div Cardiol, Goyang, South Korea
[4] Keimyung Univ, Dongsan Hosp, Div Cardiol, Daegu, South Korea
[5] Chungnam Natl Univ Hosp, Div Cardiol, Daejeon, South Korea
[6] Seoul Natl Univ, Bundang Hosp, Div Cardiol, Sungnam, South Korea
[7] Kyoto Univ Hosp, Div Cardiol, Kyoto, Japan
[8] Natl Taiwan Univ Hosp, Div Cardiol, Taipei, Taiwan
[9] Samsung Med Ctr, Heart Vasc Stroke Inst, Seoul, South Korea
[10] St Vincents Hosp, Dept Cardiol, Suwon, South Korea
[11] Kangwon Natl Univ Hosp, Div Cardiol, Chunchon, South Korea
[12] Chung Ang Univ, Gwangmyeong Hosp, Dept Cardiol, Gwangmyeong, South Korea
[13] Catholic Univ Korea, Seoul St Marys Hosp, Div Cardiol, Seoul, South Korea
[14] Chonbuk Natl Univ, Med Sch, Div Cardiol, Jeonju, South Korea
[15] Christchurch Hosp, Dept Cardiol, Christchurch, New Zealand
[16] Icahn Sch Med Mt Sinai, Zena & Michael A Wiener Cardiovasc Inst, New York, NY USA
关键词
FRACTIONAL FLOW RESERVE; OPTICAL COHERENCE TOMOGRAPHY; EXPERT CONSENSUS DOCUMENT; ARTERY-DISEASE; FOLLOW-UP; CARDIOVASCULAR ANGIOGRAPHY; INTRAVASCULAR ULTRASOUND; AMERICAN-COLLEGE; TASK-FORCE; INTERVENTION;
D O I
10.1016/j.ahj.2023.05.017
中图分类号
R5 [内科学];
学科分类号
1002 ; 100201 ;
摘要
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 random-ized 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.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.
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页码:83 / 96
页数:14
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