Evaluation of outcome and cost-effectiveness using an FDG PET-guided approach to management of patients with coronary disease and severe left ventricular dysfunction (PARR-2): rationale, design, and methods

被引:21
作者
Beanlands, R
Nichol, G
Ruddy, TD
DeKemp, RA
Hendry, P
Humen, D
Racine, NN
Ross, H
Benard, F
Coates, G
Iwanocliko, RM
Fallen, E
Wells, G
机构
[1] Univ Ottawa, Inst Heart, Cardiac PET Ctr, Ottawa, ON K1Y 4W7, Canada
[2] Univ Ottawa, Ottawa Hosp, Clin Epidemiol Program, Cardiovasc Outcomes Related Econ Grp, Ottawa, ON, Canada
[3] Univ Ottawa, Dept Epidemiol & Community Med, Ottawa, ON, Canada
[4] London Hlth Sci Ctr, Div Cardiol, London, ON, Canada
[5] Montreal Heart Inst, Div Cardiol, Montreal, PQ H1T 1C8, Canada
[6] Univ Toronto, Hlth Sci Network, Div Cardiol, Toronto Hosp, Toronto, ON, Canada
[7] CHU Sherbrooke, Div Nucl Med, Sherbrooke, PQ J1H 5N4, Canada
[8] Hamilton Hlth Sci, Dept Nucl Med, Div Cardiol, Hamilton, ON, Canada
[9] Hamilton Hlth Sci, Dept Nucl Med, ES Garnett Mem PET Ctr, Hamilton, ON, Canada
来源
CONTROLLED CLINICAL TRIALS | 2003年 / 24卷 / 06期
基金
加拿大健康研究院;
关键词
viability; fluorodeoxyglucose; heart failure; ischemic heart disease;
D O I
10.1016/S0197-2456(03)00106-5
中图分类号
R-3 [医学研究方法]; R3 [基础医学];
学科分类号
1001 ;
摘要
Patients with severe ventricular dysfunction and coronary disease have high morbidity and mortality. They may benefit from revascularization but have significant perioperative morbidity and mortality. Positron emission tomography (PET) imaging with F-18-fluorodeoxyglucose(FDG) can detect viable myocardium that may recover from revascularization in such patients. It is unclear whether use of FDG PET in this population improves outcome or is cost-effective. The principal aim of this study is to determine whether FDG PET-guided therapy improves clinical outcome compared to standard care. Secondary objectives are to determine whether FDG PET-guided therapy improves left ventricular (LV) function, improves quality of life, and provides a cost benefit versus standard care. Included in this multicenter randomized controlled trial are patients with coronary artery disease and severe LV dysfunction who are referred for revascularization, heart failure, or cardiac transplantation or in whom FDG PET is potentially useful. Consenting subjects will be randomized to therapy directed by FDG PET or standard care. The primary outcome is the composite cardiovascular endpoint of cardiac death, myocardial infarction, transplantation, or rehospitalization for unstable angina or heart failure. Secondary outcomes include health-related quality of life, costs, mortality, cardiovascular events, and LV function. Assuming two-sided alpha = 0.05, power = 80%, a sample size of 206 patients per group is required to detect a 15% absolute difference in the primary outcome between PET-directed therapy compared to standard care. Analyses will be conducted on an intention-to-treat basis. To our knowledge, this is the first large trial to evaluate whether FDG PET-directed therapy is effective and provides a cost benefit in patients with severe LV dysfunction. If so, thousands of such patients can be risk-stratified to select who is likely to benefit from revascularization. (C) 2003 Elsevier Inc. All rights reserved.
引用
收藏
页码:776 / 794
页数:19
相关论文
共 69 条
[1]  
*AG HLTH CAR POL R, 1994, UNST ANG DIAGN MAN
[2]  
*ALB HER FDN MED R, 1999, FUNCT DIAGN IM ASS M
[3]   RESULTS OF CORONARY-ARTERY SURGERY IN PATIENTS WITH POOR LEFT-VENTRICULAR FUNCTION (CASS) [J].
ALDERMAN, EL ;
FISHER, LD ;
LITWIN, P ;
KAISER, GC ;
MYERS, WO ;
MAYNARD, C ;
LEVINE, F ;
SCHLOSS, M .
CIRCULATION, 1983, 68 (04) :785-795
[4]  
[Anonymous], 1988, CLIN CHEM
[5]  
Bax JJ, 2001, CURR PROB CARDIOLOGY, V26, P147, DOI [DOI 10.1067/MCD.2001.109973, 10.1067/mcd.2001.109973]
[6]   Patient management guided by viability imaging [J].
Beanlands, RS ;
Ruddy, TD ;
Freeman, M ;
Nichol, G .
JOURNAL OF THE AMERICAN COLLEGE OF CARDIOLOGY, 2001, 38 (04) :1271-1272
[7]   F-18-fluorodeoxyglucose PET imaging alters clinical decision making in patients with impaired ventricular function [J].
Beanlands, RSB ;
deKemp, RA ;
Smith, S ;
Johansen, H ;
Ruddy, TD .
AMERICAN JOURNAL OF CARDIOLOGY, 1997, 79 (08) :1092-&
[8]   Positron emission tomography and recovery following revascularization (PARR-1): The importance of scar and the development of a prediction rule for the degree of recovery of left ventricular function [J].
Beanlands, RSB ;
Ruddy, TD ;
deKemp, RA ;
Iwanochko, RM ;
Coates, G ;
Freeman, M ;
Nahmias, C ;
Hendry, P ;
Burns, RJ ;
Lamy, A ;
Mickleborough, L ;
Kostuk, W ;
Fallen, E ;
Nichol, G .
JOURNAL OF THE AMERICAN COLLEGE OF CARDIOLOGY, 2002, 40 (10) :1735-1743
[9]   Differentiation of myocardial ischemia and necrosis by technetium 99m glucaric acid kinetics [J].
Beanlands, RSB ;
Ruddy, TD ;
Bielawski, L ;
Johansen, H .
JOURNAL OF NUCLEAR CARDIOLOGY, 1997, 4 (04) :274-282
[10]  
Beanlands RSB, 1998, CIRCULATION, V98, pII51