International Study of Comparative Health Effectiveness with Medical and Invasive Approaches-Chronic Kidney Disease (ISCHEMIA-CKD): Rationale and design

被引:46
作者
Bangalore, Sripal [1 ]
Maron, David J. [2 ]
Fleg, Jerome L. [3 ]
O'Brien, Sean M. [4 ]
Herzog, Charles A. [5 ,6 ]
Stone, Gregg W. [7 ,8 ]
Mark, Daniel B. [4 ]
Spertus, John A. [9 ]
Alexander, Karen P. [4 ]
Sidhu, Mandeep S. [10 ]
Chertow, Glenn M. [2 ]
Boden, William E. [11 ]
Hochman, Judith S. [1 ]
机构
[1] NYU, Sch Med, New York, NY USA
[2] Stanford Univ, Sch Med, Stanford, CA 94305 USA
[3] NHLBI, Bldg 10, Bethesda, MD 20892 USA
[4] Duke Clin Res Inst, Durham, NC USA
[5] Hennepin Cty Med Ctr, Minneapolis, MN 55415 USA
[6] Univ Minnesota, Minneapolis, MN USA
[7] Columbia Univ, Med Ctr, New York Presbyterian Hosp, New York, NY USA
[8] Cardiovasc Res Fdn, New York, NY USA
[9] Univ Missouri, Mid Amer Heart Inst, Kansas City, MO 64110 USA
[10] Albany Med Ctr, Albany, NY USA
[11] Massachusetts Vet Epidemiol Res & Informat Ctr, Vet Affairs New England Healthcare Syst, Boston, MA USA
关键词
PERCUTANEOUS CORONARY INTERVENTION; ASSOCIATION TASK-FORCE; CARDIOVASCULAR-DISEASE; CLINICAL-PRACTICE; MYOCARDIAL-INFARCTION; TREATMENT STRATEGIES; AMERICAN-COLLEGE; RANDOMIZED-TRIAL; ARTERY-DISEASE; REVASCULARIZATION;
D O I
10.1016/j.ahj.2018.07.023
中图分类号
R5 [内科学];
学科分类号
1002 ; 100201 ;
摘要
Background Patients with chronic kidney disease (CKD) and stable ischemic heart disease are at markedly increased risk of cardiovascular events. Prior trials comparing a strategy of optimal medical therapy (OMT) with or without revascularization have largely excluded patients with advanced CKD. Whether a routine invasive approach when compared with a conservative strategy is beneficial in such patients is unknown. Methods ISCHEMIA-CKD is a National Heart, Lung, and Blood Institute-funded randomized trial designed to determine the comparative effectiveness of an initial invasive strategy (cardiac catheterization and optimal revascularization [percutaneous coronary intervention or coronary artery bypass graft surgery, if suitable] plus OMT) versus a conservative strategy (OMT alone, with cardiac catheterization and revascularization [percutaneous coronary intervention or coronary artery bypass graft surgery, if suitable] reserved for failure of OMT) on long-term clinical outcomes in 777 patients with advanced CKD (defined as those with estimated glomerular filtration rate <30 mL/min/1.73m(2) or on dialysis) and moderate or severe ischemia on stress testing. Participants were randomized in a 1: 1 fashion to the invasive or a conservative strategy. The primary end point is a composite of death or nonfatal myocardial infarction. Major secondary endpoints are a composite of death, nonfatal myocardial infarction, hospitalization for unstable angina, hospitalization for heart failure, or resuscitated cardiac arrest; angina control; and disease-specific quality of life. Safety outcomes such as initiation of maintenance dialysis and a composite of initiation ofmaintenancedialysis or deathwillbereported. Thetrial isprojected to have 80% power to detect a 22% to 24% reduction in the primary composite end point with the invasive strategy when compared with the conservative strategy. Conclusions ISCHEMIA-CKD will determinewhether an initial invasive management strategy improves clinical outcomes when added to OMT in patients with advanced CKD and stable ischemic heart disease.
引用
收藏
页码:42 / 52
页数:11
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