Fractional flow reserve versus angiography in guiding management to optimize outcomes in non-ST-elevation myocardial infarction (FAMOUS-NSTEMI): Rationale and design of a randomized controlled clinical trial

被引：13

作者：

Berry, Colin ^{[1
,2
]}

Layland, Jamie ^{[1
,2
]}

Sood, Arvind ^{[3
]}

Curzen, Nick P. ^{[4
,5
]}

Balachandran, Kanarath P. ^{[6
]}

Das, Raj ^{[7
]}

Junejo, Shahid ^{[8
]}

Henderson, Robert A. ^{[9
]}

Briggs, Andrew H. ^{[10
]}

Ford, Ian ^{[11
]}

Oldroyd, Keith G. ^{[1
]}

机构：

[1] Golden Jubilee Natl Hosp, West Scotland Heart & Lung Ctr, Glasgow, Lanark, Scotland

[2] Univ Glasgow, Inst Cardiovasc & Med Sci, BHF Glasgow Cardiovasc Res Ctr, Glasgow G12 8TA, Lanark, Scotland

[3] Hairmyres Hosp, E Kilbride, Lanark, Scotland

[4] Univ Southampton, Univ Hosp Southampton NHS FT, Southampton SO9 5NH, Hants, England

[5] Univ Southampton, Fac Med, Southampton SO9 5NH, Hants, England

[6] Royal Blackburn Hosp, Blackburn, Lancs, England

[7] Freeman Rd Hosp, Newcastle Upon Tyne NE7 7DN, Tyne & Wear, England

[8] City Hosp Sunderland NHS Fdn, Sunderland, England

[9] Univ Nottingham Hosp, Nottingham NG7 2UH, England

[10] Univ Glasgow, Ctr Hlth Econ & Hlth Technol Assessment, Glasgow G12 8TA, Lanark, Scotland

[11] Univ Glasgow, Robertson Ctr Biostat, Glasgow G12 8TA, Lanark, Scotland

来源：

AMERICAN HEART JOURNAL | 2013年 / 166卷 / 04期

关键词：

PERCUTANEOUS CORONARY INTERVENTION; ECONOMIC-EVALUATION; UNSTABLE ANGINA; ACUTE CATHETERIZATION; FUNCTIONAL SEVERITY; HEMODYNAMIC-CHANGES; ADENOSINE INFUSION; ARTERY STENOSES; FOLLOW-UP; REVASCULARIZATION;

D O I：

10.1016/j.ahj.2013.07.011

中图分类号：

R5 [内科学];

学科分类号：

100201 [内科学];

摘要：

Background In patients with acute non-ST-elevation myocardial infarction (NSTEMI), coronary arteriography is usually recommended; but visual interpretation of the angiogram is subjective. We hypothesized that functional assessment of coronary stenosis severity with a pressure-sensitive guide wire (fractional flow reserve [FFR]) would have additive diagnostic, clinical, and health economic utility as compared with angiography-guided standard care. Methods and design Aprospectivemulticenter parallel-group 1:1 randomized controlled superiority trial in 350 NSTEMI patients with >= 1 coronary stenosis >= 30% severity (threshold for FFR measurement) will be conducted. Patients will be randomized immediately after coronary angiography to the FFR-guided group or angiography-guided group. All patients will then undergo FFR measurement in all vessels with a coronary stenosis >= 30% severity including culprit and nonculprit lesions. Fractional flow reserve will be disclosed to guide treatment in the FFR-guided group but not disclosed in the "angiography-guided" group. In the FFR-guided group, an FFR <= 0.80 will be an indication for revascularization by percutaneous coronary intervention or coronary artery bypass surgery, as appropriate. The primary outcome is the between-group difference in the proportion of patients allocated to medical management only compared with revascularization. Secondary outcomes include the occurrence of cardiac death or hospitalization for myocardial infarction or heart failure, quality of life, and health care costs. The minimum and average follow-up periods for the primary analysis are 6 and 18 months, respectively. Conclusions Our developmental clinical trial will address the feasibility of FFR measurement in NSTEMI and the influence of FFR disclosure on treatment decisions and health and economic outcomes.

引用

页码：662 / +

页数：10

共 40 条

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