近日,一项来自多国的合作研究比较了磁共振灌注与血流储备分数在冠心病治疗指导中的优劣。2019年6月20日,国际知名学术期刊《新英格兰医学杂志》发表了这一成果。
在主要的心脏不良事件方面,心血管MRI方法是否与FFR测量方法等同尚未确定。研究人员进行了一项非盲,多中心,临床有效性检测试验,将918名患者随机分配至心血管MRI组和FFR组。心血管MRI组454例患者中的184例(40.5%)和FFR组464例患者中的213例(45.9%)符合血运重建的标准(P=0.11)。与FFR组相比,心血管MRI组接受指数血运重建的患者更少(162例(35.7%)vs 209例(45.0%),p=0.005)。心血管MRI组421例中有的15例(3.6%)以及FFR组430例中的16例(3.7%)出现主要终点事件(风险差异-0.2个百分点;95%置信区间2.7 ~ 2.4),符合非劣效阈值。两组患者12个月无心绞痛发生率无显著性差异(心血管MRI组49.2%,FFR组43.8%,P=0.21)。总之,在稳定性心绞痛和冠状动脉疾病危险因素的患者中,心肌灌注心血管MRI比FFR的冠状动脉血运重建概率低,在主要心脏不良事件方面不劣于FFR。
据介绍,对于稳定型心绞痛患者,常采用两种策略来指导血运重建:一种是心肌灌注心血管磁共振成像(MRI),另一种是侵入性血管造影和分流储备分数(FFR)的测量。
附:英文原文
Title: Magnetic Resonance Perfusion or Fractional Flow Reserve in Coronary Disease
Author:Eike Nagel, M.D., John P. Greenwood, M.D., Gerry P. McCann, M.D., Nuno Bettencourt, M.D., Ajay M. Shah, M.D., Shazia T. Hussain, M.D., Divaka Perera, M.D., Sven Plein, M.D., Chiara Bucciarelli-Ducci, M.D., Matthias Paul, M.D., Mark A. Westwood, M.D., Michael Marber, M.D., Wolf-Stefan Richter, M.D., Valentina O. Puntmann, M.D., Carsten Schwenke, Ph.D., Jeanette Schulz-Menger, M.D., Rajiv Das, M.D., Joyce Wong, M.D., Derek J. Hausenloy, M.D., Henning Steen, M.D., and Colin Berry, M.D
Issue&Volume: Vol.380 No.25, 2019
Abstract:
BACKGROUND In patients with stable angina, two strategies are often used to guide revascularization: one involves myocardial-perfusion cardiovascular magnetic resonance imaging (MRI), and the other involves invasive angiography and measurement of fractional flow reserve (FFR). Whether a cardiovascular MRI–based strategy is noninferior to an FFR-based strategy with respect to major adverse cardiac events has not been established.
METHODS We performed an unblinded, multicenter, clinical-effectiveness trial by randomly assigning 918 patients with typical angina and either two or more cardiovascular risk factors or a positive exercise treadmill test to a cardiovascular MRI–based strategy or an FFR-based strategy. Revascularization was recommended for patients in the cardiovascular-MRI group with ischemia in at least 6% of the myocardium or in the FFR group with an FFR of 0.8 or less. The composite primary outcome was death, nonfatal myocardial infarction, or target-vessel revascularization within 1 year. The noninferiority margin was a risk difference of 6 percentage points.
RESULTS A total of 184 of 454 patients (40.5%) in the cardiovascular-MRI group and 213 of 464 patients (45.9%) in the FFR group met criteria to recommend revascularization (P=0.11). Fewer patients in the cardiovascular-MRI group than in the FFR group underwent index revascularization (162 [35.7%] vs. 209 [45.0%], P=0.005). The primary outcome occurred in 15 of 421 patients (3.6%) in the cardiovascular-MRI group and 16 of 430 patients (3.7%) in the FFR group (risk difference, −0.2 percentage points; 95% confidence interval, −2.7 to 2.4), findings that met the noninferiority threshold. The percentage of patients free from angina at 12 months did not differ significantly between the two groups (49.2% in the cardiovascular-MRI group and 43.8% in the FFR group, P=0.21).
CONCLUSIONS Among patients with stable angina and risk factors for coronary artery disease, myocardial-perfusion cardiovascular MRI was associated with a lower incidence of coronary revascularization than FFR and was noninferior to FFR with respect to major adverse cardiac events. (Funded by the Guy’s and St. Thomas’ Biomedical Research Centre of the National Institute for Health Research and others; MR-INFORM ClinicalTrials.gov number, NCT01236807.)
DOI: 10.1056/NEJMoa1716734
Source: https://www.nejm.org/doi/full/10.1056/NEJMoa1716734
The New England Journal of Medicine:《新英格兰医学杂志》,创刊于1812年。隶属于麻省医学协会,最新IF:70.67
官方网址:http://www.nejm.org/
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