FAME: One-Year Results  

FAME研究目的是比较以血管造影为指导的和以FFR为指导的方法对多支血管病变病人的有效性。进行该研究的前提是，医生能够通过获得更准确的动脉狭窄生理学指标，作出更好的介入治疗决策。

     为了使该试验能更好地反应临床实践，本次研究选取的患者是至少两主支血管狭窄>50%且研究者已经明确肯定患者需要置入DES的患者，共有20个中心1,005例患者参与本次研究，所有患者随机分为血管造影组和FFR组，其中血管造影组的患者按原计划置入支架，FFR组的患者在支架置入前分别测量每个病变血管的血流储备情况，只有在FFR<0.80的患者中才考虑支架置入。

     血管造影组和FFR组的基线特征，如患者的病变数、参考血管直径和狭窄的严重性都相似。利用压力导丝（Certus导丝，RADI医疗系统）来测量FFR。

     结果提示：在对多支病变患者在置入DES过程中常规测量血流储备分数（FFR）可明显提高其临床疗效。1年随访结果显示，FFR测量组的MACE（含死亡，心肌梗死，再次血运重建）以及死亡或MI的比率都显著降低（见表格），且未发生心绞痛患者的比例较对照组高。但是，单纯造影组患者与血管造影+FFR组相比，平均每例患者置入支架数量要多得多(2.7 vs. 1.9，P<0.001)，且造影剂用量也大得多(302 mL vs. 272 mL； P<0.001)。

降低成本，优化结果

（来源：www.tctmd.com）

FAME: One-Year Results      
 
Key Points:

Adverse events lower with use of FFR during PCI in multivessel disease.

By TCT Daily Staff

Routine measurement of fractional flow reserve during PCI with DES in patients with multivessel disease significantly improved clinical outcome, according to findings from the FAME trial.

At one year, rates of MACE (a composite of death, MI, and repeat revascularization) and death or MI were significantly lower in the FFR group (see Figure).

In addition, there was a trend toward a higher number of event-free patients who were free of angina (P=.07). The number of stents implanted per patient was significantly greater in the angiography-alone group compared to the angiography plus FFR group (2.7 vs. 1.9; P<.001).

The amount of contrast used also was significantly higher in the angiographic arm compared to the FFR arm (302 mL vs. 272 mL; P<.001).

The trial aimed to compare the efficacy of angiographic guidance with FFR guidance in patients with multivessel disease. The hypothesis was that by obtaining a more accurate physiological assessment of artery narrowing, clinicians could make better decisions regarding the need for PCI.

Designed to reflect daily practice, FAME included patients with stenoses >50% in at least two major epicardial vessels that the investigator believed deserved DES implantation. A total of 1,005 patients at 20 centers were randomized to angiographic or FFR guidance. Patients assigned to angiography underwent stenting as planned, while those assigned to FFR had fractional flow reserve measured first in each diseased vessel, undergoing stenting in that vessel only if the FFR was <0.80.

Baseline characteristics in the angiographic and FFR groups were similar, as were the number of lesions per patient, the reference vessel diameter, and stenosis severity. FFR was measured by Pressure Wire (Certus wire, RADI Medical Systems).

Reduce Cost, Optimize Outcome

According to presenter Nico H.J. Pijls, MD, PhD, of Catharina Hospital in Eindhoven, Netherlands, the FAME findings support the paradigm of stenting only ischemic lesions and treating nonischemic lesions medically.

Carlo Di Mario, MD, PhD, of the Royal Brompton Hospital in London, told fellow clinicians: "Let’s forget the nonsense that we tell the patient on the table, ‘We have to complete the work [by revascularizing all diseased vessels].’ You have to use a scientific, evidence-based approach also in multivessel treatment. This is one of the rare opportunities you have in medicine to reduce cost and at the same time optimize clinical outcome."

Disclosures:

Dr. Pijls reports receiving an unrestricted grant from RADI Medical Systems to conduct this study.
Dr. Di Mario reports no relevant conflicts of interest.