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【NEJM】血流储备分数指导支架植入

Fractional Flow Reserve versus Angiography for Guiding Percutaneous Coronary Intervention
Pim A.L. Tonino, M.D., Bernard De Bruyne, M.D., Ph.D., Nico H.J. Pijls, M.D., Ph.D., Uwe Siebert, M.D., M.P.H., Sc.D., Fumiaki Ikeno, M.D., Marcel van `t Veer, M.Sc., Volker Klauss, M.D., Ph.D., Ganesh Manoharan, M.D., Thomas Engstrøm, M.D., Ph.D., Keith G. Oldroyd, M.D., Peter N. Ver Lee, M.D., Philip A. MacCarthy, M.D., Ph.D., William F. Fearon, M.D., for the FAME Study Investigators
  

ABSTRACT

Background In patients with multivessel coronary artery disease who are undergoing percutaneous coronary intervention (PCI), coronary angiography is the standard method for guiding the placement of the stent. It is unclear whether routine measurement of fractional flow reserve (FFR; the ratio of maximal blood flow in a stenotic artery to normal maximal flow), in addition to angiography, improves outcomes.

Methods In 20 medical centers in the United States and Europe, we randomly assigned 1005 patients with multivessel coronary artery disease to undergo PCI with implantation of drug-eluting stents guided by angiography alone or guided by FFR measurements in addition to angiography. Before randomization, lesions requiring PCI were identified on the basis of their angiographic appearance. Patients assigned to angiography-guided PCI underwent stenting of all indicated lesions, whereas those assigned to FFR-guided PCI underwent stenting of indicated lesions only if the FFR was 0.80 or less. The primary end point was the rate of death, nonfatal myocardial infarction, and repeat revascularization at 1 year.

Results The mean (±SD) number of indicated lesions per patient was 2.7±0.9 in the angiography group and 2.8±1.0 in the FFR group (P=0.34). The number of stents used per patient was 2.7±1.2 and 1.9±1.3, respectively (P<0.001). The 1-year event rate was 18.3% (91 patients) in the angiography group and 13.2% (67 patients) in the FFR group (P=0.02). Seventy-eight percent of the patients in the angiography group were free from angina at 1 year, as compared with 81% of patients in the FFR group (P=0.20).

Conclusions Routine measurement of FFR in patients with multivessel coronary artery disease who are undergoing PCI with drug-eluting stents significantly reduces the rate of the composite end point of death, nonfatal myocardial infarction, and repeat revascularization at 1 year. (ClinicalTrials.gov number, NCT00267774 [ClinicalTrials.gov] .) Fractional Flow Reserve versus Angiography for Guiding Percutaneous Coronary Intervention
血流储备分数与血管造影指导经皮冠状动脉介入的比较

ABSTRACT
摘要:
Background In patients with multivessel coronary artery disease who are undergoing percutaneous coronary intervention (PCI), coronary angiography is the standard method for guiding the placement of the stent. It is unclear whether routine measurement of fractional flow reserve (FFR; the ratio of maximal blood flow in a stenotic artery to normal maximal flow), in addition to angiography, improves outcomes.
背景:对于接受经皮冠状动脉介入(PCI)治疗的多支冠脉病变患者,冠脉造影是指导支架植入的标准方法。在冠脉造影基础上常规测量血流储备分数(FFR;狭窄动脉的最大血流与正常最大血流的比值)是否改善预后尚不清楚。
Methods In 20 medical centers in the United States and Europe, we randomly assigned 1005 patients with multivessel coronary artery disease to undergo PCI with implantation of drug-eluting stents guided by angiography alone or guided by FFR measurements in addition to angiography. Before randomization, lesions requiring PCI were identified on the basis of their angiographic appearance. Patients assigned to angiography-guided PCI underwent stenting of all indicated lesions, whereas those assigned to FFR-guided PCI underwent stenting of indicated lesions only if the FFR was 0.80 or less. The primary end point was the rate of death, nonfatal myocardial infarction, and repeat revascularization at 1 year.
方法:在美国和欧洲的20个医学中心,我们随机分配1005例因多支冠脉病变接受 PCI术的患者,分别采用单用造影和造影加FFR测量指导支架植入。在随机分组前,根据血管造影表现决定需要行PCI的病变, FFR组的患者仅在FFR为0.80及以下时接受支架植入。主要终点为术后1年的死亡、非致死性心肌梗死和再次再血管化。
Results The mean (±SD) number of indicated lesions per patient was 2.7±0.9 in the angiography group and 2.8±1.0 in the FFR group (P=0.34). The number of stents used per patient was 2.7±1.2 and 1.9±1.3, respectively (P<0.001). The 1-year event rate was 18.3% (91 patients) in the angiography group and 13.2% (67 patients) in the FFR group (P=0.02). Seventy-eight percent of the patients in the angiography group were free from angina at 1 year, as compared with 81% of patients in the FFR group (P=0.20).
结果:造影组和FFR组患者需处理的病变分别为每人2.7±0.9和2.8±1.0 (P=0.34)。支架植入数为每人2.7±1.2 和 1.9±1.3, (P<0.001)。1年事件率为造影组18.3%(91人)和FFR组13.2%(67人)(P=0.02)。造影组78%的患者1年内无心绞痛发作,FFR组为81%(P=0.20)

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作者:admin@医学,生命科学    2011-04-18 17:11
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