Fractional Flow Reserve or Intravascular Ultrasonography to Guide PCI

被引:92
作者
Koo, Bon-Kwon [1 ]
Hu, Xinyang [12 ]
Kang, Jeehoon [1 ]
Zhang, Jinlong [12 ]
Jiang, Jun [12 ]
Hahn, Joo-Yong [2 ]
Nam, Chang-Wook [4 ]
Doh, Joon-Hyung [6 ]
Lee, Bong-Ki [7 ]
Kim, Weon [3 ]
Huang, Jinyu [13 ]
Jiang, Fan [14 ]
Zhou, Hao [16 ]
Chen, Peng [17 ]
Tang, Lijiang [15 ]
Jiang, Wenbing [18 ]
Chen, Xiaomin [19 ]
He, Wenming [20 ]
Ahn, Sung-Gyun [8 ]
Yoon, Myeong-Ho [9 ]
Kim, Ung [5 ]
Lee, Joo-Myung [2 ]
Hwang, Doyeon [1 ]
Ki, You-Jeong [10 ]
Shin, Eun-Seok [11 ]
Kim, Hyo-Soo [1 ]
Tahk, Seung-Jea [9 ]
Wang, Jian'an [12 ]
机构
[1] Seoul Natl Univ Hosp, Seoul, South Korea
[2] Samsung Med Ctr, Seoul, South Korea
[3] Kyung Hee Univ Hosp, Seoul, South Korea
[4] Keimyung Univ Dongsan Med Ctr, Daegu, South Korea
[5] Yeungnam Univ, Med Ctr, Daegu, South Korea
[6] Inje Univ, Ilsan Paik Hosp, Goyang, South Korea
[7] Kangwon Natl Univ Hosp, Chunchon, South Korea
[8] Wonju Severance Christian Hosp, Wonju, South Korea
[9] Ajou Univ Hosp, Suwon, South Korea
[10] Uijeongbu Eulji Med Ctr, Uijongbu, South Korea
[11] Ulsan Univ Hosp, Univ Ulsan Coll Med, Ulsan, South Korea
[12] Zhejiang Univ, Affiliated Hosp 2, Sch Med, Hangzhou, Peoples R China
[13] Zhejiang Univ, Affiliated Hangzhou Peoples Hosp 1, Sch Med, Hangzhou, Peoples R China
[14] Hangzhou Normal Univ, Affiliated Hosp, Hangzhou, Peoples R China
[15] Zhejiang Hosp, Hangzhou, Peoples R China
[16] Wenzhou Med Univ, Affiliated Hosp 1, Wenzhou, Peoples R China
[17] Wenzhou Med Univ, Affiliated Hosp 2, Wenzhou, Peoples R China
[18] Wenzhou Med Univ, Clin Inst 3, Wenzhou, Peoples R China
[19] Ningbo First Hosp, Ningbo, Peoples R China
[20] Ningbo Univ, Affiliated Hosp, Med Sch, Ningbo, Peoples R China
关键词
PERCUTANEOUS CORONARY INTERVENTION; CLINICAL-OUTCOMES; ARTERY-DISEASE; PLAQUE CHARACTERISTICS; STENT IMPLANTATION; ANGIOGRAPHY; STENOSIS; DESIGN; SEVERITY; THERAPY;
D O I
10.1056/NEJMoa2201546
中图分类号
R5 [内科学];
学科分类号
1002 ; 100201 ;
摘要
BACKGROUND In patients with coronary artery disease who are being evaluated for percutaneous coronary intervention (PCI), procedures can be guided by fractional flow reserve (FFR) or intravascular ultrasonography (IVUS) for decision making regarding revascularization and stent implantation. However, the differences in clinical outcomes when only one method is used for both purposes are unclear. METHODS We randomly assigned 1682 patients who were being evaluated for PCI for the treatment of intermediate stenosis (40 to 70% occlusion by visual estimation on coronary angiography) in a 1:1 ratio to undergo either an FFR-guided or IVUSguided procedure. FFR or IVUS was to be used to determine whether to perform PCI and to assess PCI success. In the FFR group, PCI was to be performed if the FFR was 0.80 or less. In the IVUS group, the criteria for PCI were a minimal lumen area measuring either 3 mm(2) or less or measuring 3 to 4 mm2 with a plaque burden of more than 70%. The primary outcome was a composite of death, myocardial infarction, or revascularization at 24 months after randomization. We tested the noninferiority of the FFR group as compared with the IVUS group (noninferiority margin, 2.5 percentage points). RESULTS The frequency of PCI was 44.4% among patients in the FFR group and 65.3% among those in the IVUS group. At 24 months, a primary-outcome event had occurred in 8.1% of the patients in the FFR group and in 8.5% of those in the IVUS group (absolute difference, -0.4 percentage points; upper boundary of the onesided 97.5% confidence interval, 2.2 percentage points; P = 0.01 for noninferiority). Patient-reported outcomes as reported on the Seattle Angina Questionnaire were similar in the two groups. CONCLUSIONS In patients with intermediate stenosis who were being evaluated for PCI, FFR guidance was noninferior to IVUS guidance with respect to the composite primary outcome of death, myocardial infarction, or revascularization at 24 months. (Funded by Boston Scientific; FLAVOUR ClinicalTrials.gov number, NCT02673424.) The grees, Appendix. wja@zju.edu.cn Cardiology, Zhejiang 88 Jiefang Tahk or Yeongtong-gu, *A equally This Copyright at
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页码:779 / 789
页数:11
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