| Background:According to the statistics of National Health and Family Planning Commission,the morbidity and mortality of coronary heart disease has been increasing in the past decade.Not only does it seriously endanger the health of citizens,but also it brings about heavy financial burdens.In this situation,the operation strategies and instruments of percutaneous coronary intervention(PCI)have been updated rapidly in response to complex coronary lesions.Fractional flow reserve(FFR),an important tool in the era of "coronary functional revascularization",is a specific physiological function parameter of coronary artery stenosis lesion.FFR plays a critical role in PCI strategies.FFR-guided PCI has been recommended in the Guidelines on Myocardial Revascularization since 2010.Numerous studies have shown that FFR-guided PCI is significantly effective for single,multiple and complex lesions.FFR is also affirmed and recommended by China's PCI Guidelines(2016).However,there are many pitfalls in the clinical application of FFR,which is not conducive to the promotion of the pressure wire technology represented by FFR.Therefore,this research will explore the “gray zone”,one of FFR's pitfalls and try to find out which PCI strategy should be adopted when the FFR gets into the “gray zone” in the coronary bifurcation lesions.In addition,in order to reduce vasodilator in FFR measurement,the instantaneous wave-free ratio(iFR)was proposed.Thus,the diagnostic performance of iFR sparked hot discussions.This study also aims to make a comparison between the diagnostic performance of iFR and FFR.Methods:1.This study included 106 patients with bifurcation lesions accommodated in Xijing Hospital from March 2012 to September 2014.All of 106 patients treated with PCI were allocated to either the one-stent(n=56)or double-stent(n=50)group.Clinical follow-ups were performed at the 3rd,6th,12 th and 24 th month by means of office visits or telephone contacts.The endpoint was the 2-year major adverse cardiac events(MACEs).The data of Seattle Angina Questionnaire were recorded at the 3rd,6th,12 th,24th month after PCI.2.We searched PubMed,EMBASE,CENTRAL,ProQuest,Web of Science and ICTRP for publications concerning the diagnostic value of i FR.We used a random-effects covariate to synthesize the data of sensitivity,specificity,positive likelihood ratio(LR+),negative likelihood ratio(LR-)and diagnostic odds ratio(DOR).Overall test performance was summarized by the summary receiver operating characteristic curve(sROC)and the area under the curve(AUC).This study was registered in PROSPERO(http://www.crd.york.ac.uk/PROSPERO/;NO.CRD42015020537).Results:1.The baseline clinical characteristics of two groups showed no significant difference.The quantitative coronary angiographic analysis(QCA)results for the MB and SB showed no significant difference in both one-stent and double-stent group before PCI.However,there was significant difference in heparin(6160.71±2013.83 vs.7180.00±1743.09 IU,p=0.024),contrast Agent(151.07±61.75 vs.231.60±73.02 ml,p<0.0001),length(27.76±18.27 vs.51.29±21.78 mm,p<0.0001)and diameter(2.75±0.22 vs.2.95±0.31 mm,p<0.0001)of stents,the duration of PCI operations(78.93±28.13 vs.102.20±28.02 min,p<0.0001)and hospital stays(2.82±1.31 vs.3.51±1.64,p=0.008)between two groups.The 2-year MACEs rates showed no significant difference between two groups.In terms of Seattle Angina Questionnaire scores,the improvement in physical activity and angina frequency was significantly greater in the one-stent group than the double-stent group during the 2 years follow-ups;However,improvement in angina stability and angina frequency was significantly greater in the double-stent group than the one-stent group;There was no significant difference in disease perception between two groups.2.Eight studies with 1611 subjects were included in the meta-analysis.The pooled sensitivity,specificity,LR+,LR-,and DOR for iFR were respectively 73.3%(70.1%–76.2% I2=80.8%,p<0.001),86.4%(84.3%–88.3% I2=70.9%,p<0.001),5.71(4.43–7.37),0.29(0.22–0.38),and 20.54(16.11–26.20).The area under the summary receiver operating characteristic curves for iFR was 0.8786.The publication bias was not found by Deek's funnel plot asymmetry test.Conclusions:1.Based on the results of this study,the simple strategy has advantages over double-stent strategy in the number of stents,the dose of heparin and contrast agent,the duration of PCI operations and hospital stay when FFR value of side branch gets into “grey zone”.The simple strategy will get more clinical benefits than complex strategy in the coronary bifurcation lesions.2.Results of meta-analysis show the diagnostic performance of iFR to detect coronary stenosis severity is impressive compared with FFR.To overcome limitations of FFR,a hybrid iFR-FFR approach can increase the diagnostic accuracy and reduce vasodilator in FFR measurement.Hybrid iFR-FFR approach may be a new technology to evaluate the coronary bifurcation lesions. |
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