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瞬时无波形比值或血流储备分数用于PCI的比较研究
Use of the Instantaneous Wave-free Ratio or Fractional Flow Reserve in PCI


Justin E. Davies ... 心脑血管疾病 • 2017.05.11
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PCI中瞬时无波形比值血流储备分数的比较

 

胡新央,王建安*

浙江大学医学院附属第二医院心血管内科

* 通讯作者

 

冠心病发病呈逐年增加态势,而经皮冠状动脉介入治疗(percutaneous coronary intervention,PCI)是治疗冠心病的主要措施。研究表明,心肌缺血是制定冠心病治疗策略的重要决定因素。近20年来,冠状动脉血流储备分数(fractional flow reserve,FFR)逐渐成为公认的有创病变功能学评价指标1,以FFR指导的治疗策略被证实安全、经济,并能改善患者的预后2,3。但是,FFR的测量需要使用静脉扩张剂达到最大充血状态,已有研究对血管扩张剂使用的必要性提出疑问。小样本的研究表明瞬时无波形比值(instantaneous wave-free ratio,iFR)诊断准确性和FFR接近4,但iFR指导的PCI是否也能同样地改善患者预后尚不明确。本期《新英格兰医学杂志》发表的一篇比较FFR与iFR指导PCI的报告,通过2,492例患者的随机对照研究,显示iFR指导的PCI在1年的主要复合终点(包括任何原因死亡、非致死性心肌梗死和非预期的血运重建)方面与FFR指导的PCI组相比没有显著差异(iFR对FFR:6.8%对7.0%)。同时,手术期间出现胸闷气急等不适症状的患者数在iFR指导的PCI组明显减少(iFR对FFR:3.1%对30.8%),而且平均手术时间在iFR组明显缩短5。在同期的《新英格兰医学杂志》发表的另一项FFR与iFR比较的研究也显示了类似的结果6

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摘要


背景

和单纯血管造影指导的冠脉血运重建相比,血流储备分数(FFR)指导的血运重建与更好的术后患者结局相关。但是,目前尚不清楚瞬时无波形比值(iFR),一种不需要使用腺苷的替代方法,是否可以提供与FFR相似的获益。

 

方法

我们将2,492例冠心病患者按照1∶1的比例随机分配使其接受iFR指导或FFR指导的冠脉血运重建。主要终点是1年的主要不良心脏事件风险,即任何原因死亡、非致死性心肌梗死或非计划血运重建构成的复合终点。本试验设计为体现iFR相对于FFR的非劣效性,风险差的界值为3.4个百分点。

 

结果

在1年时,iFR组的1,148例患者有78例(6.8%)发生了主要终点,而FFR组的1,182例患者则有83例(7.0%)(风险差是-0.2个百分点,95%置信区间[CI]是-2.3~1.8,非劣效性的P<0.001,风险比是0.95,95% CI是0.68~1.33,P=0.78)。主要终点的每个构成部分的风险,以及心血管或非心血管原因死亡的风险在两组间无显著差异。iFR组出现术中不良症状和临床体征的患者数明显少于FFR组(39例[3.1%]对385例[30.8%],P<0.001),而且iFR组的中位手术时间显著较短(40.5分钟对45.0分钟,P=0.001)。

 

结论

在1年主要不良心脏事件风险方面,iFR指导的冠脉血运重建不劣于FFR指导的血运重建。和FFR相比,iFR术中不良体征和症状的发生率较低,而且手术时间较短(由Philips Volcano公司资助,DEFINE-FLAIR在ClinicalTrials.gov注册号为NCT02053038)。





作者信息

Justin E. Davies, M.D., Ph.D., Sayan Sen, M.D., Ph.D., Hakim-Moulay Dehbi, Ph.D., Rasha Al-Lamee, M.D., Ricardo Petraco, M.B., B.S., Ph.D., Sukhjinder S. Nijjer, M.B., B.S., Ph.D., Ravinay Bhindi, M.B., B.S., Ph.D., Sam J. Lehman, M.B., B.S., Ph.D., Darren Walters, M.B., B.S., James Sapontis, M.B., B.S., Luc Janssens, M.D., Christiaan J. Vrints, M.D., Ph.D., Ahmed Khashaba, M.D., Mika Laine, M.D., Ph.D., Eric Van Belle, M.D., Ph.D., Florian Krackhardt, M.D., Waldemar Bojara, M.D., Olaf Going, M.D., Tobias Härle, M.D., Ciro Indolfi, M.D., Giampaolo Niccoli, M.D., Ph.D., Flavo Ribichini, M.D., Nobuhiro Tanaka, M.D., Ph.D., Hiroyoshi Yokoi, M.D., Hiroaki Takashima, M.D., Ph.D., Yuetsu Kikuta, M.D., Andrejs Erglis, M.D., Ph.D., Hugo Vinhas, M.D., Pedro Canas Silva, M.D., Sérgio B. Baptista, M.D., Ali Alghamdi, M.D., Farrel Hellig, M.B., B.S., Bon-Kwon Koo, M.D., Ph.D., Chang-Wook Nam, M.D., Ph.D., Eun-Seok Shin, M.D., Joon-Hyung Doh, M.D., Ph.D., Salvatore Brugaletta, M.D., Ph.D., Eduardo Alegria-Barrero, M.D., Ph.D., Martijin Meuwissen, M.D., Ph.D., Jan J. Piek, M.D., Ph.D., Niels van Royen, M.D., Ph.D., Murat Sezer, M.D., Carlo Di Mario, M.D., Ph.D., Robert T. Gerber, Ph.D., Iqbal S. Malik, Ph.D., Andrew S.P. Sharp, M.D., Suneel Talwar, M.B., B.S., M.D., Kare Tang, M.D., Habib Samady, M.D., John Altman, M.D., Arnold H. Seto, M.D., Jasvindar Singh, M.D., Allen Jeremias, M.D., Hitoshi Matsuo, M.D., Ph.D., Rajesh K. Kharbanda, M.D., Ph.D., Manesh R. Patel, M.D., Patrick Serruys, M.D., Ph.D., and Javier Escaned, M.D., Ph.D.
From Hammersmith Hospital (J.E.D., S.S., R.A.-L., R.P., S.S.N., I.S.M., P.S.) and Royal Brompton Hospital (C.D.M.), Imperial College London, Cancer Research UK and University College London Cancer Trials Centre (H.-M.D.), London, Conquest Hospital, St. Leonards-on-Sea (R.T.G.), Royal Devon and Exeter Hospital and University of Exeter, Exeter (A.S.P.S.), Royal Bournemouth General Hospital, Bournemouth (S.T.), Essex Cardiothoracic Centre, Basildon (K.T.), Anglia Ruskin University, Chelmsford (K.T.), and John Radcliffe Hospital, Oxford University Hospitals Foundation Trust, Oxford (R.K.K.) — all in the United Kingdom; Royal North Shore Hospital, Sydney (R.B.), Flinders University, Adelaide, SA (S.J.L.), Prince Charles Hospital, Brisbane, QLD (D.W.), and MonashHeart and Monash University, Melbourne, VIC (J. Sapontis) — all in Australia; Imelda Hospital, Bonheiden (L.J.), and Antwerp University Hospital, Antwerp (C.J.V.) — both in Belgium; Ain Shams University, Cairo (A.K.); Helsinki University Hospital, Helsinki (M.L.); Institut Coeur Poumon, Lille University Hospital, and INSERM Unité 1011, Lille, France (E.V.B.); Charite Campus Virchow Klinikum, Universitaetsmedizin, Berlin (F.K.), Gemeinschaftsklinikum Mittelrhein, Kemperhof Koblenz, Koblenz (W.B.), Sana Klinikum Lichtenberg, Lichtenberg (O.G.), and Klinikum Oldenburg, European Medical School, Carl von Ossietzky University, Oldenburg (T.H.) — all in Germany; University Magna Graecia, Catanzaro (C.I.), Catholic University of the Sacred Heart, Rome (G.N.), University Hospital Verona, Verona (F.R.), and University of Florence, Florence (C.D.M.) — all in Italy; Tokyo Medical University, Tokyo (N.T.), Fukuoka Sannou Hospital, Fukuoka (H.Y.), Aichi Medical University Hospital, Aichi (H.T.), Fukuyama Cardiovascular Hospital, Fukuyama (Y.K.), and Gifu Heart Center, Gifu (H.M.) — all in Japan; Pauls Stradins Clinical University Hospital, Riga, Latvia (A.E.); Hospital Garcia de Horta (H.V.) and Hospital Santa Maria (P.C.S.), Lisbon. and Hospital Prof. Doutor Fernando Fonseca, Amadora (S.B.B.) — all in Portugal; King Abdulaziz Medical City Cardiac Center, Riyadh, Saudi Arabia (A.A.); Sunninghill Hospital, Johannesburg (F.H.); Seoul National University Hospital, Seoul (B.-K.K.), Keimyung University Dongsan Medical Center, Daegu (C.-W.N.), Ulsan University Hospital, University of Ulsan College of Medicine, Ulsan (E.-S.S.), and Inje University Ilsan Paik Hospital, Daehwa-Dong (J.-H.D.) — all in South Korea; Cardiovascular Institute, Hospital Clinic, Institut d’Investigacions Biomèdiques August Pi i Sunyer (IDIBAPS), Barcelona (S.B.); Hospital Universitario de Torrejón and Universidad Francisco de Vitoria (E.A.-B.) and Hospital Clinico San Carlos and Universidad Complutense de Madrid (J.E.), Madrid; Amphia Hospital, Breda (M.M.), and AMC Heart Center, Academic Medical Center (J.J.P.), and VU University Medical Center (N.R.), Amsterdam — all in the Netherlands; Istanbul University, Istanbul Faculty of Medicine, Istanbul, Turkey (M.S.); Emory University, Atlanta (H.S.); Colorado Heart and Vascular, Lakewood (J.A.); Veterans Affairs Long Beach Healthcare System, Long Beach, CA (A.H.S.); Washington University School of Medicine, St. Louis (J. Singh); Stony Brook University Medical Center, New York (A.J.); and Duke University, Durham, NC (M.R.P.). Address reprint requests to Dr. Davies at Hammersmith Hospital, Imperial College London, London W12 OHS, United Kingdom, or at justindavies@heart123.com.

 

参考文献

1. Di Mario C, Moses JW, Anderson TJ, et al. Randomized comparison of elective stent implantation and coronary balloon angioplasty guided by online quantitative angiography and intracoronary Doppler. Circulation 2000;102:2938-2944

2. Kern MJ, Donohue TJ, Aguirre FV, et al. Clinical outcome of deferring angioplasty in patients with normal translesional pressure-flow velocity measurements. J Am Coll Cardiol 1995;25:178-187

3. Serruys PW, Di Mario C, Meneveau N, et al. Intracoronary pressure and flow velocity with sensor-tip guidewires: a new methodologic approach for assessment of coronary hemodynamics before and after coronary interventions. Am J Cardiol 1993;71:41D-53D

4. Pijls NH, van Son JA, Kirkeeide RL, De Bruyne B, Gould KL. Experimental basis of determining maximum coronary, myocardial, and collateral blood flow by pressure measurements for assessing functional stenosis severity before and after percutaneous transluminal coronary angioplasty. Circulation 1993;87:1354-1367

5. Gould KL, Kirkeeide RL, Buchi M. Coronary flow reserve as a physiologic measure of stenosis severity. J Am Coll Cardiol 1990;15:459-474

6. Tonino PAL, De Bruyne B, Pijls NHJ, et al. Fractional flow reserve versus angiography for guiding percutaneous coronary intervention. N Engl J Med 2009;360:213-224

7. Fearon WF, Shilane D, Pijls NHJ, et al. Cost-effectiveness of percutaneous coronary intervention in patients with stable coronary artery disease and abnormal fractional flow reserve. Circulation 2013;128:1335-1340

8. Patel MR, Dehmer GJ, Hirshfeld JW, et al. ACCF/SCAI/STS/AATS/AHA/ASNC/HFSA/SCCT 2012 appropriate use criteria for coronary revascularization focused update: a report of the American College of Cardiology Foundation Appropriate Use Criteria Task Force, Society for Cardiovascular Angiography and Interventions, Society of Thoracic Surgeons, American Association for Thoracic Surgery, American Heart Association, American Society of Nuclear Cardiology, and the Society of Cardiovascular Computed Tomography. J Thorac Cardiovasc Surg 2012;143:780-803

9. Patel MR, Dehmer GJ, Hirshfeld JW, Smith PK, Spertus JA. ACCF/SCAI/STS/AATS/AHA/ASNC/HFSA/SCCT 2012 appropriate use criteria for coronary revascularization focused update: a report of the American College of Cardiology Foundation Appropriate Use Criteria Task Force, Society for Cardiovascular Angiography and Interventions, Society of Thoracic Surgeons, American Association for Thoracic Surgery, American Heart Association, American Society of Nuclear Cardiology, and the Society of Cardiovascular Computed Tomography. J Am Coll Cardiol 2012;59:857-881

10. Windecker S, Kohl P, Alfonso S, et al. 2014 ESC/EACTS guidelines on myocardial revascularization. Eur Heart J 2014;35:2541-2619

11. Pijls NHJ, Tonino PAL. The crux of maximum hyperemia: the last remaining barrier for routine use of fractional flow reserve. JACC Cardiovasc Interv 2011;4:1093-1095

12. Sen S, Escaned J, Malik IS, et al. Development and validation of a new adenosine-independent index of stenosis severity from coronary wave-intensity analysis: results of the ADVISE (ADenosine Vasodilator Independent Stenosis Evaluation) study. J Am Coll Cardiol 2012;59:1392-1402

13. Sen S, Asrress KN, Nijjer S, et al. Diagnostic classification of the instantaneous wave-free ratio is equivalent to fractional flow reserve and is not improved with adenosine administration: results of CLARIFY (Classification Accuracy of Pressure-Only Ratios Against Indices Using Flow Study). J Am Coll Cardiol 2013;61:1409-1420

14. Petraco R, van de Hoef TP, Nijjer S, et al. Baseline instantaneous wave-free ratio as a pressure-only estimation of underlying coronary flow reserve: results of the JUSTIFY-CFR Study (Joined Coronary Pressure and Flow Analysis to Determine Diagnostic Characteristics of Basal and Hyperemic Indices of Functional Lesion Severity-Coronary Flow Reserve). Circ Cardiovasc Interv 2014;7:492-502

15. Layland J, Oldroyd KG, Curzen N, et al. Fractional flow reserve vs. angiography in guiding management to optimize outcomes in non-ST-segment elevation myocardial infarction: the British Heart Foundation FAMOUS-NSTEMI randomized trial. Eur Heart J 2015;36:100-111

16. Götberg M, Christiansen EH, Gudmundsdottir IJ, et al. Instantaneous wave-free ratio versus fractional flow reserve to guide PCI. N Engl J Med 2017;376:1813-1823

17. Petraco R, Park JJ, Sen S, et al. Hybrid iFR-FFR decision-making strategy: implications for enhancing universal adoption of physiology-guided coronary revascularisation. EuroIntervention 2013;8:1157-1165

18. Escaned J, Echavarría-Pinto M, Garcia-Garcia HM, et al. Prospective assessment of the diagnostic accuracy of instantaneous wave-free ratio to assess coronary stenosis relevance: results of ADVISE II international, multicenter study (ADenosine Vasodilator Independent Stenosis Evaluation II). JACC Cardiovasc Interv 2015;8:824-833

19. Sen S, Nijjer S, Petraco R, Malik IS, Francis DP, Davies J. Instantaneous wave-free ratio: numerically different, but diagnostically superior to FFR? Is lower always better? J Am Coll Cardiol 2013;62:566-566

20. van de Hoef TP, Meuwissen M, Escaned J, et al. Head-to-head comparison of basal stenosis resistance index, instantaneous wave-free ratio, and fractional flow reserve: diagnostic accuracy for stenosis-specific myocardial ischaemia. EuroIntervention 2015;11:914-925

21. Dilsizian V, Gewirtz H, Paivanas N, et al. Serious and potentially life threatening complications of cardiac stress testing: physiological mechanisms and management strategies. J Nucl Cardiol 2015;22:1198-1213

22. Cerqueira MD, Verani MS, Schwaiger M, Heo J, Iskandrian AS. Safety profile of adenosine stress perfusion imaging: results from the Adenoscan Multicenter Trial Registry. J Am Coll Cardiol 1994;23:384-389

23. Kern MJ, Seto AH. On the search for an “easy” FFR: submaximal hyperemia and NTG-induced translesional pressure drop (Pd/Pa-NTG). Catheter Cardiovasc Interv 2016;87:270-272

24. Mallet ML. Proarrhythmic effects of adenosine: a review of the literature. Emerg Med J 2004;21:408-410

25. van de Hoef TP, van Lavieren MA, Damman P, et al. Physiological basis and long-term clinical outcome of discordance between fractional flow reserve and coronary flow velocity reserve in coronary stenoses of intermediate severity. Circ Cardiovasc Interv 2014;7:301-311

26. Stone GW, Sabik JF, Serruys PW, et al. Everolimus-eluting stents or bypass surgery for left main coronary artery disease. N Engl J Med 2016;375:2223-2235

27. Mohr FW, Morice MC, Kappetein AP, et al. Coronary artery bypass graft surgery versus percutaneous coronary intervention in patients with three-vessel disease and left main coronary disease: 5-year follow-up of the randomised, clinical SYNTAX trial. Lancet 2013;381:629-638

28. Mäkikallio T, Holm NR, Lindsay M, et al. Percutaneous coronary angioplasty versus coronary artery bypass grafting in treatment of unprotected left main stenosis (NOBLE): a prospective, randomised, open-label, non-inferiority trial. Lancet 2016;388:2743-2752

29. Patel MR, Mahaffey KW, Garg J, et al. Rivaroxaban versus warfarin in nonvalvular atrial fibrillation. N Engl J Med 2011;365:883-891

30. Granger CB, Alexander JH, McMurray JJV, et al. Apixaban versus warfarin in patients with atrial fibrillation. N Engl J Med 2011;365:981-992

31. Holmes DR Jr, Kar S, Price MJ, et al. Prospective randomized evaluation of the Watchman Left Atrial Appendage Closure device in patients with atrial fibrillation versus long-term warfarin therapy: the PREVAIL trial. J Am Coll Cardiol 2014;64:1-12

32. von Birgelen C, Basalus MWZ, Tandjung K, et al. A randomized controlled trial in second-generation zotarolimus-eluting Resolute stents versus everolimus-eluting Xience V stents in real-world patients: the TWENTE trial. J Am Coll Cardiol 2012;59:1350-1361

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