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NONG in Stable Angina with Severe Coronary Stenosis: When to Perform?

This article discusses the indications for performing NONG (nonobstructive fractional flow reserve-guided percutaneous coronary intervention) in patients with stable angina and severe coronary stenosis. It includes case studies, relevant studies, and treatment strategies.

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NONG in Stable Angina with Severe Coronary Stenosis: When to Perform?

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  1. Khi nào nong động mạch vành trên bệnh nhân đau ngực ổn định với tổn thương hẹp lớn hơn 70% ? BSCK II HUỲNH NGỌC LONG VIỆN TIM TP.HCM

  2. NONG MẠCH VÀNH DỰA VÀO 1-Đau ngực 2-Test chức năng (+) không xâm lấn. 3-Số nhánh hẹp 4-Anatomy thích hợp nong ( Syntax score).

  3. TRƯỜNG HỢP 1: ĐIỂN HÌNH1-Đau ngực 2-Test không xâm lấn (+) 3.Hẹp ≥70% 4-Syntax ≤ 22 NONG

  4. COURAGE: Study design AHA/ACC Class I/II indications for PCI, suitable coronary artery anatomy + ≥70% stenosis in ≥1 proximal epicardial vessel + objective evidence of ischemia (or ≥80% stenosis + CCS class III angina without provocation testing) Optimal medical therapy* + PCI (n = 1149) Optimal medical therapy*(n = 1138) Randomized Primary outcomes: All-cause mortality, nonfatal MI Secondary outcomes: Death, MI, stroke; ACS hospitalization Follow-up: Median 4.6 years *Intensive pharmacologic therapy + lifestyle interventionCCS = Canadian Cardiovascular Society Boden WE et al. Am Heart J. 2006;151:1173-9. Boden WE et al. N Engl J Med. 2007;356:1503-16.

  5. Freedom from Angina in COURAGE Weintraub, et al. New Engl J Med 2008;359:677-687.

  6. TRƯỜNG HỢP 2: KHÔNG ĐAU NGỰC2-Test chức năng (+) 3.Hẹp ≥70% 4-Syntax ≤ 22 CÓ NÊN NONG KHÔNG ?

  7. DUKE TREADMILL SCORE DTSDuke treadmill 1-score>=+5 Low 2-Score +4 to -10 Moderate 3-Score <= -11 High risk

  8. DUKE TREAMILL SCORETIÊN LƯỢNG TỬ VONG VD = Vessel Disease;  LM = Left Main

  9. ACIP: Study design Angiographic CAD (≥50% stenosis in≥1 major vessel or branch) suitable for revascularization + ischemia during exercise or pharmacologic stress testing and ≥1 asymptomatic episode during 48-hr AECG Angina-guided strategy(n = 183) Ischemia-guided strategy(n = 183) Revascularization strategy(n = 192) Primary outcome: Absence of ischemia at 12 weeksSecondary outcomes: Death, MI, recurrent hospitalization for cardiac disease, nonprotocol revascularization at 1 and 2 years Pepine CJ et al. J Am Coll Cardiol. 1994:24:1-10.Davies RF et al. Circulation. 1997;95:2037-43. Asymptomatic Cardiac Ischemia Pilot

  10. ACIP: Two-year cumulative all-cause mortality rates 4.1% Medical treatment 558 patients , functionally significant stenosis without symptoms: randomization in 3 treatments strategies 8 % Cumulative Mortality 6.6% 6 No treatment 4 P < 0.05 2 1.1% Revascularization 0 0 4 8 12 16 20 24 mos Davies et al, Circulation, 1997

  11. SWISSI II: Study design Recent first MI with asymptomatic myocardial ischemia on exercise testing and 1- or 2-vessel coronary disease suitable for PCI PCI (n = 96) Randomized, unblinded Anti-ischemic therapy*(n = 105) Primary outcomes: Cardiac death, nonfatal MI, symptom-driven revascularization Follow-up: 10.2 years (mean) *Nitrates, β-blockers, CCBs All patients also received aspirin and statin Swiss Interventional Study on Silent Ischemia Type II Erne P et al. JAMA. 2007;297:1985-91.

  12. SWISSI II: Baseline characteristics Erne P et al. JAMA. 2007;297:1985-91.

  13. SWISSI II: THEO DÕI 15 NĂM 1.00 PCI 0.75 Event-free survival 0.50 Drug therapy 0.25 P < 0.001* 0 0 5 10 15 Time from randomization (years) *Log-rank Erne P et al. JAMA. 2007;297:1985-91.

  14. ACIP, SWISSI II: Summary and implications 1-ACIP: In patients with documented CAD + symptomatic and asymptomatic ischemia, PCI compared with anti-ischemic or antianginal therapy reduced 2-year risk of major CV events 2-SWISSI II extended these finding to post-MI patients with asymptomatic ischemia and a longer 10-year follow-up Davies RF et al. Circulation. 1997;95:2037-43. Erne P et al. JAMA. 2007;297:1985-91.

  15. TRƯỜNG HỢP 2: KHÔNG ĐAU NGỰC2-Test chức năng (+) 3.Hẹp ≥70% 4-Syntax ≤ 22 NÊN NONG

  16. TRƯỜNG HỢP 3: 1-Có đau ngực 2-Có test chức năng (+) 3-Giải phẩu thích hợp, syntax score ≤22. 4-Nhưng tổn thương hẹp trung bình 50-70% CÓ NÊN NONG KHÔNG ?

  17. HẸP 50% LAD, NÊN NONG KHÔNG ? 1-Nam 56 Tuổi 2-Đau ngực điển hình 3-Duke score= -2 4-Nguy cơ trung bình, nguy cơ tử vong 1 năm=2,9%

  18. TƯƠNG TỰ CÁCH ĐẶT VẤN ĐỀ CỦA DEPER STUDY • female, 58-y-old • underwent PCI of severe LCX lesion a minute before • 50 % stenosis in mid RCA Should this lesion be stented ?? 158 vb38/interm.RCA/Buddem (1)

  19. The DEFER Study: Design prospective randomized multicentric trial (14 centers) in 325 patients with stable chest pain and an intermediate stenosis without objective evidence of ischemia Aalst Amsterdam Eindhoven Essen Gothenborg Hamburg Liège Maastricht Madrid Osaka Rotterdam Seoul Utrecht Zwolle data collection & analysis: Jan Willem Bech, MD, PhD Pepijn van Schaardenburgh, MD

  20. THE DEFER STUDY: RANDOMIZATION deferral of PCI performance of PCI 1 : 1 randomization If FFR < 0.75 performance anyway reference group If FFR > 0.75 randomization followed defer PCI perform PCI

  21. The DEFER Study: Catheterization • 6 or 7 F guiding catheter for measurement of • aortic pressure(Pa) • QCA from 2 orthogonal views • Coronary pressure measurement (Pd)by • 0.014” pressure wire (Radi Medical Systems) • Maximum hyperemia by i.v. adenosine (140 ug/kg/min) • Calculation of Fractional Flow Reserve by: FFR = Pd / Pa

  22. Diabetes (%) 13 12 Hypertension (%) 41 35 Hyperlipidemia (%) 47 48 Current Smoker (%) 30 25 Family History CAD (%) 50 49 The DEFER Study: Base line data Randomized to Randomized to Deferral of PTCA Performance of PTCA N=167 N=158 Age, (yr) 629 6310 Female sex (%) 29 29 Ejection Fraction (%) 6710 689

  23. Randomized to Randomized to Deferral of PTCA Performance of PTCA N=167 N=158 Ref. diam. (mm) 2.96 ± 0.63 2.98 ± 0.57 1.42 ± 0.38 MLD (mm) 1.42 ± 0.40 52 ± 11 DS (%) 52 ± 10 0.730.19 FFR 0.720.19 The DEFER Study: Baseline QCA and FFR All baseline characteristics were identical between both groups

  24. DEFER: Clinical Outcome at 5 Years Non-TLR(%) 6 (6.7) 6 (6.8) 11 (8.2) Patients ≥1 event (%) 24 (27 %) 52 (39 %) 19 (21 %) FFR ≥0.75 FFR<0.75 Defer Perform Reference Number of patients 91 90 144 Lost to follow-up 1 2 10 Cardiac Death(%) 3 (3.3) 2 (2.3) 8 (6.0) 4 (3.0) Non Cardiac Death(%) 3 (3.3) 3 (3.4) Q wave MI (%) 0 4 (4.5) 6 (4.5) Non-Q wave MI(%) 0 1 (1.1) 7 (5.2) CABG(%) 1 (1.1) 4 (4.5) 14 (10.4) TLR(%) 8 (8.9) 8 (9.1) 18 (13.4) Other (%) 0 1 (1.1) 2 (1.5) Total events 21 29 70 Pts free of angina(%) 68 % 58 % 72 %

  25. Cardiac Death And Acute MI After 5 Years P< 0.03 % 20 P< 0.005 15.7 15 P=0.20 10 7.9 5 3.3 0 DEFER PERFORM REFERENCE FFR > 0.75 FFR < 0.75

  26. The risk for death or acute myocardial infarction in the next five years is 20 times higher for an ischemic lesion compared to a non-ischemic lesion !!! 8 12000 Patients ( 2 x 6000) similar stenosis severity by coronary angio 7 7.4 6 5 4 % death or Acute MI 3 2 1 0.6 0 no ischemia ischemia Iskander S, Iskandrian A E JACC 1998

  27. FFR LÀ TEST CHỨC NĂNG XÂM LẤN QUAN TRONG 1-Một nhánh, hẹp trung bình 50-70% 2-Có đau ngực 3-Không có test không xâm lấn Nhưng bù lại, có FFR ≤ 0.75 NÊN NONG

  28. HẸP 50% LAD 1-Nam 56 Tuổi 2-Đau ngực điển hình 3-Duke score= -2 4-Nguy cơ tử vong 1 năm=2,9%. Làm thêm FFR ≤ 0.75 Nong FFR >0.75Nguy cơ tử vong < 1%/năm

  29. TRƯỜNG HỢP 3: 1-Có đau ngực 2-Hẹp trung bình 50-70%. 3-FFR ≤ 0.75 test chức năng xâm lấn NÊN NONG

  30. THIẾU MÁU CƠ TIM ? 1- ECG gắng sức, Siêu âm dobutamin, Scintigraphi  “mất cân bằng cung/cầu” 2-FFR Giảm lưu lượng trong mạch vành thủ phạm FFR LÀ GÌ ?Fractional Flow Reserve

  31. LƯU LƯỢNG MÁU TRONG MẠCH VÀNH 1-Tương tự định luật Ohm trong dòng điện: U=R.I I= U/R 2-Lưu lượng mạch máu Q= Pressure/Resistance TỈ LỆ LƯU LƯỢNG MÁU SAU VÀ TRƯỚC CHỖ HẸP 3-Q sau/Q trước= Psau/P trước=FFR

  32. CÁCH THỰC HIỆN FFR 1-Đo trạng thái bình thường 2-Đo sau khi chích adenosin(140 ug/kg/min) vào mạch vành. 3-FFR ≤ 0.80  Lưu lượng máu sau chỗ hẹp đã giảm 20%. 4-FFR ≤ 0.75 Lưu lượng máu sau chỗ hẹp đã giảm 25%.

  33. FFR =TRƯỚC + BÀNG HỆ + VI TUẦN HOÀN

  34. FFR ESC GUIDELLINE 2008 Class I A

  35. TRƯỜNG HỢP 4:Hẹp nhiều nhánh và lan tỏa

  36. ECG GẮNG SỨC, SIÊU ÂM DOBUTAMIN, SCINTIGRAPHI KHÓ XÁC ĐỊNH: 1-Mạch nào thủ phạm 2-Đoạn nào cần nong NÊN DÙNG FFR

  37. FAME 2 STUDYFractional Flow Reserve (FFR) vs. Angiography in Multivessel Evaluation

  38. FAME 2: FFR-Guided PCI versus Medical Therapy in Stable CAD Available on-line on Aug 28, 2012 on www.nejm.org

  39. Background 1-The FAME 2 trial, multicenter, international, randomized study comparing fractional flow reserve (FFR)-guided percutaneous coronary intervention (PCI) to best medical therapy (MT) in patients with stable coronary disease. 2-The study was stopped early because of a significantly higher rate of the composite endpoint of death, MI and urgent revascularization in patients assigned to MT.

  40. Trial Design Stable patients with 1, 2, or 3 vessel CAD evaluated for PCI with DES n=1220 FFR in all target lesions Registry Randomized Trial At least 1 stenosis with FFR ≤ 0.80 (n=888) All FFR > 0.80 (n=322) Randomization 1:1 MT MT PCI + MT 50% randomly assigned to follow-up Primary Endpoint: Death, MI, Urgent Revascularization at 2 years

  41. Baseline Characteristics

  42. FAME study: Procedural Results (1)

  43. FAME study: Procedural Results (2)

  44. Procedural Characteristics

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