1. 冠脉分叉病变介入治疗的风险预测与策略选择 南京医科大学附属南京医院 南京市心血管病医院 田乃亮 陈绍良

2. Bifurcation Lesions are Still a Challenge 15%-20% of PCI 15%-20% of PCI Require more time, anxiety, skill, and equipment (cost) Require more time, anxiety, skill, and equipment (cost) Increased complications Increased complications peri-procedural MIs, stent thrombosis, and restenosis peri-procedural MIs, stent thrombosis, and restenosis

3. PCI 过程中分支闭塞可导致： PCI 过程中分支闭塞可导致： 心肌缺血 心肌缺血 心肌梗死 心肌梗死 死亡 死亡

4. Anatomical Features of Bif. Lesions location/length: LMd, non-LMd Lesions location/length: LMd, non-LMd SB sizes: cut-off diameter=2.5 mm SB sizes: cut-off diameter=2.5 mm Bif. Angle: inconsistent solutions Bif. Angle: inconsistent solutions Myocardium at jeopardy of risk: SB size? Myocardium at jeopardy of risk: SB size? Predictors of SB closure after stenting MV Predictors of SB closure after stenting MV Co-morbidities: DM, EF ↓,renal dysfunction Co-morbidities: DM, EF ↓,renal dysfunction Procedural failure: tortuous, angulated, calcified, diffuse Procedural failure: tortuous, angulated, calcified, diffuse Which one is the most important factor?

5. Medina A. et al. Rev Esp Cardiol. 2006; 59: 183-4 Medina Classification 1, 1, 11, 1, 01, 0, 1 0, 1, 1 1, 0, 00, 1, 0 0, 0, 1 MB Distal MB Proximal SB

7. 单支架好还是双支架好？ 单支架好还是双支架好？ 如果选双支架术，应该采取何种策略 ? 如果选双支架术，应该采取何种策略 ? 策略选择的根据 策略选择的根据 简单化 vs 复杂化 简单化 vs 复杂化 循证结果 vs 个人选择 循证结果 vs 个人选择 并发症率 (especially MI / thrombosis) 并发症率 (especially MI / thrombosis) 分叉病变介入治疗的核心问题

8. Strategy SIMPLE COMPLEX Simple (Provisional) vs. Complex (Two-Stent) Bifurcation Stenting Strategies Stenting of the main branch only. Side branch stenting for suboptimal result. Routine stenting of Both the main & side branch Crush (DK) Culotte T-stenting Others Courtesy of S. Brar; TCT 2012

9. 1. 操作时间短 2. X 线放射量低 3. 临床预后非劣效于双支架策略 双支架策略 1. 操作时间长 2. X 线放射量高 3. 技术要求高 分支闭塞风险高 心肌缺血、心肌梗死甚至死亡 分支血管置入支架 保障分支血流

11. Randomized Bifurcation Studies (NORDIC, BBC ONE, CACTUS)

13. Nordic-Bifurcation I 5-year follow-up

14. DKCRUSH-II

15. Shaoliang Chen, et al,J Am Coll Cardiol 2011;57:914–20

16. SL Chen, et al,J Am Coll Cardiol 2011;57:914–20

17. Randomized Comparison of Provisional Side Branch Stenting versus a Two-stent Strategy for treatment of True Coronary Bifurcation Lesions Involving a Large Side Branch. The Nordic-Baltic Bifurcation Study IV Indulis Kumsars, Matti Niemelä, Andrejs Erglis, Kari Kervinen, Evald H. Christiansen, Michael Maeng, Andis Dombrovskis, Vytautas Abraitis, Aleksandras Kibarskis, Terje K. Steigen, Thor Trovik, Gustavs Latkovskis, Dace Sondore, Inga Narbute, Christian Juhl Terkelsen, Markku Eskola, Hannu Romppanen, Per Thayssen, Anne Kaltoft,Tuija Vasankari, Pål Gunnes, Ole Frobert, Fredrik Calais, Juha Hartikainen, Svend Eggert Jensen, Thomas Engstrøm, Niels R. Holm, Jens F. Lassen and Leif Thuesen For the Nordic-Baltic PCI Study Group

18. Background Provisional (simple) stenting is the preferred strategy in treatment of most bifurcation lesions Provisional (simple) stenting is the preferred strategy in treatment of most bifurcation lesions It is unknown if this also applies to true bifurcation lesions involving a large side branch It is unknown if this also applies to true bifurcation lesions involving a large side branch Nordic-Baltic Bifurcation Study IV The Nordic-Baltic PCI Study Group Courtesy of I Kumsars; TCT 203

19. Patient flowchart Nordic Baltic Bifurcation study IV n=450 Provisional SB stening n=221* Two stent n=229* 1 lost to FU 1 excluded due to protocol violation Provisional Completed 6M FU n=220 Two stent Completed 6M FU n=227 1 withdrawal *numbers not balanced due to block randomization and sites with less than 4 inclusions Nordic-Baltic Bifurcation Study IV The Nordic-Baltic PCI Study Group Courtesy of I Kumsars; TCT 203

20. Eventfree survival curve at 6 months Primary endpoint 4.6% 1.8% p=0.09 Nordic-Baltic Bifurcation Study IV The Nordic-Baltic PCI Study Group Courtesy of I Kumsars; TCT 203

21. Individual endpoints at 6 months Provisional(n=220)Two-stent(n=227)p Total death (%) 00.40.32 Cardiac death (%) 00- Non-procedural myocardial infarction (%) 1.80.90.50 Stent thrombosis (%) 0.90.40.54 Target lesion revascularization (%) 3.21.30.18 Target vessel revascularization (%) 3.71.30.11 Angina CCS class ≥ II 2.71.30.39 Nordic-Baltic Bifurcation Study IV The Nordic-Baltic PCI Study Group Courtesy of I Kumsars; TCT 203

22. Conclusion After 6 months, two-stent techniques for treatment of true bifurcation lesions with a large side branch showed no significant difference in MACE rate compared to provisional side branch stenting After 6 months, two-stent techniques for treatment of true bifurcation lesions with a large side branch showed no significant difference in MACE rate compared to provisional side branch stenting Longer and more complex procedures in the two-stent group did not translate into more procedural myocardial infarctions Longer and more complex procedures in the two-stent group did not translate into more procedural myocardial infarctions Nordic-Baltic Bifurcation Study IV The Nordic-Baltic PCI Study Group Recommendations on optimal strategy for this lesion subset should await longer term follow-up

23. Chen et al. JACC 2013 DK-III study

24. Clinical follow-up (at 12-month) Chen et al. JACC e-publish ahead of print 2013 March

25. 1-year results CCCP 2013, Beijing Chen et al. JACC 2013

26. Meta analysis from 9 RCT(n=2569) Simple vs complex stenting XF Gao, et al Euro intervention 2014 in press

27. Lesion characteristics XF Gao, et al Euro intervention 2014 in press

28. Cardiac Death XF Gao, et al Euro intervention 2014 in press

29. Stent Thrombosis XF Gao, et al Euro intervention 2014 in press

30. Myocardial Infarction OR=0.60;p=0.005 XF Gao, et al Euro intervention 2014 in press The favorable results of simple strategy was concealed in follow-up MI when the BBC ONE trial was omitted (OR: 0.76, 95% CI: 0.50-1.13, p=0.17)

31. Early Myocardial Infarction OR=0.53;p=0.002 XF Gao, et al Euro intervention 2014 in press

32. TLR OR=1.72;p=0.07

33. TVR XF Gao, et al Euro intervention 2014 in press OR=1.59;p=0.09

34. MV-Restenosis XF Gao, et al Euro intervention 2014 in press OR=1.53;p=0.08

35. SB-Restenosis XF Gao, et al Euro intervention 2014 in press

36. Large SB sub-analysis — TVR OR=2.04;p=0.02 Large SB Non-Large SB XF Gao, et al Euro intervention 2014 in press

37. DK sub-analysis---SB Restenosis DK crush Non-DK crush OR=4.70;p<0.001 XF Gao, et al Euro intervention 2014 in press

38. DK sub-analysis---TLR DK crush Non-DK crush OR=3.97;p=0.002 XF Gao, et al Euro intervention 2014 in press

39. DK sub-analysis---TVR DK crush Non-DK crush OR=3.10;p=0.005 XF Gao, et al Euro intervention 2014 in press

40. Conclusion Complex strategy remains optional treatment for patients with coronary bifurcation lesions without severe concern regarding safety. Complex strategy remains optional treatment for patients with coronary bifurcation lesions without severe concern regarding safety. The dissociation of the subgroups in the complex strategy group on re-intervention is probably attributed to the novel DK-Crush technique used in the DK subgroup. The dissociation of the subgroups in the complex strategy group on re-intervention is probably attributed to the novel DK-Crush technique used in the DK subgroup. XF Gao, et al Euro intervention 2014 in press

41. Selection of techniques One-stent : × Provisional : PT vs classical crush---CACTUS Two-stenting: Classical crush vs Culotte ----NORDIC I Classical crush vs DK crush---DKCRUSH I DK crush vs Provisional T-----DKCRUSH II DK crush vs Culotte-------------DKCRUSH III

42. Why not in consistent with previous studies? No risk stratification for Bifurcation No risk stratification for Bifurcation No definition of high risk bifurcation No definition of complex bifurcation

43. Definition Study Flow Chart SL Chen, et al JACC intervention 2014 in press

44. 5/23/2015 pSen (%)Spe(%) Major 1: LMd bif, SB- DS≥70% < 0. 00 1 7871 Major 2: SB- DS≥90%, B A ≥70 0 <0.0017872 Minor 1: SB lesion length ≥10 mm 0. 006 6966 Minor 2: ≥ Moderator c alcification 0. 00 2 6465 Minor 3: Multiple lesions 0. 007 6860 Minor 4: LVEF<30% 0. 002 6553 Minor 5: eGFR<30ml/min/1.73m2 0. 008 7055 Minor 6: Thrombus-containing lesions 0.0026664 Minor 7: MV lesion length ≥ 2 5 mm 0. 01 0 5766 Severe angulation in SB 0. 039 4445 Previous PCI 0. 035 4857 Diabetes 0. 0 3 8 6249 MV RVD<2.5 mm 0.0196643 Major1 +any two of Minor 1-7 =complex ------>84 ≥ 79 Major 2 + any two of Minor 1 - 7 =complex ------>84 ≥ 79 SL Chen, et al JACC intervention 2014 in press Complex Bifurcation Lesion Definition

45. 5/23/2015 C Statics:0.79 SL Chen, et al JACC intervention 2014 in press Predictive vale of new stratification by ROC analysis

46. 5/23/2015 Comparison of MACE at 12-month between simple vs. complex bifurcation SL Chen, et al JACC intervention 2014 in press

47. 5/23/2015 SL Chen, et al JACC intervention 2014 in press TLR-free survival rate at 12 months between 2-stent and provisional stenting subgroup among 3660 patients

48. 5/23/2015 TLR-free survival rate at 12 months between 2-stent and provisional stenting subgroup among patients with simple bifurcation lesions SL Chen, et al JACC intervention 2014 in press

49. 5/23/2015 In-hospital MACE-free survival rate between 2-stent and provisional stenting subgroup among patients with complex bifurcation lesions SL Chen, et al JACC intervention 2014 in press

50. 5/23/2015 1-year cardiac death-free survival rate between 2-stent and provisional stenting subgroup among patients with complex bifurcation lesions SL Chen, et al JACC intervention 2014 in press

51. Conclusion 1. Complex bifurcation lesions had higher rates of one-year MACE and ST 1. Complex bifurcation lesions had higher rates of one-year MACE and ST 2. Two-stent techniques were harmful for simple bifurcation. 2. Two-stent techniques were harmful for simple bifurcation. However, Pro-stenting for complex lesions elicited more cases of cardiac death and MACE. However, Pro-stenting for complex lesions elicited more cases of cardiac death and MACE. 3. Further RCT is required to compare simple vs complex stenting for complex bifu. 3. Further RCT is required to compare simple vs complex stenting for complex bifu. CCCP 2013, Beijing Chen et al. JACC-Interv, in revision

52. 病例

53. 边支闭塞（ case 1 ）

55. 边支闭塞（ case 2 ）

57. 边支闭塞（ case 3 ）

60. One Stent （ case 4 ）

61. at 1 year Follow up

62. SKS(2008-10)

63. 8 月后常规复查 CAG （ 2009-06-11 ）

64. 胸痛 2013-10-15

65. After PCI

66. 策略选择：个体化  单支架并不一定优于双支架  对比介入策略的目的并非比较哪种介入策略更好， 要根据患者和病变的个体化特征选择最佳的介入策 略 要根据患者和病变的个体化特征选择最佳的介入策 略

67. 谢谢