1. 左主干分叉病变治疗策略的选择 Left main bifurcation: what is the best choice? Lei Ge, MD Department of Cardiology, Zhongshan Hospital, Fudan University

2. What do we know about the distal LM? Left main bifurcation: what is the best choice?

3. Fact #1 – Patients with LM bifurcation lesions have a significantly higher incidence of MACE than patients with ostial and midshaft lesions T-SEARCH/RESEARCH J Am Coll Cardiol 2006;47:1530-37 20-month MACE adj. HR 2.79 (95% CI 1.2-8.9), p = 0.032 n = 130 GISE/SICI Eur Heart J 2010;30:2087-94 24-month MACE adj. HR 1.50 (95% CI 1.1-2.1), p = 0.024 n = 1,111 Left main bifurcation: what is the best choice?

4. HR (95% CI)P P Death1.00 (0.50-1.99)0.990.66 (0.35-1.26)0.21 Q-MI1.42 (0.37-5.45)0.610.72 (0.23-2.23)0.57 TVR7.71 (1.78-33.4)0.0066.23 (3.12-12.4)< 0.001 Death, Q-MI or Stroke1.06 (0.57-1.99)0.850.95 (0.56-1.82)0.62 Death, Q-MI, Stroke or TVR1.51 (0.91-2.49)0.111.42 (1.02-1.97)0.04 Fact #2 – DES-PCI is associated with a similar higher risk of TVR than CABG either in patients with non-distal or distal LM lesions Ostium/shaftBifurcation Data from the MAIN COMPARE Registry; HR for DES-PCI with reference to CABG Adapted from Park SJ Left main bifurcation: what is the best choice?

5. SYNTAX Left Main arm What did it add to our understanding on Distal LM PCI? Left main bifurcation: what is the best choice?

6. Key findings from SYNTAX (LM PCI cohort)  In distal versus non-distal left main lesions:  No difference in safety (death/CVA/MI)  No significant difference in revascularization rates Distal vs non-Distal Left main bifurcation: what is the best choice?

7.  In distal left main lesions  No difference in safety (death/CVA/MI)  Trend towards higher MACCE driven by more revascularization rate for bifurcation stenting using ≥2 stents versus 1 stent 2-stent vs 1-stent Key findings from SYNTAX (LM PCI cohort) Left main bifurcation: what is the best choice?

8.  In distal left main lesions  Equivalent safety  Significantly increased MACCE and revascularization with non provisional T-stenting versus T-stenting T-stent vs non T-stent Key findings from SYNTAX (LM PCI cohort) Left main bifurcation: what is the best choice?

9. But... only 12.7% of the randomized SYNTAX cohort received PCI for a distal LM lesion Huge chance for Type I and Type II errors! Left main bifurcation: what is the best choice?

10. Beyond the SYNTAX Looking for meaningful predictors of worse outcome relevant to the LM bifurcation cohort  Stenting technique  Plaque distribution and bifurcation angle  SYNTAX score Left main bifurcation: what is the best choice?

11. MACE free survival (%) 100 75 50 25 0 Time (months) 0 12 24 80.0% 72.0% OSTIUM/SHAFT BIFURCATION P = 0.035* 1) The case for the stenting technique - LM Bifurcations treated with 2 stents have worse outcomes than LM bifurcations treated with 1 stent MACE free survival (%) 100 75 50 25 0 Time (months) 0 12 24 80.0% 67.0% OSTIUM/SHAFT BIFURCATION, 2 stents P = 0.38* BIFURCATION, 1 stent 75.0% P < 0.001** * log rank test for ostium/shaft versus bifurcation 1 stent ** log rank test for ostium/shaft versus bifurcation 2 stents * log rank test for ostium/shaft versus bifurcation Palmerini et al. Eur Heart J 2010;30:2087-94 GISE/SICI Registry (n = 1,111) Left main bifurcation: what is the best choice?

12. Worse outcomes of bifurcation LM PCI are driven by need for revascularization, but only in patients receiving 2 stents 2-year MI2-year TLR2-year death2-year cardiac death P < 0.00001 P = NS OSTIUM/SHAFT BIFURCATION, 2 stents BIFURCATION, 1 stent Palmerini et al. Eur Heart J 2010;30:2087-94 GISE/SICI Registry (n = 1,111) Left main bifurcation: what is the best choice?

13. Whole Bifurcation (WB) non-Whole Bifurcation (non-WB) Plaque Distribution Pattern in LM Bifurcation Tamburino et al. JACC Interv 2010;3:624-31 Left main bifurcation: what is the best choice?

14. 24.9% 8.3% HR: 3.12; 95% CI 1.59-6.11; p = 0.001* Adj. HR 2.84; 95% CI 1.43-564, p = 0.003 Non-WB (n = 145) WB (n = 184) 2) Plaque distribution pattern in LM bifurcation - Three-year TLR stratified by baseline plaque distribution pattern Tamburino et al. JACC Interv 2010;3:624-31 Whole Bifurcation (WB)* non-Whole Bifurcation (non-WB) *The presence of the plaque at each side was attributed regardless of the stenosis degree Left main bifurcation: what is the best choice?

15. P = 0.028 P = 0.023 = 0.55 P = 0.55 3-year target lesion revascularization (%) P = 0.29 The Impact of Plaque Distribution Pattern is Independent from the Stenting Technique P for interaction between plaque distribution and stent technique: NS Tamburino et al. JACC Interv 2010;3:624-31 Left main bifurcation: what is the best choice?

16. WB Medina non 1,1,1 (66.2%) 1,1,1 Non 1,1,1 20.7% 26.8% P = 0.57 WB lesions only 0 1 0 1 1 0 0 1 1 1 1 1 Medina 1,1,1 (33.8%) 1 1 1 WB is associated with high TLR regardless of the stenosis degree in each bifurcation segment Tamburino et al. JACC Interv 2010;3:624-31 Left main bifurcation: what is the best choice?

17. 7.8% 26.8% P = 0.0003 Medina non 1,1,1 only WB Non WB Medina non 1,1,1 Non-WB WB 0 1 0 1 1 0 1 1 1 0 0 0 Tamburino et al. JACC Interv 2010;3:624-31 WB is associated with high TLR regardless of the stenosis degree in each bifurcation segment Left main bifurcation: what is the best choice?

18. Capodanno et al. JACC Interv 2009;2:731-8 Ostium/shaft * After adjusting for confounders: HR 2.89, 1.07-7.85, p = 0.037. ** After adjusting for confounders: HR 6.09, 1.00-36.9, p = 0.049. P for interaction between SYNTAX score, lesion location and treatment: 0.249 P = 0.984 P = 0.001* Bifurcation P = 0.839 P = 0.006** 3) The case for the downstream CAD - SXscore predicts 2- year cardiac mortality regardless of lesion location Left main bifurcation: what is the best choice?

19. PCI or CABG? Would you use two stents? No Is the bifurcation fully (even subcritically) involved? Favors CABGConsider PCI Yes No Yes High SYNTAX score? 1 2 3 Left main bifurcation: what is the best choice?

20. Optimal LM Bifurcation PCI Lesion Preparation and DES Implantation Lesion preparation - strongly discourage direct stenting; RA for heavily calcified lesion DES implantation - 1.0-1.1:1 ratio at appropriate pressures for complete apposition…  Strongly recommend IVUS guidance for stent strategy, sizing, and optimal implant results (stent dimensions and apposition) Left main bifurcation: what is the best choice?

21. Optimal LM Bifurcation PCI IVUS Guidance Strongly recommended to IVUS both LAD and LCx origins and entire LM segment back to ostium, PRIOR to intervention - PLAN STRATEGY In general, LCx ostium lumen area > 4.0 mm 2 or plaque burden ≤ 60% indicates acceptable for one stent strategy Iterative post-dilatation and IVUS to achieve LM MLA > 8.5 mm 2, origin LAD > 5.5 mm 2, and origin LCx >5.5mm 2 (2 stents) or >4.0mm 2 (1 stent) IVUS desirable after kissing balloons, esp. origin LCx (if catheter passes easily) Left main bifurcation: what is the best choice?

22. Single stent crossover provisional technique is strongly recommended whenever possible; post-dilate LM stent with non-compliant balloon and also dilate origin of sidebranch if patency questioned (? IVUS or FFR), followed by kissing balloons. Provisional second stent - only consider after repetitive kissing balloon inflations: (1) severe dissection (≥ grade B), (2) TIMI flow 70% DS (visual estimate) or IVUS MLA 60% Optimal LM Bifurcation PCI Stent techniques Left main bifurcation: what is the best choice?

23. Primary two stent technique - should be considered when the sidebranch (usually LCx) is large (> 3 mm), with sidebranch disease and lesion length > 5mm OR special anatomic considerations (e.g. severe calcification); Technique at operator’s discretion (T-stent, TAP, mini-crush, culotte), but V-stenting is discouraged Optimal LM Bifurcation PCI Stent techniques Left main bifurcation: what is the best choice?

24. Kissing balloon dilatations - strongly recommended, using non-compliant balloons; (1) after crossover single stent at operator’s discretion when sidebranch patency is compromised (2) after primary two stent technique with 2-step strategy - first sidebranch at high pressures, then kissing balloons at moderate pressures Optimal LM Bifurcation PCI Kissing balloon Left main bifurcation: what is the best choice?