Important LM bifurcation studies update

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1 8 th European Bifurcation Club October Barcelona Important LM bifurcation studies update I Sheiban isheiban@yahoo.com

2 Unprotected LM Percutaneous Revascularization What is important : Assessment of left main Disease and lesion significance Procedural Challenges and Optimizing LM PCI Clinical outcomes vs surgical revascularization Present and Future: Impact on Clinical practice, Guidelines, trials.

3 Unprotected LM Percutaneous Revascularization What is important : Assessment of left main Disease and lesion significance Procedural Challenges and Optimizing LM PCI Clinical outcomes vs surgical revascularization Present and Future: Impact on Clinical practice, Guidelines, trials.

4 Left Main Lesion Assessment Angiography versus IVUS Angiographic measurements are unreliable in the assessment of intermediate LMCA lesions Visual Estimation QCA Stenosis Wide variability in visual and quantitative angiographic assessment of LMCA lesions with MLA <6 mm2 LITRO Investigators. J Am Coll Cardiol 2011;58:351-8

5 IVUS Predictors of FFR in Angiographically Intermediate LM Disease Puri et al., J A C C Cardio vasc Interv 2012 :

6 Left Main Lesion Assessment Angiography versus IVUS From a clinical perspective, MLA 6 mm2 is a safe value for deferring revascularization of the LMCA LITRO Investigators. J Am Coll Cardiol 2011;58:351-8

7 IVUS Predictors of FFR in Angiographically Intermediate LM Disease Independent determinants of FFR (N=55) Plaque rupture Minimal luminal area FFR <0.80 MLA 4.8 mm2 Sensitivity 89%, Specificity 83% FFR <0.75 MLA 4.1 mm2 Sensitivity 95%, Specificity 83% Kang et al. JACC Intvervent 2011

8 Minimal stent area threshold values for the prediction of angiographic in-stent restenosis Kang S et al. Circ Cardiovasc Interv 2011;4:

9 Frequency of Stent Underexpansion 1 vs 2 Stent Techniques 2-stent Cohort ( n = 104 ) 1-stent Cohort ( n = 289 ) 2-stent: LCX stent most frequently underexpanded and results in ISR more than half of cases 1-stent: Underexpansion is less common compared with 2 stent techniques with lower ISR *P<0.05 for comparison of LAD and POC stent underexpansion Kang S et al. Circ Cardiovasc Interv 2011;4: ;

10 Mechanisms of Luminal Loss at the LCX Ostium Morphometric Changes Pre/Post Crossover Stenting 80% of LCX ostia will have >10% reduction in MLA after crossover stenting Carina shift is principal mechanism of lumen loss; less common is plaque redistribution Narrow carina angle between LCX and LAD and wide angle between LCX and LM is associated with greater luminal loss Kang S et al. Circ Cardiovasc Interv 2011;4:

11 FFR Assessment for Angiographically Intermediate LM Disease Puri et al., J A C C Cardio vasc Interv 2012 :

12 Limitations of FFR Assessment for Angiographically Intermediate LM Disease A significant lesion at prox LAD or prox LCX can mask the true significance of the left main coronary artery lesion by compromising hyperemic flow and subsequent true maximal pressure gradient across this lesion. After treatment of the distal lesion, hyperemic blood flow through the vessel increasesn and he true fractional flow reserve (FFR) of the left main coronary artery lesion becomes apparent. Fearon WF, 8th Annual CTO Summit and Left Main Interventions Course, Puri et al., J A C C Cardio vasc Interv 2012 :

13 Unprotected LM Percutaneous Revascularization What is important : Assessment of left main Disease and lesion significance Procedural Challenges and Optimizing LM PCI Clinical outcomes vs surgical revascularization Present and Future: Impact on Clinical practice, Guidelines, trials.

14 Paclitaxel- Versus Sirolimus-Eluting Stents for Unprotected Left Main Coronary Artery Disease ( ISAR Left Main ) 1-Year Incidence and Relative Risk of Death / MI/ TLR ISAR LEFT MAIN True bifurcation and 2-stents, but not stent technique, predictive of ISR ISAR LEFT MAIN Final kissing no additional benefit on ISR for single stent crossover or 2-stent if optimal angiographic results Tiroch et al. TCT2011; Tiroch et al. TCT 2011; Mehilli et al. JACC, 2009; 19:1760 8

15 French Left Main Taxus Registry : Five-Year Outcomes 1stent vs 2 stents D. Mylotte et al, EuroIntervention, 2012 ( ahead of publication ) Cardiac Death MACE Cardiac Death / MI / Stroke

16 Clinical and Angiographic Outcomes of Patients Treated With Everolimus- Eluting Stents or First-Generation Paclitaxel-Eluting Stents for Unprotected Left Main Disease Clinical and Angiographic Outcomes R Valenti et al, J Am Coll Cardiol. 2012;60:

17 Everolimus-Eluting Stent Implantation for Unprotected Left Main Coronary Artery Stenosis The PRECOMBAT-2 Adjusted hazard ratios of EES in the RECOMBAT-2 study compared with SES in the historical control of PRECOMBAT study for the risk of events KIM YH et al ; J A C C CardioVac Interv 2012:

18 Left Main Surveillance Post Revascularization Lee, J.-Y. et al. J Am Coll Cardiol 2011;57:

19 PRE COMBAT Characteristics and Outcomes According to Angiographic Surveillance Overall 2 Year Repeat Revascularization: LM, 4.5%, non-lm 2.5% Park et al. NEJM 2011

20 UPLM DES Restenosis 71 Restenotic Cases (57 Focal, 14 Diffuse Pattern ISR) Timing of Presentation: 69% <1 year, 16.9% 1-2 years, 12.3% 2-3 years, 2.8% >3 years Medical Therapy: Ostial LCx, Focal ISR, Less severe % diameter stenosis, silent ischemia/stable angina CABG: LAD ISR, diffuse ISR Lee, J.-Y. et al. J Am Coll Cardiol 2011;57:

21 PRECOMBACT 2 Angiographic Restenosis in the Subgroups Stratified By Stenting Technique KIM YH et al ; J A C C CardioVac Interv 2012:

22 MAIN COMPARE Multivariate Predictors of In-Stent Restenosis *Compared with simple cross-over stenting of distal bifurcation lesions Lee et al. JACC Intervent 2011

23 Impact of Right Coronary Artery Total Occlusion on Survival Following LM PCI N=330 (24% RCA CTO) Predictors of 3-Year Mortality : RCA CTO, EuroSCORE Migliorini, A. et al. J Am Coll Cardiol 2011;58:

24 Unprotected LM Percutaneous Revascularization What is important : Assessment of left main Disease and lesion significance Procedural Challenges and Optimizing LM PCI Clinical outcomes vs surgical revascularization Present and Future: Impact on Clinical practice, Guidelines, trials.

25 ULM PCI with DES vs CABG Randomized Trial: Death or Myocardial Infarction Boudriot et al. J Am Coll Cardiol 2011;57:

26 ULM PCI with DES vs CABG Randomized Trial: Target Vessel Revascularization Boudriot et al. J Am Coll Cardiol 2011;57:

27 PRECOMBAT Death, MI, Stroke Park et al. NEJM 2011

28 PRECOMBAT Ischemia-Driven Repeat Revascularization Park et al. NEJM 2011

29 PRECOMBAT 2 Death, MI, Stroke Death from any cause Death, MI, or Stroke KIM YH et al ; J A C C CardioVac Interv 2012:

30 PRECOMBAT 2 Traget Vessel Revascularization & MACE Ischemia-driven TVR MACE KIM YH et al ; J A C C CardioVac Interv 2012:

31 Metanalysis of Randomizes Studies PCI Versus CABG in Left Main Disease D. C-apodanno, JACC 211, 54:

32 Metanalysis of Randomizes Studies PCI Versus CABG in Left Main Disease D. C-apodanno, JACC 211, 54:

33 Metanalysis of Randomizes Studies PCI Versus CABG in Left Main Disease MACCE Between PCI and CABG in the Pooled Analysis of the SYNTAX Left Main and PRECOMBAT Studies D. C-apodanno, JACC 211, 54:

34 DELTA Registry Multinational All-Comers Registry PCI = 1874 CABG= No difference between CABG and PCI in : Death, CVA and MI - An advantage of CABG over PCI in MACCE, (driven by the higher incidence of TLR/TVR in PCI Group ) Chieffo et al, JACC Cardiovasc Interv 2012 :

35 Meta-analysis of 3 Randomized Trials and 9 Observational Studies Comparing DES vs. CABG for Unprotected Left Main Coronary Artery Disease 5,079 pts treated with DES (n = 2,107) or CABG (n = 2,972), Death Death, MI, or Stroke TVR Jang J-S, et al. Am J Cardiol. 2012;Epub ahead of print

36 LM PCI vs CABG : Other Meta-analysis & Registries Meta-analysis of 5674 patients treated with percutaneous coronary intervention and drugeluting stents or coronary artery bypass graft surgery for unprotected left main coronary artery stenosis MP de Oliveira et al, Eur J Cardio thorac Surg 2012 Percutaneous coronary intervention versus bypass surgery for left main coronary artery disease: a meta-analysis of randomised trials EuroIntervention 2011; publish-ahead-of-print August 2011 No difference in Death, Death / MI / CVA Meta-analysis of randomized controlled trials on the treatment of unprotected left main coronary artery disease: one-year outcomes with coronary artery bypass grafting versus percutaneous coronary artery intervention with drug-eluting stent. K Kaiimoto et al J Card Surg 2011 Meta-Analysis of Clinical Studies Comparing Coronary Artery Bypass Grafting With Percutaneous Significant Coronary increase Intervention and in Drug-Eluting TLR in PCI Stents patients in Patients With Unprotected Left Main Coronary Artery Narrowings M. Lee et al, Am J Cardiol 2010 ; 105: Comparison of one-year outcomes of percutaneous coronary intervention versus coronary artery bypass grafting in patients with unprotected left main coronary artery disease and acute coronary syndromes (from the CUSTOMIZE Registry). A. Caggegi et al, Am J Cardiol 2011 ;108(3):355-9 Stenting versus coronary artery bypass grafting for unprotected left main coronary artery disease: A meta-analysis of comparative studies H Takagi et al, J Thorac Cardiovasc Surg 2009, 137:e54-e57

37 Durable 5-Year Outcomes Following Percutaneous Coronary Intervention With Drug-Eluting Stent Implantation Versus Coronary Artery Bypass Graft for Unprotected Left Main Coronary Artery Lesions: Title and subtitle BreakThe Milan Experience Cardiac Death, MI, and CVA at 5 Years A. Chieffo et al, J Am Coll Cardiol Intv. 2010;3(6): doi: /j.jcin MACCE at 5 Years

38 Durable French Left Main Taxus Registry : Five-Year Outcomes Syntax Score D. Mylotte et al, EuroIntervention, 2012 ( ahead of publication ) MACE Cardiac Death Cardiac Death / MI / Stroke

39 SYNTAX Trial LM Subgroup: 1 and 4 Year Outcomes Serruys P. TCT2011

40 MACCE at 4 Years Stratified by Baseline SYNTAX Score Tercile Tercile SYNTAX Low to Intermediate Scores 0-32 Cumulative KM Event Rate ± 1.5 SE; log-rank P value Site-reported Data; ITT population Serruys P. TCT2011

41 MACCE at 4 Years Stratified by Baseline SYNTAX Score Tercile SYNTAX High Score 33 Cumulative KM Event Rate ± 1.5 SE; log-rank P value Site-reported Data; ITT population Serruys P. TCT2011

42 MACCE at 5 Years Stratified by Baseline SYNTAX Score Tercile SYNTAX High Score 33 Cumulative Event Rate (%) CABG (N=315) TAXUS (N=290) P<0.001 Overall 44.0% 26.8% Months Since Allocation Cumulative KM Event Rate ± 1.5 SE; log-rank P value CABG PCI P value Death 11.4% 19.2% CVA 3.7% 3.5% 0.80 MI 3.9% 10.1% Death, CVA or MI 17.1% 26.1% Revasc. 12.1% 30.9% <0.001 Serruys Core lab-reported P. ESC 2012 Data; ITT population

43 The simple and extremely user-friendly ACEF score can accurately identify patients undergoing PCI for coronary bifurcation lesions at high risk of early fatal or non-fatal complications, as well as long-term fatality. Biondi Zoccai G et al,eurointervention 2012; Epub ahead of print May 2012

44 SYNTAX score and Clinical SYNTAX score as predictors of very longterm clinical outcomes in patients undergoing percutaneous coronary interventions: a substudy of SIRolimus-eluting stent compared with paclitaxel-eluting stent for coronary revascularization (SIRTAX) trial SYNTAX score and to a greater extent CSS were able to stratify risk for very long-term adverse clinical outcomes in an all-comers population receiving drug-eluting stents. Predictive accuracy for 5-year all-cause mortality was improved using CSS Girasis C et al. Eur Heart J 2011;eurheartj.ehr369

45 Global Risk Classification and Clinical SYNTAX (Synergy between Percutaneous Coronary Intervention with TAXUS and Cardiac Surgery) Score in Patients Undergoing Percutaneous or Surgical Left Main Revascularization In LM patients undergoing PCI, combined scores improve the discrimination accuracy of clinical or angiographic stand-alone tools. In LM patients undergoing CABG, the ACEF score has the best prognostic accuracy compared with other stand-alone or combined scores. The good predictive ability for PCI along with the poor predictive ability for CABG make the SYNTAX score the preferable decision-making tool in LM disease. D Capodanno et al, J Am Coll Cardiol Intv. 2011;4(3):

46 Unprotected LM Percutaneous Revascularization What is important : Assessment of left main Disease and lesion significance Procedural Challenges and Optimizing LM PCI Clinical outcomes vs surgical revascularization Present and Future: Impact on Clinical practice, Guidelines, trials.

47 Indications for CABG versus PCI in stable patients with lesions suitable for both procedures and low predicted surgical mortality In the most severe patterns of CAD, CABG appears to offer a survival advantage as well as a marked reduction in the need for repeat revascularisation.

48 2011 ACC/AHA PCI Guidelines Levine et al. J Am Coll Cardiol 2011

49 Recommendations Pertaining to Unprotected Left Main Intervention in the American College of Cardiology Foundation /American Heart Association /Society of Cardiovacular Angiography and Intervention 2011 Guidlines for PCI P. Teirstein, MJ Price, JACC 2012, 60:

50

51

52 Final Remarks Clinical trials strongly support overall no differences in death or MI, possibly lower stroke but higher TLR with PCI and these outcomes are durable over time SYNTAX Trial does encourage expansion of PCI strategy to Low SYNTAX Score patients Beside SYNTAX Score Simple Risk models can help decision making for PCI vs CABG ( i.e. ACEF ) Role for IVUS and FFR as diagnostic and guidance tools Heart Team approach for PCI and CABG is recommend in overlapping subgroups with LM disease for an optimal clinical practice

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