8th European Bifurcation Club 12-13 October 2012 - Barcelona
Important LM bifurcation studies update
I Sheiban
E-mail: [email protected]
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….
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….
Unprotected LM Percutaneous Revascularization What is important :
Visual Estimation QCA Stenosis
Angiographic measurements are unreliable in the assessment of intermediate LMCA lesions
Wide variability in visual and quantitative angiographic assessment of LMCA lesions with MLA <6 mm2
Left Main Lesion Assessment Angiography versus IVUS
LITRO Investigators. J Am Coll Cardiol 2011;58:351-8
Puri et al., J A C C Cardio vasc Interv 2012 : 6 9 7 – 7 0 7
IVUS Predictors of FFR in Angiographically Intermediate LM Disease
1999 - 2011
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
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
Minimal stent area threshold values for the prediction of angiographic in-stent restenosis
Kang S et al. Circ Cardiovasc Interv 2011;4:562-569
2-stent Cohort ( n = 104 ) 1-stent Cohort ( n = 289 )
Frequency of Stent Underexpansion 1 vs 2 Stent Techniques
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;4:562-569;
Mechanisms of Luminal Loss at the LCX Ostium Morphometric Changes Pre/Post Crossover Stenting
Kang S et al. Circ Cardiovasc Interv 2011;4:355-361
• 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
Puri et al., J A C C Cardio vasc Interv 2012 : 6 9 7 – 7 0 7
FFR Assessment for Angiographically
Intermediate LM Disease 2004 - 2009
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.
Limitations of FFR Assessment for
Angiographically Intermediate LM Disease
Fearon WF, 8th Annual CTO Summit and Left Main Interventions Course, 2011.
Puri et al., J A C C Cardio vasc Interv 2012 : 6 9 7 – 7 0 7
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….
Unprotected LM Percutaneous Revascularization What is important :
Mehilli et al. JACC , 2009; 19:1760–8
1-Year Incidence and Relative Risk of Death / MI/ TLR
Paclitaxel- Versus Sirolimus-Eluting Stents for Unprotected Left Main Coronary Artery Disease
( ISAR Left Main )
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;
French Left Main Taxus Registry : Five-Year Outcomes 1stent vs 2 stents
D. Mylotte et al , EuroIntervention, 2012 ( ahead of publication )
MACE
Cardiac Death
Cardiac Death / MI / Stroke
Clinical and Angiographic Outcomes of Patients Treated With Everolimus-Eluting Stents or First-Generation Paclitaxel-Eluting Stents for Unprotected Left Main Disease
R Valenti et al , J Am Coll Cardiol. 2012;60:1217-1222
Clinical and Angiographic Outcomes
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: 708-717
Everolimus-Eluting Stent Implantation for Unprotected Left Main Coronary Artery Stenosis
The PRECOMBAT-2
Lee, J.-Y. et al. J Am Coll Cardiol 2011;57:1349-1358
Left Main Surveillance Post Revascularization
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
Medical Therapy: Ostial LCx, Focal ISR, Less severe % diameter stenosis, silent ischemia/stable angina CABG: LAD ISR, diffuse ISR
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
Lee, J.-Y. et al. J Am Coll Cardiol 2011;57:1349-1358
PRECOMBACT 2 Angiographic Restenosis in the Subgroups Stratified By Stenting Technique
KIM YH et al ; J A C C CardioVac Interv 2012: 708-717
MAIN COMPARE Multivariate Predictors of In-Stent Restenosis
*Compared with simple cross-over stenting of distal bifurcation lesions
Lee et al. JACC Intervent 2011
Migliorini, A. et al. J Am Coll Cardiol 2011;58:125-130
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
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….
Unprotected LM Percutaneous Revascularization What is important :
ULM PCI with DES vs CABG Randomized Trial: Death or Myocardial Infarction
Boudriot et al. J Am Coll Cardiol 2011;57:538-545
ULM PCI with DES vs CABG Randomized Trial: Target Vessel Revascularization
Boudriot et al. J Am Coll Cardiol 2011;57:538-545
PRECOMBAT Death, MI, Stroke
Park et al. NEJM 2011
PRECOMBAT Ischemia-Driven Repeat Revascularization
Park et al. NEJM 2011
PRECOMBAT 2 Death, MI, Stroke
KIM YH et al ; J A C C CardioVac Interv 2012: 708-717
Death from any cause Death, MI, or Stroke
PRECOMBAT 2 Traget Vessel Revascularization & MACE
Ischemia-driven TVR MACE
KIM YH et al ; J A C C CardioVac Interv 2012: 708-717
D. C-apodanno , JACC 211, 54: 1426.32
Metanalysis of Randomizes Studies PCI Versus CABG in Left Main Disease
D. C-apodanno , JACC 211, 54: 1426.32
Metanalysis of Randomizes Studies PCI Versus CABG in Left Main Disease
Metanalysis of Randomizes Studies PCI Versus CABG in Left Main Disease
D. C-apodanno , JACC 211, 54: 1426.32
MACCE Between PCI and CABG in the Pooled Analysis of the SYNTAX Left Main and PRECOMBAT Studies
Chieffo et al , JACC Cardiovasc Interv 2012 : 718-730
DELTA Registry Multinational All-Comers Registry PCI = 1874 CABG= 900
- 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 )
Jang J-S, et al. Am J Cardiol. 2012;Epub ahead of print
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), 2001-2011.
Death, MI, or Stroke Death TVR
Meta-analysis of 5674 patients treated with percutaneous coronary intervention and drug-eluting 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
Meta-Analysis of Clinical Studies Comparing Coronary Artery Bypass Grafting With Percutaneous Coronary Intervention and Drug-Eluting Stents in Patients With Unprotected Left Main Coronary Artery Narrowings M. Lee et al , Am J Cardiol 2010 ; 105:1070-1075
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
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
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
LM PCI vs CABG : Other Meta-analysis & Registries 2011-2012
No difference in Death , Death / MI / CVA
Significant increase in TLR in PCI patients
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
A. Chieffo et al , J Am Coll Cardiol Intv. 2010;3(6):595-601. doi:10.1016/j.jcin.2010.03.014
MACCE at 5 Years Cardiac Death, MI, and CVA at 5 Years
Durable ……
French Left Main Taxus Registry : Five-Year Outcomes Syntax Score
D. Mylotte et al , EuroIntervention, 2012 ( ahead of publication )
Cardiac Death MACE
Cardiac Death / MI / Stroke
Durable ……
SYNTAX Trial LM Subgroup: 1 and 4 Year Outcomes
Serruys P. TCT2011
Cumulative KM Event Rate ± 1.5 SE; log-rank P value Site-reported Data; ITT population
Serruys P. TCT2011
MACCE at 4 Years Stratified by Baseline SYNTAX Score Tercile Tercile SYNTAX Low to Intermediate Scores 0-32
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
Overall TAXUS (N=290) CABG (N=315)
P<0.001
44.0%
26.8%
Core lab-reported Data; ITT population Cumulative KM Event Rate ± 1.5 SE; log-rank P value
CABG PCI P value
Death 11.4% 19.2% 0.005
CVA 3.7% 3.5% 0.80
MI 3.9% 10.1% 0.004
Death, CVA or
MI 17.1% 26.1% 0.007
Revasc. 12.1% 30.9% <0.001 Months Since Allocation
Cum
ulat
ive
Even
t Rat
e (%
)
0 12 24
50
0
25
48 36 60
MACCE at 5 Years Stratified by Baseline SYNTAX Score Tercile SYNTAX High Score 33
Serruys P. ESC 2012
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
Girasis C et al. Eur Heart J 2011;eurheartj.ehr369
SYNTAX score and Clinical SYNTAX score as predictors of very long-term 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
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
D Capodanno et al , J Am Coll Cardiol Intv. 2011;4(3):287-297
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.
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….
Unprotected LM Percutaneous Revascularization What is important :
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.
www.escardio/guidelines
2011 ACC/AHA PCI Guidelines
Levine et al. J Am Coll Cardiol 2011
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 , 60:1605–13
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
Final Remarks