CENTRO CUORE COLUMBUS Antonio Colombo Centro Cuore Columbus Milan, Italy S. Raffaele Hospital Milan, Italy ADVANCED ANGIOPLASTY 2007 London January 2007 Established and future techniques in left main intervention

CENTRO CUORE COLUMBUS Nothing to disclose regarding this presentation

CENTRO CUORE COLUMBUS Left main stenting with drug-eluting stents should become the standard of care in patients with this condition

CENTRO CUORE COLUMBUS NYS Database CABG for Left Main Disease CP CP Ed Hannon, David Faxon: Personal communication to Roxana Mehran DeathDeath N=16,365 N=16,365 Mortality rate (%) No exclusions!

CENTRO CUORE COLUMBUS Duke Database CABG for Left Main Disease CP CP personal communication Peter Berger to Roxana Mehran personal communication Peter Berger to Roxana Mehran N=1374 N=1374 Mortality (%) N=

CENTRO CUORE COLUMBUS Success is defined by an optimal angio and IVUS result

CENTRO CUORE COLUMBUS Bifurcation lesion - ULM Baseline Rotablator

CENTRO CUORE COLUMBUS Bifurcation lesion - ULM Result after rtb and POBA

CENTRO CUORE COLUMBUS Bifurcation lesion - ULM Stents deployment

CENTRO CUORE COLUMBUS Bifurcation lesion - ULM Post dilatation balloon : 3.5x20 mm 16Atm

CENTRO CUORE COLUMBUS Bifurcation lesion - ULM Final Result CSA : 7.4 mm 2 IVUS LCX ostial IVUS

CENTRO CUORE COLUMBUS Bifurcation lesion - ULM 5 months Follow Up

CENTRO CUORE COLUMBUS Bifurcation lesion - ULM 5 months Follow Up LCX ostial IVUS IVUS Lumen Area : 2.1mm 2

CENTRO CUORE COLUMBUS

IVUS Images Post Rotablator LAD Os Cx Os

CENTRO CUORE COLUMBUS Crush technique: 3.0x33 Cypher in Cx and 3.5x18 Cypher in LAD.

CENTRO CUORE COLUMBUS Final result after kissing No restenosis at FU

CENTRO CUORE COLUMBUS Left main distal bifurcations remain at high risk for restenosis (usually focal) Optimal lesion preparation IVUS guidance Optimal stent implantion V or Crush

CENTRO CUORE COLUMBUS Conclusions Baseline characteristics Final result: according to angiography and IVUS Angiography does not override IVUS and vice versa is also true

CENTRO CUORE COLUMBUS 823 citations retrieved from database searches 46 complete articles assessed according to the selection criteria 17 studies (16 cohorts) finally included in the systematic review 777 titles/abstracts excluded because non-relevant 29 articles excluded according to explicit inclusion/exclusion criteria 7 duplicate publications 7 duplicate publications 4 enrolling <20 patients 4 enrolling <20 patients 8 ongoing 8 ongoing 5 unpublished 5 unpublished 5 using BMS only 5 using BMS only A meta-analysis of ULM stenting with DES

CENTRO CUORE COLUMBUS Study Rate of in-hospital death (%) 2,0 (0,9-3,2) 2,0 2,8 0,0 0,0 7,1 9,5 2,0 1,9 0,0 2,4 0,0 0,0 1, Overall estimate (95%CI) Wood et al (2006, 100 pts) Sheiban et al (2006, 72 pts) Price et al (2006, 50 pts) Park et al (2005, 102 pts) Migliorini et al (2006, 156 pts) Lozano et al (2005, 42 pts) Lee et al (2006, 50 pts) KOMATE (2005, 54 pts) de Lezo et al (2004, 52 pts) Christiansen et al (2006, 42 pts) Chieffo et al (2005, 85 pts) Carriè et al (2006, 49 pts) Agostoni et al (2005, 58 pts)

CENTRO CUORE COLUMBUS Rate of in-hospital MI(%) Study Overall estimate (95%CI) Wood et al (2006, 100 pts) Sheiban et al (2006, 72 pts) Price et al (2006, 50 pts) Park et al (2005, 102 pts) Migliorini et al (2006, 156 pts) Lozano et al (2005, 42 pts) Lee et al (2006, 50 pts) KOMATE (2005, 54 pts) de Lezo et al (2004, 52 pts) Christiansen et al (2006, 42 pts) Chieffo et al (2005, 85 pts) Carriè et al (2006, 49 pts) Agostoni et al (2005, 58 pts) 3,0 2,6 8,0 6,9 0,6 0,0 0,0 0,0 3,9 0,0 5,9 4,1 3,5 2,7 (1,2-4,3)

CENTRO CUORE COLUMBUS 19,0 9,1 54,0 8,8 25,5 23,7 26,2 10,6 4,6 10,9 14,3 5,8 7,1 32,7 8,2 15, Wood et al (2006, 100 pts) Sheiban et al (2006, 72 pts) Price et al (2006, 50 pts) Park et al (2005, 102 pts) Palmerini et al (2006, 94 pts) Migliorini et al (2006, 156 pts) Lozano et al (2005, 42 pts) Lee et al (2006, 50 pts) KOMATE (2005, 54 pts) Han et al (2006, 138 pts) Dudek et al (2006, 28 pts) de Lezo et al (2004, 52 pts) Christiansen et al (2006, 42 pts) Chieffo et al (2005, 85 pts) Carriè et al (2006, 49 pts) Agostoni et al (2005, 58 pts) Rate of mid-term MACE (%) 16,3 (11,4-21,2) Overall estimate (95%CI) Study

CENTRO CUORE COLUMBUS 8,0 2,6 10,0 0,0 13,8 10,9 19,1 4,0 1,9 5,1 0,0 4,8 2,8 0,0 5, Wood et al (2006, 100 pts) Sheiban et al (2006, 72 pts) Price et al (2006, 50 pts) Park et al (2005, 102 pts) Palmerini et al (2006, 94 pts) Migliorini et al (2006, 156 pts) Lozano et al (2005, 42 pts) Lee et al (2006, 50 pts) KOMATE (2005, 54 pts) Han et al (2006, 138 pts) de Lezo et al (2004, 52 pts) Christiansen et al (2006, 42 pts) Chieffo et al (2005, 85 pts) Carriè et al (2006, 49 pts) Agostoni et al (2005, 58 pts) Study Rate of mid-term death (%) 4,9 (2,8-7,0) Overall estimate (95%CI) 60

CENTRO CUORE COLUMBUS 8,0 3,9 44,0 2,0 12,1 2,4 6,3 2,3 7,3 0,0 1,9 4,8 18,8 2,0 6, Wood et al (2006, 100 pts) Sheiban et al (2006, 72 pts) Price et al (2006, 50 pts) Park et al (2005, 102 pts) Migliorini et al (2006, 156 pts) Lozano et al (2005, 42 pts) Lee et al (2006, 50 pts) KOMATE (2005, 54 pts) Han et al (2006, 138 pts) Dudek et al (2006, 28 pts) de Lezo et al (2004, 52 pts) Christiansen et al (2006, 42 pts) Chieffo et al (2005, 85 pts) Carriè et al (2006, 49 pts) Agostoni et al (2005, 58 pts) Rate of mid-term TVR (%) 6,6 (3,7-9,4) Overall estimate (95%CI) Study

CENTRO CUORE COLUMBUS Prevalence of non-bifurcational ULM MACE rate at a median of 10 months 70%60%50%40%30%20%10%0 60% 50% 40% 30% 20% 10% 0 Beta= P=0.005 Price et al Carrié et al Wood et al Sheiban et al et al Park Palmerini Migliorini Lozano et al Lee et al et al KOMATE Han de Lezo et al Christiansen et al Chieffo et al Agostoni et al

CENTRO CUORE COLUMBUS 75 pts Body or Ostial ULM Chieffo et al submitted 2007 ( No involvement of bifurcation ) 144 pts in 5 centers 39 PES 105 SES 19.4% diabetics 50% IVUS guidance 99% procedural success 41 pts 28 pts 2 Milan, 1 Turin, 1 Rotterdam, 1 Korea

CENTRO CUORE COLUMBUS 75 pts Body or Ostial ULM Chieffo et al submitted 2007 ( No involvement of bifurcation ) 1 year Follow-Up 1 year Follow-Up Angio F-U 100 pts (70%) death : 1 pt PCI : 1 pt CABG : 1 pt 41 pts 28 pts

CENTRO CUORE COLUMBUS At 2 yrs FU there where 3 additional deaths 4 patients had late thrombosis? Patient 1Patient 2Patient 3Patient 4 Age, yrs EF, % Euroscore Parsonnet Time of death, days

CENTRO CUORE COLUMBUS Ignorance is better than Wrong Knowledge

CENTRO CUORE COLUMBUS Drug Eluting Stent Implantation Versus Bypass Surgery in Unprotected Left Stenosis: A Single Center Experience Alaide Chieffo, Nuccia Morici, *Francesco Maisano, Matteo Montorfano, Flavio Airoldi, Mauro Carlino, Lorenzo Arcobasso, Gloria Melzi, *Ottavio Alfieri, Antonio Colombo. Interventional Cardiology and *Cardiac Surgery Units, San Raffaele Hospital, Milan, Italy Published Circulation 2006

CENTRO CUORE COLUMBUS In-Hospital Outcome DES n = 107 CABG n = 142 On Pump n=86 Off Pump n=56MI 10 (9.3%) 37 (26.05%) 29 (33.7%) 8 (14.3%) Q- MI 0541 TVR0 3 (2.1%) 1 (1.2%) 2 (3.5%) CVE0 2 (1.4%) 1 (1.2%) 1 (1.7%) Death0 3 (2.1%) 2 (2.3%) 1 (1.7%)

CENTRO CUORE COLUMBUS One year Outcome DES n = 107 CABG n = 139 On Pump n=84 Off Pump n=55MI 1 (0.9%) 2 (1.4%) 1 (1.2%) 1 (1.7%) TLR 17 (15.8%) 5 (3.6%) 2 (2.4%) 3 (5.4%) TVR 21 (19.6%) 5 (3.6%) 2 (2.4%) 3 (5.4%) CVE 1 (0.9%) 1 (0.7%) 1 (1.2%) 0 Death 3 (2.8%) 9 (6.4%) 5 (5.9%) 4 (7.2%)

CENTRO CUORE COLUMBUS Cause and Time of Death in DES Patients TreatmentTime of DeathCause of Death Pt 1PCIF-up (2 ms)Pancreatitis and Sudden Death Pt 2PCIF-up (5 ms)Pulmonary Edema (severe aortic and mitral regurgitation) Pt 3PCIF-up (4 ms)Complications following elective CABG

CENTRO CUORE COLUMBUS Cumulative MACCE at 1 Year PCI better CABG better Odds Ratio and Exact 95% CI

CENTRO CUORE COLUMBUS Cumulative MACCE without Revascularization at 1 Year PCI better CABG better Odds Ratio and Exact 95% CI

CENTRO CUORE COLUMBUS Past Studies with BMS Problems: 1)Optimal IVUS results based on comparison of lumen sizes (normal vs. diseased) not based on true IVUS vessel diameter (takes advantage of positive remodeling) 2)Final MLD difference between IVUS and Angio guidance too small

CENTRO CUORE COLUMBUS Post-intervention MLD TULIPIVUSAngio Postintervention (mm) 3.01± ±0.31 OPTICUSIVUSAngio Postintervention (mm)3.02± ±0.41 RESISTIVUSAngio Postintervention (mm)2.57± ±0.46 AVID IVUSAngio Postintervention (mm) 7.54± ±2.46

CENTRO CUORE COLUMBUS IVUS criteria for optimal stenting 1) stent size: average diameters media to media at the distal segment of the lesion 2) post dilating balloon: average diameters media to media throughout the stented segments (different size and length balloons for long stents, always non compliant balloons able to reach at least 25 atm) 3) Optimal final result: at least 65% cross sectional area of the balloon used to post-dilate the stent or an area over 9 mm² Criteria based on vessel size: MEDIA TO MEDIA

CENTRO CUORE COLUMBUS 2.4 ± ± 0.49 Initial experience with IVUS guided DES implantation according to new criteria Angio Ref. diam Balloon size 35 pts mm

CENTRO CUORE COLUMBUS 28atm 28±3.6atm Initial experience with IVUS guided DES implantation according to new criteria 35 pts 2.4±0.47mm 3.0±0.49 mm

CENTRO CUORE COLUMBUS Left main stenting with drug-eluting stents should become the standard of care in patients with this condition