29th ANNUAL SCIENTIFIC SESSIONS – SCA&I CHICAGO, IL – MAY 10-14, 2006 Main Session - Drug Eluting Stents Bifurcation lesions Antonio Colombo Centro Cuore Columbus Milan, Italy S. Raffaele Hospital Milan, Italy Columbia University, NY, USA

Minor stock holder in Cappella Inc. Manufacturing side branch stent Conflicts: Minor stock holder in Cappella Inc. Manufacturing side branch stent

1 or 2 stents? A) If the side branch is significantly diseased at its ostium or nearby, it is sufficiently large to be stented, safety and duration of PCI are an issue: 2 stents B) In all other conditions 1 stents and then evaluate

Baseline Final Result Treatment of Bifurcation Lesion with two stents Can you really use one stent ? Baseline Final Result 11186/02

Treatment Baseline Treatment of Bifurcation Lesion with two stents 11162/02

Treatment of Bifurcation Lesion with two stents Final Result 11162/02

Crush Standard Crush: 7F, two stents in position together, side branch inflated first, main branch stent crushes side branch Reverse Crush, used when provisional stenting requires another stent in the side branch: 6F, main branch stent deployed first, side branch stent is crushed against the main vessel stent with a balloon Inverted Crush, makes recrossing easier and improves side branch coverage: 7F similar to Standard Crush but the side branch stent is positioned more proximally than the main branch stent, the side branch stent will crush the main branch stent. Step Crush, as standard Crush but can be done with 6F.Advance and deploy stent in side branch

About the side branch: wires for recrossing and Kissing Balloon dilatation Dilate the main vessel stent at high pressure The original Universal Balance wire Prowater/ Rinato (Asahi Intech wire) Intermediate wire Pilot 50 or 150 wire Always perform high pressure inflation in the side branch before doing kissing

DES in Bifurcation Lesions (Milan experience April 2002 – March 2005) Total number of patients: 368 Total number bifurcations: 389 True bifurcational lesions: 60% Bifurcations treated with Cypher stent: 54% Bifurcations treated with Taxus stent: 46% Type D Type F Type G

DES in Bifurcation Lesions Lesion location (389 de-novo bifurcations) Lesion location 25% 6% 51% 18%

DES in Bifurcation Lesions Stent technique 390 bifurcations 193 (49.6%) One stent on the MB 197 (50.4%) Stent on both branches

Stent technique (one stent vs two stents) DES in Bifurcation Lesions Stent technique (one stent vs two stents) Left main (n=98) Other locations (n=292) 32% 58% 42% 68% = One stent only = Stent on both branches

Stent technique (one stent vs two stents) DES in Bifurcation Lesions Stent technique (one stent vs two stents) True bifurcations (n=232) Other bifurcations (n=158) 41% 63% 59% 37% = One stent only = Stent on both branches

DES in Bifurcation Lesion in 292 lesions Two-stent techniques NO LMT lesions 3% 83% 7% 7%

DES in Bifurcation Lesion in 292 lesions Two-stent techniques Left main lesions 54% 9% 27% 10%

DES in Bifurcation Lesion Milan Experience Baseline Clinical Characteristics (II) Group 1S (n = 155 patients) Group 2S (n = 119 patients) P Value Diabetes mellitus, % 37 (24%) 24 (21%) 0.5 SYNTAX score 26.80±18.1 37.69±23.4 0.001 LVEF, % 54±9 53±9 0.2 Prior CABG, % 10 (7%) 10 (9%) Prior MI, % 68 (54%) 41 (43%) 0.8 Unstable angina, % 49 (43%) 40 (35%) 0.7 GP 2b/3a inhibitors, % 17 (11%) 27 (23%) 0.009

Clinical Follow-Up at 12 months (n=367) All patients DES in Bifurcation Lesion Milan Experience Clinical Follow-Up at 12 months (n=367) All patients Group 1S (n = 185 patients) Group 2S (n = 183 patients) P Value Death 3 (1.7%) 5 (2.7%) 0.5 MI (after hospital discharge) 1 (0.6%) 4 (2.2%) 0.2 TLR 18 (5.0%) 40 (11.0%) 0.002 TVR 25 (6.9%) 52 (14.4%) 0.001 Cumulative MACE 28 (7.6%) 55 (15.0%)

Clinical Follow-Up at 12 months DES in Bifurcation Lesion Milan Experience Clinical Follow-Up at 12 months NO left main (n=274) SES (n = 156 patients) PES (n = 118 patients) P Value Death 2 (1.3%) 1 (0.9%) 0.7 MI (after hospital discharge) 4 (2.6%) 0.08 TLR 25 (16%) 14 (12%) 0.3 TVR 33 (21%) 18 (16%) 0.2 Cumulative MACE 35 (22%) 19 (16%)

Angiographic follow-up (performed in 85% of lesions) DES in Bifurcation Lesion Milan Experience Angiographic follow-up (performed in 85% of lesions) P=0.07 17.0% 10.0% Restenosis rate (%) 8.6% 6.6%

Angiographic follow-up One stent only Stents on both branches P=0.03 P=0.04 23% 28% 12.0% 11% restenosis rate (%) 5.6% 7.3% 4.0% 4.6% = final kissing = No kissing

DES in Bifurcation Lesion Milan Experience Stent thrombosis 0.5% 2.5% 0.5% 1.5% (%) 2T 1C 0% 0.5% 4T 1C 1C 1 C 1C

Provisional SB stenting

Provisional Balloon – T stenting of Bifurcation Lesions 1 2 3 Taxus 2.75/32: LAD (wire protection of Septal) Baseline Balloon: D1

Provisional Balloon – T stenting of Bifurcation Lesions 3 STEPS: -stent at 15-18atm. KISS -stent balloon down to 8 atm. -main branch balloon up to 20 atm. 4 5 6 Intermediate result Taxus 2.5/24: D1 Balloon: LAD RESULT

Provisional Balloon – T stenting of Bifurcation Lesions (8) (7) Additional Taxus at proximal LAD (wire protection of RIM) Final result

Baseline: LAD/ Diagonal Provisional Bifurcation Crush Stenting with IVUS control Baseline: LAD/ Diagonal

Provisional Bifurcation Crush Stenting Rotablation prox/mid LAD burr 1.5mm After Rotablation

Provisional Bifurcation Crush Stenting Result after LAD stent Stenting prox LAD, Cypher 3.5/33

Result of SB Dilatation Provisional Bifurcation Crush Stenting Wiring SB Dilatation SB Result of SB Dilatation

Provisional Bifurcation Crush Stenting 3 STEPS: -stent at 15-18atm. KISS -stent balloon down to 8 atm. -main branch balloon up to 20 atm. Cypher stenting at side branch ostium: 2.5/18mm MB: Quantum Maverick 3.5 mm

Provisional Bifurcation Crush Stenting FINAL RESULT

Provisional Bifurcation Crush Stenting IVUS controlled (Main Branch) After Rotabltor at MB, before SB balloon dilatation Post bifurcation stenting

Provisional Bifurcation Crush Stenting Final IVUS: from MB to SB diagonal

Provisional Bifurcation Crush Stenting Final IVUS: from SB to MB LAD Into the diagonal

Provisional Bifurcation Crush Stenting Final IVUS: from MB and from SB LAD dia LAD dia

Ostial disease: Type B, Type 4

V Stent-Balloon Technique For bifurcational ostial lesions (IIIB and IV) Baseline HSR 39456

V Stent-Balloon Technique For bifurcational ostial lesions (IIIB and IV) Step 1 HSR 39456

V Stent-Balloon Technique For bifurcational ostial lesions (IIIB and IV) Step 2 HSR 39456

V Stent-Balloon Technique For bifurcational ostial lesions (IIIB and IV) Final Result HSR 39456

Randomized study MB vs MB and SB stenting Steigen et al ACC I2 Summit 2006 MB stenting 207 pts randomized vs MB+SB stenting 209 Procedural and fluoro time, contrast use and biomarkers > when 2 stents where implanted 6 months MACE rates < 5% in 1 or 2 stents strategy with no difference No report about angio FU, We do not know how many bifurcations where “True” bifurcations: the lesion length in the SB was 6 mm vs 16 mm in the MB

“ Crushing” CYPHER™ SELECT Provisional T CYPHER™ SELECT CACTUS: A prospective randomized study n = 250 patients “ Crushing” CYPHER™ SELECT n = 125 1- month Clinic. F/U 6- month Angio. F/U 12, 18, 24- month Clinical F/U de novo TRUE bifurcation lesions of the native coronary arteries R Pre-dilatation Provisional T CYPHER™ SELECT n = 125

Conclusions for bifurcations Most bifurcations need the SB to stay open at the end of the procedure, residual stenosis appears less relevant If optimal result on the side branch is important, in a true bifurcation 2 stents may be needed at least 50% of the time 1 stent strategy Angio F-U only if clinically needed