ANGIOPLASY SUMMIT 2007 TCT ASIA PACIFIC. Seoul, Korea: April Session: Left mains & bifurcation intervention

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ANGIOPLASY SUMMIT 2007 TCT ASIA PACIFIC Seoul, Korea: 25-27 27 April 2007 Session: Left mains & bifurcation intervention An integrated approach to bifurcation lesions: lessons from years of randomized trials, registries, debates and mature thinking 15 min Antonio Colombo Centro Cuore Columbus Milan, Italy S. Raffaele Hospital Milan, Italy

BMS and DES: side branch issue overemphasized BMS (Yamashita et al, JACC 2000) DES (Ge et al, AJC 2005) 51,0% 51,3% 38,0% 36,0% 33,3% 33,3% 38,0% 38,5% % of Patients 13,3% 8,9% 9,6% 13,5% 5,4% 5,4% 4,8% 4,8% MACE TLR MB - ISR SB - ISR MACE TLR MB - ISR SB - ISR 1 STENT 2 STENT

Studies with DES 19,0% MACE TVR TLR % of Patients 13,6% 9,0% 4,5% 11,1% 9,5% 10,6% 11,4% 9,0% 6,3% 4,5% 2,9% 1,9% 3,4% 2,1% 1,9% 1,9% 1,0% 1S 2S 1S 2S 1S 2S Colombo et al (Circ 2004) n=85 6-month Pan et al (AHJ 2004) n=91 6-month Nordic (Circ 2006) n=413 6-month

Angiographic Restenosis 28.0% Bifurcation Main Branch Side Branch % of Bifurcations 18.7% 4.8% 14.2% 5.7% 21.8% 7.0% 5.0% 20.0% 15.0% 22.5% 19.2% 16.0% 5.0% 4.6% 5.1% 11.5% 2.0% 1Stent Colombo et al (Circ 2004) n=85 6 month 2 Stents 1Stent 2 Stents 1Stent 2 Stents Pan et al (AHJ 2004) Nordic (Circ 2006) n=91 n=413 6 month 6 month

Thrombosis in bifurcations

Thrombosis rates 3,5% Total Subacute Late 4,3% 2,8% 3,0% % of Patients 2,4% 1,1% 0,6% 2,2% 1,7% 1,3% 0,2% Colombo et al (Circ 2004) Ge et al (JACC 2005) Moussa et al (AJC 2006) Hoye et al (JACC 2006) Nordic (Circ 2006)

NORDIC Bifurcation Study Individual End Points after 6 months 1 Stent 2 Stents P Patients 207 206 Cardiac death 2 (1.0) 2 (1.0) 1.00 Myocardial infarction 0 (0.0) 1 (0.5) 0.31 Stent thrombosis 1 (0.5) 0 (0.0) 0.31 Steigen et al Circulation 2006

NORDIC Bifurcation Study 2 Stents Techniques Implemented 60 50 50% 40 % 30 29% 20 21% 10 0 Crush Culotte Other Steigen et al Circulation 2006

Predictors of stent thrombosis Analysis of 2229 pts with 9 m FU Iakovou JAMA 2005 0.01 0.1 1 10 100 Prior Brachytherapy Renal Failure Umprotected Left Main 2 stents per bifurcation Stents per lesion Bifurcation Diabetes Ejection Fraction OR=4.18; 95%CI, 0.70-24.67, p=0.1 OR=11.48;95%CI, 4.27-30.83, p<0.0001 OR=2.96; 95%CI, 0.80-10.97, p=0.1 OR=1.23; 95%CI, 0.42-3.60, p=0.7 OR=1.49; 95%CI, 0.81-2.73, p=0.2 OR=7.19; 95%CI, 2.36-21.82, p<0.0001 OR=3.36; 95%CI, 1.53-7.37, p=0.02 OR=1.09; 95%CI, 1.05-1.13, p<0.0001 0.01 0.1 1 10 100

Bifurcations 1.Provisional 2.Two Stents 3. Keep It Open (KIO)

Bifurcations Provisional When the SB has minimal disease or only at the ostium AND when the SB is suitable for stenting 6 Fr guiding catheter 1. Wire both branches 2. Dilate MB and SB if needed 3. Stent MB leaving a wire in the SB 4. Re-wire SB and then remove jailed wire 5. Kissing balloon inflation 6. Stent SB only if suboptimal result (TAP or reverse crush)

SB protection Lesion on LAD-Diag Xience 3.0x28mm Baseline Angiography Stent on LAD 26319/07

balloon 3.0x20mm After Stent POBA on Diag 26319/07

Final Result 26319/07

Bifurcations Two Stents When the SB has disease extending beyond its ostium AND when the SB is suitable for stenting 8 Fr guiding catheter 1. Wire both branches 2. Dilate MB and SB if needed 3. Perform crush or V-stentV 4. If crush: rewire SB and perform high pressure SB dilatation 5. Kissing balloon inflation

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 At present time the most accepted and applied strategy is provisional SB stenting, still there are a number of anatomical settings where the SB is large and diseased to require stenting as intention to treat

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

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

A Typical Case for 2 stents Baseline Following Crush Crush 12472/05

2 stents approach when the SB may be difficult to be wired Baseline After Stent Implantation

An approach for bifurcational lesions when using 2 stents as intention to treat Bifurcational lesion with no disease proximal to the bifurcation or very short left main V-Stent Bifurcational lesion with main branch disease extending proximal to the bifurcation and side branch which w has origin with about 90 angle T-Stent Bifurcational lesion with main branch disease extending proximal to the bifurcation and side branch which ha origin with about 60 angle Short-Mini Crush Pre Post Pre Post Pre Post Cross Section

Bifurcations Keep It Open (KIO) When the SB has ostial or diffuse disease AND when the SB is not suitable (too small) for stenting or clinically not relevant 6 Fr guiding catheter 1. Wire both branches 2. Dilate MB if needed 3. Stent MB and leave wire in the SB 4. Perform post-dilatation of the MB with jailed wire in the SB Do not re-wire SB or postdilate or predilate SB

Example of Keep It Open (KIO) Baseline

Example of Keep It Open (KIO) Balloon inflated on SB (Should not have been done) Post Balloon inflation on SB

Example of Keep It Open (KIO) Stenting of MB Rewiring of SB with large dissection

Example of Keep It Open (KIO) Perforation of SB attempting to gain true lumen Final Result after cover stent on the MB

Jailed wires for side-branch protection side branches are selectively wired Cypher 3.0x33mm Baseline Side-Branch protection 12391/05

Jailed wires for side-branch protection Jailed wires Cypher 2.5x18mm After stent Stent in Diagonal 12391/05

Jailed wires for side-branch protection Final Result 12391/05

Conclusions LM bifurcation vs. other bifurcations Consider the importance of the SB: not every SB needs treatment and not every SB needs optimal result Immediate result is very important when implanting 2 stents