Bifurcation Management Update: CRT 2013 2012 Washington DC, February  Bifurcation Management Update: Choosing the Right Strategy and Technique Eberhard Grube MD FACC, FSCAI University Hospital Bonn, Germany Stanford University, School of Medicine, Palo Alto, CA Hospital Alemão Oswaldo Cruz, São Paulo, Brazil

Eberhard Grube, MD Consulting: Medtronic CoreValve, Boston Scientific Corporation, Cordis Corporation, Johnson and Johnson and Abbott Vascular Honoraria: Boston Scientific Corporation and Biosensors International Stocks, Stock Options, other ownership interest: Medtronic CoreValve and Biosensors International Off-Label: Off-label use of stents and valve prosthesis

Preamble The main limitation of all randomized studies comparing provisional versus routine double stenting is that bifurcation lesions which are randomized are most of the times suitable for provisional. Bifurcation lesions which need to be treated with two stents are usually not randomized. For bifurcation lesions, which are suitable for 1 stent or 2 stents, routine implantation of 2 stents does not give any advantage compared to routine implantation of 1 stent and cross-over to 2 stents when needed

My view If you decide to implant two stents you take more responsibilities : an optimal result will give you a low restenosis on the SB, a suboptimal result may increase the risk of thrombosis of the SB and sometimes of the MB. If you decide to implant one stent you are mainly responsible for the SB only: an incorrect decision may lead to SB closure The final decision is a balance between the clinical relevance of the SB (risk of occlusion) and how confident is the operator to obtain an optimal result

This is not an ideal lesion for a 1 vs. 2 stents trial

Bifurcations Provisional Keep It Open (KIO) Two stents

Provisional Wire both branches Dilate MB and SB if needed When the SB has minimal disease or disease at the ostium AND when the SB is suitable for stenting Wire both branches Dilate MB and SB if needed Stent MB leaving a wire in the SB Re-wire SB and then remove jailed wire Kissing balloon inflation Stent SB if suboptimal result (TAP is my preferred strategy to cross-over to 2 stents)

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

Two Stent Approach Cross over from Provisional: TAP: T and protrusion 2 stents as Intention to Treat: Mini Crush, Culotte, V: only for very suitable anatomy

non-left main bifurcations Predictors of restenosis after one and two-stent techniques in left main and non-left main bifurcations 9 9

Colombo A. et al Circulation 2009;119:71-78. 10 10

If crush 2 step kiss ! 11 11

Inflate at high pressure only the SB balloon We observed that two-step kissing was more effective than one-step kissing for improving metallic side-branch ostial area No kissing One-step kissing post-dilatation Two-step kissing post-dilatation SB ostial stenosis (%) with one step vs. two step kissing 58 crush deployments Two steps: Inflate at high pressure only the SB balloon 2) Perform kissing inflation Ormiston 12

Influence of Final Kissing in the CACTUS trial YES Final Kissing 163 pts. NO Final Kissing 14 pts. P Myocardial infarction 7.5% 29% 0.001 TLR 6.3% 12.9% 0.25 MB restenosis 4.7% 16% 0.03 SB restenosis 11.9% 36% Stent thrombosis 0.9% 6.5% 0.06

For the Nordic-Baltic PCI Study Group Nordic-Baltic Bifurcation Study III Randomized Comparison of Final Kissing Balloon Dilatation vs. no Final Kissing Balloon Dilatation in Patients with Coronary Bifurcation Lesions Treated With Main Vessel stenting Matti Niemela, Kari Kervinen, Andrejs Erglis,Niels R. Holm, Michael Maeng, Evald H Christiansen, Indulis Kumsars, Sandra Jegere, Andis Dombrovskis, Pål Gunnes, Sindre Stavnes,TerjeS teigen,Thor Trovik, Saila Vikman,Markku Eskola, Hannu Romppanen,Timo Makikallio, Knud N Hansen, Per Thayssen, Lars Åberge,Lisette Jensen, Anders Hervold, J Airaksinen, Mikko Pietila, Ole Frobert, Thomas Kellerth, Jan Ravkilde,Jens Aarøe,Steffen Helqvist, Iwar Sjögren, Stefan James,Heikki Miettinen, Jens F Lassen, Leif Thuesen For the Nordic-Baltic PCI Study Group Andis Dombrovskis. 14

(Re)stenosis at 8-months QCA: Entire bifurcation lesion % p=0.11 17.3% 11.0% Binary Restenosis: ≥50% diameter stenosis at follow-up

(Re)stenosis: Ostial Side Branch % p=0.039 15.4% 7.9% Binary Restenosis: ≥50% diameter stenosis at follow-up

True bifurcation subgroup MACE and TLR at 6 month clinical FU 2.5% % (n=121) (n=118) 1.7% 1.7% P=0.68 0.8% P=0.62

BIFURCATION ANGLE and TECHNIQUE TO USE WITH 2 STENTS In general a small bifurcation angle gives a better result with mini-crush or culotte. A large angle with T or T and protrusion With 2 stents an appropriately performed final kiss minimizes the effect of the bifurcation angle Bifurcation angle Dzavik et al Am Heart J 2006;152:762-769

Bifurcation as predictor of DES thrombosis

Bifurcation and Thrombosis The association of bifurcation with DES thrombosis has been frequent but not consistent across the studies with DES Bifurcation has been related specially with early thrombosis or even with late 1-12 months but not with very late thrombosis The use of complex techniques (2 stents) could increase the risk of thrombosis, specially in the setting of ACS: operator dependent In ESTROFA-2, bifurcation was an independent predictor for early thrombosis: The treatment of bifurcations with ZES and with double stenting was associated with a trend for a higher risk (REGISTRY) In cases with bifurcations a lower EF and smaller stent diameter were close to result independent predictors for thrombosis In ACS, thrombosis was not significantly higher, though more frequently late

Dedicated bifurcation stents At the moment for true bifurcations with short lesions in the side branch when the operator does not feel confident to recross an unprotected side branch 6 month FU Cappella sideguard Tryton

Conclusions 1 The final result is far more important than the technique utilized IVUS check on both branches every time 2 stents are implanted

Conclusions 2 Stenting coronary bifurcations requires more than deciding to implant 1 or 2 stents The most important decisions should be taken by examining: the clinical setting the extent of the disease in both branches, their size the territory of distribution and how confident is the operator with a specific approach