CRT 2011 Bifurcation Techniques and Tips for 2011

CRT 2011 Bifurcation Techniques and Tips for 2011 Samin Sharma, MD, FACC Professor of Medicine (Cardiology) Director Cardiac Cath Lab & Intervention Co-Director Cardiovascular Institute Mount Sinai Hospital, NY

Conflict of Interest Research Grant support & Speaker Bureau for: - BSc - Abbott Vascular - DSI/Lilly - The Medicines Co - Abiomed - Angioscore

Bifurcation Lesion Intervention Scope of The Problem • Bifurcation lesion intervention is performed in about 15% of PCI at most centers • Technically challenging with higher learning curve • PCI of these lesions requires higher number of devices • Higher LOS, higher MACE and higher restenosis • Most of these lesions are complex: High Syntax score

SYNTAX Score: Bifurcation Lesion Classification Modified from Duke, Medina and ICPS Classifications Systems 50% Type A: Pre-branch stenosis not involving the ostium of the SB; 1, 0, 0 Type B: Post SB stenosis of the MV not involving the origin of the SB; 0, 1, 0 Type C: Stenosis encompassing the SB but not involving its ostium; 1, 1, 0 Type D: Stenosis involving the MV and ostium of the SB; 1, 1, 1 Type E: Stenosis involving only the ostium of the SB; 0, 0, 1 Type F: Stenosis directly involving the MV (pre-SB) and the ostium of the SB; 1, 0, 1 Type G: Stenosis directly involving the MV (post-SB) and the ostium of the SB; 0, 1, 1

Other Important Aspects of Bifurcation Lesions; SBr is the ‘Key’ Side-branch Angulations Side-branch Size Small <1. 5 mm Medium 1. 5 -2. 9 mm Large >3. 0 mm Side-branch Ostial Disease

Bifurcation Lesion Intervention Technical Tips for Common issues • BMS vs. DES • Any DES preference • One stent or 2 stents • If 2 stents; which technique • Leave the wire in sidebranch (‘jailed’) • Final kiss or no kiss

DES vs. BMS for Coronary Bifurcation Lesion 126 with bifurcation lesions SES vs. BMS from overall SCANDSTENT trial Sirolimus Stent (n=68) Bare Metal Stent (n=58) P= 0. 009 28. 1 P= 0. 016 % DES >>> BMS 21. 1 P= 0. 019 NS 11. 7 NS 0 5. 2 1. 8 Death 8. 8 6. 0 3. 0 MI TVR MACE 0 Stent Thrombosis Theusen L, et al Am Heart J. 2006; 152: 1140

Randomized Spanish Bifurcation DES Study* Primary Endpoint: Binary Angiographic Restenosis and TLR @2 yrs SES (n=53) PES (n=56) SES (n=103) PES (n=102) 29 P=0. 02 P=0. 01 % 13 9 4 Binary Angiographic Restenosis *no difference in ST, MI of death TLR Pan et al, Am Heart J 2007; 153: 15.

Various Techniques for Stenting Bifurcation Lesions Stent the MV+ Balloon or Debulk SB Bifurcation Lesion Main vessel Sidebranch . . and stent the SB only if suboptimal results: CP, EKG , <TIMI III flow, >90% stenosis Provisional/ Conventional Stent Technique Stent+stent (“T stenting”) restenosis/ TLR Stent+stent (“reverse-T”)

Technique Dardas PS, et al, J Invasive Cardiol. 2003; 15: 180

MV and SB Stenting vs. Optional SB Stenting Using Sirolimus-Eluting Stents in Bifurcation Lesions: NORDIC Bifurcation Study 6 -Months Follow-Up MV (n = 207) MV + SB (n = 206) P = NS P = NS 2. 5 % 2. 0 1. 5 1. 0 Death 1. 4 1. 0 MI TLR TVR 1. 0 0. 0 Stent Thrombosis Steigen et al, Circulation 2006; 114: 1955

The BBC ONE Study: Fewer MACE with Provisional T-Stenting for Bifurcations End Points at 9 -Months Complex treatment strategy group 2 DES (n=250) Simple treatment strategy group 1 DES (n=250) 15. 2 P = 0. 001 11. 2 % P = 0. 009 P = 46 8. 0 7. 2 5. 6 P = NS 0. 8 ST 2. 0% 0. 4% 3. 6 0. 4 Death MI *Primary endpoint: death, TVF or MI at 9 -month TVF Primary endpoint* Hildick et al. Circulation 2010; 121: 1234.

Bifurcation Stenting: 1 vs. 2 DES Planned One DES approach is preferred • Short length of SBr lesion (<10 mm) • Small-medium vessel size SBr (<2. 75 mm) • SBr angle >70% • Issues of DAPT compliance

Coronary Artery Bifurcation Lesion Interventional Techniques Interventional Bifurcation Techniques One Stent Technique (OST) Crush Stent Kissing Stent Technique (SKS) Technique (Cr. ST) OST with SBR Dilatation (SBT) ‘T’ Stent Technique (TST) Culotte Stent Technique (CUT)

Bifurcation Lesion Intervention Using DES “Stent Crush” Technique Deployment of the stent in the side-branch Post

The CACTUS Study of Coronary Bifurcations: Application of the Crush Technique Using Sirolimus-Eluting Stents 6 -12 months Results Crush (n=177) Provisional T (n=173) 13. 2 14. 7 % P= NS for all 7. 9 7. 5 6. 7 4. 6 0. 5 MB binary SB binary stenosis MI 0. 5 TVR 0 Death 1. 7 1. 1 Stent thrombosis Colombo et al, Circulation 2009; 119: 71

Influence of Final Kissing in the CACTUS trial Colombo A, et al Circulation. 2009; 119: 71.

Bifurcation Lesion Intervention Using DES “Simultaneous Kissing Stent” (SKS) Technique If carina is <5 mm= V-stenting Pre Post

SKS-PRECISE Trial 9 -12 months Results P = 0. 09 SKS technique (n=51; angio=42) CSS (n=49; angio=41) 100 92 % P = 0. 06 P = NS 24. 4 4. 0 Clinical success 12. 0 2. 4 TLR 4. 9 7. 1 Angiographic restenosis MV SB 1 - yr F/U: No ST and 1 Death & 1 MI in each group Sharma et al. AHA 2008

Clinical Outcomes in Trials Comparing One-DES (1 S) vs. Two-DES (2 S) Strategy in Treating Coronary Bifurcations MACE TLR 19 18. 0 15. 2 13. 6 15 12. 9 % 9. 5 12. 8 11. 9 11. 4 10. 9 8. 0 5. 6 2. 9 3. 4 1. 9 1 S 2 S 12. 0 8. 9 7. 2 4. 5 15. 8 1. 0 1 S 2 S 5. 8 5. 6 4. 5 4. 0 2. 1 1 S 2 S Colombo et al. Hildick et al. Ferenc et al. Steigen et al. Colombo et al. Pan et al. Sharma et al. T-stenting NORDIC Trial CACTUS trial SES stents PRECISE-SKS SES stents BBC ONE (n=85) (n=202) (n=413) (n=91) (n=85) (n=100) (n=500)

Clinical Outcomes in Trials Comparing One-DES (1 S) vs. Two-DES (2 S) Strategy in Treating Coronary Bifurcations Incidence of Reported Stent Thrombosis 1 S group 2 S group 3. 5 3. 0 % 2. 0 1. 7 1. 1 0 1 S 2 S 0. 5 0. 4 1 S 2 S 0 1 S 2 S Colombo et al. Hildick et al. Ferenc et al. Steigen et al. Colombo et al. Pan et al. SES stents BBC ONE T-stenting NORDIC Trial CACTUS trial SES stents (n=85) (n=413) (n=85) (n=202) (n=500) (n=91) 0 0 1 S 2 S Sharma et al. PRECISE-SKS (n=100)

NORDIC BIFURCATION II Study Crush vs. Culotte Technique; 8 -months Results Crush stenting (n=209) Culotte stenting (n=215) P = 0. 04 P = 0. 09 % P = 0. 10 P = 0. 19 12. 1 10. 5 9. 2 6. 6 4. 5 4. 7 4. 5 2. 0 MV and/or SB In-stent diam. angiographic stenosis restenosis > 50% 4. 3 3. 7 MV in-lesion SB in-lesion MACE angiographic (death/MI/TLR) restenosis Erglis et al. Circ Cardiovasc Intervent. 2009; 2: 27.

DKCRUSH Technique for Bifurcation Lesions 1. SBr stenting 2. Balloon crush 4. MV stent and crush 3. 1 st Kissing balloon inflation 5. Final Kissing balloon inflation Chen S et al. J Interven Cardiol 2009; 22: 127

A Randomized Clinical Study Comparing Double Kissing Crush With Provisional Stenting for Treatment of Coronary Bifurcation Lesions: DK Crush II Study Conventional (n= 185) p<0. 001 % DK Crush (n=185) 22. 2 p=0. 017 p=0. 07 17. 3 14. 6 p=0. 036 10. 3 9. 7 p=0. 37 6. 5 3. 8 4. 9 0. 5 Main Vessel Side Vessel Angiographic Restenosis TVR MACE 2. 2 ST Chen S et al, JACC 2011; 57: 914

Bifurcation Stenting: 1 vs. 2 DES Planned Two DES approach is preferred • Diffuse long SBr lesion (<20 mm) • Large vessel size SBr (>3. 0 mm) • SBr angle <70% • Sure of DAPT compliance & adherence

Significant Post Stenting SB Stenosis: QCA Vs FFR (Jailed side branch lesions, n=94) Functionally significant stenosis FFR 38% of lesions Avoid Oculo-stenotic reflex 75% % Stenosis Koo et al. JACC 2005; 46: 633.

Trapping the Wire: TULIPE Study • Failure to use a “jailed wire” in the SB was an independent predictor of re-intervention at 7 months (OR 4. 26; 95% CI 1. 27 – 14. 2) • Favorably modifies angulation • Maintains patency of SBr • Identifies ostium when rewiring • Trap only non-hydrophilic wire ? Hydrophilic • Don’t trap large amount of wire • Don’t trap radio-opaque portion • Don’t trap wire in a distal small branch • If trouble removing – use balloon backup Brunel et al. CCI 2006; 68: 67

When PTCA or Stent Through MB: Absolutely End with a Kiss Provisional T-Stent

Nordic-Baltic Bifurcation Study III Estimate of eligible patients (n=2385) Randomized patients (n=477) No FKBD* (n=477) *Final kissing balloon dilatation No FKBD* (n=238) 6 months clinical F/U (n=239, 100%) 6 months clinical F/U (n=238, 100%) Scheduled Angiographing F/U After 8 months (n=189) Scheduled Angiographing F/U After 8 months (n=185) Angiographic F/U available (n=162, 86%) Angiographic F/U available (n=164, 88%) Niemela M et al. Circulation 2011: 123: 79

Nordic Bifurcation Study III- Final Kiss or No Kiss MACE and Clinical Outcomes at 6 Months No FKBD (n=239) FKBD (n=238) ST p=1. 00 % No FKBD 0. 4 12. 0 11. 7 CCS >2 Angina 2. 5 p=1. 00 2. 1 p=0. 62 p=0. 24 1. 7 1. 3 0. 8 0. 4 0 MACE Death MI TLR Niemela M et al. Circulation 2011: 123: 79

The Draw-Back Stent Deployment Technique Side-branch (Pullback or Balloon Stopper Technique) Our study of 110 pts using DES for non-aorto ostial lesions showed significantly lower need for main branch intervention with stent pullback technique The(2% undeployed stent has. Conventional been drawn. After stent 18% deployment and removal of 55 pts) Vs. stent of 45 pts) back until it comes into contact with of the stent delivery balloon and the deployment inflated balloontechnique in the main(p=0. 007). vesseldeflation of the main vessel balloon Kini & Sharma et al. AJC 2005; 96: 1123.

TAP: T-stenting and Small (SBr) Stent Protrusion • Stent main branch trapping wire • Rewire sidebranch, remove the trapped wire • Dilate through struts of MB stent • Deliver SB stent (proximal end of SB stent 1 -2 mm into MB) • Deploy SB stent (balloon in MB) • Pull back SB deployment balloon slightly & kiss • Exchange for non-compliant SB balloon – 2 step SB dilatation (high pressure in SB then Kiss)

Drug Eluting Stents Dedicated Bifurcation Stents B A C A E D G H I F J

Suggested Approach for Bifurcation Lesions with 1 or 2 Stents Approach Based on the Side-Branch Size, Angulation and Obstruction Sharma et al. Cardiology Clinic Feb 2010

Interventional Algorithm for Bifurcation Lesions DES for True Bifurcation lesion Side-branch size >3. 0 mm 1. 5 – 2. 9 mm Lesion preparation: Rota, CB Dissection Plaque modification Bifurcation long lesion of the side-branch Stenting 2 S • “SKS” technique • “T” stent technique • “TAP” technique <1. 5 mm Stent only the main vessel • Atherotomy, Rota Leave the wire in the SBr + GP IIb/IIIa inhibitors Keep It Open (KIO) + Stent only the main vessel For side-branch… • “Cullote” technique • “Crush T” technique Save the 2 nd stent for restenosis • “DKCRUSH technique Even if goes down Call 1 -800 -FLOWERS