1. Bifurcation Overview
A comprehensive overview of Bifurcation disease, treatment options and techniques

2. Bifurcation Overview Prevalence of Bifurcation lesions
Anatomy of Bifurcation lesions
Bifurcation Lesion and Technique Classification Systems
Medina System
MADS System
Important Stent Attributes for treating Bifurcation lesions
Bifurcation Treatment Techniques
Provisional Stenting
Two-stent
Kissing Balloon
Clinical Evidence impacting current techniques
Summary

3. Recent All-Comers Trials and Registries
Bifurcation Overview
Bifurcation Lesions - Prevalence
Based on recent trials which included bifurcation treatment, bifurcation lesions occur in about 25% of PCI cases.
Several large recent trials have enrolled an all-comer population allowing bifurcation lesion treatment
Recent All-Comers Trials and Registries
Study
# Patients
% Bifurcations
RESOLUTE All Comers1
2265
17%
RESOLUTE International2
2349
18%
TWENTE3
1391
26%
LEADERS4
1707
29%
NOBORI 25
3067
20%
Real-world representation of bifurcation lesions is about 25% of all PCI’s.
A Bifurcation lesion is a narrowing at the takeoff of a significant side-branch
1 Diletti R, et al. Heart 2013;99:1267–1274.
2 Neumann, F. et al. EuroIntervention 2012 Feb;7(10):1181-8
3 von Birgelen et al. J Am Coll Cardiol 2012 Vol 59, Issue 15
4 Garg et al. EuroIntervention 2011 Mar;6(8):
5 Danzi , GB, et al EuroIntervention2012 May15;8)1):109-16

4. Bifurcation Overview
The Goal of Bifurcation PCI
Bifurcation PCI aims to restore the natural configuration of the bifurcation, including:
Optimal blood flow
Well apposed stent
Easy access to the SB in the future
Pre Treatment*
Post Treatment*
*A. Colombo

5. Bifurcation Overview Bifurcation treatment may be complicated by:
Lesions are difficult to treat
Bifurcation treatment may be complicated by:
Vessel geometry: different angles and tapers affect the shape of the ostium
Variable stenting techniques
Procedural success is low while complications and MACE rates are high for bifurcation as compared to non-bifurcation lesion treatment 1,2
Stankovic, EBC 2012
Vessel geometry – vessel diameters and branches have different angles and tapers which affect the shape of the ostium
Variable stenting techniques – many variations of techniques and approaches currently exist to treat bifurcation lesions
Adverse event rates – procedural success is low while complications and MACE rates are high for bifurcations as compared to non-bifurcation lesion treatment
Images – Louvard Y. SEOUL Classification and Treatment Strategy of Bifurcation Lesions
1 Hildick-Smith, D. Bifurcation Stenting: Should You Keep it Simple. theheart.org
2 Stankovic et al. EuroIntervention 2009;5(1):39-49

6. Bifurcation Overview
Classification of Bifurcation Lesions – Medina System
The Medina System uses the proximal and distal main branches and the side branch as reference for the location of significant stenosis (>50%).
The system cannot be used to describe the angles, the calcifications and length of the lesions.
A “true” bifurcation involves both the main and side branch
Medina System: The binary number corresponds with the presence or absence of a lesion within main, distal and side branches, respectively.
In the majority of bifurcation lesions, one stent or “Provisional Stenting” is the treatment of choice;1 however, in true bifurcations (large diameter vessels and significant ostial side branch length), two stents may be needed2 1 Legrande et al. EuroIntervention 2007;3:44-49
2 Hildick-Smith et al. EuroIntervention 3010;6:34-38
Y. Louvard, T. Lefevre EuroIntervention 2011; 7(1):
Stankovic et al. EuroIntervention 2009;5(1):39-49

7. Bifurcation Overview
Classification of Bifurcation Techniques - MADS
The MADS System highlights classification of a number of bifurcation techniques, but does not reflect every possible bifurcation treatment strategy
Main – stenting of the proximal main first; Across - stenting of the proximal main to the distal main, across the SB; Distal – historically starts with simultaneous stent placement at the ostium of both distal branches; Side – side branch is stented first
Y. Louvard, T. Lefevre EuroIntervention 2011; 7(1):

8. Bifurcation Overview
Important Stent Attributes in Provisional Stenting
Side branch access and stent apposition are key attributes in provisional stenting and are dependent on several factors:1
Strut shape/size: smaller, smoother struts are easier to cross; apposition can be affected by torsion of the rectangular stent struts at the peaks leading to a ‘bumpy’ stent surface2
Cell shape/size: smooth round struts allow for easy wire and balloon sidebranch access; complex irregular cell shape may obstruct wire or catheter advancement through the stent3
1 Stankovic EBC Mortier EBC Carrie TCT Mediterranean 2012

9. Bifurcation Overview
Important Stent Attributes in Provisional Stenting
Cell expansion area: larger maximum achievable cell area allows for less obstruction into the side branch
Number of Links: connections hold rings together, provide longitudinal strength, control flexibility, cell size and SB access2,3
Conformability: well apposed stent struts minimize the risk of wire or catheter snagging
1 Mortier EBC 2012
2 OrmistonT CT 2012
3 Stankovic EBC 2012

10. Bifurcation Overview Techniques – Provisional Stenting
The preferred treatment approach for bifurcation disease known as provisional stenting, accounts for 80% of bifurcation lesion treatement:1
Provisional stenting uses only one stent, is not as technically difficult compared to two-stent techniques, procedure times are shorter and patients are exposed to less contrast and fluoroscopy
In this NORDIC/BBC1 subgroup analyses there remained an increased risk of the primary end point associated with the complex group3
Provisional stenting - The technique starts with a single-stent approach for the main vessel (MV) and ignore side branch (SB) disease unless clinical circumstances warrant placement of an SB stent - Stankovic ESC 2012
Clinical circumstances include: Presence of chest pain, EKG changes, <3 TIMI flow, unstable dissection, severe residual stenosis, large (>2.5mm) SB with >5mm ostial disease, very difficult SB access
Subgroup Analysis: from Simple or Complex Stenting for Bifurcation Coronary Lesions: A Patient-Level Pooled-Analysis of the NORDIC and BBC1,
1 Routledge H. Interventional Cardiology. 2011;6(2):150–3
2Louvard & Lefèvre. EuroIntervention 2011;7:
3 Behan, M. Circulation: Cardiovascular Interventions. 4(1):57-64, February 2011.
Figure 2 . Odds ratio plot of the primary outcome for individual subgroups. Equivalence indicates that the SB is <0.25 mm smaller than the MV. Size of data markers indicates the number of patients in that subgroup. SB indicates side branch; MV, main vessel; CI, confidence interval.

11. Bifurcation Overview Techniques – Provisional Stenting
Provisional stenting steps include stenting the MB and optimizing flow and access to the side branch
Both branches are wired starting with the most difficult one
MB is stented (stent sized according to MB distal reference) and SB wire is jailed
The stent is post-dilated using the Proximal Optimization Technique (POT) to maximize stent apposition
Stent is now well apposed proximally, while the SB is partially covered by scaffolding
MB wire is pulled back and re-inserted through the most distal strut of the SB opening scaffold
Jailed wire is removed and re-inserted in the distal MB (with a formed loop at the distal end)
The Kissing Balloon inflation is done to optimize side branch flow and access
Final result (if suboptimal, can then place additional stents)
Louvard & Lefèvre. EuroIntervention 2011;7:

12. Bifurcation Overview Techniques – Provisional Stenting
The key steps to provisional stenting include: distal main branch sizing and proximal main branch proximal optimization technique (POT) and/or Final Kissing balloon (FKB)
Proximal
Proximal
POT
FKB
No carina shift
Carina shift
In single stent techniques, the primary stent should be sized according to the distal main vessel diameter. This avoids the risk of carina shift, which can lead to occlusion of the side branch.1 1 Stankovic EBC 2012
Postdilitation (POT) or kissing balloon inflations (FKB), are required to optimize the proximal main vessel stent diameter.2 2 Stankovic ESC 2012
Distal
Distal
Stankovic EBC 2012

13. Strut expansion at carina
Bifurcation Overview
Techniques – Proximal Optimization Technique (POT)
The proximal optimization technique (POT) is a variation of the provisional stenting technique and expands the stent at the carina, using a short oversized balloon.
This optimizes the proximal main vessel stent diameter and produces curved expansion of the stent into the bifurcation point, which facilitates:
Proximal oversizing
- Re-crossing into the SB
- Distal re-crossing
- Kissing inflations
- Ostial stent coverage of the side branch
Opinion remains divided as to whether POT should be a part of the standard approach to bifurcation lesions, but there is consensus that this technique should be used in any case of difficulty re-crossing into a side branch with either a wire or balloon.
Strut expansion at carina
Hildick-Smith et al. EuroIntervention 2010;6:34-38

14. Bifurcation Overview Techniques – Two Stent Approach
The following are required for a 2-stent approach:
Final kissing balloon inflations
High pressure ostial and proximal stent inflations to correct stent deformation
Figure depicts the most common two stent techniques that can be used after provisionally stenting the main branch. Out of these options, crush is the least-preferred 2-stent technique.
Main branch stenting first
The range of potential steps and techniques to treat bifurcation lesions is extremely complex
No consensus exists on the ideal 2-stent technique and each operator has their own tips and tricks on how to overcome technical challenges.
Stankovic ESC 2012

15. Bifurcation Overview
Techniques – Two Stent Approach (T-stenting, Culotte, Crush)
The range of potential steps and techniques to treat bifurcation lesions is extremely complex – no consensus exists on the ideal 2-stent technique and each operator has their own tips and tricks on how to overcome technical challenges.
T-Stenting Technique
Culotte technique
Crush technique
Gutersohn TCT 2012, Adapted from A. Colombo

16. Bifurcation Overview Final Kissing Balloon (FKB)
Kissing balloon technique is done mainly to optimize the proximal main vessel stent diameter as well as side branch flow and access.
Advantages of final kissing inflations:1,2
Correction of the main vessel stent distortion
Expansion/apposition of the main vessel stent
Better scaffolding at the side branch ostium
Correction of carina shift
Future access to the SB
Systematic kissing balloon inflation
Routine use of Final Kissing Balloon (FKB) did not improve clinical (MACE) outcomes but did reduce angiographic side branch restenosis, especially in patients with true bifurcation lesions3
Kissing balloon inflations, or pressure wire interrogation, should be used when an angiographically significant (>75%) side branch lesion remains after main vessel stenting.4
1 Stankovic et al. EuroIntervention 2009;5:39-49
2 Darremont EBC 2012
3 Niemela, M. et al Circulation 2011 Jan 4;123(1):79-86.
4 Hildick-Smith et al. EuroIntervention 2010;6:34-38

17. Bifurcation Overview Final Kissing Balloon (FKB)
Crossing of the distal side cells of the main vessel stent is associated with better ostium scaffolding and reduced need for side branch stenting1
Image adapted from Carrie TCT Mediterranean 2012
Although it remains up to physician preference, to prevent overdilation during kissing inflations EBC recommends the use of non-compliant balloons2
Image from Darremont EBC 2012
1 Burzotta et al. EuroIntervention Supplement (2010) Vol. 6 (Supplement J) J72-J80
2 Hildick-Smith et al. EuroIntervention 2010;6:34-38

18. Bifurcation Overview
Clinical Data’s impact on Bifurcation techniques?
Prior to 2008, there was limited clinical data on the treatment of bifurcation lesions with specific bifurcation techniques. Up to that time, 2-stent techniques were often thought to be an optimal treatment for true bifurcations.
In 2008 the NORDIC and BBC trials shifted the perception and practice to the simpler, provisional strategy by showing first generation DES are effective at treating bifurcation lesions.
Prior to 2008, the Crush technique was a highly preferred 2-stent technique. Based on BBC ONE outcomes, the investigators went as far as labeling Crush stenting as ‘dead’.

19. Bifurcation Overview
Provisional Stenting as the Gold Standard
Randomized bifurcation trials comparing provisional 1-stent vs. systematic 2-stent strategy have shown no benefit using two stents.
Stankovic ESC 2012

20. Bifurcation Overview
NORDIC I - Overview
NORDIC I was a randomized trial of 400 patients (200 to simple – provisional stenting and 200 to a complex – dual stent strategy with either crush, culotte, T, or Y stenting using SES (Cypher)). The Primary Endpoint was MACE at 6 months and 5-year follow up.
Figure 1 5-Year Follow-Up Patient Flow Chart of the Nordic Bifurcation Study ∗ A total of 307 patients had a quantitative coronary assessment at the index procedure and after 8 months. MV = main vessel; SB = side branch.
M. Maeng, et al. Journal of the American College of Cardiology, Vol 62, Issue

21. Bifurcation Overview
NORDIC I – Study Conclusions
Short and long-term follow-up showed no difference in MACE. Both stenting strategies have a high and similar procedural success, but simple stenting is associated with reduced procedure and fluoroscopy time as well as significantly lower incidence of increased levels of biomarkers (possible infarctions).
M. Maeng, et al. Journal of the American College of Cardiology, Vol 62, Issue

22. Bifurcation Overview
BBC ONE - Overview
BBC ONE was a randomized trial of 500 patients (250 to simple – provisional stenting and 250 to a complex – dual stent strategy with either crush or culotte, stenting using PES (Taxus)). The Primary Endpoint was MACE at 9 months.
Hildick-Smith theheart.org
HildickSmith TCT 2008

23. Bifurcation Overview
BBC ONE – Study Conclusions
A systematic 2-stent technique resulted in longer procedures, higher x-ray doses, more procedural complications, and a higher rate of in-hospital and 9-month MACE.
Hildick-Smith theheart.org
HildickSmith TCT 2008

24. Bifurcation Overview
NORDIC III - Overview
NORDIC III was a randomized trial comparing final kissing balloon (FKBD) vs. no FKBD in patients treated with main vessel stenting using SES (Cypher)
1 Erglis Korea 2010
2 Niemela, M. et al Circulation 2011 Jan 4;123(1):79-86.
3 Hildick-Smith TCT 2011

25. Bifurcation Overview
NORDIC III – Study Conclusions
Similar 6-month clinical outcome with and without FKBD
Angiographic restenosis was significantly less in the FKBD group
Simple no-FKBD strategy was associated with shorter procedure and fluoro times and reduced use of contrast media.1,2
It has been proposed that FKBD should be used in cases where the side branch ostial narrowing is >75%.3
Secondary end point
P=0.039
1 Erglis Korea 2010
2 Niemela, M. et al Circulation 2011 Jan 4;123(1):79-86.
3 Hildick-Smith TCT 2011

26. Bifurcation Overview European Bifurcation Club
What is EBC?
A “think-tank” of cardiologists with a particular interest in bifurcations
Independent club with a yearly scientific meeting and publication of consensus statement (established 2004)
Educational collaboration with EuroPCR
Based on current clinical evidence and expert consensus, EBC provides recommendations to help improve bifurcation treatment technique and outcomes.
Lassen EBC 2012