Bifurcation stentig

CORONARY BIFURCATION LESIONS –
HOW TO STRATEGISE ?
Dr. Lokesh Khandelwal
MD, DM Cardiology

 PCI affecting a bifurcation lesion are encountered in 15-20% of cases.*
 Apart from the acute risk of periprocedural SB occlusion, bifurcation PCI is
associated with an increased risk of long-term stent-related ischaemic adverse
events, including stent restenosis and thrombosis.
 Bifurcation PCI is resource-demanding due to the use of multiple guidewires,
balloons and stents,
 Therefore, it is important to optimize the strategy for bifurcation stenting.
Introduction
EuroIntervention 2018;13:e1804-e1811

DEFINITION
A lesion located in a bifurcation point with a side branch >2 mm in
diameter
>50% diameter stenosis in PMV/DMV
+
>50% diameter stenosis in the ostium of the contiguous side
branch
Circulation 1998;78:486–502.

Side branch
• Significant side branch - branch that the operator does not want to
lose after evaluating the individual patient.
• Wiring of the SB before MV stenting is recommended when the SB is
deemed important by the operator.
EuroIntervention 2018;13:e1804e1811

1 stent vs 2 stent strategy
• Simplicity
• Safe
• Require single stent in 80% to
90%
• Cheaper
• Less Time
• Largely Similar outcome as with
complex strategies
• Even for the left main coronary
artery
1 stent stretegy 2 stent stretegy
• Complex, expensive
• Not needed upfront in most of
the cases
• Suitable for large side branches
having lengthy stenosis
• Large side branch having
difficult access

258 patients
Left main bifurcation lesions
44%
true bifurcation lesions 66%
Conservative strategy for provisional SB intervention was associated with similar long-
term clinical outcomes and a lower incidence of procedure- related myocardial
necrosis.

2,044 patients with non-LM bifurcation
853 with LM bifurcation
Retrospective multicenter registry

LM Bifurcation Lesions
The 1-stent strategy, if possible, should initially be considered the preferred
approach for the treatment of coronary bifurcation lesions, especially LM
bifurcation lesions.

JACC:
CARDIOVASCULARINTERVENTIONS,
VOL6
,NO.
7,
2013

JACC:
CARDIOVASCULARINTERVENTIONS,
VOL6
,NO.
7,
2013
SDS should be the preferred approach, as DDS is associated with an
increased risk of MI, likely driven by DES thrombosis.

Single stent Two stents P Value
All-cause death 5.9 10.4 0.16
Cardiac death 2.5 4.0 0.40
Myocardial infarction 4.0 7.9 0.09
Target lesion
revascularization
11.3 15.3 0.24
Target vessel
revascularization
13.4 18.3 0.14
Target vessel
revascularization by CABG
2.0 3.5 0.38
Stent thrombosis 3.0 1.5 0.32
Clinical outcomes after simple optional side branch stenting remained at least equal to
the more complex strategy of planned stenting of both the main vessel and the side
branch.

–450 Patients
–SB ≥2.75mm
–If TIMI flow<III or >75%DS in ostial SB: kissing balloon dilatation
–If SB TIMI flow <III after kissing balloon dilatation, SB stenting using
a T- or Culotte technique
Nordic bifurcation study IV (2013)

Provisional
(n=221)
Two-stent
(n=229)
p
Procedure time (min) 73.9 92.6 <0.0001
Contrast volume (mL) 187 238 <0.0001
Flouroscopy time (min) 14.0 22.8 <0.0001
Tx succesful* (%) 97.7 99.1 ns
Procedural CK-MB>5x UPL** (%) 3.0 3.1 ns
Procedural CK-MB>3x UPL** (%) 6.0 6.1 ns
* Residual stenosis <30% of MV + TIMI flow III in SB
** Assessment possible in 327 patients

Eventfree survival curve at 6 months
4.6%
1.8%
p=0.09

Provisional
(n=220)
Two-stent
(n=227)
p
Total death (%) 0 0.4 0.32
Cardiac death (%) 0 0 -
Non-procedural myocardial infarction (%) 1.8 0.9 0.50
Stent thrombosis (%) 0.9 0.4 0.54
Target lesion revascularization (%) 3.2 1.3 0.18
Target vessel revascularization (%) 3.7 1.3 0.11
Angina CCS class ≥ II 2.7 1.3 0.39
Bifurcation lesion involving a large side branch, a 2-stent strategy did not
reduce adverse cardiac events; however, there was a suggestion of benefit
from this approach.
A planned 2-stent strategy significantly increased procedure time.

Trial Complex
MACE
(%)
Simple
MACE
(%)
P value No of patients
Complex/simple
Follow-up
Months
CACTUS 15.8 15 NS 173/177 6
Colombo et
al
23 22 NS 63/22 6
Pan et al 8.5 7 NS 47/44 6
Ferenc et al 12.9 11.9 NS 101/101 6
NORDIC 3.4 2.9 NS 207/206 6
NORDIC 21.8 15.8 NS 202/202 60
BBC-ONE 15.2 8 0.009 249/248 9
International Journal of Cardiology 187 (2015) 48–57
Studies comparing1 vs 2 stent strategy

Provisional SB treatment is recommended as the preferred technique
Non-true bifurcations should always be treated with a provisional
strategy
True bifurcations- may require 2 stents in approximately 30% of the
Non LMCA & upto 50% of LMCA bifurcation lesions
When to prefer provisional stenting
Latib and Colombo Bifurcation Disease, JACC : CARDIOVASCULARINTERVENTIONS, VOL. 1 , N O. 3 ,2008

 Is the side branch large enough to Stent? (>2.5 mm)
 Large SBs (>2.5 mm) with significant disease
 Is the side branch plaque lengthy (not focal)?
 Extending (>5 mm) into the SB
 Will it be difficult to rewire after main branch stent?
 Larger SBs whose access is particularly challenging should be secured by stenting once accessed.
 Will the side branch close?
 Plaque at ostium and angulation
 Is the sidebranch angle (<70o ) ?
When to prefer dedicated stenting : main consideration -The branch

Provisional SB Stenting
No
Proposed Approach to Bifurcation
True Bifurcation Lesion
(Significant Stenosis in MB and SB – Medina 1,1,1 – 1,0,1 – 0,1,1)
Stent MB & Wire/PTCA SB
No
Yes
Sidebranch Suitable for Stenting
Yes
Sidebranch Disease Focal < 5mm
Elective MB and SB Stenting
No - Diffuse Yes
Provisional SB Stenting

Predilatation of SB before MV Stenting
 No firm evidence
Advantages
• Increased ostial SB
lumen
Disadvantages
• Dissections
• Risk of rewiring a
EuroIntervention 2014;10:545-560

Predilatation of the SB is in most cases probably not needed
Predilatation of the SB is recommended in some circumstances
Extensive ostial SB involvement
Heavy calcification
Predilatation of SB before MV Stenting

Proximal Optimisation Technique
Expanding the stent from the proximal stent edge to just
proximal to the carina, using a short oversized balloon
To ensure adequate stent apposition in the proximal MV
Used to facilitate easier SB access due to the oblique take-off
in the direction of the SB

Difficult Side Branch Wiring
Plaque modification by balloon dilatations or rotablation
Use of hydrophilic wires
Reverse wire technique
Microcatheter Use
POT
SB
PMV
DMV

CHOICE OF STENT
DES are recommended
MV stent should be sized according to the distal MV
Choose a stent where the platform can expand upto proximal MV
diameter
Catheter Cardiovasc Interv. 2013;82:1075-82.

KBI in Simple Stenting
No clinical advantage of a routine kissing strategy in
single-stent treatment.
EuroIntervention 2014;10:545-560 AsiaIntervention 2015

Study included 4314 Pts
Favourable outcome with FKBD but only with two stent strategy

Circulation. 2011;123:79-86.
Kaplan-Meier curves for MACE-free survival (cardiac death, non–procedure-related index
lesion MI, TLR, definite stent thrombosis) in the FKBD and no-FKBD groups during the 6-
month of follow-up.

 Kissing balloon inflations are not routinely required
 May be used when >75% DS ostial SB or TIMI flow <3 remains after MV stenting
 Ballon for KBI should be short, noncompliant and size should be matched with
side branch.
 Minimal overlapping of balloons is recommended.
 Simultaneous deflation of both balloons
KBI in Simple Stenting

Provisional
stenting
Results acceptable
>75% DS ostial SB
or TIMI flow <3,
FFR < 0.8
Ballooning/Kissing
Significant
dissections
Side branch
stenting
70-90o
T/TAP
<70o
Cullote/ Internal
crush
FAILS

ROLE OF FFR
• Increasing evidence that angiographically significant
result in the SB may not be physiologically important
• Majority of significant SB lesions are not functionally
significant by FFR analysis

Summary of Studies with FFR
Trials No. of
patients
Side-branch
crossing (%)
FFR <0.8 [%] SB stenosis
present (%)
Kumsars et al 83 91 19 45
Koo et al 95 96 31 79
Koo et al 93 97 27 79
Koh et al. 77 100 27 66
Koo et al 68 90 43 54
Ahn et al. 241 97 10.4 45
Kang et al. 90 100 18 36
Ye et al. 51 100 15
Total 798 96 21 52

Restenosis at 13 Months
was lesser with FFR

FFR for bifurcation lesions
Optimal IVUS or OCT criteria to define the functional significance of
SB lesion are not known yet
Technically difficult to perform IVUS or OCT in jailed SB lesions
FFR can be easily measured in bifurcation lesions both before and
during intervention
EuroIntervention Supplement (2010) Vol. 6 (Supplement J) J94-J98

52 patients were included.
OCT-guided stent recrossing (group 1, n=12), and angiography-guided recrossing (group 2,
n=40)

Proposed Approach to Bifurcation
Lesions with DES
Two Stents Necessary
(SB>2.5mm)
• Long Plaque in Sidebranch (>5mm)
• Severe Dissection pre-Dilatation
• Unfavorable Geometry for Rewiring
No • Crush/ Mini-
crush/ DK crush
• Culotte
-- MB = SB
• V-stent/SKS (0,1,1)
Acute Side Branch Angle – Near 90o?
• Modified T
• TAP
Yes

Is one technique better than others
Insufficient data for showing obvious clinical benefit of one technique
over others in Non- LM bifurcations.
DK-crush is shown to be better technique in LM- bifurcations.
Both elective T stenting and SKS technique are not recommended by
the EBC due to the lack of predictable results in terms of stent
distortion and vessel wall coverage and concerns regarding safety with
the long, double-layer neocarina using SKS.

All Lesions
No Difference
LM Lesions

Selection of Technique
Stability of the patient
Familiarity and competence of the operator with a specific technique
Anatomical factors
Diameter of the two branches (similar or discrepant)
Bifurcation angle
Extent of disease in the MB proximal to the carina
Severity of the ostial SB stenosis (does it require aggressive pre-
dilatation)
Presence of dissection in MB or SB after predilatation

CULOTTE TECHNIQUE
Similar size of PMV & SB
Open-cell stents are preferred
6F guiding catheter
Rewiring of both branches through the stent struts
Limits use if both branches are dissected after pre-dilatation and in
very complex disease
Full coverage of bifurcation
Excess of metal covering the proximal end

3.0 mm stents, dilatation with a 4.0mm NC balloon at 14 atm
BioMime

Mystent S Genxsync Pronova Biomime Yukon
Metal Co-Cr Co-Cr Co-Cr Co-Cr Co-Cr
Strut
thichness
59 µm 65μm 60, 90,
120μm
65 μm) 87μm
Drug Sirolimus Sirolimus Sirolimus Sirolimus Sirolimus
Cell
architecture
Hybrid Hybrid Hybrid-
close cells in
middle
Hybrid Open
Commonly used stents

Crush Technique
• Requires a 7 or 8 Fr guiding catheter
• Both side branch and main branch stents are deployed at least at high pressure
• Immediate patency of both branches
• Has to cross 3 layers of struts
• Difficult in very wide angle
• Immediate patency of both branches is assured and therefore it should be applied in
conditions of instability or when the anatomy appears complex
• MINI CRUSH- decrease as much as possible amount of stent overlap between SB and
MB, associated with better results than classical crush.*
J Am Coll Cardiol Intv 2008;1:351–7

Mini-Crush Stenting
Classical Crush
Bifurcation Stenting

Step crush (6F)
MV & SB are wired & predilated
Side branch stented
SB stent is crushed by balloning in MV
MV is stented
FKBI

DK crush (6F)
MV & SB are wired & predilated
Side branch stented
SB stent is crushed by balloning in MV
First Kissing Balloning
MV is stented
Final KBI

DK crush
• Optimize stent deployment and opposition.
• 6F guiding catheter
• DK crush technique has shown to be better LM bifurcation
lesions.

T-techniques
Most frequently utilized:
To crossover from provisional stenting to stenting the SB
Where the angle between the branches is close to 90°
oLess laborious (no recrossing)
oImmediate patency
oRisk of leaving a small gap b/w two stents
oLeading to ostial restenosis of SB
With angles 70°, there is almost
always incomplete coverage of the
SB ostium
Latib A, Colombo A. Bifurcation disease: what do we know, what should we do? J Am Coll Cardiol Intv 2008;1:218 –26

V stenting / SKS
• Indication
– Medina 0,1,1 bifurcations - proximal MB relatively free of disease - angle< 90
degree.
– Short lmca, free from disease and critical disease of both the lad and lcx
ostia.
• Advantages
– Access preserved - no need for rewiring any of the branches. Its is relatively
easy and fast.
• Disadvantages
– Creation of a metallic neo carina (particularly the SKS) - with stent mal-
apposition - several concerns:
• The risk of proximal dissection
• Re-intervention - rewiring the stented vessels may be complicated by wire
passage behind stent struts.
• Restenosis in neo carina or proximal stent edge

Wire Recrossing Site
Provisional Distal
Crush/DK
crush
Central/
proximal cell
Culotte
Distal
/central

FKBI
Important for all 2 stent strategies

IMPORTANCE OF FKBI

How FKBI Works
Seung-Jea Tahk, Suwon, Korea 13th Angioplasty Summit TCT. April 23-25, 2008

DEDICATED BIFURCATION DEVICES
1. Devices treating the MB with some degree of SB
scaffolding
2. Proximal bifurcation stents
3. Bifurcated stents
4. Side branch stents

Self-alignment Devices
Devices treating the MB with some degree of SB scaffolding

Controlled-alignment Devices No need for alignment
Devices treating the MB with some degree of SB scaffolding

PROXIMAL BIFURCATION STENT
DEVAX stent
AXXESS stent
(Biolimus)

Bifurcated Stents
Medtronic Y stent

SIDE BRANCH STENTS
Biomime Branch

• Randomly assigned 704 patients with true bifurcation lesions to
a main vessel stent plus provisional stentingor the bifurcation
stent.
• Tryton Side Branch Stent
• Primary endpoint (powered for noninferiority) – cardiac death,
• target vessel myocardial infarction and TVR.
• Secondary endpoint (powered for superiority) was in-segment
percent diameter stenosis of the SB at 9 months.
• Follow up period- 9 months

Provisional stenting should remain the preferred strategy for
treatment of non–left main true coronary bifurcation lesions.

Ongoing trial - BioMime Branch -1 Study
 To evaluate the safety and performance of BioMime Branch - Sirolimus Eluting Coronary Side Branch Stent
System and BioMime in main branch vs. XIENCE family DES in side branch and main branch in patients with
coronary bifurcation lesions
 Randomized trial
 183 subjects to be enrolled at 6 sites across India
 Primary Safety Endpoint - Ischemia Driven Target Lesion Failure
 Secondary Safety Endpoints - Major Adverse Cardiac Events , Stent Thrombosis Rate , Ischemia-driven
Target Vessel Revascularization
 Study start date: March 2018
 Estimated study completion: December 2021

Issues with Dedicated Bifurcation Stents
Positioning is difficult
Limited Range of sizes
May not be applied to complex anatomy
Validation is still a major issue

CONCLUSIONS
One stent strategy is always preferred – until unless there
are compelling indications.
DK Crush has shown superiority over other techniques in LM
bifurcation lesions.
Never forget FKBI & POT- essential tools of complex strategy
/ sometimes in provisional strategy
Dedicated stents have a novel concept but still have not
improved results

Bifurcation stentig

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