“Provisional strategy is the gold standard for bifurcation stenting

“Provisional strategy is the
gold standard for bifurcation
stenting: Often but not
always !”
Ramesh Daggubati, MD FACC FSCAI
Clinical Professor of Medicine
Director of Interventional Cardiology
Clinical Associate Professor
Brody School of Medicine
Greenville, NC, USA
Disclosures
•  Speaker’s Bureau: Abbott, Abiomed, Astra
Zeneca, Gilead, Janssen, Medtronic,
Volcano
David thinks he crushed the
2-stent strategy with one sling
shot
What all David said is true,
but…
•  In BBC one and Nordic one, side
branch intervention is required in 28%
of patients.
•  BBC one showed peri-procedural MI is
greater(13 patients) in complex stent
strategy.
•  David said that the significance of these
MI is debatable.
Circulation. 2010; 121: 1235-1243
JACC: Cardiovascular Interventions, Volume 6, Issue 2, 2013, 139 - 145
Limitations of BBC One
•  Clinical trial without angiographic f/u.
•  Study not restricted to true bifurcations.
•  Additional lesions were treated in 16%
of simple vs 20% of complex groups.
•  Local PI bias
•  Allowed only Culotte and Crush for the
2 stent strategy.
Circulation. 2010; 121: 1235-1243
Why does David do PCI?
•  Regardless of technique used,
bifurcation PCI improved functional
status and QOL.
JACC: Cardiovascular Interventions, Volume 6, Issue 2, 2013, 139 - 145
Figure 4 Direction of Change in Individual Patients’ Scores on SAQ Patients' scores at baseline (pre-PCI) and at 9 month follow-up
were compared. The graphs indicate the proportions of patients who improved, deteriorated, and remained unchanged over this ...
Alex Sirker , Manav Sohal , Keith Oldroyd , Nick Curzen , Rod Stables , Adam de Belder , David Hildick-Smith
The Impact of Coronary Bifurcation Stenting Strategy on Health-Related Functional Status : A Quality-of-Life Analysis
From the BBC One (British Bifurcation Coronary; Old, New, and Evolving Strategies) Study
JACC: Cardiovascular Interventions, Volume 6, Issue 2, 2013, 139 - 145
http://dx.doi.org/10.1016/j.jcin.2012.10.010
He does have an open mind
Applying the data (and conventions) of bifurcation PCI to UPLM CAD.
Issues to consider:
Single vs. Double?
Does the Data Support
a Preferred
Technique?
DES vs BMS?
79 year old male.
Recent diagnosis of pancreatic cancer.
Seen pre-op in the setting of ACS.
To undergo a Whipple procedure.
Current standards
•  The main vessel stent should be sized
according to the distal diameter
•  Proximal Optimization Technique
•  Kissing NC balloon inflations
•  Wire the SB via the distal stent strut
•  Provisional T stent is the standard
•  Culotte is better than crush
BBC ONE NORDIC metaanalysis
Odds ratio and 95% CI
True bifurcations (657)
1.91 (1.23-­‐2.96)
Angle>60-­‐70° (217)
1.69 (0.78-­‐3.65)
SB diameter≥2.75mm (281)
2.34 (1.15-­‐ 4.77)
SB lesion>5mm (464)
1.66 (1.02-­‐2.68)
SB diameter≥2.75mm/lesion>5mm (137)
2.55 (1.03-­‐6.40)
Equivalence (111)
1.62 (0.50-­‐4.76)
Total (913)
1.84 (1.27-­‐2.65)
Favours Simple
Favours Complex
Behan et al Circ Card Intvn 2012
5 Year Follow-Up Nordic Bifurcation Study
Simple vs Complex Stenting Strategy in Non-LM PCI
• 
MACE event were low and did not differ
significantly in patients treated with a
simple versus a complex bifurcation
stenting technique.
• 
Stent thrombosis rate was not increased
in patients treated with 2-stents.
Meta-Analysis: NORDIC I & BBC I (Non LM Bifurcations)
Probability of MACE (Death/MI/TVR)
In the Nordic-BBC meta analysis the
average SB stenosis was 59% and 65% for
theDifference
simple
& complex strategy respectively.
in MACE
favoring a simple strategy
In many of these trials, up to 25% of
patients have no SB disease.
BBK I study - Clinical outcome 5 year post PCI
Death (%)
Death and/or MI (%)
Stent thrombosis def./probable (%)
TLR (%)
MACE (%)
Provisional
T-Stenting
n=101
Systematic
T-Stenting
n=101
p
7.9
9.9
2.0
13.2
17.0
10.0
6.9
5.1
16.4
22.9
0.65
0.15
0.25
0.56
0.33
Influence of FKB from CACTUS
Widely Perceived to Be Applicable to Left
Main and Non-LM Disease
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%
0.001
Stent
thrombosis
0.9%
6.5%
0.06
DK Crush Technique
Double Kiss and Crush
1 Year Outcomes DK Crush Versus Provisional Stenting
↓TLR and ↓TVR favoring DK Crush
↓ in MB and SB angiographic restenosis favoring DK Crush
Trend toward reduced MACE
Table 1. OneYear Outcomes
MACE
Cardiac Death
MI
TVR
TLR
Definite Stent
Thrombosis
↓ TLR and TVR
↓ Angiographic
restenosis (MB &
SB)
Trend toward a
DK Crush in non-LM Bifurcation
↓ in MACE
Double Kissing
Crush
10.3%
1.1%
Provisional
Stenting
17.3%
1.1%
P Value
3.2%
6.5%
4.3%
2.2%
14.6%
13.0%
0.751
0.017
0.005
2.2%
0.5%
0.372
0.070
1.000
DK CRUSH vs Cuolotte in UPLM
DK Crush in UPLM PCI
ACC 2013
A Randomized Pilot Trial for Treatment of Large Bifurcation
Lesions with Simultaneous Kissing Stents: PRECISE-SKS Trial
Optimal stenting strategy for coronary bifurcation lesions continues to evolve with most of the earlier studies
favoring stenting the main vessel (MV) over stenting both MV and the side-branch (SB). Simultaneous
kissing stents (SKS) techniques involves deploying two stents simultaneously in both branches with
guaranteed coverage of SB ostium, no stent deformation and excellent long-term results. Present SKSPrecise study is a randomized trial comparing SKS technique vs conventional stent strategy (CSS) of
deploying stent in MV and provisional stent of the SB for the treatment of large bifurcation lesions (Duke
type D). The primary endpoints were angiographic restenosis (>50% diameter stenosis of the target lesion)
at 8-month and a major adverse cardiac events (MACE: TLR, stent thrombosis, MI or death) at 1-yr. A total
of 100 pts were randomized (51 in SKS group and 49 in CSS group), with 1-yr clinical follow-up available in
all pts and angiographic follow-up in 83 cases. The SB stenting in CSS group was needed in 28%. All pts
received sirolimus-eluting stents (SES). Baseline clinical and angiographic variables were comparable, with
lower angiographic success of SB in CSS. The SKS technique for large bifurcation lesions resulted in a
trend towards better acute success and long-term patency, especially in the SB, compared to conventional
stent technique. Therefore, SKS technique can be safely recommended in the treatment of the true large
coronary bifurcations.
Numbers in these studies are generally small
DK Crush
•  Showing excellent results for systematic
two-stent technique
NORDIC IV
•  What did I learn as it flashed by?
NORDIC IV
–  1.3% vs 4.6% in favour of the two-stent
approach
–  Huge difference!
–  (p=0.09)
NORDIC IV
•  Difference largely driven by
reintervention
•  …large side branches cause angina!
•  We have found our group at last
Nordic-Baltic Bifurcation Study IV
Methods
Inclusion criteria
Exclusion criteria
• Age≥18
• Stable Angina, UAP,
NSTEMI
• MV≥3.0mm
• SB ≥2.75mm
• Bifurcation stenosis
involving both MV and SB
(≥50%DS by eyeballing)
• STEMI
• Cardiogenic shock
• Other critical illness
• Relevant allergies
• Cr ≥ 200 µmol/L
• SB lesion length >15mm
The Nordic-Baltic PCI Study Group
Nordic-Baltic Bifurcation Study IV
Lesion characteristics
Provisional
(n=221)
Two-stent
(n=229)
p
LAD/diagonal (%)
74.1
76.7
ns
CX/obtuse marginal (%)
16.8
17.6
ns
RCA PDA/PLA (%)
6.4
4.0
ns
LM/LAD/CX (%)
2.7
1.3
ns
Ref. diameter main vessel (mm)*
3.5
3.4
0.04
Ref. diameter side branch (mm)*
2.9
2.9
ns
Lesion length SB (mm)*
7.4
8.0
<0.0001
Angulation > 60-70° (%)*
50.9
51.1
ns
*visual estimation
PCI in Coronary Bifurcation Lesions
The Evidence-Base
SB Stenosis Severity
SB Lesion Severity (%)
SB Lesion Length (mm)
100
20
80
15
60
40
10
20
5
al
EN
H
C
C
B
B
et
E
-O
N
S
A
C
TU
B
IC
CHEN et
al
C
BBCONE
B
CACTUS
O
BBK
N
NORDIC
R
D
0
K
0
No
Data
No
QCA
RCTs of Provisional vs. Elective Stenting
“Higher-Risk” Bifurcations
Chen SL, et al. J Am Coll Cardiol 2011;57:914–20.
Recent Metaanalysis by Gao
EuroIntervention. 2014 Sep 22;10(5):561-9. doi: 10.4244/EIJY14M06_06
Double vessel stenting is safe
EuroIntervention. 2014 Sep 22;10(5):561-9. doi: 10.4244/EIJY14M06_06
Why Does PCI of Coronary Bifurcations Remain a Challenge?
Bifurcation Type
Technique
X
X
Provisional
Stenting
Provisional
Stenting
Medina1,1,1
1,1,1
Medina
Elective Double
Stenting
Fallacies in Zimarino’s study
•  Several non-randomized registries and
not true bifurcation studies.
•  Selection bias.
•  Increased TLR, TVR could be due to
first generation stents and patient
factors.
JACC: Cardiovascular Interventions, Volume 6, Issue 7, July 2013, Pages 696-697
David now is against strong data
Simple vs Complex
DK Crush
Nordic IV
David
Conclusions
•  Bifurcation stenting is Class II b.
•  Differentiate Simple vs Complex
bifurcation
•  SB > 2.5 mm, >10 mm long, >75% is
complex, eccentric plaque and DM are
complex features and need 2 stent
strategy.