“provisional strategy is the gold standard for bifurcation ... · a randomized pilot trial for...
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“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
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Disclosures • Speaker’s Bureau: Abbott, Abiomed, Astra
Zeneca, Gilead, Janssen, Medtronic, Volcano
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David thinks he crushed the 2-stent strategy with one sling
shot
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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.
JACC: Cardiovascular Interventions, Volume 6, Issue 2, 2013, 139 - 145
Circulation. 2010; 121: 1235-1243
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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
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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
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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
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He does have an open mind
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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.
Applying the data (and conventions) of bifurcation PCI to UPLM CAD.
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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
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BBC ONE NORDIC meta-analysis
Total (913)
True bifurcations (657)
Angle>60-‐70° (217)
SB diameter≥2.75mm (281)
SB lesion>5mm (464)
SB diameter≥2.75mm/lesion>5mm (137)
Equivalence (111)
Favours Simple Favours Complex
1.84 (1.27-‐2.65)
1.91 (1.23-‐2.96)
1.69 (0.78-‐3.65)
2.34 (1.15-‐ 4.77)
1.66 (1.02-‐2.68)
2.55 (1.03-‐6.40)
1.62 (0.50-‐4.76)
Odds ratio and 95% CI
Total (913)
True bifurcations (657)
Angle>60-‐70° (217)
SB diameter≥2.75mm (281)
SB lesion>5mm (464)
SB diameter≥2.75mm/lesion>5mm (137)
Equivalence (111)
Favours Simple Favours Complex
1.84 (1.27-‐2.65)
1.91 (1.23-‐2.96)
1.69 (0.78-‐3.65)
2.34 (1.15-‐ 4.77)
1.66 (1.02-‐2.68)
2.55 (1.03-‐6.40)
1.62 (0.50-‐4.76)
1.84 (1.27-‐2.65)
1.91 (1.23-‐2.96)
1.69 (0.78-‐3.65)
2.34 (1.15-‐ 4.77)
1.66 (1.02-‐2.68)
2.55 (1.03-‐6.40)
1.62 (0.50-‐4.76)
Odds ratio and 95% CI
Behan et al Circ Card Intvn 2012
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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.
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Meta-Analysis: NORDIC I & BBC I (Non LM Bifurcations) Probability of MACE (Death/MI/TVR)
Difference in MACE favoring a simple strategy
In the Nordic-BBC meta analysis the average SB stenosis was 59% and 65% for the simple & complex strategy respectively. In many of these trials, up to 25% of patients have no SB disease.
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BBK I study - Clinical outcome 5 year post PCI
Provisional T-Stenting
Systematic T-Stenting p
n=101 n=101
Death (%) 7.9 10.0 0.65 Death and/or MI (%) 9.9 6.9 0.15 Stent thrombosis def./probable (%) 2.0 5.1 0.25 TLR (%) 13.2 16.4 0.56 MACE (%) 17.0 22.9 0.33
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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
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DK Crush Technique Double Kiss and Crush
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1 Year Outcomes DK Crush Versus Provisional Stenting
Table 1. One-Year Outcomes
↓ TLR and TVR ↓ Angiographic restenosis (MB & SB)
Trend toward a ↓ in MACE
Double Kissing Crush
Provisional Stenting
P Value
MACE 10.3% 17.3% 0.070 Cardiac Death 1.1% 1.1% 1.000
MI 3.2% 2.2% 0.751 TVR 6.5% 14.6% 0.017 TLR 4.3% 13.0% 0.005 Definite Stent Thrombosis 2.2% 0.5% 0.372
↓TLR and ↓TVR favoring DK Crush ↓ in MB and SB angiographic restenosis favoring DK Crush Trend toward reduced MACE
DK Crush in non-LM Bifurcation
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DK CRUSH vs Cuolotte in UPLM DK Crush in UPLM PCI
ACC 2013
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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 SKS-Precise 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
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DK Crush
• Showing excellent results for systematic two-stent technique
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NORDIC IV
• What did I learn as it flashed by?
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NORDIC IV
– 1.3% vs 4.6% in favour of the two-stent approach
– Huge difference!
– (p=0.09)
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NORDIC IV
• Difference largely driven by reintervention
• …large side branches cause angina!
• We have found our group at last
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Methods Inclusion criteria • Age≥18 • Stable Angina, UAP, NSTEMI • MV≥3.0mm • SB ≥2.75mm • Bifurcation stenosis involving both MV and SB (≥50%DS by eyeballing)
Exclusion criteria • STEMI • Cardiogenic shock • Other critical illness • Relevant allergies • Cr ≥ 200 µmol/L • SB lesion length >15mm
Nordic-Baltic Bifurcation Study IV
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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
Nordic-Baltic Bifurcation Study IV The Nordic-Baltic PCI Study Group
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PCI in Coronary Bifurcation Lesions The Evidence-Base
SB Stenosis Severity
0
5
10
15
20
NORDIC BBK CACTUS BBC-ONE
CHEN etal
0
20
40
60
80
100
NORDICBBK
CACTUS
BBC-ONE
CHEN et al
SB Lesion Length (mm) SB Lesion Severity (%)
No Data
No QCA
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RCTs of Provisional vs. Elective Stenting “Higher-Risk” Bifurcations
Chen SL, et al. J Am Coll Cardiol 2011;57:914–20.
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Recent Metaanalysis by Gao
EuroIntervention. 2014 Sep 22;10(5):561-9. doi: 10.4244/EIJY14M06_06
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Double vessel stenting is safe
EuroIntervention. 2014 Sep 22;10(5):561-9. doi: 10.4244/EIJY14M06_06
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Medina 1,1,1
Why Does PCI of Coronary Bifurcations Remain a Challenge?
Bifurcation Type Technique
Provisional Stenting
Elective Double Stenting
X Provisional
Stenting
Medina 1,1,1
X
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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
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Simple vs Complex David now is against strong data
DK Crush Nordic IV
David
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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.