“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.

JACC: Cardiovascular Interventions, Volume 6, Issue 2, 2013, 139 - 145

Circulation. 2010; 121: 1235-1243

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

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.

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 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

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)

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.

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

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

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

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 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

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

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

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

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

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

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

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

Simple vs Complex David now is against strong data

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.