Hetzel

A Flow-guided Concept To Treat Side Branches In True Bifurcation Lesions: A

Randomized Clinical Study

Hubertus von Korn, Marc-Alexander Ohlow, JiangtaoYu, Burkhard Huegl, Walter

Schulte, Andreas Wagner, Kai Haberl, Bernward LauerClinic for Cardiology,

Neustadt/W Clinic for Cardiology, Bad

BerkaGermany

• Treatment of bifurcation lesions is a complex problem

• Different techniques are commonly used (Y-/T-stenting, „culotte“ technique, „kissing stent“ technique…)

• Long-time data are sparse

Introduction

0

20

40

Stent/stent Stent/PCI

Restenosis @ 6 Mon

P= ns

Colombo et al, Circulation 2004

Bifurcations: stenting the side branch ?

Stenting of the MB with protection of the side branch with a 2. wire keeps the SB open in 91 %

Terkamp et al, ZFK 2002

Bifurcations: protection of the SB using an inserted 2. wire

Stenting of the main branch aftercovering the side branch using a flowguided concept to treat the side branch (PCIonly in case of TIMI flow 0 or 1)

is not inferior to a scheduled final kissing balloon PCI withprovisional stenting for the SB

Study hypothesis

• Primary endpoint: – TLR

• Secondary endpoints:– Restenosis > 50 %– TVR

• MACE:– Death– Myocardial infarction– Stent thrombosis– CABG

Study design I: pre-defined endpoints

• 110 patients enrolled (September 2004 – December 2006)

• PES stents were used (Taxus Liberte) • Mean FU-duration: 6.1 months

Study design II

Inclusion criteria• Stable Angina/silent ischemia• De-novo true bifurcation lesions (vessel

size > 2.25 mm in both branches)Exclusion criteria• NSTEMI/STEMI, cardiogenic shock• Stenosis of the LM• Restenosis/CTO

Inclusion/Exclusion criteria

110 consecutive pts with bifurcations

- Stenting MB (PES) - „Kissing balloon“-PCI- Provisional stenting SB Group A

- Stenting MB (PES)-PCI SB only @ TIMI 0 or 1 Group B (n=54)

Scheduled angio @ 6 months

(n=56)

„Complex strategy“ „Simple strategy“

Study design: flow chart

Complex strategy

Simple strategy

p

Age 66.8 65.1 0.4

Men (%) 71.4 77.8 0.5

Diabetics (%) 25 25.9 0.9

EF (%) 62.4 60.1 0.2

Bifurcation LCA (%)

80.4 81.5 0.9

Basic data

Complex strategy

Simple strategy

p

Direct stenting MB (%)

53.6 75.9 0.01

PCI SB (%) 82.1 16.7 < 0.01

Final kissing balloon-PCI (%)

73.2 13.0 < 0.01

Crossover A <-> B (%)

17.9 16.7 0.9

Final TIMI III SB (%)

94.6 88.9 0.3

Procedural charakteristics

Complex strategy

Simple strategy

p

Final TIMI III MB (%)

100 100 1

Duration X-ray (min)

14.2 7.8 < 0,01

Contrast medium (ml)

209 152 < 0,01

Troponin I after PCI (24 h)

4 2,4 0,6

Procedural charakteristics II

Complex strategy

Simple strategy

p

Re-PCI MB (%) 5.4 5.6 1.0

(Re)-PCI SB (%) 5.4 0 0.09

Stent thrombosis (%) 3.6 3.7 1.0

CABG related to lesion (%)

3.6 5.6 0.6

TLR (sum, %) 17.9 14.8 0.7PCI target vessel, non target lesion (%)

5.4 5.6 1.0

TVR (sum, %) 23.2 20.4 0.7Cardiac death (%) 0 3.7 0.2

ALL MACE (%) 23.2 24.1 0.9

Follow-up data @ 6 months

Complex strategy

Simple strategy

p

Binary restenosis MB (%)

10.7 5.6 0.32

Late lumen loss MB (mm)

0.24 0.29 0.5

Follow-up data: QCA (In-Segment)

• A simple strategy using PES with only provisional SB-PCI according to the TIMI flow of the SB is not inferior to a more complex strategy with mandatory SB-PCI

Conclusions I: treatment of bifurcation lesions

• MACE rates are nearly identical for both strategies

• Comparing the duration of radioscopy + the amount of contrast medium benefits were revealed for the simple strategy

• The more simpler strategy may be the more better strategy…

Conclusions II: treatment of bifurcation lesions

Thank you very

much for

your attention