Post on 18-Jan-2018
description
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