Eight Months Angiographic Follow-up in Patients Randomized to Crush or Culotte Stenting of Coronary Artery Bifurcation Lesions The Nordic Bifurcation Stent Technique Study

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Eight Months Angiographic Follow-upin Patients
Randomized to Crush or Culotte Stenting of
Coronary Artery Bifurcation LesionsThe Nordic
Bifurcation Stent Technique Study

• Pål Gunnes, Matti Niemela, Kari Kervinen, Andrejs
  Erglis, Indulis Kumsars, Jens F Lassen, Michael
  Mæng, Jan Skov Jensen, Anders Galløe, Terje
  Steigen, Jan Ravkilde, Timo Makikallio, Kari
  Ylitalo, Inga Narbute, Evald Christiansen, Lars
  Krusell, Sindre Stavnes, Ulrik Abildgaard, Peter
  Riis Hansen, Jan Mannsverk, Thor Trovik, Per
  Thayssen, Steffen Helqvist, Saila Vikman, Rune
  Wiseth, Jens Aarøe, Leif Thuesen
• For the Nordic-Baltic PCI Study Group

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• None of the authors had disclosures with regard
  to the present study

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The Nordic Bifurcation Stent Technique Study

• Nordic-Baltic PCI Study Group independent
  working group of interventional cardiologists in
  the Nordic and Baltic countries
• The Cypher Select stents used in this study were
  purchased at market price
• An unrestricted grant of 625 was donated by
  Cordis J?J to the participating hospitals per
  randomized patient

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Participating Centres

• Finland
• Oulu University Hospital (87 pts)
• Helsinki University Hospital (11 pts)
• Tampere University Hospital (8 pts)
• Kuopio University Hospital (2 pts)
• Norway
• Feiring Heart Clinic (50 pts)
• Tromsø University Hospital (15 pts)
• St Olav Hospital, Trondheim (4 pts)

• Denmark
• Aarhus University Hospital, Skejby (83 pts)
• Gentofte University Hospital (44 pts)
• Odense University Hospital (14 pts)
• Rigshospitalet, Copenhagen (11 pts)
• Aalborg University Hospital (3 pts)
• Latvia
• Paul Stradins Hospital, Riga (92 pts)

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Purpose

• In a randomized trial to compare
• CRUSH
• CULOTTE
• bifurcation stenting techniques
• using sirolimus-eluting stents

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Crush-stenting
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Crush-stenting
Culotte-stenting
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Inclusion criteria

• Stable or unstable AP or silent ischemia
• Bifurcation lesion of LAD/diagonal, Cx/obtuse
  marginal, RCA-PDA/posterolateral branch or
  LM/Cx/LAD in a right dominant system
• Diameter of main vessel by visual estimate gt3.0
  mm
• Diameter of side branch by visual estimate gt2.5 mm

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Randomization (n 424)
CULOTTE (n 215)
CRUSH (n 209)
n 424 (100)
Clinical Follow up, 6 months (n 215)
Clinical Follow up, 6 months (n 209)
n 424 (100)
Stratification at randomization
Scheduled Angiographic Follow up, 8 months (n189)
Scheduled Angiographic Follow up, 8 months (n
184)
n 373 (88)
Angiographic FU available (n 160)
Angiographic FU available (n 164)
n 324 (87)
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(No Transcript)
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Randomization (n 424)
CULOTTE (n 215)
CRUSH (n 209)
n 424 (100)
Clinical Follow up, 6 months (n 215)
Clinical Follow up, 6 months (n 209)
n 424 (100)
Stratification at randomization
Scheduled Angiographic Follow up, 8 months (n189)
Scheduled Angiographic Follow up, 8 months (n
184)
n 373 (88)
Angiographic FU available (n 160)
Angiographic FU available (n 164)
n 324 (87)
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Angiographic end points

• In-lesion gt50 stenosis of the entire bifurcation
• In-stent gt50 stenosis of the entire bifurcation
• In lesion gt50 stenosis of MV
• In lesion gt50 stenosis of SB
• Late loss of MV and SB

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Baseline demographics

• CRUSH CULOTTE p-value
• (n160) (n164)
• Age (yrs) 65 64 ns
• Male sex () 76 75 ns
• Diabetes () 14 15 ns
• Smoker () 23 31 ns
• Hypertension () 63 64 ns
• Statin tx () 84 73 0.02
• Family history () 54 62 ns
• History of PCI () 46 35 0.05
• History of CABG () 3 6 ns

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Vessels treated
CRUSH (n160)
CULOTTE (n164)
10
11
5
8
16
19
62
68
ns
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Procedural data

• CRUSH CULOTTE p-value
• (n160) (n164)
• MV stented () 100.0 99.4 ns
• SB stented () 99.4 97.0 ns
• Kissing balloon () 88.8 93.9 ns
• Tx successful () 98.8 100.0 ns
• (Residual stenosis lt30 of MV TIMI flow III
  in SB)

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Ejection fraction Diseased Vessels
Crush n 160 Culotte n 164 p-value
EF (), meanSD 57.4 11 58.3 11 ns
1-VD () 34 35 ns
2-VD () 44 44 ns
3-VD () 23 22 ns

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Patients with true bifurcation lesion
Medina classification 1,1,1 - 1,0,1 - 0,1,1
CRUSH CULOTTE p-value (n160) (n164) True
bifurcation 125 (78) 140 (85) ns
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Quantitative coronary angiography (QCA)

• Computer-based system dedicated to bifurcation
• analysis (Qangio XA version 7.0, Medis, Leiden,
• The Netherlands)
• Angiographic core labs
• Aarhus University Hospital, Skejby, Denmark
• Paul Stradins Clinical Hospital, Riga, Latvia

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Angiographic follow-up after 8 months
Complete angiographic evaluation in 324 (87)
patients
MV prox
SB

• QCA measurements in
• Proximal main vessel
• Distal main vessel
• Side branch
• Edge (5 mm)

MV dist
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Reference diameter (mm)before procedure
mm
ns
ns
ns
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Rate of main vessel and/or side branch in-lesion
diameter stenosis gt50 at 8 months follow-up

12.1
p0.10
6.6
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Rate of main vessel and/or side branch in-stent
diameter stenosis gt50 at 8 months follow-up

10.5
p0.046
4.5
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Rate of main vessel in-lesion diameter stenosis
gt50 at 8 months follow-up

p0.19
4.7
2.0
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Rate of side branch in-lesion diameter stenosis
gt50 at 8 months follow-up

p0.10
9.2
4.5
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Localization of in-stent restenosisat 8 months
follow-up
CRUSH
CULOTTE
0.0
0.0
3.8
9.8
0.6
2.0
p0.04
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Localization of edge restenosisat 8 months
follow-up
CHRUSH
CULOTTE
0.0
2.0
2.0
1.3
1.3
0.7
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In-stent late lumen loss (mm)
mm
ns
ns
ns
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Conclusion

• CRUSH and CULOTTE bifurcation stenting using
  sirolimus eluting stents were associated with low
  rates of restenosis at eight months angiographic
  follow-up
• The few restenoses were primarily located in side
  branches treated with the CRUSH technique
• The CULOTTE bifurcation stenting technique was
  associated with a single digit restenosis rate
  and may be preferred in suitable bifurcation
  anatomies
• Extended follow-up needed to evaluate the safety
  of the investigated two-stent bifurcation
  techniques