The Nordic Bifurcation Stent Technique Study

A Randomized trial of CRUSH vs CULOTTE Stenting

Pål Gunnes, Matti Niemela, Kari Kervinen, Andrejs Erglis, Indulis Kumsars, Jens F Lassen, Michael Mæng, Jan SkovJensen, 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

P Gunnes EBC Prague 27.9.08

• 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

The Nordic Bifurcation Stent Technique Study

Participating Centres

DenmarkAarhus University Hospital, Skejby (83 pts)Gentofte University Hospital (44 pts)Odense University Hospital (14 pts)Rigshospitalet, Copenhagen (11 pts)Aalborg University Hospital (3 pts)

LatviaPaul Stradins Hospital, Riga (92 pts)

FinlandOulu University Hospital (87 pts)Helsinki University Hospital (11 pts)Tampere University Hospital (8 pts)Kuopio University Hospital (2 pts)

NorwayFeiring Heart Clinic (50 pts)Tromsø University Hospital (15 pts)St Olav Hospital, Trondheim (4 pts)

Purpose

In a randomized trial to compare– CRUSH– CULOTTEbifurcation stenting techniquesusing sirolimus-eluting stents

Crush-stenting

Crush-stenting Culotte-stenting

• 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 >3.0 mm

• Diameter of side branch by visual estimate >2.5 mm

Inclusion criteria

Randomization(n: 424)

CRUSH(n: 209)

CULOTTE(n: 215)

Clinical Follow up, 6 months (n: 209)

Clinical Follow up, 6 months(n: 215)

Scheduled Angiographic Follow up, 8 months

(n: 184)

Scheduled Angiographic Follow up, 8 months

(n:189)

Angiographic FU available(n: 160)

Angiographic FU available(n: 164)

n: 424 (100%)

n: 424 (100%)

n: 373 (88%)

n: 324 (87%)

Stratification at randomization

CRUSH CULOTTE p-value(n=160) (n=164)

Age (yrs) 65 64 nsMale sex (%) 76 75 nsDiabetes (%) 14 15 nsSmoker (%) 23 31 nsHypertension (%) 63 64 nsStatin tx (%) 84 73 0.02Family history (%) 54 62 ns History of PCI (%) 46 35 0.05History of CABG (%) 3 6 ns

Baseline demographics

Ejection fraction – Diseased Vessels

Crush n = 160

Culotten = 164 p-value

EF (%), mean±SD 57.4 ± 11 58.3 ± 11 ns

1-VD (%) 34 35 ns

2-VD (%) 44 44 ns

3-VD (%) 23 22 ns

Patients with true bifurcation lesion

Medina classification1,1,1 - 1,0,1 - 0,1,1

CRUSH CULOTTE p-value(n=160) (n=164)

True bifurcation 125 (78%) 140 (85%) ns

Vessels treated

LADCxRCALM62% 68%

19%

16%

8%5%11% 10%

CRUSH(n=160)

CULOTTE(n=164)

ns

CRUSH CULOTTE p-value(n=160) (n=164)

MV stented (%) 100.0 99.4 nsSB stented (%) 99.4 97.0 nsKissing balloon (%) 88.8 93.9 ns

Tx successful* (%) 98.8 100.0 ns

* (Residual stenosis <30% of MV + TIMI flow III in SB)

Procedural data

Individual endpoints after 6 months

Crushn = 210

Culotten = 215

P Value

Non-cardiac death, % 0.0 0.5 nsCardiac death, % 1.0 0.0 nsMyocard. infarc., % 0.5 0.9 nsTVR, % 3.3 3.3 ns

Stent thrombosis, % 1.9 1.4 ns

Angiographic end points

• In-lesion >50% stenosis of the entire bifurcation• In-stent >50% stenosis of the entire bifurcation• In lesion >50% stenosis of MV• In lesion >50% stenosis of SB• Late loss of MV and SB

Angiographic follow-up after 8 months

MV prox

MV dist

SB

Complete angiographic evaluation in 324 (87%) patients

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

0

2

4

6

8

10

12

14

CRUSH CULOTTE

p=0.10

Rate of main vessel and/or side branchin-lesion diameter stenosis >50%

at 8 months follow-up%

12.1

6.6

0

2

4

6

8

10

12

14

CRUSH CULOTTE

p=0.046

Rate of main vessel and/or side branchin-stent diameter stenosis >50%

at 8 months follow-up%

10.5

4.5

0

2

4

6

8

10

12

14

CRUSH CULOTTE

p=0.19

Rate of main vesselin-lesion diameter stenosis >50%

at 8 months follow-up%

4.7

2.0

0

2

4

6

8

10

12

14

CRUSH CULOTTE

p=0.10

Rate of side branchin-lesion diameter stenosis >50%

at 8 months follow-up%

9.2

4.5

Localization of in-stent restenosisat 8 months follow-up

CRUSH CULOTTE

0.0% 0.0%

2.0% 0.6%9.8%*

3.8%*

* p=0.04

In-stent late lumen loss (mm)

0,000,050,100,150,200,25

Proximal MV segment

Distal MV segment

Side branch

CRUSHCULOTTE

ns ns ns

mm

Conclusions (1)Conclusions (1)

• Both crush and culotte stent techniques using sirolimus-eluting stents in bifurcation lesions were performed with high and similar success rates

• There was a low and similar incidence of cardiac death, TVR and stentthrombosis in the two treatment groups

Conclusions (2)

• 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

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

Quantitative coronary angiography (QCA)

CRUSH CULOTTE

2.0%0.0%

0.7% 1.3%

2.0% 1.3%

Localization of edge restenosisat 8 months follow-up

00,5

11,5

22,5

33,5

44,5

MV prox MV dist SB

CRUSH beforeCULOTTE before

Reference diameter (mm)before procedure

mm

nsnsns

None of the authors had disclosures withregard to the present study