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

Eight Months Angiographic Follow-upin Patients Randomized to Crush or Culotte Stenting

of Coronary Artery Bifurcation Lesions

The 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

• 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 JJ 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

– CULOTTE

bifurcation stenting techniques

using 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

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

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

Vessels treated

LAD

Cx

RCA

LM62% 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

Ejection fraction – Diseased Vessels

Crush n = 160

Culotte n = 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 classification

1,1,1 - 1,0,1 - 0,1,1

CRUSH CULOTTE p-value

(n=160) (n=164)

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

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)

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

0,5

1

1,5

2

2,5

3

3,5

4

4,5

MV prox MV dist SB

CRUSH beforeCULOTTE before

Reference diameter (mm)before procedure

mm

nsns

ns

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%


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%


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%


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

CHRUSH CULOTTE

2.0%0.0%

0.7% 1.3%

2.0% 1.3%

Localization of edge restenosisat 8 months follow-up

In-stent late lumen loss (mm)

0,00

0,05

0,10

0,15

0,20

0,25

Proximal MV segment

Distal MV segment

Side branch

CRUSH

CULOTTE

ns ns ns

mm

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

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

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