Nordic-Baltic Bifurcation Study III
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Nordic-Baltic Bifurcation Study III Randomized Comparison of Final Kissing Balloon Dilatation vs. no Final Kissing Balloon Dilatation in Patients with Coronary Bifurcation Lesions Treated With Main Vessel stenting.

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Nordic-Baltic Bifurcation Study IIIRandomized Comparison of Final Kissing Balloon Dilatation vs. no Final Kissing Balloon Dilatation in Patients with Coronary Bifurcation Lesions Treated With Main Vessel stenting

MattiNiemela, Kari Kervinen, AndrejsErglis,Niels R. Holm, Michael Maeng, Evald H Christiansen, IndulisKumsars, Sandra Jegere, AndisDombrovskis, PålGunnes, SindreStavnes,TerjeSteigen,ThorTrovik, SailaVikman,MarkkuEskola, HannuRomppanen,TimoMakikallio, Knud N Hansen, Per Thayssen, Lars Åberge,Lisette Jensen, Anders Hervold, J Airaksinen, MikkoPietila, Ole Frobert, Thomas Kellerth, Jan Ravkilde,Jens Aarøe,SteffenHelqvist, IwarSjögren, Stefan James,HeikkiMiettinen, Jens F Lassen, Leif Thuesen

For the Nordic-Baltic PCI Study Group


Nordic baltic bifurcation study iii participating centers
Nordic-Baltic Bifurcation Study IIIParticipating Centers

Denmark

AarhusUniversityHospital

Odense UniversityHospital

AalborgUniversityHospital

RigshospitaletCopenhagen

Latvia

Paul StradinsHospital, Riga

Sweden

Örebro Hospital

Uppsala UniversityHospital

Falun Hospital

Finland

Oulu UniversityHospital

Tampere UniversityHospital

Turku UniversityHospital

Kajaani Central Hospital

Rovaniemi Central Hospital

Kemi Central Hospital

Kuopio UniversityHospital

Norway

FeiringHeartClinic

Tromsø University Hospital

Rikshopsitalet


Background
Background

The provisional SB stenting strategy has emerged the preferred bifurcation treatment strategy

Whether routine Final Kissing Balloon Dilatation (FKBD) after MV stenting improves clinical and angiographic outcome is less well known


Purpose of the nordic iii study
Purpose of the NORDIC III study

In a randomized multicenter setting in coronary bifurcations treated with MV stenting using SES to compare

No FKBD

FKBD

  • To assess the effect of these strategies to patient outcomes

  • and angiographic results


Estimate of eligible patients

(n= 2385)

Randomized patients

(n= 477)

No FKBD

(n= 239)

FKBD

(n= 238)

6 month clinical FU

(n= 239, 100%)

6 month clinical FU

(n= 238, 100%)

Stratification at randomization

Scheduled

angiographic FU

after 8 months (n= 189)

Scheduled

angiographic FU

after 8 months (n=185)

Angiographic FU

available

(n= 162, 86%)

Angiographic FU

available

(n=164, 88%)


Inclusion criteria
Inclusion criteria

Indication

Stable angina pectoris

Unstable angina pectoris

Silent ischaemia

Lesion location

LAD/diagonal

CX/obtuse marginal

RCA PDA/postero-lateral branch

LM/LAD/CX

Vesselsize

main vessel diameter ≥ 2.50mm

side branch diameter ≥ 2.25 mm


Exclusion criteria
Exclusion criteria

ST-segment elevation MI within 24 hours

Expected survival< 1 year

S-creatinine> 200 µmol/L

Allergy to aspirin, clopidogrel, or to sirolimus


The main treatment principles
The main treatment principles

  • Wiring of both MV and SB

  • Predilatation of MV/SB at discretion of the operator

  • Stenting MV, jailing SB wire

  • If TIMI flow 3 in MV and SB → Randomization

  • No-FKBD group: procedure terminated

  • FKBD group:

    • 4. rewiring of jailed SB

    • 5. FKBD

    • - if SB TIMI flow<3 → SB stenting


Baseline demographics

-

Age, mean+SD 64+10 65+10 ns

Male (%) 72.4 73.1 ns

Diabetes (%) 16 18 ns

Smoking (%) 23 20 ns

Hypertension (%) 66 61 ns

Statin Tx (%) 84 83 ns

Family history (%) 61 56 ns

History of PCI (%) 31 24 ns

History of CABG (%) 2 3 ns

Baseline demographics

p value

No FKBD

FKBD

n=239

n=238

+kiss

Kissing

P value

n=238


Coronary angiography visual assessment
Coronary angiographyVisual assessment

p value

No FKBD

FKBD

Crush Culotte P-value

(n=210) (n=215)

MV lesion length (mm) 17.7 + 10.2 17.3 + 8.6 ns

MV stent length (mm) 22.9 + 10.5 23.6 + 11.1 ns

SB lesion length (mm) 3.6 + 4.2 3.4 + 3.9 ns

Prx. MV ref. diam. (mm) 3.4 + 0.4 3.4 + 0.6 ns

Dis. MV ref. diam. (mm) 3.2 + 0.3 3.2 + 0.4 ns

SB ref. diam. (mm) 2.7 + 0.4 2.6 + 0.3 ns

n=239

n=238



Procedure data

Crush Culotte P-value

(n=210) (n=215)

SB predilatation, (%) 27.6 29.0 0.76

Final Kissing (%) 0.8 97.1 0.0001

SB dilatation thr. MV 1.7 97.1 0.0001

stent or FKBD

SB stented, n (%) 0(0) 3 (1.3) 0.12

Tr. successful*, n (%) 236( 98,7) 236 (99.2) ns

Procedure time (min) 47 + 22 61 + 28 0.0001

Fluorosc. time (min) 11 + 10 16 + 12 0.0001

Contrast (ml) 200 + 92 235 + 97 0.0001

Procedure data

P value

Culotte

No FKBD

FKBD

p-value

n=210

n=210

n=238

n=239

*residual stenosis <30% of MV+TIMI III flow in SB


Primary composite end point of

MACE (cardiac death, index lesion MI, TLR, stent thrombosis)

after 6 months

%

2.5

2.1

ns

FKBD

No - FKBD


CCS angina class > 2 before treatment

and at 6-month follow up

ns



Quantitative Coronary Analysis (QCA) procedure

Joint angiographic core lab:

  • -Aarhus University Hospital, Skejby, Denmark

  • - Paul StradinsClinical Hospital, Riga, Latvia

    Analysed by computer-based software dedicated to bifurcation

    analysis (QAngio XA version 7.2, Medis, Leiden,

    The Netherlands)

At 8 months


The patient demographics showed no significant differences between

the treatment groups

Lesion characteristics


Procedure data1

Crush Culotte P-value between

(n=210) (n=215)

SB predilated (%) 31.3 35 ns

FKBD (%) 0.8 97.1 0.0001

SB stented (%) 0.0 0.6 ns

Tr. successful* (%) 98.8 99.4 ns

Procedure data

P value

Culotte

No FKBD

FKBD

p-value

n=210

n=210

n=164

n=162

*residual stenosis <30% of MV+TIMI III flow in SB


(Re)stenosis at 8-months QCA: Entire bifurcation lesion between

%

p=0.11

17.3%

11.0%

Binary Restenosis: ≥50% diameter stenosis at follow-up


Restenosis: In-Segment Main Vessel between

%

P=0.68

3.1%

2.5%

Binary Restenosis: ≥50% diameter stenosis at follow-up


(Re)stenosis: Ostial Side Branch between

%

p=0.039

15.4%

7.9%

Binary Restenosis: ≥50% diameter stenosis at follow-up


Late Lumen Loss between

mm

p=0.42

p=0.23

p=0.34

P=0.42

P=0.23

P=0.52



True bifurcation subgroup at 8 month angio fu
True bifurcation subgroup at 8 month angio FU between

Medina classification

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

No FKBD

FKBD

p value

In-segment MV ≥50% DS, n (%) 2 (2.2) 3 (3.8) ns

SB ≥50% DS, n (%) 16 (20) 7 (7.6) 0.024

n=80 (46.5%)

n=92 (53.5%)


True bifurcation subgroup mace and tlr at 6 month clinical fu
True bifurcation subgroup betweenMACE and TLR at 6 month clinical FU

%

P=0.68

2.5%

P=0.62

1.7%

1.7%

(n=121)

(n=118)

0.8%


Conclusion
Conclusion between

In coronary bifurcation lesions MV stenting with and without FKBD was associated with similar 6-month clinical outcome

The simple no-FKBD strategy was associated to shorter procedure and fluoroscopy time and reduced use of contrast media

FKBD reduced angiographic SB (re)stenosis especially in patients with true bifurcation lesion, which was not, however, translated into the clinical outcome


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