1. For the Nordic-Baltic PCI Study Group
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
Matti Niemela, Kari Kervinen, Andrejs Erglis,Niels R. Holm, Michael Maeng, Evald H Christiansen, Indulis Kumsars, Sandra Jegere, Andis Dombrovskis, Pål Gunnes, Sindre Stavnes,TerjeS teigen,Thor Trovik, Saila Vikman,Markku Eskola, Hannu Romppanen,Timo Makikallio, Knud N Hansen, Per Thayssen, Lars Åberge,Lisette Jensen, Anders Hervold, J Airaksinen, Mikko Pietila, Ole Frobert, Thomas Kellerth, Jan Ravkilde,Jens Aarøe,Steffen Helqvist, Iwar Sjögren, Stefan James,Heikki Miettinen, Jens F Lassen, Leif Thuesen
For the Nordic-Baltic PCI Study Group
Andis Dombrovskis. 1

2. Nordic-Baltic Bifurcation Study III Participating 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

3. 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 3

4. 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

5. Stratification at randomization
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%)

6. Inclusion criteria Indication Lesion location Vesselsize
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

7. 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

8. 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

9. Baseline demographics
No FKBD
FKBD
p value
n=239
n=238
Kissing
+kiss
P value
n=238 -
Age, mean+SD ns
Male (%) ns
Diabetes (%) ns
Smoking (%) ns
Hypertension (%) ns
Statin Tx (%) ns
Family history (%) ns
History of PCI (%) ns
History of CABG (%) ns

10. Coronary angiography Visual assessment
No FKBD
FKBD
p value
Crush Culotte P-value
(n=210) (n=215)
MV lesion length (mm) ns
MV stent length (mm) ns
SB lesion length (mm) ns
Prx. MV ref. diam. (mm) ns
Dis. MV ref. diam. (mm) ns
SB ref. diam. (mm) ns
n=239
n=238

11. Reference diameter before procedure on QCAmm ns ns ns

12. Procedure data No FKBD FKBD p-value n=210 n=210 n=239 n=238 Culotte
Crush Culotte P-value
(n=210) (n=215)
SB predilatation, (%)
Final Kissing (%)
SB dilatation thr. MV
stent or FKBD
SB stented, n (%) 0(0) (1.3)
Tr. successful*, n (%) ( 98,7) (99.2) ns
Procedure time (min)
Fluorosc. time (min)
Contrast (ml)
*residual stenosis <30% of MV+TIMI III flow in SB

13. Primary composite end point of
MACE (cardiac death, index lesion MI, TLR, stent thrombosis)
after 6 months %
2.5
2.1 ns
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FKBD
No - FKBD 13 13

14. CCS angina class > 2 before treatment
and at 6-month follow up ns

15. Quantitative Coronary Analysis (QCA) at 8 month after PCI procedure

16. Quantitative Coronary Analysis (QCA)
At 8 months
Joint angiographic core lab:
- Aarhus University Hospital, Skejby, Denmark
- Paul Stradins Clinical Hospital, Riga, Latvia
Analysed by computer-based software dedicated to bifurcation
analysis (QAngio XA version 7.2, Medis, Leiden,
The Netherlands)

17. Lesion characteristics
The patient demographics showed no significant differences between
the treatment groups
Lesion characteristics
FKBD
(n=164)
No-FKBD (n=162) p
LAD/diagonal (%)
76.1
66.3
0.033
CX/obtuse marginal (%)
11.0
19.8
0.021
RCA PDA/PLA (%)
3.1
5.3 ns
LM (%)
9.8
8.6
”True” bifurcation (%)
53.5
46.5
1-VD (%)
50.9
43.6
2-VD (%)
36.8
38.7
3-VD (%)
17.8
0.057

18. Procedure data No FKBD FKBD p-value SB predilated (%) 31.3 35 ns
Culotte
P value
No FKBD
FKBD
p-value
Crush Culotte P-value
(n=210) (n=215)
SB predilated (%) ns
FKBD (%)
SB stented (%) ns
Tr. successful* (%) ns
n=210
n=210
n=162
n=164
*residual stenosis <30% of MV+TIMI III flow in SB

19. (Re)stenosis at 8-months QCA: Entire bifurcation lesion%
p=0.11
17.3%
11.0%
Binary Restenosis: ≥50% diameter stenosis at follow-up

20. Restenosis: In-Segment Main Vessel%
P=0.68
3.1%
2.5%
Binary Restenosis: ≥50% diameter stenosis at follow-up

21. Binary Restenosis: ≥50% diameter stenosis at follow-up
(Re)stenosis: Ostial Side Branch %
p=0.039
15.4%
7.9%
Binary Restenosis: ≥50% diameter stenosis at follow-up

22. Late Lumen Loss mm
p=0.42
p=0.23
p=0.34
P=0.42
P=0.23
P=0.52

23. True Bifurcation Subgroup Analysis

24. True bifurcation subgroup at 8 month angio FU
Medina classification
1,1,1 - 1,0,1 - 0,1,1
No FKBD
FKBD
p value
In-segment MV ≥50% DS, n (%) (2.2) (3.8) ns
SB ≥50% DS, n (%) (20) 7 (7.6)
n=80 (46.5%)
n=92 (53.5%)

25. True bifurcation subgroup MACE 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%

26. Conclusion
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