Nordic-Baltic Bifurcation Study III 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

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

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 In a randomized multicenter setting in coronary bifurcations treated with MV stenting using SES to compare No FKBD FKBD FKBD To assess the effect of these strategies to patient outcomes and angiographic results

Estimate of eligible patients (n= 2385) FKBD (n= 238) Randomized patients (n= 477) No FKBD (n= 239) 6 month clinical FU (n= 238, 100%) 6 month clinical FU (n= 239, 100%) Scheduled angiographic FU after 8 months (n=185) Scheduled angiographic FU after 8 months (n= 189) Angiographic FU available (n=164, 88%) Angiographic FU available (n= 162, 86%) Stratification at randomization

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 ST-segment elevation MI within 24 hours Expected survival< 1 year S-creatinine> 200 µmol/L Allergy to aspirin, clopidogrel, or to sirolimus

1.Wiring of both MV and SB 2.Predilatation of MV/SB at discretion of the operator 3.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 The main treatment principles

- Age, mean+SD ns Male (%) ns Diabetes (%)16 18 ns Smoking (%) ns Hypertension (%) ns Statin Tx (%) ns Family history (%) ns History of PCI (%) ns History of CABG (%) 2 3 ns Baseline demographics +kiss P value Kissing n=238 No FKBD FKBD n=239 n=238 p value

Coronary angiography Visual assessment CrushCulotteP-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 No FKBD p value n=239 FKBD n=238

Reference diameter before procedure on QCA mm ns

CrushCulotteP-value (n=210)(n=215) SB predilatation, (%) Final Kissing (%) SB dilatation thr. MV 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) Fluorosc. time (min) Contrast (ml) Procedure data P value n=210 Culotte n=210 No FKBD p-value n=239 FKBD n=238 *residual stenosis <30% of MV+TIMI III flow in SB

FKBDNo - FKBD % Primary composite end point of MACE (cardiac death, index lesion MI, TLR, stent thrombosis) after 6 months ns

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

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

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) Quantitative Coronary Analysis (QCA) At 8 months

The patient demographics showed no significant differences between the treatment groups the treatment groups Lesion characteristics FKBD (n=164) No-FKBD (n=162) p LAD/diagonal (%) CX/obtuse marginal (%) RCA PDA/PLA (%) ns LM (%) ns True bifurcation (%) ns 1-VD (%) ns 2-VD (%) ns 3-VD (%)

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

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

Restenosis: In-Segment Main Vessel % P= %3.1% Binary Restenosis: 50% diameter stenosis at follow-up

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

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

True Bifurcation Subgroup Analysis

True bifurcation subgroup at 8 month angio FU Medina classification 1,1,1 - 1,0,1 - 0,1,1 In-segment MV 50% DS, n (%) 2 (2.2) 3 (3.8) ns SB 50% DS, n (%) 16 (20) 7 (7.6) No FKBD FKBD n=80 (46.5%)n=92 (53.5%) p value

True bifurcation subgroup MACE and TLR at 6 month clinical FU 1.7% 2.5% 0.8% 1.7% % (n=121) (n=118) P=0.62 P=0.68

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