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For the Nordic -Baltic PCI Study Group

Randomized Comparison of Provisional Side Branch Stenting versus a Two-stent Strategy for treatment of True Coronary Bifurcation Lesions Involving a Large Side Branch. The Nordic-Baltic Bifurcation Study IV.

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For the Nordic -Baltic PCI Study Group

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  1. Randomized Comparison of Provisional Side Branch Stentingversus a Two-stent Strategy for treatment of True Coronary Bifurcation Lesions Involving a Large Side Branch. The Nordic-Baltic Bifurcation Study IV IndulisKumsars, MattiNiemelä, AndrejsErglis, Kari Kervinen, Evald H. Christiansen, Michael Maeng, AndisDombrovskis, VytautasAbraitis, AleksandrasKibarskis, Terje K. Steigen, Thor Trovik, GustavsLatkovskis, Dace Sondore, Inga Narbute, Christian Juhl Terkelsen, Markku Eskola, Hannu Romppanen, Per Thayssen, Anne Kaltoft,Tuija Vasankari, PålGunnes, Ole Frobert, Fredrik Calais, Juha Hartikainen, SvendEggertJensen, Thomas Engstrøm, Niels R. Holm, Jens F. Lassenand Leif Thuesen For the Nordic-Baltic PCI Study Group

  2. Disclosure Statement of Financial Interest I, Indulis Kumsars, DO NOT have a financial interest/arrangement or affiliation with one or more organizations that could be perceived as a real or apparent conflict of interest in the context of the subject of this presentation. The Nordic-Baltic Bifurcation IV Study was an academic study primarily funded by participating hospitals. Theparticipatinginstitutionsreceived unrestricted study grants form Cordis and Abbot.

  3. Nordic-Baltic Bifurcation Study IVParticipating Centers Denmark Aarhus University Hospital (112 pts) Aalborg University Hospital (13 pts) Odense University Hospital (10 pts) Rigshospitalet Copenhagen (3 pts) Latvia P.Stradins University Hospital, Riga (159 pts) Sweden Örebro Hospital (11 pts) Linköping (3 pts) Karolinska University Hospital (1 pts) The Nordic-Baltic PCI Study Group Finland Oulu University Hospital (75 pts) Tampere University Hospital (8 pts) Turku University Hospital (6 pts) Kuopio University Hospital (2 pt) Norway Tromsø University Hospital (18pts) ArendalHospital (3 pts) Feiring Heart Clinic (2 pts) Lithuania VilniusUniversityHospital (21 pts)

  4. The Nordic-Baltic PCI Study Group Nordic-BalticBifurcationStudy IV Background • Provisional (simple) stenting is the preferred strategy in treatment of most bifurcation lesions • It is unknown if this also applies to truebifurcation lesionsinvolving a large sidebranch

  5. The Nordic-Baltic PCI Study Group Nordic-BalticBifurcationStudy IV Aim • To compare provisional stenting and two-stent techniques for the treatment of true coronary bifurcation lesions involving a large side branch

  6. The Nordic-Baltic PCI Study Group Nordic-BalticBifurcationStudy IV Hypothesis • Two stent techniques are superior to provisional stenting in treatment of true coronary bifurcation lesions involving a large side branch

  7. The Nordic-Baltic PCI Study Group Nordic-BalticBifurcationStudy IV Methods • Open label, randomized, multicenter trial • 1:1 randomization • Clinical FU at 0, 1 and 6 months • Angiographicsubstudy with 8 months FU • Studystents: • SirolimuselutingCordisCypherSelect+ (first 225 patients) • Everolimuseluting Abbott Xience V (last 225 patients)

  8. Nordic-BalticBifurcationStudy IV Primary endpoint Combined endpoint after 6 months: • cardiac death • non-index procedure related myocardial infarction • TLR • definite stent thrombosis

  9. Nordic-BalticBifurcationStudy IV Secondary endpoints • Individual endpoints of: • Total death • Cardiac death • Non-indexprocedurerelated MI • Target lesion revascularization (TLR) • Target vessel revascularization (TVR) • Definite stent thrombosis • Procedure related myocardialinfarction • 8-month angiographic follow-up results

  10. Nordic-BalticBifurcationStudy IV Methods Inclusioncriteria • Age≥18 • Stable Angina, UAP, NSTEMI • MV≥3.0mm • SB ≥2.75mm • Bifurcation stenosis involvingboth MV and SB (≥50%DS by eyeballing) Exclusioncriteria • STEMI • Cardiogenicshock • Othercriticalillness • Relevant allergies • Cr≥ 200 µmol/L • SB lesionlength >15mm

  11. Nordic-BalticBifurcationStudy IV Implantation techniques Provisional SB stenting • Two wires • Predilatation • MV stenting • If TIMI flow<III or >75%DS in ostial SB: kissingballoondilatation • If SB TIMI flow <III after kissing balloon dilatation, SB stenting using a T- or Culotte technique

  12. The Nordic-Baltic PCI Study Group Nordic-BalticBifurcationStudy IV Implantation techniques Two-stent techniques • Two wires • Predilatation of segments to be stented • Culotte stenting recommended • T-stenting and mini-crushallowed • Final kissingballoon dilatation

  13. The Nordic-Baltic PCI Study Group Nordic-BalticBifurcationStudy IV Patient flowchart Nordic Baltic Bifurcation study IV n=450 Provisional SB stening n=221* Two stent n=229* 1 lost to FU 1 excluded due to protocolviolation 1 withdrawal Provisional Completed 6M FU n=220 Two stent Completed 6M FU n=227 *numbers not balanced due to block randomization and sites with less than 4 inclusions

  14. The Nordic-Baltic PCI Study Group Nordic-BalticBifurcationStudy IV Baseline clinicalcharacteristics

  15. The Nordic-Baltic PCI Study Group Nordic-BalticBifurcationStudy IV Lesion characteristics *visual estimation

  16. The Nordic-Baltic PCI Study Group Nordic-BalticBifurcationStudy IV Procedural data * (Residual stenosis <30% of MV + TIMI flow III in SB)

  17. The Nordic-Baltic PCI Study Group Nordic-BalticBifurcationStudy IV Procedural data * Residual stenosis <30% of MV + TIMI flow III in SB ** Assessment possible in 327 patients

  18. The Nordic-Baltic PCI Study Group Nordic-BalticBifurcationStudy IV Eventfree survival curve at 6months 1.8% 4.6% p=0.09

  19. The Nordic-Baltic PCI Study Group Nordic-BalticBifurcationStudy IV Individual endpointsat 6months

  20. The Nordic-Baltic PCI Study Group Nordic-BalticBifurcationStudy IV Conclusion • After 6 months, two-stent techniques for treatment of true bifurcation lesions with a large side branch showed no significant difference in MACE ratecompared toprovisional side branch stenting • Longer and more complex procedures in the two-stent group did not translate into more procedural myocardial infarctions • Recommendations on optimal strategy for this lesion subset should await longer term follow-up

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