1. Eight Months Angiographic Follow-up in 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

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

3. 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 J  J to the participating hospitals per randomized patient The Nordic Bifurcation Stent Technique Study

4. Participating Centres Denmark Aarhus University Hospital, Skejby (83 pts) Gentofte University Hospital(44 pts) Odense University Hospital(14 pts) Rigshospitalet, Copenhagen(11 pts) Aalborg University Hospital(3 pts) Latvia Paul Stradins Hospital, Riga(92 pts) Finland Oulu University Hospital(87 pts) Helsinki University Hospital(11 pts) Tampere University Hospital(8 pts) Kuopio University Hospital(2 pts) Norway Feiring Heart Clinic(50 pts) Tromsø University Hospital(15 pts) St Olav Hospital, Trondheim(4 pts)

5. Purpose In a randomized trial to compare – CRUSH – CULOTTE bifurcation stenting techniques using sirolimus-eluting stents

6. Crush-stenting

7. Culotte-stenting

8. 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

9. 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: 373 (88%) n: 324 (87%) Stratification at randomization

11. 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: 373 (88%) n: 324 (87%) Stratification at randomization

12. 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

13. CRUSH CULOTTE p-value (n=160) (n=164) Age (yrs)6564ns Male sex (%)7675ns Diabetes (%)1415ns Smoker (%)2331ns Hypertension (%)6364ns Statin tx (%)8473 0.02 Family history (%)5462ns History of PCI (%)46350.05 History of CABG (%)36ns Baseline demographics

14. Vessels treated 62% 68% 19% 16% 8% 5% 11% 10% CRUSH (n=160) CULOTTE (n=164) ns

15. CRUSHCULOTTE p-value (n=160)(n=164) MV stented (%) 100.0 99.4 ns SB stented (%)99.4 97.0 ns Kissing balloon (%)88.8 93.9 ns Tx successful* (%)98.8100.0 ns * (Residual stenosis <30% of MV + TIMI flow III in SB) Procedural data

16. Ejection fraction – Diseased Vessels Crush n = 160 Culotte n = 164 p-value EF (%), mean±SD 57.4 ± 1158.3 ± 11ns 1-VD (%) 3435ns 2-VD (%) 44 ns 3-VD (%) 2322ns

17. Patients with true bifurcation lesion Medina classification 1,1,1 - 1,0,1 - 0,1,1 CRUSHCULOTTEp-value (n=160)(n=164) True bifurcation 125 (78%)140 (85%) ns

18. 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)

19. 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)

20. Reference diameter (mm) before procedure mm ns

21. p=0.10 Rate of main vessel and/or side branch in-lesion diameter stenosis >50% at 8 months follow-up % 12.1 6.6

22. p=0.046 Rate of main vessel and/or side branch in-stent diameter stenosis >50% at 8 months follow-up % 10.5 4.5

23. p=0.19 Rate of main vessel in-lesion diameter stenosis >50% at 8 months follow-up % 4.7 2.0

24. p=0.10 Rate of side branch in-lesion diameter stenosis >50% at 8 months follow-up % 9.2 4.5

25. Localization of in-stent restenosis at 8 months follow-up CRUSH CULOTTE 0.0% 2.0% 0.6% 9.8%* 3.8%* * p=0.04

26. CHRUSH CULOTTE 2.0% 0.0% 0.7% 1.3% 2.0% 1.3% Localization of edge restenosis at 8 months follow-up

27. In-stent late lumen loss (mm) ns mm

28. 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