The Nordic Bifurcation Stent Technique Study. A Randomized trial of CRUSH vs CULOTTE Stenting

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1 The Nordic Bifurcation Stent Technique Study A Randomized trial of CRUSH vs CULOTTE Stenting 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 P Gunnes EBC Prague

2 The Nordic Bifurcation Stent Technique Study 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

3 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)

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

5 Crush-stenting

6 Crush-stenting Culotte-stenting

7 Inclusion criteria 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

8 Randomization (n: 424) CRUSH (n: 209) n: 424 (100%) CULOTTE (n: 215) Clinical Follow up, 6 months (n: 209) n: 424 (100%) Clinical Follow up, 6 months (n: 215) Stratification at randomization Scheduled Angiographic Follow up, 8 months (n: 184) n: 373 (88%) Scheduled Angiographic Follow up, 8 months (n:189) Angiographic FU available (n: 160) n: 324 (87%) Angiographic FU available (n: 164)

9 Baseline demographics CRUSH CULOTTE p-value (n=160) (n=164) Age (yrs) ns Male sex (%) ns Diabetes (%) ns Smoker (%) ns Hypertension (%) ns Statin tx (%) Family history (%) ns History of PCI (%) History of CABG (%) 3 6 ns

10 Ejection fraction Diseased Vessels Crush n = 160 Culotte n = 164 p-value EF (%), mean±sd 57.4 ± ± 11 ns 1-VD (%) ns 2-VD (%) ns 3-VD (%) ns

11 Patients with true bifurcation lesion Medina classification 1,1,1-1,0,1-0,1,1 CRUSH CULOTTE p-value (n=160) (n=164) True bifurcation 125 (78%) 140 (85%) ns

12 Vessels treated CRUSH (n=160) CULOTTE (n=164) 8% 11% 10% 5% LAD 19% 62% 16% 68% Cx RCA LM ns

13 Procedural data CRUSH CULOTTE p-value (n=160) (n=164) MV stented (%) ns SB stented (%) ns Kissing balloon (%) ns Tx successful* (%) ns * (Residual stenosis <30% of MV + TIMI flow III in SB)

14

15 Individual endpoints after 6 months Crush n = 210 Culotte n = 215 P Value Non-cardiac death, % ns Cardiac death, % ns Myocard. infarc., % ns TVR, % ns Stent thrombosis, % ns

16 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

17 Angiographic follow-up after 8 months Complete angiographic evaluation in 324 (87%) patients MV prox SB MV dist QCA measurements in: Proximal main vessel Distal main vessel Side branch Edge (5 mm)

18 Rate of main vessel and/or side branch in-lesion diameter stenosis >50% at 8 months follow-up % CRUSH p= CULOTTE

19 Rate of main vessel and/or side branch in-stent diameter stenosis >50% % at 8 months follow-up CRUSH p= CULOTTE

20 Rate of main vessel in-lesion diameter stenosis >50% at 8 months follow-up % p= CRUSH CULOTTE

21 Rate of side branch in-lesion diameter stenosis >50% at 8 months follow-up % CRUSH p= CULOTTE

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

23 In-stent late lumen loss (mm) mm 0,25 0,20 0,15 0,10 0,05 0,00 ns ns ns Proximal MV segment Distal MV segment Side branch CRUSH CULOTTE

24 Conclusions (1) Both crush and culotte stent techniques using sirolimus-eluting stents in bifurcation lesions were performed with high and similar success rates There was a low and similar incidence of cardiac death, TVR and stent thrombosis in the two treatment groups

25 Conclusions (2) 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

26 Quantitative coronary angiography (QCA) 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

27 Localization of edge restenosis at 8 months follow-up CRUSH CULOTTE 2.0% 0.0% 2.0% 1.3% 0.7% 1.3%

28 Reference diameter (mm) before procedure mm 4,5 4 3,5 3 2,5 2 1,5 1 0,5 0 ns ns ns MV prox MV dist SB CRUSH before CULOTTE before

29 None of the authors had disclosures with regard to the present study

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