How to Improve Stenting Results in Bifurcations? Platform and technique

Transcription

1 Welcome to the 7 th European Bifurcation Club October LISBON How to Improve Stenting Results in Bifurcations? Platform and technique Nicolas Foin, Carlo Di Mario

2 Stent Design and Mechanical considerations Boston Scientific, Element white paper Different designs (crowns, cells) depending on diameters

3 Choosing the right workhorse for provisional stenting: comparison of DES designs Element Xience V Taxus Integrity Biomatrix Cypher 2.25 Small vessel workhorse: max exp. 2.75mm 2.50 Small workshorse (8 crowns, 2 cells) : max expansion 3.5mm Medium Workhorse: (6 crowns, 3 cells) max. expansion to 3.5mm 2.75 Medium 3.00 Medium Workhorse (8 crowns, 2 cells) : max expansion 4.25mm 3.50 Large 4.00 Large workhorse (10 crowns) max expansion 5.75mm 4.50 workhorse: (9 crowns, 3 cells) max expansion 4.5mm Small workshorse (2 cells) : max expansion 3.5mm Workhorse (3 cells): max expansion 4.25mm Large workhorse: (3 cells) max expansion 4.5mm Small workhorse (7crowns, 2 cells*) Max expansion 3.2mm *1 cell in resolute Medium workhorse (10 crowns, 2 cells) : max expansion 4.4mm Medium workhorse (6 crowns, 2 cells design): max expansion 3.75 Large vessel workhorse (9 crowns, 3 cells) max expansion 5.0 Medium workhorse (6 cells design): max expansion 3.75 Large vessel workhorse (7 cells design): max expansion 4.75 Sources: stent manufacturers

4 Anatomy of Bifurcations D SB D MV D MB Principle Relation Ratio Dm/Dd for Dd1~ Dd2 Murray s law Minimum Work Dm3= Dd13 + Dd HK: Hong- Kassab Flow conservation Minimum Energy Dm7/3 = Dd17/3 + Dd27/ Qm= Qd1 + Qd2 Dm2= Dd12 + Dd Finet Measurement Dm= (Dd1 + Dd2) 1.36 The larger the SB, the larger the change in MV diameter throughout the bifurcation

5 Oversized Stent: risk of carina shift BK Koo. Eurointervention 2011

6 Examples Element 2.75 Biomatrix 2.75 MV deployment MV deployment KB KB MSA proximal 8.2 mm2 In presence of a large diameter mismatch, we should look at workhorse maximal expansion capacity Or upscale to a larger diameter (at low pressure) MSA proximal 11.0 mm2

7 Choosing the right workhorse for provisional stenting: comparison of DES designs Element Xience V Taxus Integrity Biomatrix Cypher 2.25 Small vessel workhorse: max exp. 2.75mm 2.50 Small workshorse (8 crowns, 2 cells) : max expansion 3.5mm Medium Workhorse: (6 crowns, 3 cells) max. expansion to 3.5mm 2.75 Medium 3.00 Medium Workhorse (8 crowns, 2 cells) : max expansion 4.25mm 3.50 Large 4.00 Large workhorse (10 crowns) max expansion 5.75mm 4.50 workhorse: (9 crowns, 3 cells) max expansion 4.5mm Small workshorse (2 cells) : max expansion 3.5mm Workhorse (3 cells): max expansion 4.25mm Large workhorse: (3 cells) max expansion 4.5mm Small workhorse (7crowns, 2 cells*) Max expansion 3.2mm *1 cell in resolute Medium workhorse (10 crowns, 2 cells) : max expansion 4.4mm Medium workhorse (6 crowns, 2 cells design): max expansion 3.75 Large vessel workhorse (9 crowns, 3 cells) max expansion 5.0 Medium workhorse (6 cells design): max expansion 3.75 Large vessel workhorse (7 cells design): max expansion 4.75 Sources: stent manufacturers

8 Bifurcation ostium: angle matters! Acute angle produce larger ostium area

9 Stent Cell Size *Based on 3mm stent Maximum cell circumference* (mm) Maximum cell diameter* (mm) P. Mortier and manufacturer data

10 Stent Cell Size: the larger the better? Endeavor/Resolute Endeavor 2.75mm after KB with 2.5/2.75 Integrity

11 Cell opening capacity with Biomatrix BioMatrix 3.0 x 14 mm With a 6 crown BioMatrix ( mm) dilation of a cell is possible with balloons up to 3.5 mm With a 9 crown BioMatrix ( mm) dilatation of a cell is possible with balloons up to 3.75 mm Ø 3.71 mm Ø 3.95 mm BioMatrix 6 crown 3.0mm expansion BioMatrix 9 crown 4.0mm expansion

12 Provisional Stenting 45º A 3.5 mm 2.75 mm B C

13 Biomatrix Flex after KB

14 Bench Biomatrix Flex Results 3.0 MV, 2.5 SB at 12 ATM N.Foin/C. Di Mario MV STENT Biomatrix Flex Xience AFTER KB 2.5/3.0 mm Biomatrix Flex Xience

15 Conclusions Workhorse design has a critical impact on apposition of the strut and performance when used in bifurcation settings The Flex design offers good post-dilatation capacity and a large opening when dilated through the struts, sufficient to fit almost all coronary bifurcation anatomies

16 Biolimus in Bifurcations: OCT case examples and clinical results Carlo Di Mario, Nicolas Foin

17 Proximal LCx A=12.99smm; MD=4.14mm StJude FD-OCT from Dist 2 cm/sec Distal LCX: A=8.54smm; MD=3.41mm 3.0x28 & 4.0x8 Biomatrix Flex + KB 3.0/3.0

18 70 years-old caucasian male. HTN, Hypercholesterolemia, Positive FH. Severe multivessel CAD with multiple complex PCI (RCA, LAD, Cx). Increasing angina in the previous month

19 70 years-old caucasian male. HTN, Hypercholesterolaemia, Positive FH. Severe multivessel CAD with multiple complex PCI (RCA, LAD, Cx). Increasing angina in the previous month 1.5 Rotablation burr towards LAD

20 PCI to ostial LCx & final tri-kissing ballooon Additional 2.50 x 11 Biomatrix early OM1; Final triple -3.5, 3.0, 2.5- balloon dilatation in LAD, OM1 and LCx Post-Dilatatation with NCB 3.5 mm 3.0 x 11 mm Biomatrix stent in the proximal LCx Malapposed Struts

21 MLA 7.09 mm 2 MLA mm 2 MLA 9.08 mm 2

22

23 LEADERS Trial (Windecker, Serruys) Multicentre (n=10) Non-inferiority Allcomers 2,467 lesions in 1,707 patients SES Randomised BES Patient groups 850 patients Patient groups 857 patients No Bifurcation 611 Bifurcation % Pts have at least 1 Bifurc. Technique Type 1-stent 197 True 99 2-stent 42 Partial 140 Lesion groups 1213 lesions No Bifurcation 961 Bifurcation % Lesions are bifurcations True, 1-stent technique 75 True, 2-stent technique 27 Partial, 1-stent technique 135 Partial, 2-stent technique 15 Final Analysis 497 patients 534 lesions No Bifurcation 599 Bifurcation % Pts have at least 1 Bifurc. Technique Type 1-stent 204 True stent 54 Partial 134 Lesion groups 1254 lesions No Bifurcation 972 Bifurcation % Lesions are bifurcations True, 1-stent technique 94 True, 2-stent technique 37 Partial, 1-stent technique 129 Partial, 2-stent technique 22 Procedural data was collected on bifurcation technique by reviewing the angiogram of each bifurcation lesion (Dr Scot Garg) True bifurcation: Medina 1,1,1; 1,0,1; 0,1,1 Partial bifurcation: Medina 1,0,0; 1,1,0; 0,1,0; 0,0,1

24 Treated Bifurcation Lesions 534 lesions/497 patients True bifurcations* 233 lesions Partial bifurcations 301 lesions Two wires 174 lesions One wire 59 lesions Two wires 229 lesions One wire 72 lesions 2-stent technique 64 lesions Classic T 30 Crush 23 Culotte 7 Modified T 1 V stenting 3 1-stent technique 169 lesions 2-stent technique 37 lesions Cross-over 9 Classic T 16 Crush 7 Culotte 1 Modified T 2 V stenting 2 One stent technique 264 lesions 27.4% 72.6% 12.3% 87.7% Post stenting dilatation 49 lesions Post stenting dilatation 73 lesions Post stenting dilatation 15 lesions Post stenting dilatation 95 lesions 67.2% 21.9% 32.4% 14.4% Kissing balloon 43 Kissing balloon 37 Kissing balloon 12 Kissing balloon 38 *Includes 8 trifurcation lesions True bifurcation: Medina 1,1,1; 1,0,1; 0,1,1 Partial bifurcation: Medina 1,0,0; 1,1,0; 0,1,0; 0,0,1

25 Clinically Justified 24 Mths Bifurcation Group BES vs. SES HR 0-2 days : 0.62 [ ] p= days : 0.33 [ ] p=0.005 Sirolimus Bifurcation group Biolimus Bifurcation group Sirolimus Non-bifurcation group Biolimus Non-bifurcation group Garg et, EuroIntervention 2009

26 % Clinically-Indicated 3 Years BES SES 1-year HR 0.37 [0.18 to 0.74] P= 0.005* 11.5% Δ7.2% Bifurcations 2-year HR 0.49 [0.27 to 0.89] P = 0.018* 13.2% Δ6.4% 3-year HR 0.53 [0.31 to 0.89] P = 0.015* 16.0% Δ7.1% 8.9% 5 4.3% 6.8% Number at risk Months BES SES *P values for superiority From Windecker et al, TCT 2010

27 % BES SES 1-year HR 0.77 [0.24 to 2.52] P = 0.67* 2.0 Definite ST Bifurcations 2.5% Δ 0.6% 2-year HR 0.52 [0.17 to 1.54] P = 0.23* 3.8% Δ 1.9% 3-year HR 0.46 [0.16 to 1.35] P = 0.15* 4.3% Δ 2.4% 1.9% 1.9% 1.9% Number at risk Months BES SES *P values for superiority From Windecker et al, TCT 2010

28 with biostable polymers is highly desirable Conclusions The Biomatrix Flex stent offers a large opening when dilated through the struts, and post-dilatation capacity of the proximal segment sufficient to fit almost all coronary anatomies Biolimus eluting stent appears to offer an advantage over first generation SES in treating patients with bifurcational lesions Comparison with other second generation platforms