Bifurcation Stenting: IVUS and OCT Information

Transcription

1 Bifurcation Stenting: IVUS and OCT Information Yoshinobu Murasato MD, PhD (New Yukuhashi Hospital) On behalf of J-REVERSE investigators October 14-15, 2011, Lisbon

2 Proximal stent deformation induced by KB inflation a a b b c d d c KB inflation caused oval-shape dilation with the eccentricity value of 0.75 and 30% enlargement e was obtained compared to distal site. Guérin P. Circ Cardiovasc Interv, 2010, 3, 120 Murasato Y, EBC 2010 e

3 Intimal growth Symmetrical vs. Asymmetrical expansion Symmetrical Homogenous intimal growth Asymmetrical Uneven intimal growth Frequent uncovered struts thrombus Otake H, JACC Intrv, 2009, 2,459

4 Impact of symmetricity KBT SEI: stent eccentricity index NUS: neointima unevenness score Otake H, JACC Intrv, 2009, 2,459

5 Japanese Registry Study in Comparison between Everolimus-eluting Stent and Sirolimus-eluting Stent for the Bifurcation Lesion Principal Investigators Yoshinobu Murasato (New Yukuhashi Hospital) Yoshihisa Kinoshita (Toyohashi Heart Center) Core laboratory QCA, QCU: Cardiovascular Imaging Center (Toyohashi) OCT: Kobe University (J REVERSE)

6 Purpose of the study Study-1 To compare the long-term outcome of provisional stenting between EES and SES deployment. Study-2 To prove the following hypothesis Asymmetrical expansion in the bifurcation lesion leads to frequent inhomogeneous intimal growth on the strut and thrombus attachment.

7 Study design 300pts Bifurcation lesion Provisional stenting 75% stenosis in MV with /wo SB stenosis ( 75% ) Size: MV 2.5mm SB 2mm Lesion length < 46mm EES (Xience V / Promus) SES (Cypher select plus) KBT (+) KBT (-) KBT (+) KBT (-)

8 Study protocol Before PCI Post PCI Mo Mo Y EES SES CAG IVUS + + OCT + (n=100) ECG, blood sample Clinical event

9 Endpoint Study-1 1. Major adverse cardiac event (MACE) at 3Y Death Myocardial infarction Target lesion revascularization (TLR) Target vessel revascularization (TVR) Stent thrombosis Study-2 1. The following OCT findings Unevenness of intimal growth Number of uncovered struts Frequency of thrombus attachment Relation between stent eccentricity index in IVUS 2. Relation between the above factors and MACE at 3Y

10 Study enrollment From July 2010 till Sept, Group Patient No. EES KBT+ EES KBT- SES KBT+ SES KBT Total 189

11 Patient background 189 patients Age /- 9.2 y.o. Male 78.3% HT 74.1% Dyslipidemia 68.8% DM 40.7% Insulin 6.3% Smoking history 58.7% Previous MI 15.3% Previous PCI 30.7% Access Radial 74.6% Femoral 25.4% Guiding catheter 6Fr 75.7% 7Fr 19.6% 8Fr 3.7%

12 IVUS: Stent Eccentricity Index in the MV : p<0.05 vs. KBT- : p<0.1 vs. KBT- SES KBT+ EES KBT+ SES KBT- EES KBT- (n = 8) (n = 8) (n = 8) (n = 8) 0.7 P6 P5 P4 P3 P2 P1 P0 D0 D1 D2 D3 D4 D5 D6

13 IVUS volumetric analysis Percent change in the MV after PCI (%) (%) (%) * Lumen * 120 Vessel 120 Plaque prox MV dist MV KBT+ * P<0.05 vs. KBTprox vs. dist P< EES KBT+ EES KBT- SES KBT+ SES KBT- 80 EES KBT+ EES KBT- SES KBT+ SES KBT- 80 EES KBT+ EES KBT- SES KBT+ SES KBT-

14 (%) 140 IVUS volumetric analysis Percent change in the SB after PCI EES KBT+ SES KBT Lumen Vessel Plaque

15 Experience in Kobe University* *OCT core laboratory of J-REVERSE De Novo Native Coronary Artery Lesions at True Bifurcation Treated with DES N=76 Non-FKI N=43 FKI N=33 Cypher N=27 Taxus Liberte N=16 Cypher N=22 Taxus Liberte N=11 Hariki H, Shinke T, Otake H, Shite J et al. ACC2011

16 Distal segment 5 mm Segment location Hariki H, Shinke T, Otake H, Shite J et al. ACC2011 Bifurcation segment Proximal segment 5 mm Distal segment (Analized every 1mm) Bifurcation segment (Analized every cross section) Proximal segment (Analized every 1mm)

17 Neointimal thickness (µm) OCT analysis Hariki H, Shinke T, Otake H, Shite J et al. ACC2011 SO Bifurcation AO %Uncoverd strut = Number of uncovered struts / total struts AO OO %Malapposed strut = Number of malapposed struts / total struts AO : Adjacent to the orifice SO : Side branch orifice Jailed strut OO :Opposite to the orifice

18 Thrombus attachment (1) P= Non-FKI FKI Hariki H, Shinke T, Otake H, Shite J et al. ACC2011

19 Thrombus attachment (2) Non - FKI FKI Proximal AO * Bifurcation Distal OO SO # Prox Bifurc Dist * p=0.02, # P<0.1 Prox Dist Bifurc Hariki H, Shinke T, Otake H, Shite J et al. ACC2011

20 %Uncovered strut in bifurcation segment Non-FKI(n=43) FKI(n=33) P Over all 12.2±10.3% 5.0±5.8% P= AO 10.8±16.6% 4.5±6.4% P= SO 20.1±30.3% 18.7±32.5% P= OO 11.6±14.5% 5.0±8.6% P= AO : Adjacent to the orifice SO : Side branch orifice OO : Opposite to the orifice Hariki H, Shinke T, Otake H, Shite J et al. ACC2011

21 %Malapposed strut in each segment Non-FKI (n=43) FKI(n=33) P Distal segment Bifurcation segment (at AO,OO) Proximal segment 2.26±5.93% 0.38±1.04% P= ±5.50% 0.39±1.00% P= ±9.28% 1.37±5.79% P= Hariki H, Shinke T, Otake H, Shite J et al. ACC2011

22 mm The increase of NIT and JSCT from 6M F/U to 12M F/U Non - jailed strut NIT P=0.02 mm Jailed strut NIT 0.2 P= ±0.087 vs 0.140± ±0.053 vs 0.105±0.059 JSCT NIT Neointimal thickness mm Jailed strut complex thickness 0.6 P ±0.157 vs 0.406±0.162 Hariki H, Shinke T, Otake H, Shite J et al. ACC2011

23 The increase of NIT and JSCT from 6M F/U to 12M F/U mm Growth of JSCT: 0.12mm P / 6M 0.16 More growth in the future? Thrombogenic? 0.12 P= Non jailed Strut- NIT Jailed strut-nit JSCT Hariki H, Shinke T, Otake H, Shite J et al. ACC2011

24 Conclusion KB inflation brings asymmetrical expansion which may lead to a risk of disturbance of endthelialization and the J-REVERSE has approached this issue. There is no significant difference between SES and EES in the stent deformation induced by KB inflation in the preliminary data. KB inflation induces more expansion of the lumen volume in the distal MV and reduces uncovered struts and thrombus attachment around the bifurcation compared to the treatment without it. The jailed strut complex increases its thickness more than the neointimal growth in any other site, which may evoke a concern on the thrombosis on the jailed strut.