Side branch occlusion in 500 ABSORB BVS

Transcription

1 Side branch occlusion in 500 ABSORB BVS Clinical implications and Solutions Robert-Jan van Geuns, MD, PhD Associate Professor,Thoraxcenter, Erasmus Medical Center, Rotterdam, the Netherlands On behalf of the ABSORB-Extend investigators Takashi Muramatsu, MD Yoshinobu Onuma, MD, PhD EBC, Barcelona 2012 Patrick Serruys, MD, PhD

2 Background Periprocedural myocardial infarction (MI) has been associated with unfavorable late clinical outcomes. 1-3 Side branch occlusion contributes to the periprocedural MI. Previous drug-eluting metallic stent studies suggest that the incidence of side branch occlusion is presumably attributable to the strut/polymer thickness and width. 4,5 The incidence of side branch occlusion after bioresorbable scaffold implantation has been unexplored Taxus-Ex Endeavor Xience BVS Strut thickness 1. Califf RM, et al. JACC 1998;31: Prasad A, et al. JACC 2006;48: Jensen LO, et al. JACC 2007;50: Popma JJ, et al. Circ Cardiovasc Intv 2009;2: Lansky AJ, et al. EuroIntervention 2010;6:J44-52.

3 In the ABSORB Cohort A trial, Bioresorption of jailed side branch are real phenomenon. (M2/3, 1-3mm/s, 15-20fps) Okamura et al. EHJ 2010)

4 Netherlands France Italy Germany Israel Poland Switzerland UK Belgium Denmark Spain Sweden Austria Australia New Zealand India Japan Hong Kong Malaysia Singapore Brazil Canada Argentina Number registered ABSORB EXTEND: Status as of February 27, sites are open; 27 actively registering 496 patients are registered, shown by country EMEA (241) ANZ (59) 100 APJ (159) LA (37)

5 ABSORB EXTEND Clinical Outcomes (ITT Interim Snapshot) Non-Hierarchical % (n) 30 Days * (N=451) Cardiac Death % (n) 0.0 (0) Myocardial Infarction % (n) 2.2 (10) Q-wave MI 0.7 (3) Non Q-wave MI 1.6 (7) Ischemia driven TLR % (n) 0.2 (1) CABG 0.0 (0) PCI 0.2 (1) Ischemia driven non-tl TVR % (n) 0.0 (0) CABG 0.0 (0) PCI 0.0 (0) Hierarchical MACE % (n) 2.2 (10) Hierarchical TVF % (n) 2.2 (10) *Reflects an interim snapshot with only cleaned data as of the cut-off date of Jan.11, 12

6 Side branch analysis Consecutive 469 patients who were enrolled since 11-Jan-2010 to 11-Jan-2012 Exclusion: 2 patients Metallic stent instead of BVS was implanted (1 delivery failure and 1 undersizing) Total N of side branches 1127 N of analyzed side branches per patient 2.4 N of analyzed side branches per lesion 2.2 Reference diameter (mm) 1.18 ± 0.39 Diameter stenosis (%) 20.0 ± 13.7 Side branches originating from: - obstruction segment 392 (34.8 %) - to-be-scaffolded segment outside obstruction 571 (50.7 %) - outside scaffolded segment (5 mm proximal and distal) 164 (14.6 %)

7 Today, with 3-D OFDI we can further evaluate the bioresorption process. Non-jailed 1b V type 40% Classification of Jailed sidebranch ostium according to number of compartment created by the overhanging struts with different configuration (e.g. V, T and H type) 1 T type H type % 25% Absorb Cohort B (n=17) %

8 Case Pre procedure Post procedure Platinum marker Side branch TIMI flow grade 1 Highest CK-MB = 6.30 x ULN

9 Periprocedural MI in patients with side branch occlusion Per protocol definition of MI = elevation of CK 2x ULN with elevated CK-MB (%) (%) Patients with SBO (n=59) 90 All patients (n=467) % (3/51) 12.5% (1/8) 6.8% (4/59) % (3/139) 0.3 % (1/328) 0.9 % (4/467) Patients who had no SBO with a RVD of > 1.0 mm Patients who had at least 1 SBO with a RVD of > 1.0 mm All patients withsbo Patients who had no side branch with a RVD of > 1.0 mm Patients who had at least 1 side branch with a RVD of > 1.0 mm All patients

10 Comparison with previous studies Study Publish Inclusion criteria of SB DES SPIRIT-Ⅲ Lansky AJ, et al. EuroIntervention 2010 N/A Xience V Taxus-Ex Scaffold thickness (μm) N of patients N of side branches (SB) N of SB per lesion Baseline SB mean RVD (mm) Baseline SB mean DS (%) Post procedural SB occlusion 2.7 % 4.3 % ABSORB-EX Unpublished Any visible SB ABSORB % ENDEAVOR-Ⅳ Popma JJ, et al. Circ Cardiovasc Intv 2009 RVD of > 1.0 mm ABSORB-EX Unpublished RVD of > 1.0 mm Endeavor Taxus-Ex ABSORB N/A N/A % 3.4 % 1.5 %

11 Summary of Absorb-Extend Overall incidence rate of post-procedural side branch occlusion was 5.9% (66/1127). Out of 66 occluded side branches, 58 (87.9%) had a RVD of 1.0 mm and 59 (89.4%) were originated within the obstruction segment. Overall incidence rate of post-procedural MI (per protocol definition) due to side branch occlusion was 0.9% (4/467) in this study population.

12 Bifurcations in daily practice: Unexpected (sub-)occlusion may appear Overexpansion possibilities in BVS are limited 3.0 mm can max deployed at 3.5 mm Side-branch fenestration (2.5 x 13 mm, 8atm) Proximal

13 Only type A lesions -> Bif lesion Post Implant

14 BVS Extend case Post Dilatation

15 Summary of BVS in Bifurcations Overall incidence rate of post-procedural side branch occlusion was 5.9% (66/1127). BVS can be recrossed if necessary with small balloon Kissing should be avoided, POT is possible

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17 Only type A lesions? 47 year male patient No cardiac history Dislipidemia Fam + Stable angina

18 Only type A lesions? 53 year female patient Stable angina Prior TIA, Hypertension, Fam BVS: 3.0 x 28 mm

19 Only type A lesions? 53 year female patient Stable angina Prior TIA, Hypertension, Fam BVS: 3.0 x 28 mm

20 Only type A lesions? 53 year female patient Stable angina Prior TIA, Hypertension, Fam Postdilatation NC 3.0 x 15 mm