The 2-year Clinical Outcomes of the ABSORB II Trial: First Randomized Comparison between the Absorb Everolimus Eluting Bioresorbable Vascular Scaffold and the XIENCE Everolimus Eluting Stent Bernard Chevalier Institut Jacques Cartier, Massy, France Patrick W. Serruys Imperial College, London, UK Erasmus University MC, Netherlands on behalf of the ABSORB II Investigators 12 October 2015 - San Francisco, CA - U.S.A Plenary Session VII. First Report Investigations 1. 12:00pm
Presentor Disclosures Bernard Chevalier is a consultant for Abbott Vascular Patrick Serruys is a member of the international advisory board of Abbott Vascular
ABSORB II Study Design 501 subjects Randomized 2:1 Absorb BVS:XIENCE / 46 sites (Europe and New Zealand) Clinical Follow-Up 30d 6 m 12 m 24m 36 m 48m 60m QoL follow-up Angio, IVUS follow-up MSCT follow-up (Absorb arm only)* Study Objective Randomized against XIENCE control. First Patient In: 28-Nov-2011 Vasomotion assessed by change in Mean Lumen Diameter between pre- Co-primary and post-nitrate at 3 years (superiority) Endpoints Minimum Lumen Diameter (MLD) at 3 years post nitrate minus MLD 36 months post procedure post nitrate (non-inferiority, reflex to superiority) Up to 2 de novo lesions in different epicardial vessels Treatment Planned overlapping allowed in lesions ≤ 48 mm Device diameters: 2.5, 3.0, 3.5 mm Device Sizes Device lengths: 12 (3.5 mm diameter only), 18, 28 mm The ABSORB II study is sponsored by Abbott Vascular
2-Year Patient Flowchart Intent To Treat N=501 Absorb BVS XIENCE N=335 N=166 Baseline 1 subject consent withdrawn N=334 30-day N=166 3 subjects 1 subject consent died withdrawn 180-day N=331 N=165 2 subjects 1 subject consent consent withdrawn withdrawn 1-year N=329 N=164 3 subjects 1 subject consent consent withdrawn. withdrawn 2 subjects N=324 N=163 died 2-year (96.7%) (98.2%)
1-year Summary Absorb BVS XIENCE p value N=335 N=166 Hierarchical PoCE*, % 7.3 9.1 0.47 0.0 0.6 0.33 All death (Non-hierarchical) 4.5 1.2 0.06 All MI (Non-hierarchical) 3.6 7.3 0.07 All revascularization (Non-hierarchical) Per Protocol Myocardial Infarction (MI): PoCE (Patient oriented Composite Endpoint)*: All death, all myocardial infarction, and all • Q wave MI revascularisation. Development of new, pathological Q wave on the ECG. • Non-Q wave MI Elevation of CK levels to ≥ two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves. *Per ARC. Cutlip et al. , Circulation . 2007;115:2344-2351
1-year Summary Absorb BVS XIENCE p value N=335 N=166 Hierarchical PoCE*, % 7.3 9.1 0.47 0.0 0.6 0.33 All death (Non-hierarchical) 4.5 1.2 0.06 All MI (Non-hierarchical) 3.6 7.3 0.07 All revascularization (Non-hierarchical) Hierarchical DoCE* or TLF, % 4.8 3.0 0.35 0.0 0.0 1.00 Cardiac death (Non-hierarchical) 4.2 1.2 0.07 TV-MI (Non-hierarchical) 1.2 1.8 0.69 CI-TLR (Non-hierarchical) Per Protocol Myocardial Infarction (MI): PoCE (Patient oriented Composite Endpoint)*: All death, all myocardial infarction, and all • Q wave MI revascularisation. Development of new, pathological Q wave on the ECG. DoCE (Device oriented Composite Endpoint)*/ TLF • Non-Q wave MI (Target Lesion Failure): Elevation of CK levels to ≥ two times the upper limit of Cardiac death, target-vessel myocardial infarction, normal (ULN) with elevated CK-MB in the absence of and clinically indicated target-lesion revascularisation new pathological Q waves. (TLR). *Per ARC. Cutlip et al. , Circulation . 2007;115:2344-2351
2-year Clinical Outcomes Composite Endpoints Absorb BVS XIENCE p value N=335 N=166 PoCE (%) 11.6 12.8 0.70 PoCE (Patient oriented Composite Endpoint): All death, all myocardial infarction, and all revascularisation
2-year Clinical Outcomes Composite Endpoints Absorb BVS XIENCE p value N=335 N=166 PoCE (%) 11.6 12.8 0.70 7.6 4.3 0.16 MACE (%) PoCE (Patient oriented Composite Endpoint): All death, all myocardial infarction, and all revascularisation MACE (Major Adverse Cardiac Events): Cardiac death, all myocardial infarction, and clinically indicated target-lesion revascularisation (TLR)
2-year Clinical Outcomes Composite Endpoints Absorb BVS XIENCE p value N=335 N=166 PoCE (%) 11.6 12.8 0.70 7.6 4.3 0.16 MACE (%) 7.0 3.0 0.07 DoCE, TLF (%) PoCE (Patient oriented Composite Endpoint): All death, all myocardial infarction, and all revascularisation MACE (Major Adverse Cardiac Events): Cardiac death, all myocardial infarction, and clinically indicated target-lesion revascularisation (TLR) DoCE (Device oriented Composite Endpoint)/ TLF (Target Lesion Failure): Cardiac death, target-vessel myocardial infarction, and clinically indicated target-lesion revascularisation (TLR)
2-year Clinical Outcomes Composite Endpoints Absorb BVS XIENCE p value N=335 N=166 PoCE (%) 11.6 12.8 0.70 7.6 4.3 0.16 MACE (%) 7.0 3.0 0.07 DoCE, TLF (%) 8.5 6.7 0.48 TVF (%) PoCE (Patient oriented Composite Endpoint): All death, all myocardial infarction, and all revascularisation MACE (Major Adverse Cardiac Events): Cardiac death, all myocardial infarction, and clinically indicated target-lesion revascularisation (TLR) DoCE (Device oriented Composite Endpoint)/ TLF (Target Lesion Failure): Cardiac death, target-vessel myocardial infarction, and clinically indicated target-lesion revascularisation (TLR) TVF (Target Vessel Failure): Cardiac death, all myocardial infarction, clinically indicated target-vessel revascularisation (TVR)
Patient oriented Composite Endpoint (PoCE) 25 XIENCE Absorb BVS 37-day HR 37-758-day HR 20 1.75 [0.58,5.31] 0.69 [0.37,1.28] PoCE (%) p=0.3151 p=0.2317 15 10.3% 10 ∆ =-3.0% 4.2% 7.3% ∆ =1.8% 2.4% 5 0 0 90 180 270 360 450 540 630 720 Time Post Index Procedure (Months) PoCE: All death, all myocardial infarction, and all revascularisation
Major Adverse Cardiac Events (MACE) 25 XIENCE Absorb BVS 37-day HR 37-758-day HR 20 3.49 [0.79,15.34] 1.13 [0.39,3.24] MACE (%) p=0.0760 p=0.8242 15 10 4.2% 3.5% 5 ∆=3.0% ∆=0.4% 3.1% 1.2% 0 0 90 180 270 360 450 540 630 720 Time Post Index Procedure (Months) MACE: Cardiac death, all myocardial infarction, and clinically indicated target-lesion revascularisation
Device oriented Composite Endpoint (DOCE)/ Target Lesion Failure (TLF) 25 XIENCE Absorb BVS 37-day HR 37-758-day HR 20 DoCE/TLF (%) 3.24 [0.73,14.33] 1.71 [0.47,6.20] p=0.0996 p=0.4109 15 10 3.9% 3.2% 5 ∆=2.7% ∆=1.4% 1.8% 1.2% 0 0 90 180 270 360 450 540 630 720 Time Post Index Procedure (Months) DoCE/TLF : Cardiac death, target-vessel myocardial infarction, and clinically indicated target-lesion revascularisation (TLR)
Target Vessel Failure (TVF) 25 XIENCE Absorb BVS 37-day HR 37-758-day HR 20 2.33 [0.67,8.10] 0.89 [0.37,2.12] TVF (%) p=0.1683 p=0.7914 15 10 4.2% 4.9% ∆ =2.4% 5 ∆ =-0.4% 1.8% 4.5% 0 0 90 180 270 360 450 540 630 720 Time Post Index Procedure (Months) TVF : Cardiac death, all myocardial infarction, clinically indicated target-vessel revascularisation
Clinical Outcomes Non Hierarchical Events 2 years Absorb XIENCE BVS p value N=166 N=335 Death* (%) 1.2 0.6 0.67 0.6 0.0 0.55 Cardiac Non cardiovascular 0.6 0.6 1.00 *Per ARC. Cutlip et al. , Circulation . 2007;115:2344-2351
Clinical Outcomes Non Hierarchical Events 2 years Absorb XIENCE BVS p value N=166 N=335 Death* (%) 1.2 0.6 0.67 0.6 0.0 0.55 Cardiac Non cardiovascular 0.6 0.6 1.00 Myocardial Infarction (%) 5.8 2.4 0.10 1.5 0.6 0.67 Q-wave Non Q-wave 4.3 1.8 0.16 *Per ARC. Cutlip et al. , Circulation . 2007;115:2344-2351
Clinical Outcomes Non Hierarchical Events 2 years Absorb XIENCE BVS p value N=166 N=335 Death* (%) 1.2 0.6 0.67 0.6 0.0 0.55 Cardiac Non cardiovascular 0.6 0.6 1.00 Myocardial Infarction (%) 5.8 2.4 0.10 1.5 0.6 0.67 Q-wave Non Q-wave 4.3 1.8 0.16 Definite/Probable ST* (%) 1.5 0.0 0.17 0.6 0.0 1.00 Acute/sub-acute (0-30 days) Late (31-365 days) 0.3 0.0 1.00 0.6 0.0 0.55 Very late (365 – 758 days) *Per ARC. Cutlip et al. , Circulation . 2007;115:2344-2351
Post-Procedure Usage of Antiplatelet Medication through 2 years Absorb XIENCE BVS p value N=166 N=335 On Aspirin (%) at 1 year 95.8 95.2 0.75 92.2 92.2 0.99 at 2 years On DAPT (%) at 1 year 81.7 81.3 0.91 36.2 34.3 0.68 at 2 years
Very Late Scaffold Thrombosis Cases
Proximal D-max 3.00 mm, Distal D-Max 3.01 mm Absorb 3.0x18 mm, 10 atm Pre-dilatation MLD 1.84 mm MLD 3.44 mm Hiryu 2.75x10 mm acute gain 1.6 mm %DS 39.0 %DS 20.5 Post-dilate Hiryu 3.25x10, 10 atm IVUS Post procedure Malapposed struts Proximal MSA frame definite very late ST 447 days Possible cause : LA 5.85 mm 2 LD 2.73 mm SA 7.23 mm 2 VD 3.03 mm 1.Proximal stent malapposition LA 9.51 mm 2 LD 3.48 mm Residual stenosis 21.5% 2.Suboptimal expansion Malapposition at proximal edge Suboptimal expansion DAPT: Aspirin only at time of the event
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