Safety-outcomes of bioresorbable Everolimus eluting scaffold in (German-Austrian-ABSORB RegIsteR)

Transcription

1 Safety-outcomes of bioresorbable Everolimus eluting scaffold in 2168 patients with CAD: 30 days follow-up from the GABI-R (German-Austrian-ABSORB RegIsteR) C. Hamm, University of Giessen, Germany on behalf of the Steering-Committee and all GABI-R Investigators

2 Potential conflicts of interest Speaker's name: Christian Hamm I have the following potential conflicts of interest to report: Consultant: BRAHMS, Medtronic, Abbott

3 Background The ABSORB Vascular Scaffold (Absorb BVS, Abbott Vascular, Illinois, USA) has gained CE-mark five years ago and has been implanted in over pts so far In the well-controlled ABSORB III trial Absorb BVS showed similar safety and efficacy in comparison to everolimus-eluting metallic stent GABI-R aims to show safety and efficacy of BVS in an all-comers cohort with coronary artery disease

4 Top Enrolling Sites Segeberger Kliniken Herzzentrum Krankenhaus Buchholz Elisabethkrankenhaus Essen Universitätsklinikum Mainz Universitätsklinikum Mannheim Rems-Murr-Kliniken Winnenden 93 Centers in Germany and Austria Universitätsklinikum Giessen Kerckhoff-Klinik Bad Nauheim Universitätsklinikum Erlangen Herz- und Gefäßzentrum Oberallgäu Kempten Universitätsklinikum Ulm

5 Patient Population Included patients from November 2013 until May 2015 N=2168 OCT: 110/2217(5%) IVUS: 81/2217 (4%) 30-days FU N= 2168 eligible (100%) Age, years±sd ± Female 22.7 % Diabetes mellitus 21.5 % On insulin 35.2 % Hyperlipoproteinemia 58.7 % Hypertension 75.2 % Smoker (current or previous) 57.1 % Previous PCI 28.7 % Prior CABG 2.9 % Stroke/TIA 2.7 % ACS 51.1 % Unstable angina 23.3 % NSTEMI 44.3 % STEMI 32.4 %

6 Lesion Characteristics Lesion Location (treated lesions) LMCA 1.7 % (14/2168 Pt.) LAD 73.5 % LCX 58.2 % RCA 68.5 % ACC/AHA Lesion complexity A 25.4% (795/2984) B1 36.7% (1096/2984) B2 20.9% (625/2984) C 16.9% (504/2984) 6

7 Lesion Characteristics GABI-R DES-Study* RVD (mm) 2.93 ± ± 0.58 Median (1., 3. Quartile) 3.00 (2.57, 3.18) MVD (mm) 1.47 ± ± 0.55 Median (1., 3. Quartile) 1.33 (1.00, 1.90) Diameter stenosis (%) ± ± Median (1., 3. Quartile) (80.00, 95.00) *Serruys PW et al. Comparison of zotarolimus-eluting and everolimus-eluting coronary stents. N Engl J Med Jul 8;363(2):

8 Procedural characteristics GABI-R DES-Study* Predilation 91.6% (2744/2996) Ca. 75% GABI-R: Ballon-Diameter: 2.74 ± 0.43mm Ballon-Length: ± 4.54mm Implantation Pressure : ± 3.28bar NC-Balloon: 69% Cutting/Scoring-Balloon: 5.2% (145/2746) 8

9 Procedural characteristics GABI-R DES-Study Implanted BVS per Lesion 1.17 ± ± 0.51* Implanted BVS per patient 1.56 ± ± 1.31* Implantation lenth per lesion (mm) ± ± 11.25* Median (1., 3. Quartile) (15.00, 28.00) Stent diameter (mm) 3.1 ± ± 0.4** Median (1., 3. Quartile) 3.00 (3.00, 3.50) *Serruys PW et al. Comparison of zotarolimus-eluting and everolimus-eluting coronary stents. N Engl J Med Jul 8;363(2): **Costopoulos C et al. Comparison of early clinical outcomes between ABSORB bioresorbable vascular scaffold and everolimus-eluting stent implantation in a real-world population. Catheter Cardiovasc Interv Jan 1;85(1):E10-5 9

10 Procedural Characteristics Number of implanted BVS 1 Scaffold 87.4% (2303/2635) 2 Scaffolds 11.2% (296/2635) 3 Scaffolds 1.3% (33/2635) 4 Scaffolds 0.1% (3/2635) Implantation characteristics Mean implantation pressure 13.6 ± 2.6 bar postdilation 68.2% (2041/2994) NC-Balloon 92.1% Mean pressure 16.5 ± 4.1 bar 10

11 Numbers in % Lesion Characteristics

12 Procedural Details Patient based Radial Access 45.5 % Lesion/Pt. 1.3 Multivessel Disease 59.0 % Hybrid procedure 12.2 % Total scaffold length (mm) 19.7 Average Scaffold diameter (mm) 3.1 Lesion based Predilation 95.2 % NC-Ballon 69.6 % Semi-compliant 30.4 % Post-dilation 68.1 % 100% 90% 80% 70% 60% 50% 40% 30% 20% 10% 0% Successful Procedure 99.0 % 12

13 events in % Endpoints after 30-days FU GABI-R GHOST-EU 4,0 3,6 3,5 3,0 2,5 2,0 1,5 2,0 2,3 1,6 1,4 1,7 1,6 1,3 1,5 2,3 1,9 2,2 1,5 1,1 1,0 0,5 0,4 0,8 0,3 0,6 0,0 MI TVR TLF TLR 13

14 cumulative events ARC Scaffold thrombosis (def/prob) scaffold thromboses within the first seven days! days after index procedure 14

15 ARC Scaffold Thrombosis (def/prob) Pat. time_to_event Age Diabetes mellitus ACS Selection P2Y12inhib, Hospital discharge Vitalstatus Average Scaffold diameter [mm] Total Scaffold length [mm] Predilatation_yn Postdialation_yn Instabile Angina Ticagrelor Clopidogrel 3, U Clopidogrel deceased NSTEMI Ticagrelor 2, NSTEMI Ticagrelor 3, Clopidogrel 3, Prasugrel 2, Instabile Angina Clopidogrel Clopidogrel STEMI Prasugrel STEMI Prasugrel Instabile Angina deceased 2, NSTEMI Ticagrelor deceased 2, Clopidogrel Prasugrel 3, Prasugrel NSTEMI deceased U Instabile Angina Ticagrelor 3, Clopidogrel deceased STEMI Prasugrel Clopidogrel deceased 3, NSTEMI Clopidogrel Clopidogrel 3, NSTEMI Ticagrelor 3, Prasugrel 3, Prasugrel 2, NSTEMI Ticagrelor 3,

16 Predictors for ST? Patient based Def/Prob ST No ST p Diabetes mellitus 20.6% 21.5% 0.21 ACS 48.6% 51.15% 0.77 Predilation % 95.1 % 0.18 Postdilation 65.7 % 73.3 % 0.32 Total scaffold length (mm) Average Scaffold diameter (mm) No Loading Dose P2Y12 Antagonist ± ± ± ± % 36.1% 0.92

17 in 2015 In 2015 events in % before 2015 before 2015 In 2015 in 2015 before 2015 before 2015 In 2015 in 2015 before 2015 before 2015 Endpoints and Time of Procedure 2,5 2,3 2,2 2 1,5 1,3 1,3 1,5 0,9 1 0,5 0 TVF (Card. Death, TV-MI, TVR) TLF (Card. Death, TV-MI, TLR) ARC ST (definite/probable)

18 Difference: 2014 and 2015? Patient based p Renal failure 9.1% 6.2% <0.05 No other Comorbidities 61.1% 69.9 % < Postdilation 71.1 % 76.2 % <0.05 Intravascular Imaging 9.4% 6.9 % 0.32 B2/C 40.4% 32% <0.05 Debulking Device 3.3% 9.7% <

19 Conclusions Real-world registry shows safety and efficacy of the bioresorbable scaffold system ABSORB. Preliminary analysis after 30 days with pts. showed low MACE rate. Scaffold thrombosis rate remained low. Long-term FU analysis has to be awaited for final conclusions. 19

20 Thank you! KERCKHOFF KLINIK

21 Thank you 21

22 Oral Anticoagulation 103 of 2217 (4.6%) patients were on oral anticoagulation at the time of BVS procedure Vitamin K-antagonists: 52 out of 103 (50.5%) NOAK: 51 out of 103 (49.5%) 22