Outcomes of 10.312 Patients Treated with Everolimus-eluting Bioresorbable Scaffolds During Daily Clinical Practice: Results from the European Absorb Consortium Holger M. Nef Jens Wiebe, Nick West, Andreas Baumbach, Didier Carrie, Eduardo Pinar Bermudez, Guillaume Cayla, Felipe Hernandez Hernandez, Jose M de la Torre Hernandez, René Koning, Bruno Loi, Elisabetta Moscarella, Giuseppe Tarantini, Azfar Zaman, Christiane Lober, Thomas Riemer, Stephan Achenbach, Christian W. Hamm on behalf of the European ABSORB Consortium (EAC) investigators University of Giessen, Germany
Disclosure Statement of Financial Interest I, (Holger M. Nef) disclose the following potential conflicts of interests: Research Grant: Abbott Vascular, Elixir Medical Speaker‘s fee: Abbott Vascular, Elixir Medical
Background • The European ABSORB Consortium (EAC) was designed to monitor usage and outcomes of bioresorbable scaffold (BVS) implantation in everyday interventional practice in European countries. • The EAC is the largest registry of BVS globally and allows accurate assessment of low-frequency clinical outcome parameters including device thrombosis and restenosis.
Participating registries GERMANY/AUSTRIA GABI-R GREAT BRITAIN PI Dr. Hamm UK registry PI Dr. A. Baumbach FRANCE SPAIN ABSORB France REPARA PI Dr. Koning PI Dr. Hernandez ITALY RAI Registry PI Dr. Steffenino
Predefined FUs in the collected registries n=10.312 30 days 6 mo 12 mo 24 mo 36 mo 60 mo REPARA BVS ✓ Registry (n=2448) FRANCE ABSORB ✓ ✓ ✓ ✓ (n=2089) BVS RAI Registry ✓ ✓ (n=1500) ABSORB UK Registry ✓ ✓ (n=1005) ✓ ✓ ( ✓ ) ✓ ✓ GABI-R (n=3287) In total: 10.312 patients with 95.5% FU @ 12 months
Baseline characteristics Patients 58.4 11.1 Age Male sex, no. (%) 8141 (78.9%) Diabetes mellitus 2119/10277 (20.6%) Treated with oral medication 558/827 (67.5%) Treated with insulin 402/1404 (28.6%) Hypertension 5998/10245 (58.5%) Family history of coronary artery disease 1979/6254 (31.6%) Current or previous Smoker 4988/10127 (49.3%) Ejection fraction < 30% 96/6147 (1.6%) Medical Hisotry Previous stroke 162/5732 (2.8%) Previous myocardial infarction 2027/10252 (19.8%) Previous PCI 2081/8341 (24.9%) Previous CABG 172/10291 (1.7%) Stable angina 2897/10302 (28.1%) ACS 6006/10302 (58.3%) Non-ST elevation myocardial infarction 2655/6002 (44.2%) ST-elevation myocardial infarction 2053/6002 (34.2%) Unstable angina 1317/6006 (21.9%) Other 1420/10302 (13.7%)
Lesion characteristics Lesions Total no. 13488 Coronary artery location – no. (%) Left main 63/10214 (0.6) Left anterior descending 6021/10214 (59.0) Left circumflex 2479/10213 (24.3) Right coronary artery 3008/10231 (23.9) Venous bypass graft 4/10214 (0.0) Number of treated segments 1 75.8 % (7765/10247) 2 18.1 % (1857/10247) 3 5.0 % (508/10247) >3 1.1 % (117/10247) AHA/ACC lesion type – no. / total no. target lesions (%) A/B1 6583/11210 (58.7) B2/C 4627/11210 (41.3) Single vessel disease – no. (%) 5456/10238 (53.3) Multivessel disease – no. (%) 4782/10238 (46.7) Lesion type – no./total no. (%) De novo 13061/13484 (96.9) Moderately or severely Calcification 4765/13070 (36.5) Ostial lesion 227/8925 (2.5) Bifurcation 940/11485 (8.2)
Procedural parameters Patients Total device length implanted (mm), median [IQR] 23.0 [18.0, 35.0] Minimum device diameter per patient (mm), median [IQR] 3.0 [2.5, 3.5] Access route – no. / total (%) Femoral 2139/6675 (32.0) Radial 4523/6675 (67.8) Imaging - no. / total (%) Intravascular ultrasound 274/9640 (2.8) Optical coherence tomography 450/9640 (4.7) Patient with BVS treated – no. (%) 8463/10282 (82.3) Patient with BVS and DES treated - no. (%) 1819/10282 (17.7) Predilation of lesion – no. (%) 12068/13382 (90.2) Max. balloon diameter of predilation (mm), median [IQR] 3.0 [2.5, 3.0] Postdilation - no. (%) 9858/13365 (73.8) Max balloon diameter of postdilation (mm), median [IQR] 3.5 [3.0, 3.5] Medication at discharge Aspirin 7904/8232 (96.0) P2Y12 inhibitor 7841/8230 (95.3)
Clinical outcome @ 12 months 5 4.5 EAC 4 3.6 3.2 Cumulative Event Rates (%) 3 2.7 2.6 1.8 2 1.6 1.2 1 0.6 0
Distribution and cumulative incidence of ST @12 months Definite/probable 1.6 % (157/9849) Acute (<= 24h) 0.3 % (34/9848) Subacute (>24h to 30 days) 0.6 % (63/9849) Late (>30 days to 1 yr) 0.6 % (60/9848)
Landmark analysis @12 months Device Thrombosis Definite/probable Target Lesion Failure (Cardiac death/TV-MI/ TLR)
Independent predictors of ST and TLF ST TLF
Learning curve 5.0 5 Total 4.5 4.2 4.1 Early BVS (before 2015) 4 3.7 3.6 Late BVS (after 2015) Cumulative Event Rates (%) 3.3 3.2 3.2 3.0 2.9 3 2.7 2.6 2.4 2.2 2.1 1.8 1.8 2 1.7 1.6 1.5 1.4 1.2 1.0 1 0.6 0.6 0.5 0 * P-Value <0.05
Summary • In the EAC low clinical event rates could be documented after 12 months • ST rate was lower than expected from RCT • Pre- and postdilatation were performed frequently and thoroughly • Independent predictors of ST at 12 months were identified to be lack of predilatation and bifurcation lesion • The landmark analysis demonstrated clustering of events within the first 30 days without an exceptional rate of ST beyond that point • A learning curve for the adapted implantation technique was associated with lower rates of TLF and TVF
Conclusion • The EAC demonstrates favorable real-world clinical outcome data for BVS, with TLF comparable to data available for second- generation DES. • Clinical outcome after treatment with everolimus-eluting bioresorbable scaffold might be improved by specific implantation protocols and newer iterations of bioresorbable scaffolds
Thank you! René Koning, France Elisabetha Moscarella, Italy Jochen Wöhrle, Germany Didier Carre, France Guiseppe Tarantini, Italy Gerd Richardt, Germany Guilaume Cayla, France Alfonoso Lelasi, Italy Ralf Zahn, Germany Patrick Motreff, France Bruno Loi, Italy Julina Mehilli, Germany Vincent Bataille, France Andreas Baumbauch, UK Axel Schmermund, Germany Gilard Martine, France Nick West, UK Johannes Kastner, Austria Nicole Naccache, France Azfar Zaman, UK Alexander Neumer, Germany Felipe Hernandez, Spain Christian Hamm, Germany Christiane Lober, Germany Jose M de la Torre Hernandez, Spain Stephan Achenbach, Germany Alexandra Bernhardt, Germany Juan Jose Cruz, Spain Jens Wiebe, Germany Wolfgang Witsch, Germany Eduardo Pinar Bermudez, Spain Tommaso Gori, Germany Thomas Pfannebecker, Germany Bernardo Cortese, Italy Christoph Naber, Germany Els Boone, Belgium Guiseppe Steffenino, Italy Till Neumann, Germany Adriaan Potgieter, Belgium
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