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 Re ID: 726023
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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
, GermanySlide2
Disclosure Statement of Financial Interest
I, (Holger M. Nef) disclose the following potential conflicts of interests:Research Grant:Abbott Vascular, Elixir MedicalSpeaker‘s fee:Abbott Vascular, Elixir MedicalSlide3
BackgroundThe 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.
Slide4
Participating registries
ITALYRAI RegistryPI Dr. Steffenino
SPAIN
REPARA
PI Dr.
Hernandez
FRANCE
ABSORB France
PI Dr.
Koning
GREAT BRITAIN
UK
registry
PI Dr. A.
Baumbach
GERMANY/AUSTRIA
GABI-R
PI Dr. HammSlide5
Predefined FUs in the collected registries
n=10.31230 days6 mo12 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 monthsSlide6
Baseline characteristicsPatients
Age 58.411.1Male 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 angina2897/10302 (28.1%)ACS6006/10302 (58.3%)Non-ST elevation myocardial infarction2655/6002 (44.2%)ST-elevation myocardial infarction2053/6002 (34.2%)Unstable angina1317/6006 (21.9%)Other1420/10302 (13.7%)Slide7
Lesion characteristicsLesions
Total no.13488Coronary 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 lesion227/8925 (2.5)Bifurcation940/11485 (8.2)Slide8
Procedural parametersPatients
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 Aspirin7904/8232 (96.0)P2Y12 inhibitor7841/8230 (95.3)Slide9
Clinical outcome @ 12 monthsSlide10
Distribution and cumulative incidence of ST@12 months
Definite/probable1.6 % (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)Slide11
Landmark
analysis @12 monthsDevice Thrombosis Definite/probable
Target
Lesion
Failure
(
Cardiac
death
/TV-MI/ TLR)Slide12
Independent predictors of ST and TLF
STTLFSlide13
Learning curve
* P-Value <0.05Slide14
SummaryIn the EAC low clinical event rates could be documented after 12 monthsST rate was lower than expected from RCT
Pre- and postdilatation were performed frequently and thoroughlyIndependent predictors of ST at 12 months were identified to be lack of predilatation and bifurcation lesionThe landmark analysis demonstrated clustering of events within the first 30 days without an exceptional rate of ST beyond that pointA learning curve for the adapted implantation technique was associated with lower rates of TLF and TVFSlide15
ConclusionThe 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 scaffoldsSlide16
Thank you!René
Koning, FranceElisabetha Moscarella, ItalyJochen Wöhrle, GermanyDidier Carre, FranceGuiseppe Tarantini, ItalyGerd Richardt, Germany
Guilaume
Cayla
, France
Alfonoso
Lelasi
,
Italy
Ralf Zahn, Germany
Patrick
Motreff
, France
Bruno
Loi, ItalyJulina Mehilli, Germany
Vincent Bataille, FranceAndreas Baumbauch, UKAxel Schmermund, GermanyGilard Martine, France
Nick West, UK
Johannes Kastner, Austria
Nicole
Naccache
, France
Azfar
Zaman, UK
Alexander
Neumer, GermanyFelipe Hernandez, SpainChristian Hamm, GermanyChristiane Lober, GermanyJose M de la Torre Hernandez, SpainStephan Achenbach, GermanyAlexandra Bernhardt, GermanyJuan Jose Cruz, SpainJens Wiebe, GermanyWolfgang Witsch, GermanyEduardo Pinar Bermudez, SpainTommaso Gori, GermanyThomas Pfannebecker, GermanyBernardo Cortese, ItalyChristoph Naber, GermanyEls Boone, BelgiumGuiseppe Steffenino, ItalyTill Neumann, GermanyAdriaan Potgieter, Belgium