CLINICAL RESEARCH
CORONARY INTERVENTIONS
1320
EuroIntervention 2017;13: 1320-1327 published online June 2017 DOI: 10.4244/EIJ-D-17-00291
© Europa Digital & Publishing 2017. All rights reserved.
*Corresponding author: Department of Cardiology, Munich University Clinic, Marchioninistr. 15, 81377 Munich, Germany.
E-mail: Julinda.Mehilli@med.uni-muenchen.de
Clinical restenosis and its predictors after implantation of
everolimus-eluting bioresorbable vascular scaffolds: results
from GABI-R
Julinda Mehilli
1,2
*, MD; Stephan Achenbach
3
, MD; Jochen Wöhrle
4
, MD; Morritz Baquet
1
, MD;
Thomas Riemer
5
, PhD; Thomas Münzel
6,7
, MD; Holger M. Nef
8
, MD; Christoph Naber
9
, MD;
Gert Richardt
10
, MD; Ralf Zahn
11
, MD; Tommaso Gori
6,7
, MD; Till Neumann
12
, MD, PhD;
Johannes Kastner
13
, MD; Axel Schmermund
14
, MD; Christian Hamm
8,15
, MD;
for the GABI-R Study Group
1. Department of Cardiology, Munich University Clinic, LMU, Munich, Germany; 2. German Centre for Cardiovascular
Research, partner site Munich Heart Alliance, Munich, Germany; 3. Department of Cardiology, Friedrich-Alexander University
Erlangen-Nürnberg, Erlangen, Germany; 4. Department of Internal Medicine II, University of Ulm, Ulm, Germany; 5. IHF
GmbH - Institut für Herzinfarktforschung, Ludwigshafen, Germany; 6. Zentrum für Kardiologie, University Medical Center,
Johannes Gutenberg University Mainz, Mainz, Germany; 7. German Centre for Cardiovascular Research, partner site Rhine
Main, Mainz, Germany; 8. Medizinische Klinik I, Department of Cardiology, University of Giessen, Giessen, Germany; 9. Klinik
für Kardiologie und Angiologie, Elisabeth-Krankenhaus, Essen, Germany; 10. Herzzentrum, Segeberger Kliniken GmbH,
Bad Segeberg, Germany; 11. Abteilung für Kardiologie, Herzzentrum Ludwigshafen, Ludwigshafen, Germany; 12. Department of
Cardiology, University of Essen, Essen, Germany; 13. Department of Cardiology, University of Vienna Medical School, Vienna,
Austria; 14. Bethanien Hospital, Frankfurt, Germany; 15. Department of Cardiology, Kerckhoff Heart and Thorax Center,
Bad Nauheim, Germany
Abstract
Aims: The aim of this study was to assess clinical restenosis and its predictors after implantation of
bioresorbable vascular scaffolds (BVS) in everyday practice in the large-scale German-Austrian ABSORB
Registry (GABI-R).
Methods and results: Between November 2013 and January 2016, 3,264 patients underwent BVS implan-
tation in the 93 centres of GABI-R (ClinicalTrials.gov NCT02066623). At six-month follow-up, 24 patients
experienced clinically indicated target lesion revascularisation (cTLR) unrelated to BVS thrombosis (cumu-
lative incidence 0.76%; angiographically, 58.3% of in-BVS restenosis of focal pattern). Compared to
patients without cTLR, patients with cTLR had more lesions per patient (1.83±1.0 vs. 1.36±0.7), complex
(52.3% vs. 36.2%) and mild-to-moderately calcified lesions (65.9% vs. 60.5%) treated, and more frequently
had overlapping BVS (22.2% vs. 10.8%), all p<0.05. Implanted BVS length was 40.0 mm (28.0, 46.9)
vs. 23.0 mm (18.0, 30.0), p<0.001, remaining in the multivariable analysis the only independent predictor
of cTLR (hazard ratio 1.02, 95% CI: 1.01-1.04, p<0.001). The myocardial infarction rate was also signi-
ficantly higher among patients with cTLR, 29.2% vs. 1.7%, p<0.0001.
Conclusions: cTLR related to BVS restenosis at six months after BVS implantation is a rare event depend-
ing on implanted BVS length. Whether cTLR increases the myocardial infarction risk needs to be evaluated
at longer-term follow-up and within the setting of adequately powered randomised trials.
KEYWORDS
• bioresorbable
scaffolds
• in-stent restenosis
• stent thrombosis
SUBMITTED ON 09/04/2017 - REVISION RECEIVED ON 1
st
05/05/2017 / 2
nd
13/06/2017 - ACCEPTED ON 23/06/2017