Clinical restenosis and its predictors after implantation of everolimus-eluting bioresorbable vascular scaffolds: results from GABI-R
Julinda Mehilli, Stephan Achenbach, Jochen Woehrle, Moritz Baquet, Thomas Riemer, Thomas Muenzel, Holger Nef, Christoph Naber, Gert Richardt, Ralf Zahn, Tommaso Gori, Till Neumann, Johannes Kastner, Axel Schmermund, Christian Hamm, Julinda Mehilli, Stephan Achenbach, Jochen Woehrle, Moritz Baquet, Thomas Riemer, Thomas Muenzel, Holger Nef, Christoph Naber, Gert Richardt, Ralf Zahn, Tommaso Gori, Till Neumann, Johannes Kastner, Axel Schmermund, Christian Hamm
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 implantation in the 93 centres of GABI-R. At six-month follow-up, 24 patients experienced clinically indicated target lesion revascularisation (cTLR) unrelated to BVS thrombosis (cumulative 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 significantly 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 depending 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.
Source: PubMed