Hendrik Wienemann1,2, Felix Meincke3,4, Marius Vach5, Christian-Hendrik Heeger3,6, Annika Meyer7, Tobias Spangenberg3,4, Karl Heinz Kuck3,6, Alexander Ghanem3,5,8. 1. Department of Cardiology, Asklepios Klinik St. Georg, Hamburg, Germany. hendrik.wienemann@uk-koeln.de. 2. Faculty of Medicine and University Hospital Cologne, Clinic III for Internal Medicine, University of Cologne, Cologne, Germany. hendrik.wienemann@uk-koeln.de. 3. Department of Cardiology, Asklepios Klinik St. Georg, Hamburg, Germany. 4. Department of Cardiology, Asklepios Klinik Altona, Hamburg, Germany. 5. Department of Medicine II, Heart Center Bonn, University Hospital Bonn, Bonn, Germany. 6. Department of Rhythmology, University Heart Center Lübeck, UKSH Lübeck, Lübeck, Germany. 7. Faculty of Medicine and University Hospital Cologne, Clinic III for Internal Medicine, University of Cologne, Cologne, Germany. 8. Department of Cardiology, Asklepios Klinik Nord, Hamburg, Germany.
Abstract
BACKGROUND: Polymer-free and carrier-free drug-coated stents (DCS) represent a novel therapeutic option for the treatment of coronary artery disease. The objective of this pilot registry is to evaluate the safety and efficacy of DCS implantation in bifurcation lesions. METHODS: Overall, 23 consecutive patients with 24 lesions received a Biolimus A9-coated DCS for coronary bifurcation lesions. Patients were examined with quantitative coronary angiography (QCA) and optical coherence tomography (OCT) at 3-6 months of follow-up. RESULTS: A total of 23 patients with 24 bifurcation lesions were included in this study. Nine (33.3%) lesions of eight patients revealed angiographical target lesion failure due to in-stent restenosis (ISR). In total, 19 patients with 20 bifurcation lesions were suitable for OCT analysis. A total of 2936 struts were analyzed and 14 struts (0.47%) were classified as malapposed. The mean luminal area (mm2) was not different in lesions with ISR vs. lesions with no ISR (5.07 ± 2.0 vs. 5.73 ± 1.34, p = 0.39) at follow-up. Lesions with ISR showed higher mean neointimal burden (27.11 ± 10.59 vs. 13.93 ± 9.16%, respectively; p = 0.009). All of the patients who presented with significant ISR required percutaneous re-intervention. CONCLUSIONS: We observed a high rate of DCS ISR in bifurcation lesions, possibly related to increased inflammation and neoatherosclerosis. The small size of the study warrants careful interpretation of our results. Larger trials are necessary to expand knowledge of these findings.
BACKGROUND: Polymer-free and carrier-free drug-coated stents (DCS) represent a novel therapeutic option for the treatment of coronary artery disease. The objective of this pilot registry is to evaluate the safety and efficacy of DCS implantation in bifurcation lesions. METHODS: Overall, 23 consecutive patients with 24 lesions received a Biolimus A9-coated DCS for coronary bifurcation lesions. Patients were examined with quantitative coronary angiography (QCA) and optical coherence tomography (OCT) at 3-6 months of follow-up. RESULTS: A total of 23 patients with 24 bifurcation lesions were included in this study. Nine (33.3%) lesions of eight patients revealed angiographical target lesion failure due to in-stent restenosis (ISR). In total, 19 patients with 20 bifurcation lesions were suitable for OCT analysis. A total of 2936 struts were analyzed and 14 struts (0.47%) were classified as malapposed. The mean luminal area (mm2) was not different in lesions with ISR vs. lesions with no ISR (5.07 ± 2.0 vs. 5.73 ± 1.34, p = 0.39) at follow-up. Lesions with ISR showed higher mean neointimal burden (27.11 ± 10.59 vs. 13.93 ± 9.16%, respectively; p = 0.009). All of the patients who presented with significant ISR required percutaneous re-intervention. CONCLUSIONS: We observed a high rate of DCS ISR in bifurcation lesions, possibly related to increased inflammation and neoatherosclerosis. The small size of the study warrants careful interpretation of our results. Larger trials are necessary to expand knowledge of these findings.
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