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Impact of lesion calcification on angiographic outcomes after Absorb everolimus-eluting bioresorbable vascular scaffold implantation: an observation from the ABSORB Japan trial

1. Kurashiki Central Hospital, Kurashiki, Japan; 2. Thoraxcenter, Erasmus MC, Rotterdam, The Netherlands; 3. Teikyo University Hospital, Tokyo, Japan; 4. Mitsui Memorial Hospital, Tokyo, Japan; 5. Kansai Rosai Hospital Cardiovascular Center, Hyogo, Japan; 6. Shinkoga Hospital, Fukuoka, Japan; 7. Iwate Medical University Hospital, Iwate, Japan; 8. Sakakibara Heart Institute, Tokyo, Japan; 9. Saiseikai Kumamoto Hospital, Kumamoto, Japan; 10. Osaka University Hospital, Osaka, Japan; 11. Tokushima Red Cross Hospital, Tokushima, Japan; 12. Miyazaki Medical Association Hospital, Miyazaki, Japan; 13. Abbott Vascular, Santa Clara, CA, USA; 14. Columbia University Medical Center, NewYork-Presbyterian Hospital, and the Cardiovascular Research Foundation, New York, NY, USA; 15. Beth Israel Deaconess Medical Center, Boston, MA, USA; 16. Kyoto University Hospital, Kyoto, Japan

Aims: We aimed to investigate the impact of lesion calcification on angiographic outcomes after Absorb everolimus-eluting bioresorbable vascular scaffold (BVS) implantation in comparison with those after cobalt-chromium everolimus-eluting stent (CoCr-EES) implantation.

Methods and results: The present post hoc analysis of the ABSORB Japan randomised trial compared post-procedure and 13-month angiographic outcomes between patients implanted with BVS and CoCr-EES based on the presence or absence of calcification, excluding extremely heavily calcified lesions or lesions requiring rotational atherectomy. The study population comprised 384 patients with 384 lesions (including 114 lesions [29.7%] with moderate or severe calcification), classified into two subgroups: calcification, 114 (BVS: n=72 and CoCr-EES: n=42) and non-calcification, 270 (BVS: n=181 and CoCr-EES: n=89). Follow-up angiography was performed in 94.8% of patients. Both post-procedure and follow-up in-device minimal lumen diameters were comparable in both the BVS arm (calcification vs. non-calcification: 2.43±0.32 mm vs. 2.43±0.39 mm, p=0.91 and 2.17±0.49 mm vs. 2.27±0.47 mm, p=0.17) and in the CoCr-EES arm (2.68±0.34 mm vs. 2.65±0.42 mm, p=0.62 and 2.57±0.52 mm vs. 2.47±0.53 mm, p=0.36).

Conclusions: Moderate or severe lesion calcification (excluding patients with extremely heavily calcified lesions or lesions requiring rotational atherectomy) does not negatively affect angiographic outcomes at both post-procedure and 13-month follow-up after BVS implantation. ClinicalTrials.gov Identifier: NCT01844284

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