Procedural findings and early healing response after implantation of a self-apposing bioresorbable scaffold in coronary bifurcation lesions

• Published in: The International Journal of Cardiovascular Imaging Vol. 35; no. 7; pp. 1199 - 1210
• Main Authors: Holck, Emil Nielsen, Fox-Maule, Camilla, Barkholt, Trine Ørhøj, Jakobsen, Lars, Tu, Shengxian, Maeng, Michael, Dijkstra, Jouke, Christiansen, Evald Høj, Holm, Niels Ramsing
• Format: Journal Article
• Language: English
• Published: Dordrecht Springer Netherlands 01-07-2019; Springer Nature B.V
• Subjects: Angina; Angina pectoris; Bifurcations; Biocompatibility; Biomedical materials; Blood clots; Blood vessels; Cardiac Imaging; Cardiology; Feasibility studies; Healing; Imaging; Implantation; Lesions; Medicine; Medicine & Public Health; Optical Coherence Tomography; Original Paper; Patients; Properties (attributes); Radiology; Scaffolds; Stenosis; Stents; Struts; Surgical implants; Thrombosis; Coronary bifurcations; Bioresorbable stent; Optical coherence tomography; Stent fracture
• ISSN: 1569-5794; 1573-0743; 1875-8312
• DOI: 10.1007/s10554-019-01537-5

We aimed to evaluate feasibility, early healing and self-correcting properties of the Desolve 150 bioresorbable scaffold (BRS) implanted in bifurcation lesions, using the simple, provisional side branch (SB) stenting technique. BIFSORB pilot was a proof-of-concept study enrolling 10 patients with stable angina pectoris and a bifurcation lesion with SB ≥ 2.5 mm and less than 50% diameter stenosis. Procedure and 1-month outcome was evaluated by optical coherence tomography (OCT) to assess scaffold performance and healing patterns. Nine patients were treated with Desolve 150 BRS and one delivery to the target bifurcation failed. Thrombus formation in the jailed SB ostium was seen in three cases, but was completely resolved at 1-month. OCT confirmed acute self-correcting properties. No clinical events were reported after six months. Scaffold diameter by OCT increased in the proximal main vessel from 3.09 ± 0.16 mm to 3.34 ± 0.18 mm (p = 0.01) and in distal main vessel from 2.82 ± 0.26 mm to 3.02 ± 0.29 mm (p < 0.01) at one-month follow-up. SB ostial diameter stenosis improved from 42 ± 15% to 34 ± 12% (p = 0.01). Malapposition was effectively reduced after 1 month from 4.1 (1.4; 6.1)% to 0.1 (0; 0.6)% (p = 0.002). Treatment of bifurcation lesions using Desolve 150 BRS was feasible except for a delivery failure and unsettling thrombus formation behind jailing SB struts, which was completely resolved at 1-month. Self-correcting and even self-expanding properties were confirmed.