Holck Emil Nielsen, Fox-Maule Camilla, Barkholt Trine Ørhøj, Jakobsen Lars, Tu Shengxian, Maeng Michael, Dijkstra Jouke, Christiansen Evald Høj, Holm Niels Ramsing
Department of Cardiology, Aarhus University Hospital Skejby, Palle Juul-Jensens Boulevard 99, 8200, Aarhus N, Denmark.
Biomedical Instrument Institute, School of Biomedical Engineering, Shanghai Jiao Tong University, Wenxuan Building, 800 Dongchuan RD, Minhang District, Shanghai, China.
Int J Cardiovasc Imaging. 2019 Jul;35(7):1199-1210. doi: 10.1007/s10554-019-01537-5. Epub 2019 May 4.
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.
我们旨在采用简单的临时边支（SB）支架置入技术，评估植入分叉病变处的Desolve 150生物可吸收支架（BRS）的可行性、早期愈合情况及自我纠正特性。BIFSORB试点研究是一项概念验证性研究，纳入了10例稳定型心绞痛且伴有SB≥2.5 mm且直径狭窄小于50%的分叉病变患者。通过光学相干断层扫描（OCT）评估手术过程及1个月的结局，以评估支架性能及愈合模式。9例患者接受了Desolve 150 BRS治疗，1次向目标分叉处的输送失败。3例患者在被覆盖的SB开口处出现血栓形成，但在1个月时完全消退。OCT证实了急性自我纠正特性。6个月后未报告临床事件。在1个月随访时，OCT显示近端主血管处支架直径从3.09±0.16 mm增加至3.34±0.18 mm（p = 0.01），远端主血管处从2.82±0.26 mm增加至3.02±0.29 mm（p < 0.01）。SB开口处直径狭窄从42±15%改善至34±12%（p = 0.01）。1个月后贴壁不良从4.1（1.4；6.1）%有效降低至0.1（0；0.6）%（p = 0.002）。除了一次输送失败及在被覆盖的SB支架后方出现令人不安的血栓形成（在1个月时完全消退）外，使用Desolve 150 BRS治疗分叉病变是可行的。证实了自我纠正甚至自我扩张特性。
