Deloose Koen, Bosiers Marc, Callaert Joren, Peeters Patrick, Verbist Jurgen, van den Eynde Wouter, Maene Lieven, Beelen Roel, Keirse Koen
A.Z. Sint-Blasius, Dendermonde, Belgium -
A.Z. Sint-Blasius, Dendermonde, Belgium.
J Cardiovasc Surg (Torino). 2019 Apr;60(2):230-236. doi: 10.23736/S0021-9509.17.09916-5. Epub 2017 May 26.
The BeGraft Peripheral PMCF study is a prospective, non-randomized study, conducted at the vascular departments of 4 hospitals in Belgium. This manuscript reports the findings up to 12-month follow-up time for the total cohort. The primary endpoint of the study is primary patency at 12 months. Primary patency is defined as a target lesion without a hemodynamically significant stenosis on Duplex ultrasound (>50%, systolic velocity ratio no greater than 2.4) and without target lesion revascularization (TLR) within 12 months.
Between June 2014 and March 2015, 70 patients with TASC II Class A (77.1%), B (14.3%), C (5.7%) or D (2.9%) aortoiliac lesions were included. The mean lesion length was 34.3 mm with a mean degree of stenosis of 83.16%.
Primary patency rate for the total patient population was 94.4% at 12-month follow-up. Freedom from TLR at 12-month was 96.7%.
These results confirm the already existing enthusiasm of the use of covered stents in the aorto-iliac field. Longer follow-up and more complex lesions have to be studied in the upcoming future.
BeGraft外周前瞻性上市后临床随访研究是一项在比利时4家医院血管科开展的前瞻性、非随机研究。本论文报告了整个队列长达12个月随访期的研究结果。该研究的主要终点是12个月时的原发性通畅率。原发性通畅定义为双功超声检查时目标病变无血流动力学意义的狭窄（>50%，收缩期速度比不大于2.4）且12个月内无目标病变血运重建（TLR）。
2014年6月至2015年3月期间，纳入了70例患有TASC II A类（77.1%）、B类（14.3%）、C类（5.7%）或D类（2.9%）主髂动脉病变的患者。平均病变长度为34.3 mm，平均狭窄程度为83.16%。
在12个月的随访中，整个患者群体的原发性通畅率为94.4%。12个月时无TLR的比例为96.7%。
这些结果证实了在主髂动脉领域使用覆膜支架已有的热情。未来需要对更长时间的随访和更复杂的病变进行研究。
