Palena Luis M, Diaz-Sandoval Larry J, Sultato Enrico, Brigato Cesare, Candeo Alessandro, Brocco Enrico, Manzi Marco
Interventional Radiology Unit, Foot & Ankle clinic, Policlinico Abano Terme - Abano Terme (PD), Italy.
Department of Internal Medicine, Division of Cardiovascular Medicine, Metro Health Hospital, Michigan State University, Wyoming, Michigan.
Catheter Cardiovasc Interv. 2017 Apr;89(5):910-920. doi: 10.1002/ccd.26863. Epub 2016 Nov 12.
Stent-based revascularization of long femoro-popliteal (FP) lesions has been mainly studied in claudicants and compromised by restenosis and stent fractures. The Supera stent's biomimetic design allows enhanced fracture resistance. Data for Supera stenting to treat long chronic total occlusions (CTOs) in patients with critical limb ischemia (CLI), are scarce.
To assess long-term outcomes of subintimal revascularization with Supera stenting, for long FP CTOs in patients with CLI.
Prospective, single-center, single-arm study of 34 consecutive CLI patients with FP TASC C and D CTOs, who underwent Supera stenting after subintimal crossing. Primary efficacy endpoint was 1-year patency and freedom from target lesion revascularization (TLR). Primary safety endpoint was the composite rate of freedom from death from any cause, major amputations, and TLR at a year. Secondary endpoints were stent integrity, clinical improvement, amputation free-survival, quality of life, and cost-efficiency.
Mean lesion length was 27.9 ± 10.2 cm. Acute technical success was 100%. Primary patency was 94.1%. Freedom from TLR was 97.1%. Limb salvage was 100%. Clinical improvement was observed in 100% of patients: T PO increased from 12.7 ± 6.2 to 54.8 ± 8.4 mm Hg (p < 0,0001); and 100% of patients experienced a shift in Rutherford to class 0 (p < 0.0001). There were no stents fractures. Amputation free-survival was 82.4%.
Subintimal revascularization with Supera stenting in CLI patients with long FP occlusions, is feasible and superior to validated efficacy performance goals. Larger multicenter studies are needed to validate the safety and efficacy of this novel alternative approach. © 2016 Wiley Periodicals, Inc.
基于支架的长段股腘（FP）病变血管重建术主要在间歇性跛行患者中进行研究，且受到再狭窄和支架断裂的影响。Supera支架的仿生设计可增强抗断裂能力。关于Supera支架置入术治疗严重肢体缺血（CLI）患者的长段慢性完全闭塞（CTO）的数据较少。
评估Supera支架置入术对CLI患者长段FP CTO进行内膜下血管重建的长期疗效。
对34例连续的CLI患者进行前瞻性、单中心、单臂研究，这些患者患有FP TASC C和D级CTO，在内膜下穿过病变后接受Supera支架置入术。主要疗效终点是1年通畅率和无靶病变血管重建（TLR）。主要安全终点是1年时任何原因导致的死亡、大截肢和TLR的复合免除率。次要终点包括支架完整性、临床改善情况、无截肢生存率、生活质量和成本效益。
平均病变长度为27.9±10.2 cm。急性技术成功率为100%。原发通畅率为94.1%。无TLR率为97.1%。肢体挽救率为100%。100%的患者观察到临床改善：经皮氧分压（T PO）从12.7±6.2 mmHg增加到54.8±8.4 mmHg（p<0.0001）；100%的患者Rutherford分级转变为0级（p<0.0001）。未发生支架断裂。无截肢生存率为82.4%。
在患有长段FP闭塞的CLI患者中，采用Supera支架置入术进行内膜下血管重建是可行的，且优于已验证的疗效性能目标。需要更大规模的多中心研究来验证这种新型替代方法的安全性和有效性。©2016威利期刊公司
