■对于慢性威胁肢体缺血(CLTI)患者而言,有效和持久的选择有限。
■Saval试验是一项前瞻性试验,多中心,CLTI和膝下动脉病变患者的随机试验,总病变长度为140mm,狭窄70%,卢瑟福第4-5类按2:1分为SAVAL自膨式紫杉醇药物洗脱支架(DES)或无涂层球囊经皮腔内血管成形术(PTA)。主要有效性终点是主要血管通畅(即,在没有临床驱动的靶病变血运重建或靶病变手术旁路的情况下,12个月时,核心实验室裁定的基于双工超声的血流)。主要安全终点为12个月无主要不良事件(MAE)率;MAE定义为踝关节以上指数截肢的复合,重大再干预,30天死亡率在2.5%的单方面显著性水平下预先指定了终点的优越性(有效性)和非劣效性(安全性)。
■共纳入201例患者,并随机分配接受治疗(N=130DES,N=71PTA)。DES组为68.1±35.2mm,PTA组为68.7±49.2mm,和31.0%和27.6%的患者,分别,有闭塞。DES组的12个月主要通畅率为68.0%,PTA组为76.0%(P差=0.8552)。MAE游离率分别为91.6%和95.3%,分别为(次优=0.0433)。
■Saval试验未显示与PTA相比,镍钛诺DES在长度达140mm的膝下动脉病变中的有效性和安全性相关的益处。需要持续创新,为CLTI提供最佳治疗方法。(ClinicalTrials.gov标识符:NCT03551496)。
Effective and durable options for infrapopliteal artery revascularization for patients with chronic limb-threatening ischemia (CLTI) are limited.
The SAVAL
trial is a prospective, multicenter, randomized
trial of patients with CLTI and infrapopliteal artery lesions with total lesion length ⩽ 140 mm, stenosis ⩾ 70%, and Rutherford category 4-5 assigned 2:1 to treatment with the SAVAL self-expandable paclitaxel drug-eluting stent (DES) or percutaneous transluminal angioplasty (PTA) with an uncoated balloon. The primary effectiveness endpoint was primary vessel patency (i.e., core lab-adjudicated duplex ultrasound-based flow at 12 months in the absence of clinically driven target lesion revascularization or surgical bypass of the target lesion). The primary safety endpoint was the 12-month major adverse event (MAE)-free rate; MAEs were defined as a composite of above-ankle index limb amputation, major reintervention, and 30-day mortality. The endpoints were prespecified for superiority (effectiveness) and noninferiority (safety) at a one-sided significance level of 2.5%.
A total of 201 patients were enrolled and randomly assigned to treatment (N = 130 DES, N = 71 PTA). Target lesion length was 68.1 ± 35.2 mm for the DES group and 68.7 ± 49.2 mm for the PTA group, and 31.0% and 27.6% of patients, respectively, had occlusions. The 12-month primary patency rates were 68.0% for the DES group and 76.0% for the PTA group (Psuperiority = 0.8552). The MAE-free rates were 91.6% and 95.3%, respectively (Pnoninferiority = 0.0433).
The SAVAL
trial did not show benefit related to effectiveness and safety with the nitinol DES compared with PTA in infrapopliteal artery lesions up to 140 mm in length. Continued innovation to provide optimal treatments for CLTI is needed. (ClinicalTrials.gov Identifier: NCT03551496).