METHODS: In a post-hoc analysis, the SuperB trial and Zilverpass databases were merged. Patients in the endovascular treatment arms were included, and data was analyzed in an intention-to-treat (ITT) and a per-protocol (PP) fashion. Data included baseline and lesion characteristics, procedural details, and follow-up data. The primary endpoint of this study was primary patency at 1-year follow-up. The secondary endpoints were secondary patency, target lesion revascularization (TLR), limb loss, and all-cause mortality.
RESULTS: A total of 176 patients were included; 63 in the SECS arm and 113 in the DES arm. Through 1-year follow-up, there were no significant differences in primary patency (ITT: 63.4% vs 71.1%: P = .183 and PP: 60.8% vs 71.1%; P = .100). Secondary patency rates were not significantly different in the ITT analysis (86.5% vs 95.1%; P = .054), but in the PP analysis, there was a significant difference in favor of the DES group (SECS, 85.6% vs DES, 95.1%; P = .038). There was no significant difference in freedom from TLR between groups (79.6% vs 77.0%; P = .481). No major amputations were performed in the SECS group, and two were performed in the DES group (1.8%). Survival rate was 98.2% in the SECS group, and 91.3% in the DES group after 1-year follow-up (P = .106). Based on diagnosis (intermittent claudication vs chronic limb-threatening ischemia) no differences between patients with intermittent claudication and chronic limb-threatening ischemia were observed in primary patency, secondary patency and freedom from TLR.
CONCLUSIONS: Treatment of complex femoropopliteal arterial disease with the heparin-bonded Viabahn endoprosthesis and the Zilver PTX drug-eluting stent are related to similar primary and secondary patency, and TLR rates at 1 year, except for secondary patency in the PP analysis. This study further supports the endovascular treatment of long complex lesions in the femoropopliteal artery.
方法:在事后分析中,SuperB试验和Zilverpass数据库被合并.纳入血管内治疗组的患者,并以意向治疗(ITT)和符合方案(PP)的方式分析数据。数据包括基线和病变特征,程序细节,和后续数据。这项研究的主要终点是一年随访时的主要通畅性。次要终点是次要通畅,靶病变血运重建(TLR),肢体丧失,和全因死亡率。
结果:共纳入176例患者;SECS组63例,DES组113例。通过1年的随访,原发性通畅性没有显着差异(ITT63.4%vs71.1%:p=0.183,PP60.8%vs71.1%;p=0.100)。在ITT分析中,次级通畅率没有显着差异(86.5%vs95.1%;p=0.054),但是在PP分析中,DES组有显著差异(SECS85.6%对DES95.1%;p=0.038)。两组间的TLR自由度无显著差异(79.6%vs77.0%,p=0.481)。SECS组未进行大截肢,DES组未进行两次截肢(1.8%)。SECS组生存率为98.2%,随访一年后,DES组为91.3%(p=0.106)。根据诊断(IC与CLTI),在原发性,二级通畅和无TLR。
结论:使用肝素结合的Viabahn内假体和ZilverPTX药物洗脱支架治疗复杂的股pop动脉疾病与相似的主要和次要通畅性有关,和一年期TLR率,除了PP分析中的二次通畅性。这项研究进一步支持了股pop动脉中长复杂病变的血管内治疗。