Abstract：
OBJECTIVE: In two randomized controlled trials, the outcomes of endovascular treatment of complex femoropopliteal arterial lesions were compared with bypass surgery and considered a valid alternative treatment. The aim of this study was to compare both endovascular treatment options with the hypothesis that implantation of heparin-bonded self-expanding covered stents (Viabahn [SECS]) or drug-eluting stents (ZilverPTX [DES]) are related to similar clinical outcomes at 1-year follow-up.
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.
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.
摘要：
目的：在两项随机对照试验中，我们比较了复杂股pop动脉病变的腔内治疗与搭桥手术的结果,认为这是一种有效的替代治疗方法.这项研究的目的是将两种血管内治疗方案与以下假设进行比较：植入肝素结合的自扩张覆膜支架（Viabahn，SECS)或药物洗脱支架(ZilverPTX,DES）在一年的随访中与相似的临床结果有关。
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。
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。
