Abstract：
OBJECTIVE: To assess the comparative safety and efficacy of covered stents (CS) and bare metal stents (BMS) in the endovascular treatment of aorto-iliac disease in patients with peripheral arterial disease.
METHODS: A systematic review was conducted adhering to the PRISMA 2020 and PRISMA for Individual Participant Data 2015 guidelines.
METHODS: A search of PubMed, Scopus, and Web of Science for articles published by December 2023 was performed. The primary endpoint was primary patency. Certainty of evidence was assessed via the Grading of Recommendations Assessment, Development, and Evaluation (GRADE) framework.
RESULTS: Eleven studies, comprising 1 896 patients and 2 092 lesions, were included. Of these, nine studies reported on patients\' clinical status, with 35.5% classified as Rutherford 4 - 6. Overall primary patency for CS and BMS at 48 months was 91.2% (95% confidence interval [CI] 84.1 - 99.0%) (GRADE, moderate) and 83.5% (95% CI 70.9 - 98.3%) (GRADE, low). The one stage individual participant data meta-analyses indicated a significant risk reduction for primary patency loss favouring CS (hazard ratio [HR] 0.58, 95% CI 0.35 - 0.95) (GRADE, very low). The 48 month primary patency for CS and BMS when treating TransAtlantic Inter-Society Consensus (TASC) C and D lesions was 92.4% (95% CI 84.7 - 100%) (GRADE, moderate) and 80.8% (95% CI 64.5 - 100%) (GRADE, low), with CS displaying a decreased risk of patency loss (HR 0.39, 95% CI 0.27 - 0.57) (GRADE, moderate). While statistically non-significant differences were identified between CS and BMS regarding technical success, 30 day mortality rate, intra-operative and immediate post-operative procedure related complications, and major amputation, CS displayed a decreased re-intervention risk (risk ratio 0.59, 95% CI 0.40 - 0.87) (GRADE, low).
CONCLUSIONS: This review has illustrated the improved patency of CS compared with BMS in the treatment of TASC C and D lesions. Caution is advised in interpreting overall primary patency outcomes given the substantial inclusion of TASC C and D lesions in the analysis. Ultimately, both stent types have demonstrated comparable safety profiles.
METHODS: A systematic review was conducted adhering to the PRISMA 2020 and PRISMA for Individual Participant Data 2015 guidelines.
METHODS: A search of PubMed, Scopus, and Web of Science for articles published by December 2023 was performed. The primary endpoint was primary patency. Certainty of evidence was assessed via the Grading of Recommendations Assessment, Development, and Evaluation (GRADE) framework.
RESULTS: Eleven studies, comprising 1 896 patients and 2 092 lesions, were included. Of these, nine studies reported on patients\' clinical status, with 35.5% classified as Rutherford 4 - 6. Overall primary patency for CS and BMS at 48 months was 91.2% (95% confidence interval [CI] 84.1 - 99.0%) (GRADE, moderate) and 83.5% (95% CI 70.9 - 98.3%) (GRADE, low). The one stage individual participant data meta-analyses indicated a significant risk reduction for primary patency loss favouring CS (hazard ratio [HR] 0.58, 95% CI 0.35 - 0.95) (GRADE, very low). The 48 month primary patency for CS and BMS when treating TransAtlantic Inter-Society Consensus (TASC) C and D lesions was 92.4% (95% CI 84.7 - 100%) (GRADE, moderate) and 80.8% (95% CI 64.5 - 100%) (GRADE, low), with CS displaying a decreased risk of patency loss (HR 0.39, 95% CI 0.27 - 0.57) (GRADE, moderate). While statistically non-significant differences were identified between CS and BMS regarding technical success, 30 day mortality rate, intra-operative and immediate post-operative procedure related complications, and major amputation, CS displayed a decreased re-intervention risk (risk ratio 0.59, 95% CI 0.40 - 0.87) (GRADE, low).
CONCLUSIONS: This review has illustrated the improved patency of CS compared with BMS in the treatment of TASC C and D lesions. Caution is advised in interpreting overall primary patency outcomes given the substantial inclusion of TASC C and D lesions in the analysis. Ultimately, both stent types have demonstrated comparable safety profiles.
摘要：
目的：评估覆膜支架（CS）和裸金属支架（BMS）在周围动脉疾病患者主动脉-髂疾病血管内治疗中的安全性和有效性。
方法：遵循PRISMA2020和PRISMA2015个人参与者数据指南进行了系统评价。
方法：搜索PubMed，Scopus,和WebofScience对2023年12月发表的文章进行了研究。主要终点是原发性通畅。通过建议分级评估证据的确定性，评估,发展,和评估（等级）框架。
结果：11项研究，包括1896名患者和2092个病变，包括在内。其中,九项研究报告了患者的临床状况，35.5%被列为卢瑟福4-6级。48个月时，CS和BMS的总体主要通畅率为91.2%（95%置信区间[CI]84.1-99.0%）（等级，中等）和83.5%（95%CI70.9-98.3%）（等级，低)。单阶段个体参与者数据荟萃分析表明，主要通畅性损失的风险显着降低，有利于CS（风险比[HR]0.58，95％CI0.35-0.95）（等级，非常低)。治疗跨大西洋国际社会共识（TASC）C和D病变时，CS和BMS的48个月主要通畅率为92.4％（95％CI84.7-100％）（等级，中等）和80.8%（95%CI64.5-100%）（等级，低),CS显示通畅性丧失的风险降低(HR0.39，95%0.27-0.57)(等级，中度)。虽然在技术成功方面，CS和BMS之间存在统计学上的非显著性差异，30天死亡率，术中和术后即刻相关并发症，严重截肢,CS显示再干预风险降低(风险比0.59，95%CI0.40-0.87)(等级，低)。
结论：这篇综述说明了与BMS相比，CS治疗TASCC和D病变的通畅性得到改善。考虑到TASCC和D病变的大量纳入分析，在解释总体主要通畅性结果时建议谨慎。最终,两种类型的支架都证明了具有可比性的安全性.
方法：遵循PRISMA2020和PRISMA2015个人参与者数据指南进行了系统评价。
方法：搜索PubMed，Scopus,和WebofScience对2023年12月发表的文章进行了研究。主要终点是原发性通畅。通过建议分级评估证据的确定性，评估,发展,和评估（等级）框架。
结果：11项研究，包括1896名患者和2092个病变，包括在内。其中,九项研究报告了患者的临床状况，35.5%被列为卢瑟福4-6级。48个月时，CS和BMS的总体主要通畅率为91.2%（95%置信区间[CI]84.1-99.0%）（等级，中等）和83.5%（95%CI70.9-98.3%）（等级，低)。单阶段个体参与者数据荟萃分析表明，主要通畅性损失的风险显着降低，有利于CS（风险比[HR]0.58，95％CI0.35-0.95）（等级，非常低)。治疗跨大西洋国际社会共识（TASC）C和D病变时，CS和BMS的48个月主要通畅率为92.4％（95％CI84.7-100％）（等级，中等）和80.8%（95%CI64.5-100%）（等级，低),CS显示通畅性丧失的风险降低(HR0.39，95%0.27-0.57)(等级，中度)。虽然在技术成功方面，CS和BMS之间存在统计学上的非显著性差异，30天死亡率，术中和术后即刻相关并发症，严重截肢,CS显示再干预风险降低(风险比0.59，95%CI0.40-0.87)(等级，低)。
结论：这篇综述说明了与BMS相比，CS治疗TASCC和D病变的通畅性得到改善。考虑到TASCC和D病变的大量纳入分析，在解释总体主要通畅性结果时建议谨慎。最终,两种类型的支架都证明了具有可比性的安全性.
