摘要
腔内治疗目前被认为是大多数症状性外周动脉疾病患者的一线治疗方法,近期相关研究主要关注在短期或中期(≤2年)的随访期间,腔内方法治疗新发股腘动脉病变的疗效差异。然而,长期随访下新发股腘动脉病变的最佳腔内治疗方法仍未明确。因此,本研究通过随机对照试验(RCT)的网络Meta分析,比较普通球囊血管成形术(BA)、裸镍钛合金支架(BNS)、药物涂层球囊(DCB)和药物洗脱支架(DES)植入术在短期和长期随访中治疗新发股腘动脉病变的疗效。
检索多个医学数据库后,共纳入26项RCT(共4 480例患者),对各种方法的疗效与安全性进行网络Meta分析。结局指标包括1、2和(或)3年随访期间的一期通畅率、靶病变血运重建(TLR)率、大截肢率和全因病死率。
在1、2、3年随访的一期通畅率方面,DES均显示为最有效的治疗方法,并且其2年的一期通畅率明显均高于BA(OR=11.11,95% CI=3.06~40.28)、BNS(OR=2.82,95% CI=1.06~7.53)和DCB(OR=4.19,95% CI=1.06~16.51)。在1、2、3年随访的TLR率方面,DES均显示为最有效的治疗方法,并且其2年的TLR率明显均低于BA(OR=0.08,95% CI=0.03~0.25)、BNS(OR=0.43,95% CI=0.19~0.97)和DCB(OR=0.29,95% CI=0.09~0.88)。在1、2、3年随访的大截肢率方面,各治疗方法之间均无明显差异,但1、2、3年的累积排序曲线下面积值显示,DCB是免于大截肢最有效的方法。在1、2、3年的全因病死率方面,各治疗方法之间均无明显差异。
股腘动脉是外周动脉疾病患者最常见的受累部
传统的Meta分析方法仅涉及两种干预措施之间的成对比较,而网络Meta分析方法可用于比较所有证据中的所有干预措施,不论是否在临床试验中存在直接的成对比
系统搜索MEDLINE、Embase和Cochrane Library中的所有潜在RCT,没有出版语言的限制。所有检索均包括截至2023年9月17日的出版物。检索关键词包括:Superficial Femoral、Femoropopliteal、Infrainguinal、Endovascular、Balloon Angioplasty、Plain Balloon、Bare Metal Stent、Nitinol Stent、Drug Eluting Stent、Paclitaxel Eluting Stent、Sirolimus Eluting Stent、Drug Coated Balloon、Paclitaxel Coated Balloon、Sirolimus Coated Balloon。同时,还对纳入的研究和相关综述的参考文献进行了查阅,以便发现在数据库检索中可能漏掉的RCT。
纳入标准:⑴ 前瞻性RCT;⑵ 文献比较了新发股腘动脉病变的腔内治疗方法,腔内治疗方法包括BA、BNS、DCB和DES;⑶ 文献中提供在1、2年和(或)3年随访的一期通畅率、TLR率、重大截肢率和病死率的结果。排除标准:如果某些研究中的数据在另一项纳入的研究中被报告过,则排除该研究。
共检索出4 949篇文献,最终入选了39篇文

图1 文献筛选流程图
Figure 1 Literature selection process
纳入研究 | 随访时间(年) | 干预措施 | 患者数量 (n) | 男性占比(%) | 平均年龄(岁) | 病变长度(mm) | 闭塞病变占比(%) | CLTI 占比(%) |
---|---|---|---|---|---|---|---|---|
Krankenberg, | 1 | BA vs. BNS | 121 vs. 123 | 68.9 | 66.5 | 44.9 | 30.7 | 3.0 |
Schillinger, | 1、2 | BA vs. BNS | 53 vs. 51 | 52.9 | 66.5 | 96.4 | 34.6 | 12.5 |
Dick, | 1 | BA vs. BNS | 39 vs. 34 | 68.5 | 69.0 | 72.9 | 38.4 | 5.5 |
Zdanowski, | 1 | BA vs. BNS | 17 vs. 15 | 43.8 | 71.5 | 72.4 | 100.0 | 84.4 |
Chalmers, | 1 | BA vs. BNS | 76 vs. 74 | 82.0 | 67.9 | 119.9 | 93.3 | 18.0 |
Rastan, | 1、2 | BA vs. BNS | 127 vs. 119 | 64.3 | 72.5 | 42.3 | 33.0 | 20.7 |
Scheinert, | 1 | BA vs. DCB | 30 vs. 30 | 57.0 | 70.8 | 60.0 | n/a | 16.7 |
Tepe, | 1、2 | BA vs. DCB | 75 vs. 78 | 68.0 | 68.1 | 131.6 | 26.1 | 0.0 |
Werk, | 2 | BA vs. DCB | 42 vs. 45 | 60.0 | 68.7 | 43.4 | 15.9 | 5.8 |
Werk, | 1 | BA vs. DCB | 44 vs. 41 | 61.6 | 71.0 | 67.9 | 30.8 | 4.4 |
Schroeder, | 1、2 | BA vs. DCB | 72 vs. 222 | 71.1 | 67.5 | 71.8 | 19.0 | 1.7 |
Steiner, | 1 | BA vs. DCB | 34 vs. 71 | 72.4 | 67.7 | 65.4 | 34.0 | 2.9 |
Scheinert, | 2 | BA vs. DCB | 52 vs. 49 | 63.3 | 68.5 | 80.5 | 41.5 | 6.9 |
Rosenfield, | 1 | BA vs. DCB | 160 vs. 316 | 63.0 | 68.2 | 63.0 | 21.3 | 8.0 |
Duda, | 2 | BNS vs. DES | 46 vs. 47 | 72.0 | 66.1 | 83.0 | 61.3 | 未描述 |
Bausback, | 3 | DCB vs. DES | 75 vs. 75 | 68.0 | 68.9 | 152.6 | 52.7 | 13.3 |
Dake, | 1、2、5 |
BA vs. DES BNS vs. DES |
118 vs. 236 59 vs. 61 | 64.8 | 67.8 | 64.7 | 27.1 | 8.6 |
Laird, | 1、3 | BA vs. BNS | 72 vs. 134 | 69.4 | 67.3 | 68.3 | 17.5 | 0.5 |
Iida, | 3 | BA vs. BNS | 26 vs. 51 | 75.3 | 74.0 | 92.3 | 22.1 | 24.7 |
Krishnan, | 1、4 | BA vs. DCB | 100 vs. 200 | 58.7 | 68.8 | 83.0 | 18.7 | 4.3 |
Nowakowski, | 3 | BA vs. DCB | 33 vs. 33 | 80.3 | 65.5 | 61.7 | 34.8 | 15.2 |
Tepe, | 1、2、3、5 | BA vs. DCB | 111 vs. 220 | 66.0 | 67.7 | 88.7 | 24.7 | 5.4 |
Soga, | 3 | BA vs. DCB | 32 vs. 68 | 76.0 | 73.6 | 90.7 | 16.0 | 4.0 |
Teichgräber, | 5 | BA vs. DCB | 86 vs. 85 | 64.9 | 68.0 | 57.5 | 22.8 | 2.4 |
Tepe, | 2、5 | BA vs. DCB | 54 vs. 48 | 63.9 | 68.5 | 74.5 | 26.5 | 12.8 |
Jia, | 1、5 | BA vs. DCB | 100 vs. 100 | 73.5 | 65.8 | 149.5 | 54.5 | 42.0 |
注: CLTI,慢性肢体威胁性缺血
Note: CLTI, chronic limb-threatening ischemia
文章的筛选和数据提取由2位研究者独立进行分析。提取的主要信息如下:随访时间、研究设计、人群基线特征、结局指标和研究质量(偏倚风险)。
根据Cochrane合作组织偏倚风险评估工
结局事件包括:⑴ 一期通畅,指的是治疗后的血管病变没有发生TLR和再狭窄(经血管造影显示直径狭窄程度≥50%或多普勒超声提示峰值收缩速度比≥2.4);⑵ TLR;⑶ 大截肢,定义为踝关节以上的截肢;⑷ 全因死亡。结局指标即为结局事件的发生率。随访时间包括术后1、2、3年。
本研究采用多变量网络Meta分析方法,综合来自不同来源的证据,对多种干预方法的相对有效性进行推
所有的研究都是前瞻性RCT,都采用了随机化分组。其中大多数研究都没有对受试者及研究者设盲。在大多数研究中,采用了分配隐藏,但在少数研究中存在不完整结局数据和选择性结果报告。一些研究没有详细描述是否对数据分析者设盲以及其他潜在偏倚的信息。
纳入研究 | 随机序列生成 | 分配隐藏 | 研究者和受试者设盲 | 数据分析者设盲 | 不完整结局数据 | 选择性报告结果 | 其他偏移 |
---|---|---|---|---|---|---|---|
Krankenberg, | + | + | - | ? | + | + | - |
Schillinger, | + | + | - | ? | + | + | ? |
Dick, | + | + | - | ? | + | + | ? |
Zdanowski, | + | + | - | ? | ? | ? | ? |
Chalmers, | + | + | - | ? | + | + | ? |
Rastan, | + | + | - | + | + | + | + |
Scheinert, | + | + | - | + | + | + | + |
Tepe, | + | + | - | + | + | + | + |
Werk, | + | - | - | + | + | - | + |
Werk, | + | + | - | + | + | + | + |
Schroeder, | + | + | - | + | + | + | + |
Steiner, | + | + | - | + | + | + | + |
Scheinert, | + | + | - | + | + | + | + |
Rosenfield, | + | + | - | + | + | + | + |
Duda, | + | ? | + | + | + | + | + |
Bausback, | + | + | - | ? | + | + | ? |
Dake, | + | ? | ? | + | + | + | ? |
Laird, | + | + | - | ? | + | + | ? |
Iida, | + | + | - | ? | + | - | - |
Krishnan, | + | + | - | ? | + | + | + |
Nowakowski, | + | + | ? | + | + | + | ? |
Tepe, | + | + | - | + | + | + | + |
Soga, | + | + | - | + | + | + | ? |
Teichgräber, | + | + | + | + | + | + | + |
Tepe, | + | ? | - | - | + | + | + |
Jia, | + | + | - | + | + | + | + |
11项研

图2 各种方法一期通畅率的网络图
Figure 2 Network plot for primary patency rates of each method

图3 各种方法一期通畅率的森林图
Figure 3 Forest plot for primary patency rates of each method

图4 各种方法一期通畅率SUCRA排序图
Figure 4 SUCRA ranking plot for primary patency rates of each method
2.2.2 TLR率 16项研

图5 各种方法TLR率的网络图
Figure 5 Network plot for TLR rates of each method

图6 各种方法TLR率的森林图
Figure 6 Forest plot for TLR rates of each method

图7 各种方法TLR率的SUCRA排序图
Figure 7 SUCRA ranking plot for TLR rates of each method
17项研

图8 各种方法大截肢率的网络图
Figure 8 Network plot for major amputation rates of each method

图9 各种方法大截肢率的森林图
Figure 9 Forest plot for major amputation rates of each method

图10 各种方法大截肢率的SUCRA排序图
Figure 10 SUCRA ranking plot for major amputation rates of each method
14项研

图11 各种方法全因病死率的网络图
Figure 11 Network plot for all-cause mortality rates of each method

图12 各种方法全因病死率的森林图
Figure 12 Forest plot for all-cause mortality rates of each method

图13 各种方法全因病死率的SUCRA累积排序曲线图
Figure 13 SUCRA ranking plot for all-cause mortality rates of each method
使用1年一期通畅率和1年TLR率的SUCRA值,生成了治疗方法的聚类分析结果,并呈现为聚类排序图,聚类数为3,治疗方法从优到劣的排序为:DES、DCB(第一聚类)、BNS(第二聚类)和BA(第三聚类);使用2年一期通畅率和2年TLR率的SUCRA值,生成了治疗方法的聚类分析结果,并呈现为聚类排序图,聚类数为2,治疗方法从优到劣的排序为:DES、BNS、DCB(第一聚类)和BA(第二聚类);使用3年一期通畅率和3年TLR率的SUCRA值,生成了治疗方法的聚类分析结果,并呈现为聚类排序图,聚类数为2,治疗方法从优到劣的排序为:DES、DCB、BNS(第一聚类)和BA(第二聚类)(

图14 一期通畅率和TLR率的SUCRA值生成的聚类排序图
Figure 14 Clustered ranking plot produced by SUCRA values of the primary patency and TLR rates
本研究发现,在短期和长期随访的情况下,BA、BNS、DCB和DES治疗新发股腘动脉病变的疗效存在显著差异。首先,DES在1、2、3年一期通畅率方面都是最有效的治疗方法,并且在2年随访时,其一期通畅率均明显高于BA、BNS和DCB。其次,DES在1、2、3年TLR率方面都是最有效的治疗方法,并且在2年随访时,其TLR率均明显高于BA、BNS和DCB。这些结果表明,DES在短期和长期随访中在提高一期通畅和减少TLR方面都具有巨大的优势。第三,DCB在1年、2年和3年大截肢率方面都是最有效的治疗方法,这表明在减少大截肢方面,DCB可能具有一定的优势。2018年,欧洲心脏病学会指
近年来,已经发表了多篇关于新发股腘动脉病变的腔内治疗方法疗效对比的Meta分析,Abdoli
支架植入可能会增加再次腔内干预的难度,甚至可能由于覆盖搭桥着陆区域而影响之后开放搭桥手术的实施。用“没有遗留”腔内技术,例如BA和DCB等,治疗外周动脉疾病是最新趋势。欧洲心脏病学会指
此外,在下肢动脉疾病术后全因病死率方面,Katsanos
在1、2、3年随访的一期通畅率和TLR率构建的聚类排序图中,DES和DCB始终处在第一聚类中。并且,与其他治疗方法相比,DES和DCB在1、2、3年的大截肢率和全因病死率方面没有显著差异,两者都没有明显的安全性劣势。因此,在治疗新发股腘动脉病变时,DES和DCB应该被优先考虑使用。
本研究存在一些不足。首先,由于纳入研究中,间歇性跛行和肢体严重缺血患者以及闭塞和狭窄患者的独立数据的缺失,笔者没有按照这些特征对结果进行进一步亚组分析。其次,大多数研究没有对受试者及研究者设盲,这可能会引起结果的偏差。第三,本研究纳入了一项小样本研
综上所述,在1、2、3年随访的一期通畅率和TLR率方面,DES都是最有效的治疗方法,并且在2年随访时均明显优于BA、BNS和DCB。在1、2、3年随访的大截肢率方面,DCB是最有效的治疗方法。在治疗新发股腘动脉病变时,DES和DCB应该被优先考虑使用。这些研究结果可能对临床实践指南的制定和未来RCT研究的设计具有潜在的临床意义和应用价值。
作者贡献声明
周阳、舒畅共同参与研究构思与设计、数据收集、分析和结果解释;周阳负责初稿撰写;舒畅负责文稿审阅与修改及提供研究经费。所有作者都同意对研究的各个方面负责。
利益冲突
所有作者均声明不存在利益冲突。
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