Zenunaj Gladiol, Traina Luca, Acciarri Pierfilippo, Mario Cosacco Alessio, Alesiani Francesca, Baldazzi Giulia, Gasbarro Vincenzo
Azienda Ospedaliero Universitaria di Ferrara Arcispedale Sant'Anna, Italy; Università degli Studi di Ferrara, Italy.
Azienda Ospedaliero Universitaria di Ferrara Arcispedale Sant'Anna, Italy.
Ann Vasc Surg. 2023 May;92:294-303. doi: 10.1016/j.avsg.2023.01.043. Epub 2023 Feb 4.
In this systematic review and meta-analysis, we aimed to compare drug-coated balloon (DCB) to drug-eluting stent (DES) angioplasty as a primary option in patients with femoropopliteal lesions in terms of primary patency and freedom from clinically driven target lesion revascularization (cdTLR) and major adverse limb events (MALE).
A comprehensive literature search was performed using the PubMed and Embase databases. All studies written in English language and reporting data presenting a comparison between patients receiving primary percutaneous balloon angioplasty using the DCB versus primary percutaneous stenting with DES for native femoropopliteal lesions were included in this meta-analysis.
There were 984 patients with 1,078 femoropopliteal lesions, of which procedures with DCB and DES were performed in 514 and 564 lesions, respectively. Overall, majority patients were men with a mean age of 70.9 years, and there were no significant differences between the 2 groups regarding the cardiovascular comorbidities. With regards to the procedural strategy, there was significant heterogeneity in the DCB group. This included adjunctive procedures such as atherectomy besides the angioplasty of the target vessel, which was reported in 1 study as a part of 32.1% of the procedures in the DCB group. Provisional bare metal stents (pBMS) for residual stenosis and dissection were used in 4 studies with a percentage varying from 14.8 to 25.3%. Overall, at 1 year, all outcomes were similar for all the end points; however, where adjunctive procedures were performed (atherectomy + pBMS) in the DCB group, the outcomes were better (primary patency p.001, freedom cdTLR p.001, and freedom form MALE p.002). In studies where no adjunctive procedures were performed in the DCB group, the results favored the DES group for the primary patency (p.026) and freedom from cdTLR (p.044).
DES seems to be superior in terms of cdTLR and primary patency at 1 year when compared to the procedures performed solely with DCB. For DCB to achieve optimal results, further adjunctive procedures such as pBMS and atherectomy are needed. More studies are needed to confirm the superiority of the primary stenting with DES at the femoropopliteal segment.
在本系统评价和荟萃分析中，我们旨在比较药物涂层球囊（DCB）与药物洗脱支架（DES）血管成形术作为股腘病变患者的主要治疗选择时，在原发性通畅率、免于临床驱动的靶病变血管重建术（cdTLR）和主要不良肢体事件（MALE）方面的差异。
使用PubMed和Embase数据库进行全面的文献检索。所有用英文撰写且报告了接受DCB原发性经皮球囊血管成形术与DES原发性经皮支架置入术治疗原发性股腘病变患者之间比较数据的研究均纳入本荟萃分析。
共有984例患者，1078个股腘病变，其中分别对514个和564个病变进行了DCB和DES手术。总体而言，大多数患者为男性，平均年龄70.9岁，两组在心血管合并症方面无显著差异。关于手术策略，DCB组存在显著异质性。这包括除了靶血管成形术之外的辅助手术，如旋切术，在1项研究中报道其占DCB组手术的32.1%。4项研究中使用了用于残余狭窄和夹层的临时性裸金属支架（pBMS），其比例从14.8%到25.3%不等。总体而言，在1年时，所有终点的所有结果均相似；然而，在DCB组中进行辅助手术（旋切术+pBMS）的情况下，结果更好（原发性通畅率p<0.001，免于cdTLR p<0.001，免于MALE p<0.）。在DCB组未进行辅助手术的研究中，结果在原发性通畅率（p=0.026）和免于cdTLR（p=0.044）方面有利于DES组。
与仅使用DCB进行的手术相比，DES在1年时的cdTLR和原发性通畅率方面似乎更具优势。为使DCB取得最佳效果，需要进一步的辅助手术，如pBMS和旋切术。需要更多研究来证实DES在股腘段原发性支架置入术的优越性。
