Primary Drug-Coated Balloon Versus Drug-Eluting Stent for Native Atherosclerotic Femoropopliteal Lesions: A Systematic Review and Meta-Analysis.

BACKGROUND: 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). METHODS: 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. RESULTS: 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). CONCLUSIONS: 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.

Superficial Femoral Artery Access for Infrainguinal Antegrade Endovascular Interventions in the Hostile Groin: A Prospective Randomized Study.

BACKGROUND: In a hostile groin, it may be difficult to perform antegrade endovascular procedures at the lower extremities using the ipsilateral common femoral artery as vascular access; therefore, the use of the ipsilateral superficial femoral artery (SFA) could be a useful alternative. In this study, we evaluated the feasibility and safety of ultrasound-guided SFA puncture versus traditional SFA cutdown to achieve arterial access. METHODS: This prospective observational randomized study examined patients with symptomatic peripheral arterial disease who required endovascular interventions at the lower extremities. A hostile groin was defined as a high femoral bifurcation, obesity, and surgical scarring due to previous surgical interventions. A 6-Fr sheath (12 cm long; ULTIMUM EV INTRODUCER; Abbott, Plymouth, MN, USA) was used in all procedures. In the percutaneous group, the puncture was performed under ultrasound guidance and hemostasis was performed using a percutaneous closure device (PCD) (ANGIO-SEAL VIP 6-Fr; Terumo Medical Corporation, Somerset, NJ, USA). The primary end points were technical success and perioperative complications. The secondary end points were the time required for the management of vascular access and the type of anesthesia administered. RESULTS: Between 2020 and 2021, 107 patients who underwent antegrade revascularization were enrolled. SFA was achieved in 50 cases by the femoral cutdown technique (c-group) and in 57 cases by percutaneous ultrasound-guided puncture (p-group). In the c-group, the time from incision to sheath introduction and the time of suturing the artery and wound closure was 35 ± 8 min. In the p-group, the time from skin puncture and sheath placement plus that from the sheath removal and hole closure with the PCD was 6 ± 3 min. For the c-group versus p-group, the following variables were as follows: high bifurcation, 10 vs. 6 cases (P = 0.2); severe obesity, 33 vs. 40 cases (P = 0.46); and previous surgical groin interventions, 7 vs. 9 cases (P = 0.53), respectively. The technical success rates were 100% vs. 96.49% for the c-group versus p-group, respectively (P = 0.63). Two percutaneous puncture failures were managed using the cutdown technique. In the p-group, 2 postprocedural hematomas were recorded, with only one requiring surgical treatment and 2 with SFA occlusion to intravascular cap hemostatic dislocation, which were subjected to surgical revision. A total of 3 percutaneous procedures in the p-group required surgical revision versus none in the c-group (P = 0.1). Within 3 months, complications consisted of 6 cases of surgical wound complications in the c-group versus none in the p-group (P = 0.009). All procedures in the p-group versus 72% of patients in the c-group were managed with local anesthesia (P < 0.0001). CONCLUSIONS: The femoral cutdown technique seems to be a safe and successful approach for achieving vascular access in cases of hostile groin. Ultrasound-guided puncture and PCD make SFA puncture a successful and safe alternative with an acceptable complications rate. Moreover, it reduces the time required to manage vascular access and can be performed mainly under local anesthesia.