Randomized Trial Comparing a Stent-Avoiding With a Stent-Preferred Strategy in Complex Femoropopliteal Lesions.

BACKGROUND: Limited comparative data exist on different interventional strategies for endovascular revascularization of complex femoropopliteal interventions. OBJECTIVES: In this study, the authors aimed to compare a stent-avoiding (SA) vs a stent-preferred (SP) strategy, promoting optimal lesion preparation and the use of drug-eluting technologies in both arms. METHODS: Within a prospective, multicenter, pilot study, 120 patients with symptomatic complex femoropopliteal lesions (Rutherford classification 2-4, mean lesion length 187.7 ± 78.3 mm, 79.2% total occlusions) were randomly assigned in a 1:1 fashion to endovascular treatment with either paclitaxel-coated balloons or polymer-coated, paclitaxel-eluting stents. Lesion preparation including the use of devices for plaque modification and/or removal was at the operators' discretion in both treatment arms. RESULTS: In the SA group, lesion preparation was more frequently performed (71.7% SA [43/60] vs 51.7% [31/60] SP; P = 0.038) with a high provisional stenting rate (48.3% [29/60]). At the 12-month follow-up, primary patency was 78.2% (43/55) in the SA group and 78.6% (44/56) in the SP group (P = 1.0; relative risk: 0.995; 95% CI: 0.818-1.210). Freedom from major adverse events was determined in 93.1% (54/58) in the SA group and in 94.9% (56/59) in the SP group (P = 0.717; relative risk: 0.981; 95% CI: 0.895-1.075), with all adverse events attributable to clinically driven target lesion revascularization. CONCLUSIONS: Both endovascular strategies promoting lesion preparation before the use of drug-eluting devices suggest promising efficacy and safety results in complex femoropopliteal procedures with a high proportion of total occlusions through 12 months. Ongoing follow-up will show whether different results emerge over time. (Best Endovascular Strategy for Complex Lesions of the Superficial Femoral Artery [BEST-SFA]; NCT03776799).

ELECT: prospective, randomized trial comparing microvascular plug versus platinum-fibered microcoils for embolization of aneurysm sac side branches before endovascular aortic aneurysm repair.

BACKGROUND: Preemptive selective embolization of aneurysm sac side branches (ASSBs) has been proposed to prevent type II endoleak after endovascular aortic aneurysm repair (EVAR). This study aimed to explore if an embolization strategy using microvascular plugs (MVP) reduces intervention time and radiation dose compared to platinum-fibered microcoils. Furthermore, the effectiveness of the devices in occluding the treated artery was assessed. METHODS: Sixty patients scheduled for EVAR underwent percutaneous preemptive embolization of ASSBs using MVPs or coils after a 1:1 randomization. Follow-up imaging was performed during aortic stentgraft implantation. RESULTS: Overall, 170 ASSBs were successfully occluded (83 arteries by MVPs and 87 by coils) and no acute treatment failure occurred. The mean procedure time was significantly lower in the group treated with MVPs (55 ± 4 min) compared to coil occlusion (67 ± 3 min; p = 0.018), which was paralleled by a numerically lower radiation dose (119 Gy/cm2 vs. 140 Gy/cm2; p = 0.45). No difference was found for contrast agent use (34 ml MVP group vs 35 ml coil group; p = 0.87). At follow-up, reopening of lumbar arteries was seen in nine cases (four after coil embolization; five after MVPs). CONCLUSION: Both microvascular plugs and coils can be effectively used for preemptive embolization of aneurysm sac side branches before EVAR. Use of plugs offers a benefit in terms of intervention time. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT03842930 Registered 15 February 2019.

First Experience With The GoBack-Catheter For Successful Crossing of Complex Chronic Total Occlusions in Lower Limb Arteries.

PURPOSE: To evaluate the use of the GoBack-catheter (Upstream Peripheral Technologies) in complex revascularizations in lower limb arteries. MATERIALS AND METHODS: In this retrospective single-center study, the results of the first 100 consecutive patients including 101 limb-revascularizations, performed between May 2018 and July 2020 with the study device, were analyzed. In all cases, guidewire-crossing failed, and all lesions were chronic total occlusions (CTO), either de novo, reocclusions, or in-stent reocclusions. Successful crossing was defined as passing the CTO using the study device. Patency at discharge and after 30 days was defined as less than 50% restenosis on duplex sonography, without target lesion revascularization. RESULTS: Median lesion length was 24 cm and 38 patients (37.6%) had a calcium grading according to the peripheral arterial calcium scoring system (PACSS) of 4 or 5. In 20.8% of patients, an occluded stent was treated. CTOs involved the femoropopliteal segment in 91.1%, iliac arteries in 5.9%, and tibial arteries in 7.9%. The GoBack-catheter was employed for entering into or crossing through parts or the full length of a CTO or an occluded stent as well as for re-entering into the true lumen after subintimal crossing. The device was used via contralateral and ipsilateral antegrade as well as retrograde access with an overall technical success rate of 92.1%. In 3 patients minor bleeding occurred at the crossing or re-entry site, which were managed conservatively. Thirty-day adverse limb events comprised minor amputations in 4 patients (4.0%), 1 major amputation (1.0%), and reocclusions in 7 limbs (6.9%). CONCLUSION: The new GoBack-catheter offers versatile endovascular applicability for complex CTO recanalization in a broad range of peripheral vascular interventions with a high technical success and low complication rate.