Randomized clinical Trial Comparing drug Eluting Stent Zilver PTX® Versus Bare Metal Stent Zilver Flex® for Treatment of Lesions in Femoral and Popliteal Arteries in Chronic Limb Threatening Ischemia.

OBJECTIVE: Drug eluting stents (DES) might improve the results of stenting in the femoropopliteal (FP) segment, but randomized data between DES and BMS in the treatment of patients with chronic limb threatening ischemia (CLTI) is lacking. The aim of this study was to perform a randomized comparison, between DES and bare metal stent (BMS) implantation in a subgroup of CLTI patients with lesions in the superficial femoral artery (SFA) and the P1-P2 portion of the popliteal artery. METHODS: Patients presenting with CLTI scheduled for endovascular treatment of FP lesions were randomly assigned by blinded envelopes 1:1 in a single blinded, parallel group design to DES or BMS after lesion crossing. Primary endpoints were target lesion revascularization (TLR) at 12 and 24 months and primary patency at 12 and 24 months. Secondary endpoints were technical success (TS), clinical success, secondary patency at 12 and 24 months, limb salvage, serious adverse events (SAE) at 24 month and survival at five years. RESULTS: A total of 48 CLTI patients and 49 limbs, were enrolled, 22 in the BMS group and 27 in the DES group. Demographics, comorbidities, and Rutherford class were similar in both treatment arms. The overall rate of total occlusions was 96% and the corresponding overall median lesion length was 240 mm. No patients were lost to follow up. No significant differences were detected between groups regarding TLR and primary patency. The overall primary patency at 12 and 24 months was 42.9% and 36.7% respectively and the overall freedom from TLR was 67.3% and 61.2% respectively. The results in the two groups were also similar regarding secondary outcomes. CONCLUSIONS: This single centre, randomized study could not demonstrate superiority of DES compared to BMS when treating long FP lesions in patients with CLTI but was limited by insufficient patient inclusion.

Drug-eluting balloon (DEB) versus plain old balloon angioplasty (POBA) in the treatment of failing dialysis access: A prospective randomized trial.

OBJECTIVE: To compare the efficacy of angioplasty using drug-eluting balloons (DEB) compared with plain old balloon angioplasty (POBA) to reduce the rate of restenosis. METHODS: This prospective, single-centre, single-blinded, 1:1 randomized, clinical trial enrolled patients that had primary or restenotic lesions in native upper extremity arteriovenous (AV) fistulas or at the graft-venous anastomosis. Patients were randomized to angioplasty with a POBA or a DEB. The primary effectiveness endpoints were freedom from target lesion revascularization (TLR) and functional status of access circuit at 12 months. RESULTS: A total of 42 (28 male, 14 female; age range, 42-83 years) patients were enrolled. Patients were followed for 12 months. No significant differences were detected between the POBA and DEB groups regarding total number of TLR procedures (31 versus 36, respectively), freedom from TLR (3 versus 4, respectively) and functional status of the access circuit at 12 months (14 of 20 patients [70%] versus 17 of 22 patients [77%], respectively). CONCLUSION: This clinical trial did not demonstrate any significant differences between DEB angioplasty and standard balloon angioplasty when treating dysfunctional haemodialysis access.