Clinical Outcome of Drug-Eluted Stenting (Zilver PTX) in Patients With Femoropopliteal Occlusive Disease a Single Center Experience

Abstract

Background: Few industry sponsored trials reported satisfactory outcomes in the use of drug-eluting stents (DES) for treatment of femoropopliteal arterial disease. This study analyzed the early/late clinical outcome from a real world single center. Patient Populations/Methods: A total of 115 limbs treated with Zilver PTX were analyzed for: major adverse limb event (MALE: above ankle limb amputation/major intervention at 1 year), major adverse events (MAEs; death, amputation, and target lesion thrombosis/reintervention), primary patency (based on duplex ultrasound ± ankle brachial indexes), limb salvage, and amputation free survival rates (AFS) at 1 and 2 years. Results: Indications included claudication in 32% and critical limb threatening ischemia (CLTI) in 68%. Lesions treated included: superficial femoral artery (SFA) 66%, both SFA and popliteal artery (PA) 19% and PA 15%. Mean lesion length was 21 cm and 68% had total occlusion. 45% were Trans-Atlantic Inter-Society Consensus (TASC) TASC II D lesions and 55% A–C lesions. Mean follow-up was 18.4 months (1–76 months). Perioperative major morbidity rate was 8.7% with 0% mortality. MALE rate at 1 year was 17% (13.5% for claudication vs 19.2% for CLTI, p=0.4499). MAE rate was 30% for claudication versus 52% for CLTI (p=0.0392). Overall primary patency rates at 1 and 2 years were 75% and 54% (86% and 71% for claudication vs 70% and 46% for CLTI, respectively, p=0.0213). Primary patency rates at 1 and 2 years were 94% and 88% for TASC A-C lesions versus 50% and 16% for TASC D lesions (p<0.0001). Overall freedom from MALE rate at 1 and 2 years were 85% and 79% (86% and 86% for claudication vs 84% and 74% for CLTI, p=0.2391). These rates were 96% and 93% for TASC A-C lesions versus 70% and 50% for D lesions, respectively (p<0.0001). Limb salvage rates at 1 and 2 years were 93% and 86% (100% and 100% for claudication vs 89% and 78% for CLTI, p=0.012). Overall AFS rates at 1 and 2 years were 79% and 71% (93% and 82% for TASC A–C vs 59% and 59% for D lesions, p=0.001). Conclusion: Clinical outcomes after DES (Zilver PTX) in femoropopliteal arterial lesions were satisfactory for TASC A–C lesions but inferior/unsatisfactory for TASC D lesions.

[Retracted] Construction of Stomach Cancer Lesion Detection Combined with Drug Therapy Based on Artificial Intelligence

“…Studies have shown that about 50% of Chinese patients are insensitive to platinum-based chemotherapy drugs and 5-Fu due to secondary multidrug resistance. Another unavoidable problem is that chemotherapy drugs cause severe collateral damage to actively proliferating normal cells [ 11 , 12 ]. Therefore, it is of great significance to find a highly targeted and noncytotoxic drug for postoperative chemotherapy and nonsurgical treatment of SC [ 13 , 14 ].…”

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

“…This is not fully in line with results in studies of nitinol stenting in the FP region. 16,17,[20][21][22][23][24][25][26][27]29,32,34,48,53,54 A possible reason for low primary patency is a high percentage of total occlusions, long lesions with overall median length of 240 (163-285) mm, and overall Rutherford class 5 (4-5), indicating a high incidence of complex lesions and subjects in our study population.…”

“…However, some other publications on BMS and DES report on a similar limited number of participants. 16,34,37,53,67 Another limitation is the relative high rate of technical failure in the trial. The TS rate was unusually suboptimal.…”

“…Endovascular revascularization is widely considered the first treatment option for femoropopliteal (FP) arteriosclerosis, due to reproducible and acceptable clinical results. [16][17][18][19][20][21][22][23][24][25][26][27][28][29][30][31][32][33][34] Recent guidelines recommend endovascular therapy as first line treatment for FP lesions <250 mm in length. 1,35,36 However, long-term clinical success of endovascular therapies may be complicated by early restenosis caused by neointimal hyperplasia necessitating redo procedures to maintain patency.…”

“…To reduce in-stent restenosis, drugeluting stents (DES) have been developed as an option for treatment of FP lesions. 16,20,23,24,26,29,[37][38][39] The Zilver PTX® randomized controlled trial (RCT) 39 showed good results up to five years in the treatment of FP lesions with a polymer-free, Paclitaxel eluting, self-expanding DES compared to PTA and optional bare metal stent (BMS). However, most of the subjects in this study suffered primarily from intermittent claudication caused by short FP lesions.…”