The zilver ptx randomized controlled trial of paclitaxel. Ninemonth data for zilver ptx drugeluting stent trial at international symposium on. The zilver ptx drugeluting peripheral stent is a selfexpanding stent made of nitinol and coated with the drug paclitaxel. Zilver ptx drug eluting stent vs drug coated ballon 1. Fouryear data from the zilver ptx trial demonstrated a 75% primary patency rate compared to a 57. This trial was a 479patient, multicenter, prospective, randomized study designed to evaluate the zilver ptx stent as a treatment for peripheral arterial disease in the. Durable clinical effectiveness with paclitaxeleluting stents in the femoropopliteal artery. In the course of responding to a query on 2year data, we identified a data correction needed in the 1year kaplanmeier analysis of primary patency.
Fiveyear evaluation of zilver ptx stent in a realworld population continues to show favourable outcomes. Data from the zilver ptx randomized controlled trial of paclitaxeleluting stents for femoropopliteal disease showed fiveyear primary patency of 66. The authors included the published intenttotreat data from the zilver ptx randomized controlled trial rct dake et al. Cook medical in challenging patient populations concluded that risk factors such as rutherford classification, sex, calcification and diabetes did not have a significant impact on the target lesion revascularisation tlr rate in patients treated with the zilver ptx stent. The authors included the published intenttotreat data from the zilver ptx. Results between march 2014 and august 2016, 186 patients were enrolled. October 8, 20cook medical bloomington, in announced that 4 year data from the zilver ptx randomized controlled trial were presented at the viva 20. Conclusions for 5year zilver ptx rct as the first randomized controlled sfa device trial with 5year followup, these results with the zilver ptx stent provide important insights regarding longterm outcomes for endovascular treatment 5year data for zilver ptx versus standard care. These 2 year results indicate that the des placed in fp lesions of crf patients is safe and effective with similar patency and tlr rates compared to patients without crf. Zilver ptx drugeluting stent study data show continued.
Battle flow chart 186 were included 5 not randomized 4 screen failures 1 twice randomized zilver ptx 86 underwent assigned intervention mitt misago 85 underwent assigned intervention mitt 82 completed 1year followup 78 completed 1year followup 181 underwent randomization. The advantage of pes in primary patency was maintained across subgroups based on diabetic status, total occlusion, rutherford class category 23 and 4 6, and lesion length 07 mm and 7 mm. The zilverptx randomized trial of paclitaxel eluting. Contact your local cook representative or customer service for details. The previously published zilver ptx rct data reported 5year allcause mortality for only the primary randomization intenttotreat groups.
Zilver ptx dose analysis 5 year mortality rate quintile 1 quintile 2 quintile 3 quintile 4 quintile 5 11. November 4, 2014 following up on the presentation of four year data for the zilver ptx drugeluting stent at last years viva meeting, cook medical today announced the five year outcomes and the results show that patients arteries have remained open, and that there has been no late catchup with the zilver stent. Durable clinical effectiveness with paclitaxeleluting. These data also demonstrate the longterm benefit of the drug coating over the corresponding bms. Drug elution, data, and decisions endovascular today. This is a first comparative study of zilver ptx between crf and noncrf groups. To evaluate the 1 and 2year patency and reintervention rates with the zilver ptx drugeluting stent des in long complex femoropopliteal disease. These include 1year results from clinical trials of paclitaxel drugcoated balloons randomly assigned against pta. Fda approves zilver ptx drugeluting stent for peripheral. A separate analysis comparing the japanese postmarket studies on zilver ptx and bms showed no significant difference in mortality, same mortality rate of 5. Handle of the zilver ptx delivery system zilver ptx drugeluting peripheral stent indicated. Zilver ptx global data analysis highlights des benefits in.
There were 61 deaths in the des group and 23 deaths in the ptabms group through. The primary endpoint is efs as defined for the randomized study. But gary ansel, md ohiohealthriverside methodist hospital, columbus, oh, wasnt ready to write off zilver ptx just yet, pointing out that there are longterm data available for the device. Hiroyoshi yokoi recently presented data from the japan postmarket study with a 12month freedom from tlr rate of 91. Zilver ptx key points itt data available to katsanos k, et al. The data collection plan through 12 months is summarized in table 1, with additional data collection continuing through 2 years. Cook medical presents 4year primary patency data for. Zilver ptx is the first and only drugeluting stent approved for. Bosiers presented preliminary data on the first 114 patients enrolled in the study.
Zilver ptx drugeluting peripheral stent cook medical. New zilver ptx global data finds 76% freedom from tlr at. Lesion segments must be fully covered with one eluvia stent or. Evaluating the zilver ptx stent endovascular today. The zilver ptx drugeluting stent is indicated for improving. Stents for femoropopliteal disease showed 5year primary patency of 66. Long lesion tlr is astreated as presented at fda panel 2019. We have 5year results on zilver ptx and theyre very good, so until somebody can replicate that 5. The zilver vascular stent is intended for use as an adjunct to percutaneous transluminal angioplasty pta in the treatment of symptomatic vascular disease of the iliac arteries up to 100 mm in length, with a reference vessel diameter of 5 to 9 mm.
Zilverpass randomised trial compares zilver ptx and bypass. The addition of the new data confirmed no mortality signal for zilver ptx. Fiveyear results from a japanese postmarket surveillance study aimed at evaluating the zilver ptx drugeluting stent des in a realworld population show consistently positive outcomes. Sustained safety and effectiveness of paclitaxeleluting stents for femoropopliteal lesions. Articles a polymercoated, paclitaxeleluting stent eluvia versus a. Therefore, as one of the largest randomized controlled trials of an endovascular device to treat patients with femoropopliteal artery disease, and the first to provide 5year followup, the evaluation of the zilver ptx drugeluting stent in the abovetheknee femoropopliteal artery zilver ptx randomized clinical trial provides longterm data. Paclitaxelcoated zilver ptx drugeluting stent treatment does not. Zilver ptx 5 was the first des in the united states used in the treatment of pad and is the only drugeluting superficial femoral artery stent with fiveyear data. November 4, 2014 following up on the presentation of fouryear data for the zilver ptx drugeluting stent at last years viva meeting, cook medical today announced the fiveyear outcomes and the results show that patients arteries have remained open, and that there has been no late catchup with the zilver stent. Zilver ptx n242 pta optimal n118 suboptimal zilver flex n56 zilver ptx n63 sas more complex lesions japan pms allcomers us pas similar lesions to rct eu longer lesions premarket studies postmarket studies zilver ptx n787 n904 zilver ptx n200 zilver ptx n45 china zilver ptx n178 more than 2400 patients to be included in current. Although there is significant longterm data in the use of drugeluting. Vascular interventional advances conference in las vegas, nevada. Zilver ptx experiences for femoropopliteal artery disease.
Causes of death for zilver ptx are similar to ptabms. Some des use permanent polymer carriers for drug delivery. Kaplanmeier 1year estimates of freedom from isr were 88. Zilver ptx drugeluting stent mortality analysis cook medical. Angiography a way of taking xrays of blood vessels after a special dye is. The cook analysis of actual treatment of zilver ptx patients included the updated status for 92% of patients who were previously lost to followup. Twoyear data from the zilver ptx randomized controlled trial of paclitaxeleluting stents for femoropopliteal disease indicate that the stent demonstrated 74. Recent correction to 5 year zilver ptx publication katsanoset al. Fiveyear mortality data were available for 94% of patients.
Fiveyear evaluation of zilver ptx stent in a realworld. The findings were presented for the first time at the cardiovascular and interventional radiological society of europe 2018 meeting cirse. The allcause mortality rate for the ptabms group was 15. Zilver ptx is the worlds first and only approved sfa drugeluting stent. Results from an aggregated data analysis of the use of the zilver ptx drugeluting peripheral stent des. Analysis of all global zilver ptx data confirms rct findings mortality rates for the zilver ptx stent are consistent with rates reported in literature for pad patients. Scheinert, germany n 150 patients, 75 in each group stratification for lesion length for both groups 1. Zilver ptx at 24 months clinicallydriven tlr rate p0. The primary safety endpoint of eventfree survival was higher in the zilver ptx arm, as compared with the pta arm 90. However, 40% of the patients included in the pta group in that mortality analysis were actually treated with the des as part of protocoldefined secondary randomization and crossover. It received its initial ce mark in 2009 and fda clearance in 2012. A polymerfree paclitaxeleluting stent versus a bare.
Eligible patients were treated with up to four zilver ptx stents, with no limitation on lesion. Paclitaxelcoated zilver ptx drugeluting stent treatment. Significantly lower clinicallydriven tlr rate for eluvia vs zilver ptx 12. With its proven drug effect, zilver ptx inhibits neointimal. In imperial rct, eluvia demonstrated a statistically significant reduction in tlr vs.
The 1year primary endpoints of efs and primary patency showed superiority of primary des compared. It is a flexible, slotted tube that is designed to provide support while maintaining flexibility in the vessel upon deployment. Maximum 4 zilver ptx stents per patient lesion length. Zilver ptx dose analysis 5year mortality rate quintile 1 quintile 2 quintile 3 quintile 4 quintile 5 11.
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