Zilver ptx 4 year data pdf

Zilver ptx experiences for femoropopliteal artery disease. Hiroyoshi yokoi recently presented data from the japan postmarket study with a 12month freedom from tlr rate of 91. The allcause mortality rate for the ptabms group was 15. To evaluate the 1 and 2year patency and reintervention rates with the zilver ptx drugeluting stent des in long complex femoropopliteal disease.

In imperial rct, eluvia demonstrated a statistically significant reduction in tlr vs. Durable clinical effectiveness with paclitaxeleluting stents in the femoropopliteal artery. Fiveyear mortality data were available for 94% of patients. This is a first comparative study of zilver ptx between crf and noncrf groups. 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. The cook analysis of actual treatment of zilver ptx patients included the updated status for 92% of patients who were previously lost to followup. Some des use permanent polymer carriers for drug delivery. Eligible patients were treated with up to four zilver ptx stents, with no limitation on lesion.

It is a flexible, slotted tube that is designed to provide support while maintaining flexibility in the vessel upon deployment. These data also demonstrate the longterm benefit of the drug coating over the corresponding bms. 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 is the first and only drugeluting stent approved for. 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. Recent correction to 5 year zilver ptx publication katsanoset al. 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. These include 1year results from clinical trials of paclitaxel drugcoated balloons randomly assigned against pta.

Although there is significant longterm data in the use of drugeluting. Scheinert, germany n 150 patients, 75 in each group stratification for lesion length for both groups 1. Handle of the zilver ptx delivery system zilver ptx drugeluting peripheral stent indicated. The findings were presented for the first time at the cardiovascular and interventional radiological society of europe 2018 meeting cirse. We have 5year results on zilver ptx and theyre very good, so until somebody can replicate that 5. Vascular interventional advances conference in las vegas, nevada. A separate analysis comparing the japanese postmarket studies on zilver ptx and bms showed no significant difference in mortality, same mortality rate of 5. 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. Ninemonth data for zilver ptx drugeluting stent trial at international symposium on. 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.

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. Zilver ptx at 24 months clinicallydriven tlr rate p0. The zilver ptx drugeluting peripheral stent is a selfexpanding stent made of nitinol and coated with the drug paclitaxel. Paclitaxelcoated zilver ptx drugeluting stent treatment. Long lesion tlr is astreated as presented at fda panel 2019. 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. Zilver ptx drugeluting stent study data show continued. 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. It received its initial ce mark in 2009 and fda clearance in 2012.

Bosiers presented preliminary data on the first 114 patients enrolled in the study. Twoyear data from the zilver ptx randomized controlled trial of paclitaxeleluting stents for femoropopliteal disease indicate that the stent demonstrated 74. The 1year primary endpoints of efs and primary patency showed superiority of primary des compared. Fouryear data from the zilver ptx trial demonstrated a 75% primary patency rate compared to a 57. The data collection plan through 12 months is summarized in table 1, with additional data collection continuing through 2 years. Paclitaxelcoated zilver ptx drugeluting stent treatment does not. Kaplanmeier 1year estimates of freedom from isr were 88.

Lesion segments must be fully covered with one eluvia stent or. Zilver ptx is the worlds first and only approved sfa drugeluting stent. A polymerfree paclitaxeleluting stent versus a bare. The authors included the published intenttotreat data from the zilver ptx. Results between march 2014 and august 2016, 186 patients were enrolled. 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.

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. Zilver ptx global data analysis highlights des benefits in. The authors included the published intenttotreat data from the zilver ptx randomized controlled trial rct dake et al. The previously published zilver ptx rct data reported 5year allcause mortality for only the primary randomization intenttotreat groups. Evaluating the zilver ptx stent endovascular today. Zilver ptx drugeluting stent mortality analysis cook medical. 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. Causes of death for zilver ptx are similar to ptabms. The primary endpoint is efs as defined for the randomized study. New zilver ptx global data finds 76% freedom from tlr at. 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. With its proven drug effect, zilver ptx inhibits neointimal. 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.

Fda approves zilver ptx drugeluting stent for peripheral. Cook medical presents 4year primary patency data for. The zilverptx randomized trial of paclitaxel eluting. Drug elution, data, and decisions endovascular today. Fiveyear evaluation of zilver ptx stent in a realworld. October 8, 20cook medical bloomington, in announced that 4 year data from the zilver ptx randomized controlled trial were presented at the viva 20. 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.

Data from the zilver ptx randomized controlled trial of paclitaxeleluting stents for femoropopliteal disease showed fiveyear primary patency of 66. Sustained safety and effectiveness of paclitaxeleluting stents for femoropopliteal lesions. Stents for femoropopliteal disease showed 5year primary patency of 66. Zilver ptx key points itt data available to katsanos k, et al. Zilver ptx drugeluting peripheral stent cook medical. Contact your local cook representative or customer service for details. Significantly lower clinicallydriven tlr rate for eluvia vs zilver ptx 12. Fiveyear evaluation of zilver ptx stent in a realworld population continues to show favourable outcomes. The addition of the new data confirmed no mortality signal for zilver ptx. Maximum 4 zilver ptx stents per patient lesion length. Zilver ptx dose analysis 5 year mortality rate quintile 1 quintile 2 quintile 3 quintile 4 quintile 5 11. Durable clinical effectiveness with paclitaxeleluting.

Zilver ptx dose analysis 5year mortality rate quintile 1 quintile 2 quintile 3 quintile 4 quintile 5 11. Zilver ptx drug eluting stent vs drug coated ballon 1. 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. Angiography a way of taking xrays of blood vessels after a special dye is. The zilver ptx randomized controlled trial of paclitaxel. There were 61 deaths in the des group and 23 deaths in the ptabms group through. The zilver ptx drugeluting stent is indicated for improving. Zilverpass randomised trial compares zilver ptx and bypass. Articles a polymercoated, paclitaxeleluting stent eluvia versus a.