Dataset Information

Paclitaxel-Coated Zilver PTX Drug-Eluting Stent Treatment Does Not Result in Increased Long-Term All-Cause Mortality Compared to Uncoated Devices.

ABSTRACT: PURPOSE:Patient-level data from two large studies of the Zilver PTX drug-eluting stent (DES) with long-term follow-up and concurrent non-drug comparator groups were analyzed to determine whether there was an increased mortality risk due to paclitaxel. METHODS:Data from the Zilver PTX randomized controlled trial (RCT) and Zilver PTX and bare metal stent (BMS) Japan post-market surveillance studies were analyzed. Five-year follow-up is complete in both DES studies; follow-up for the BMS study was limited to 3 years and is complete. Kaplan-Meier analyses assessed mortality. A Cox proportional hazards model identified significant factors related to mortality. RESULTS:In the RCT, there were 336 patients treated with the DES and 143 patients treated with percutaneous transluminal angioplasty (PTA) or BMS. In Japan, there were 904 DES patients and 190 BMS patients. There was no difference in all-cause mortality for the DES compared to PTA/BMS in the RCT (19.1% DES versus 17.1% PTA/BMS through 5 years, p?=?0.60) or Japan (15.8% DES versus 15.3% BMS through 3 years, p?=?0.89). Cox proportional hazard models revealed that age, tissue loss, and congestive heart failure were significantly associated with mortality in the RCT, and critical limb ischemia, age, renal failure, and gender were significantly associated with mortality in Japan (all p?

SUBMITTER: Dake MD

PROVIDER: S-EPMC6940321 | biostudies-literature | 2020 Jan

REPOSITORIES: biostudies-literature

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Paclitaxel-Coated Zilver PTX Drug-Eluting Stent Treatment Does Not Result in Increased Long-Term All-Cause Mortality Compared to Uncoated Devices.

Dake Michael D MD Ansel Gary M GM Bosiers Marc M Holden Andrew A Iida Osamu O Jaff Michael R MR Lottes Aaron E AE O'Leary Erin E EE Saunders Alan T AT Schermerhorn Marc M Yokoi Hiroyoshi H Zeller Thomas T

Cardiovascular and interventional radiology 20190909 1

<h4>Purpose</h4>Patient-level data from two large studies of the Zilver PTX drug-eluting stent (DES) with long-term follow-up and concurrent non-drug comparator groups were analyzed to determine whether there was an increased mortality risk due to paclitaxel.<h4>Methods</h4>Data from the Zilver PTX randomized controlled trial (RCT) and Zilver PTX and bare metal stent (BMS) Japan post-market surveillance studies were analyzed. Five-year follow-up is complete in both DES studies; follow-up for the ...[more]

PMID: 31502026

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Project description:Currently, endovascular treatment is indicated to treat femoropopliteal lesions ?15 cm. However, the Achilles' heel of femoropopliteal endovascular repair remains restenosis. Paclitaxel eluting stents have shown promising results to prevent restenosis in femoropopliteal lesions compared to percutaneous transluminal angioplasty. A recently released prospective registry using a newer generation of self-expandable nitinol stents (Misago®; Terumo Corp., Tokyo, Japan) supports primary bare metal stenting as a first-line treatment for femoropopliteal lesions. To date, no studies have been designed to compare bare metal stents to paclitaxel eluting stents for the treatment of femoropoliteal lesions. The BATTLE trial was designed to compare paclitaxel eluting stents (Zilver® PTX®) and a last generation bare self-expandable nitinol stents (Misago® RX, Terumo Corp., Tokyo, Japan) in the treatment of intermediate length femoropopliteal lesions (?14 cm).A prospective, randomized (1:1), controlled, multicentric and international study has been designed. One hundred and eighty-six patients fulfilling the inclusion criteria will be randomized to one of the two assessments of endovascular repair to treat de novo femoropopliteal lesions ?14 cm in symptomatic patients (Rutherford 2 to 5): bare stent group and paclitaxel eluting stent group. The primary endpoint is freedom from in-stent restenosis at 1 year defined by a peak systolic velocity index >2.4 (restenosis of >50%) at the target lesion and assessed by duplex scan. Our main objective is to demonstrate the clinical superiority of primary stenting using Zilver® PTX® stent system versus bare metal self-expandable stenting in the treatment of femoropopliteal lesions in patients with symptomatic peripheral arterial disease.This is the first randomized and controlled study to compare the efficacy of bare metal stents and paclitaxel eluting stents for the treatment of femoropopliteal lesions. It may clarify the indication of stent choice for femoropopliteal lesions of intermediate length.Clinicaltrials.gov identifier: NCT02004951. 3 December 2013.

Dataset Information

Paclitaxel-Coated Zilver PTX Drug-Eluting Stent Treatment Does Not Result in Increased Long-Term All-Cause Mortality Compared to Uncoated Devices.

Publications

Paclitaxel-Coated Zilver PTX Drug-Eluting Stent Treatment Does Not Result in Increased Long-Term All-Cause Mortality Compared to Uncoated Devices.

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