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Peripheral Intervention
June 28th, 2016

Zilver® PTX® superior 5-year results published in Circulation


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Check out the April 12 issue of Circulation to read about the 5-year results of the Zilver PTX randomized controlled trial in an article titled “Durable Clinical Effectiveness With Paclitaxel-Eluting Stents in the Femoropopliteal Artery: 5-Year Results of the Zilver PTX Randomized Trial.”

The Cook-sponsored Zilver PTX RCT is the first and only endovascular study of SFA stents to report 5-year results. The long-term study shows that Zilver PTX, the world’s first drug-eluting stent and only DES that has been approved by the FDA, has maintained superior results to standard care (percutaneous transluminal angioplasty and Zilver bare-metal stent) and to the Zilver BMS, even after 5 years.1

In the prospective, multinational RCT, 474 patients with de novo or restenotic SFA lesions were randomized to Zilver PTX stent placement or percutaneous transluminal angioplasty (PTA).1

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One hundred and twenty PTA patients experienced acute failure and underwent secondary randomization to provisional stenting with the Zilver BMS or Zilver PTX.1

Patients in the Zilver PTX group maintained an 83.1% freedom from target lesion revascularization compared to 67.6% for the standard care group (optimal PTA or provisional BMS), and a 5-year primary patency rate of 72.4% for provisional Zilver PTX compared to 53.0% for provisional BMS. Patients treated with Zilver PTX experienced a greater than 40% reduction in reintervention and restenosis compared to standard care and to BMS.1

According to the study’s authors, “The 5-year results show durable safety, effectiveness, and clinical benefit with the Zilver PTX drug-eluting stent, which may represent a new gold standard for the treatment of SFA disease.”1

1. Dake MD, Ansel GM, Jaff MR, et al. Durable clinical effectiveness with paclitaxel-eluting stents in the femoropopliteal artery: 5-year results of the Zilver PTX randomized trial. Circulation. 2016;133(15):1472-83.

Zilver® PTX® Drug-Eluting Peripheral Stent
ESSENTIAL PRESCRIBING INFORMATION

CAUTION: U.S. federal law restricts this device to sale by or on the order of a physician (or properly licensed practitioner).

INDICATIONS: Indicated for improving luminal diameter for the treatment of de novo or restenotic symptomatic lesions in native vascular disease of the above-the-knee femoropopliteal arteries having reference vessel diameter from 4 mm to 7 mm and total lesion lengths up to 140 mm per limb and 280 mm per patient.

CONTRAINDICATIONS: Women who are pregnant, breastfeeding, or plan to become pregnant in the next 5 years should not receive a Zilver PTX Drug-Eluting Peripheral Stent. It is unknown whether paclitaxel will be excreted in human milk, and there is a potential for adverse reaction in nursing infants from paclitaxel exposure. • Patients who cannot receive recommended anti-platelet and/or anti-coagulant therapy. • Patients judged to have a lesion that prevents proper placement of the stent or stent delivery system.

WARNINGS: Persons with allergic reactions to nitinol, or its components, nickel and titanium, may suffer an allergic reaction to this implant. • Persons allergic to paclitaxel or structurally-related compounds may suffer an allergic reaction to this implant. • The inner package should not be opened or damaged prior to use to maintain sterility; do not use if inner package is opened or damaged. • The use of this Drug-Eluting Peripheral Stent carries the risks associated with peripheral artery stenting, including vascular complications, and/or bleeding events. • The safety and effectiveness of implanting multiple Zilver PTX Drug-Eluting Peripheral Stents with a total drug coating quantity of greater than 3 mg paclitaxel (i.e., an additive stent length greater than 160mm per limb) has not been established.

POTENTIAL ADVERSE EVENTS: Potential adverse events that may occur include, but are not limited to, the following: Allergic reaction to anticoagulant and/or antithrombotic therapy or contrast medium • Allergic reaction to nitinol • Atheroembolization (Blue Toe Syndrome) • Arterial aneurysm • Arterial rupture • Arterial thrombosis • Arteriovenous fistula • Death • Embolism • Hematoma/hemorrhage • Hypersensitivity reactions • Infection • Infection/abscess formation at access site • Ischemia requiring intervention (bypass or amputation of toe, foot, or leg) • Pseudoaneurysm formation • Renal failure • Restenosis of the stented artery • Stent embolization • Stent malapposition • Stent migration • Stent strut fracture • Vessel perforation or rupture • Worsened claudication/rest pain • Although systemic effects are not anticipated, refer to the Physicians’ Desk Reference for more information on the potential adverse events observed with paclitaxel. Potential adverse events, not described in the above source, may be unique to the paclitaxel drug coating: Allergic/immunologic reaction to the drug coating • Alopecia • Anemia • Blood product transfusion • Gastrointestinal symptoms • Hematologic dyscrasia (including leukopenia, neutropenia, thrombocytopenia) • Hepatic enzyme changes • Histologic changes in vessel wall, including inflammation, cellular damage, or necrosis • Myalgia/Arthralgia • Myelosuppression • Peripheral neuropathy

See package insert for full product information.
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