October 7, 2013
Cook Medical Presents 4-Year Primary Patency Data for Zilver PTX
October 8, 2013—Cook Medical (Bloomington, IN) announced that 4-year data from the Zilver PTX randomized controlled trial were presented at the VIVA 2013: Vascular Interventional Advances conference in Las Vegas, Nevada. This trial was a 479-patient, multicenter, prospective, randomized study designed to evaluate the Zilver PTX stent as a treatment for peripheral arterial disease in the superficial femoral artery (SFA). Gary Ansel, MD, one of the Zilver PTX trial’s Principal Investigators, presented the data at the aforementioned meeting.
According to Cook Medical, the data demonstrate 75% primary patency in the SFA at 4 years for patients treated with the Zilver PTX paclitaxel-eluting stent compared to 57.9% patency for patients treated with a provisional bare-metal stent (BMS) in the study. This represents a 41% reduction in the 4-year restenosis rate with the paclitaxel coating in the head-to-head comparison of provisional paclitaxel-eluting stent placement versus BMS placement.
Dr. Ansel, who is Director of the Center for Critical Limb Care at Riverside Methodist Hospital in Columbus, Ohio, commented in the company’s press release, “Certainly, as we face the challenge of ‘health care value,’ the Zilver PTX results allow for confidence of long-term procedural success and patient benefit.”
As announced last month at the Cardiovascular and Interventional Radiological Society of Europe’s 2013 meeting in Barcelona, Spain, the Zilver PTX trial’s Global Principal Investigator, Michael Dake, MD, presented the 4-year data showing the rates of freedom from target lesion revascularization (TLR).
The 4-year data show that 83.2% of patients with femoropopliteal lesions who were treated with Zilver PTX did not require revascularization after 4 years. In comparison, 69.4% of patients treated with acutely successful percutaneous transluminal angioplasty (PTA) or provisional BMS placement did not require revascularization.
In the company’s press release, Dr. Dake stated, “The 4-year freedom from TLR data documents the sustained clinical benefit of Zilver PTX. When compared to standard-of-care therapy, consisting of either acutely successful PTA or provisional bare stent placement after suboptimal PTA, the paclitaxel-eluting Zilver stent provides a 45% reduction in the reintervention rate in this study.” Dr. Dake is Professor of Cardiothoracic Surgery at Stanford University Medical School in Palo Alto, California.