Cook Medical is reporting that an international study, involving 792 patients implanted with the company’s paclitaxel-coated peripheral arterial stent, has demonstrated “that 82 percent of patients who were treated… were free from reintervention at two-year follow up.” The device used in the follow up is Zilver® PTX™, a drug-eluting peripheral stent (DES).
More details from the press statement issued by Cook Medical:
“These results are extremely encouraging as it’s the first time paclitaxel-coated stents have been used in the treatment of blockages in arteries outside the heart,” said Zilver PTX global principal investigator, Dr. Michael Dake, Professor in the Department of Cardiothoracic Surgery at Stanford University Medical School and Medical Director of the Cath/Angio Laboratories at Stanford University Medical Center. “Patients treated with the Zilver PTX had a very low complication rate and required fewer reinterventions.”
Data was compiled at 12 and 24 months for 593 patients and 177 patients respectively from the registry study, which enrolled a broad spectrum of patients, including those with complex lesions (e.g., long lesions, total occlusions, in-stent restenosis). The corresponding event-free survival (EFS) rates were 87 percent and 78 percent, and freedom from TLR (target lesion revascularisation) was 89 percent and 82 percent. Clinical measures that included ankle-brachial index, Rutherford score, and walking distance and speed scores showed significant improvement at six and 12 months and were maintained through 24 months.
Detailed evaluation of stent x-rays demonstrated excellent stent integrity through 12 months, confirming previously published results showing 99 percent completely intact stents with a mean follow up of 2.4 years in the challenging superior femoral artery and popliteal arteries, including behind the knee locations.
“We are confident the outstanding results seen in the registry study will be reflected in the randomised Zilver PTX trial which is currently ongoing,” said Rob Lyles, global leader of Cook Medical’s Peripheral Intervention products division. “Cook is committed to continually improving the efficacy and safety of our products, with the overall aim of improving patient outcomes. Our clinical research with the self-expanding, polymer-free Zilver PTX stent is demonstrating its potential benefits for patients suffering from PAD.”
In addition to the registry arm of the study, the 480 patient randomised component is designed to evaluate the Zilver PTX across 45 trial sites in the United States, Japan and Europe. Of the 480 patients enrolled in the randomised study, 240 received the Zilver PTX DES. Enrollment in the randomised study was completed in 2008.