Kimihiko Kichikawa, Department of Radiology at Nara Medical University in Japan, reported two-year results of the Zilver PTX post-market surveillance (PMS) study on 27 September 2015, in Lisbon, Portugal. Kichikawa presented initial target data on lesion revascularisation at Cardiovascular and Interventional Radiological Society of Europe (CIRSE) 2015.
The two-year results indicate a continued low rate of revascularisation in patients with complex lesions and comorbidities. No exclusion criteria were in the Japan PMS. The 1,075 lesions were complex, with an average lesion length of 14.7cm, 42% total occlusions, and 19% in-stent restenosis. In addition, 21% of Japanese patients in the PMS had critical limb ischaemia, 59% had diabetes, and 44% had renal disease.
The two-year freedom from target lesion revascularisation is 85%.
According to Kichikawa, the positive two-year Japan PMS results are consistent with other Zilver PTX trials and confirm the long-term benefits of Zilver PTX technology.
Two other major Zilver PTX trials showed similar numbers at the two-year mark. Freedom from target lesion revascularisation was 85.7% in the randomised controlled trial and was 83.3% in the single-arm study. The three trials enrolled more than 2,000 patients.
“The consistency of these three Zilver PTX studies is what we have now come to expect,” said Mark Breedlove, vice president of Cook Medical’s Peripheral Interventional division. “We have seen positive numbers even at five years post-implantation, which is extraordinary in vascular device studies. It is a very good sign for vascular disease patients that this drug-eluting stent provides such meaningful improvement, even for real-world patients whose disease has already progressed to such a critical level.”
Zilver PTX has been approved for use in the European Union since August 2009 and in the United States and Japan since 2012. It is now approved in 48 countries.