Approval of Xience Prime in Japan was supported by results from the SPIRIT PRIME clinical trial, a prospective, open-label trial that evaluated Xience Prime in approximately 500 patients with coronary artery disease. The trial met its primary endpoint, with low rates of target lesion failure at one year. Stent thrombosis rates at one year also were very low (0.5%), with all cases occurring within 30 days and no cases of stent thrombosis reported in patients treated for long lesions.
Xience Prime, which uses the same drug and biocompatible polymer as the Xience VEverolimus Eluting Coronary Stent System, features an enhanced stent design and a delivery system designed for greater flexibility, ideal radial strength, excellent longitudinal strength and more accurate stent placement. With this approval in Japan, Xience Prime is available in all of the major markets worldwide, including the United States, Europe, China, India and other countries in the Asia-Pacific and Latin America regions.
“New stent technologies such as Xience Prime play an important role in enhancing the care we provide to patients in Japan who have coronary artery disease,” said Takaaki Isshiki, Division of Cardiology, Teikyo University Hospital, Japan. “Xience Prime retains many of the features that have made Xience V an important treatment option for patients, and incorporates improvements that will enhance our ability to access challenging and complex lesions. Importantly, Xience Prime includes a broad size matrix and is the only everolimus eluting coronary stent in Japan with long-length stent sizes of 33 mm and 38 mm.”
Xience Prime is based on the stent design of the Multi-Link family. It utilises cobalt chromium technology and features a “peak-to-valley” mechanical design that imparts longitudinal strength and stability to the stent. Xience Prime features one of the thinnest drug-eluting stent struts available while maintaining radial strength to support the vessel, and it provides excellent visibility under X-ray during stent implantation procedures. It is offered in lengths up to 38 mm to treat long lesions.
About the SPIRIT PRIME clinical trial
The trial was conducted at more than 60 centres in the United States and Australia. Two registry arms were evaluated: the Core Size arm and the Long Lesion arm. The Core Size arm utilised Xience Prime stents measuring 2.25 mm to 4.0 mm in diameter and from 8 mm to 28 mm in length. The Long Lesion arm utilised Xience Prime stents measuring 2.5 mm to 4.0 mm in diameter and either 33 mm or 38 mm in length. The primary endpoint was target lesion failure at one year, which was a composite of cardiac death, target vessel myocardial infarction and clinically indicated target lesion revascularisation.
Xience Prime received CE mark in 2009 and US FDA approval in 2011, and is available in the United States, Europe, the Middle East, Japan and several countries in Asia-Pacific and Latin America.
In Japan, Xience Prime is indicated for improving coronary artery luminal diameter in patients with symptomatic heart disease due to de novonative coronary artery lesions (lesions ≤32 mm) with reference vessel diameters of ≥2.5 mm to ≤3.75 mm.