PLATINUM Small Vessel Data Support Boston Scientific's Promus Element Stent

May 20, 2011—Boston Scientific Corporation (Natick, MA) announced that 12-month results from its PLATINUM Small Vessel study demonstrated excellent safety and effectiveness outcomes for the 2.25-mm Promus Element everolimus-eluting platinum chromium stent system in treating small-vessel coronary disease. The PLATINUM clinical program's Coprincipal Investigator Prof. Ian T. Meredith, MD, presented an analysis of the data at the EuroPCR 2011 conference in Paris.

The study is a global, prospective, single-arm, subtrial of the PLATINUM clinical program. It compares the Promus Element stent (2.25 mm) in 94 patients with small vessels (≥ 2.25 to < 2.50 mm reference vessel diameter and ≤ 2.8 mm in lesion length) to a prespecified performance goal based on results from patients treated with the company's Taxus Express paclitaxel-eluting stent. 

“The PLATINUM Small Vessel data demonstrate exceptionally low rates of revascularization while reporting no myocardial infarction or stent thrombosis at 1 year in patients treated with the 2.25 mm Promus Element stent,” commented Prof. Meredith. “These results are impressive, especially considering the small vessel diameter in this patient population.”

According to the company, the PLATINUM Small Vessel study met its primary endpoint of target lesion failure at 12 months with a rate of 2.4% for the 2.25-mm Promus Element stent in the per protocol population compared to a prespecified performance goal of 21.1% (P < .001) based on historical outcomes for the 2.25-mm Taxus Express stent. Components of target lesion failure in the per protocol population included cardiac death related to the target vessel (2.4%), myocardial infarction related to the target vessel (0%), and ischemia-driven target lesion revascularization (0%). Clinical outcome rates at 12 months in the intent-to-treat population were also low for cardiac death (3.3%), myocardial infarction (0%), target lesion revascularization (2.2%), and Academic Research Consortium definite/probable stent thrombosis (0%).

The PLATINUM clinical program is evaluating the safety and effectiveness of the Promus Element stent in five multicenter studies totaling more than 1,800 patients, including a global, randomized, pivotal controlled trial in workhorse lesions, and single-arm studies evaluating small vessels, long lesions, pharmacokinetics, and quantitative coronary angiography and intravascular ultrasound data.

The Promus Element stent system received CE Mark approval and was launched in Europe and other international markets in 2009. Boston Scientific anticipates US Food and Drug Administration approval for the Promus Element stent, including the 2.25-mm version, in mid 2012. In the United States, it is an investigational device, limited by applicable law to investigational use and not available for sale, the company advised.