PLATINUM SV's 2-Year Data Support Boston Scientific's Promus Element DES

May 18, 2012—Boston Scientific Corporation (Natick, MA) announced that an analysis of 2-year results from the PLATINUM SV study was presented at the EuroPCR 2012 conference in Paris. The data demonstrated the safety and effectiveness of the company's 2.25-mm Promus Element everolimus-eluting platinum chromium stent system for treating de novo coronary lesions in small coronary vessels.

According to a company press release, the PLATINUM SV study is a prospective, multicenter, single-arm subtrial of the PLATINUM clinical program that is studying its 2.25-mm Promus Element stent for the treatment of de novo coronary lesions in patients with small vessels (reference vessel diameter ≥ 2.25 to < 2.5 mm; lesion length ≤ 28-mm). The PLATINUM clinical program's Coprincipal Investigator is Prof. Ian Meredith, MD, who is also Director of MonashHeart at Monash Medical Centre in Melbourne, Australia.

“The PLATINUM Small Vessel data continue to demonstrate very low revascularization rates, with no myocardial infarction or stent thrombosis through 2 years of follow-up in patients treated with the 2.25-mm Promus Element stent,” commented Prof. Meredith. “These long-term results are impressive, especially considering the small vessel diameters that were evaluated in this study.”

As detailed in Boston Scientific's press release, the 2-year data presented at EuroPCR showed a target lesion failure rate of 4.7% with the 2.25-mm Promus Element stent, and the rate of target lesion revascularization was 2.5%. Rates of other major adverse events, including cardiac death (2.3%), myocardial infarction (0.0%), and Academic Research Consortium (ARC) definite/probable stent thrombosis (0.0%), remained low at 2 years postprocedure. There were no deaths between 1 and 2 years in patients treated with the 2.25-mm Promus Element stent.

The PLATINUM SV study previously met its primary endpoint of target lesion failure at 12 months, which was 2.4% for the 2.25-mm Promus Element stent compared to a prespecified performance goal of 21.1% (P < .001) based on historical outcomes for the company's 2.25-mm Taxus Express paclitaxel-eluting stent, advised Boston Scientific.

Boston Scientific received CE Mark approval for the Promus Element stent system in 2009. In 2011, the Promus Element Plus stent system received CE Mark and US Food and Drug Administration approval, noted the company's press release.