Two-year results from the PLATINUM Small Vessel study, demonstrating excellent safety and effectiveness outcomes for the 2.25mm Promus Element Everolimus-Eluting Platinum Chromium (PtCr) Stent System in treating de novo coronary lesions in small coronary vessels. Analysis of the data was presented at EuroPCR.
The PLATINUM Small Vessel study is a prospective, multicentre, single-arm, subtrial of the PLATINUM clinical programme designed to evaluate the safety and effectiveness of the Promus Element stent (2.25mm) for the treatment of de novo coronary lesions in patients with small vessels (greater than or equal to 2.25 to <2.50mm reference vessel diameter and less than or equal to 28mm lesion length).
“The PLATINUM Small Vessel data continue to demonstrate very low revascularisation rates, with no myocardial infarction or stent thrombosis through two years of follow up in patients treated with the 2.25mm Promus Element stent,” said Ian Meredith, professor and director of MonashHeart, at Monash Medical Centre, Melbourne, Australia, and co-principal investigator for the PLATINUM study. “These long-term results are impressive, especially considering the small vessel diameters that were evaluated in this study.”
The PLATINUM Small Vessel study previously met its primary endpoint of target lesion failure (TLF) at 12 months with a rate of 2.4% for the 2.25mm Promus Element stent compared to a pre-specified performance goal of 21.1% (p<0.001) based on historical outcomes for the 2.25mm Taxus Express Paclitaxel-Eluting Stent (Boston Scientific). The TLF rate at two years was 4.7% with the 2.25mm Promus Element Stent while the rate of target lesion revascularisation (TLR) was 2.5%. Rates of other major adverse events remained low in patients treated with study stents at two years, including cardiac death (2.3%), myocardial infarction (0.0%) and Academic Research Consortium (ARC) definite/probable stent thrombosis (0.0%). There were no deaths between 1 and 2 years for patients treated with the 2.25mm Promus Element Stent.
“The PLATINUM Small Vessel data build on the positive long-term outcomes from the PLATINUM Workhorse trial, which reported excellent safety and effectiveness of the Promus Element stent in workhorse lesions and demonstrated superior efficacy compared to the Xience V (Promus) stent in a landmark analysis of revascularisation outcomes from year one to year two,” said Keith D Dawkins, global chief medical officer, Boston Scientific. “The results demonstrate a highly effective platinum chromium small vessel stent platform with an excellent safety profile.”
Boston Scientific received CE mark approval for the Promus Element stent system in 2009 and for the Promus Element Plus stent system in 2011. In the USA, the Promus Element Plus stent system was approved by the FDA in 2011.
Xience is a trademark of Abbott Laboratories. Promus is a private-labeled Xience V everolimus-eluting stent system manufactured by Abbott and distributed by Boston Scientific.