At the ACC 2013 sessions, Ian Meredith, Monash University, Melbourne, Australia, reported clinical endpoint data from the PLATINUM workhorse clinical trial comparing the safety and effectiveness of the Promus Element Everolimus-Eluting Platinum Chromium (PtCr) Coronary Stent System (Boston Scientific) to the Cobalt Chromium (CoCr) Xience V Everolimus-Eluting Coronary Stent System (Abbott). At three years, the Promus Element Stent continued to demonstrate advantages over the Xience V Stent.
“The Promus Element Platinum Chromium Stent continues to demonstrate excellent safety and effectiveness with low rates of cardiac death, myocardial infarction, stent thrombosis and repeat revascularisation,” said Meredith. “These three-year results confirm that this device benefits patients with symptomatic coronary artery disease requiring percutaneous coronary intervention.”
The trial reported a three-year target lesion revascularisation rate of 3.5% for the Promus Element Stent, the lowest target lesion revascularisation rate in any pivotal FDA approval trial, compared to 4.9% for the Xience V Stent (p=0.21). Both stents demonstrated low rates of ARC/Definite stent thrombosis of 0.7% and 0.5% respectively (p=0.76).
Trial results also confirmed a previously reported significant reduction in unplanned (bail-out or emergency) stenting with the Promus Element Stent compared to the Xience V Stent (5.9% vs 9.8%, p=0.004), including a significantly lower rate of inadequate lesion coverage (1.4% vs 3.4%, p=0.01).
These clinical observations reinforce the results of comparative bench and pre-clinical studies, which have demonstrated the enhanced visibility and deliverability of the Promus Element Stent relative to the Xience V Stent. The reduction in bail-out stenting has also been tied to cost savings per procedure.
Separately, Jeffrey Popma, Beth Israel Deaconess Medical Center, Boston, USA, presented data that demonstrated significantly less vessel straightening, which may be associated with improved blood flow within the vessel, when using the conformable Promus Element Stent compared to the more rigid Xience V stent (40% relative reduction in angulation change from pre- to post- procedure with Promus Element, P=0.01).
“The PLATINUM three-year results support the theory that platform matters,” said Popma. “The flexible and conformable platinum chromium Promus Element Stent causes less vessel straightening than Xience stents, possibly contributing to the low clinical event rates observed at three years with Promus Element Stents.”
Boston Scientific received the CE mark approval for the Promus Element Stent System in 2009 and for the Promus Element Plus Stent System in 2011. The Promus Element Plus Stent System was approved by the FDA in 2011.