Separate three-year study demonstrates Promus Element Stent has significantly less vessel straightening than the Xience V Stent
NATICK, Massachusetts (March 2013) — Boston Scientific Corporation 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 to the cobalt chromium (CoCr) Xience V everolimus-eluting coronary stent system. At three years, the Promus Element stent continued to demonstrate advantages over the Xience V Stent (Abbott Laboratories).
Data were presented by Ian Meredith, MD, Monash University, Melbourne, Australia, at the 62nd Annual Scientific Session of the American College of Cardiology in San Francisco on 10th March.
The trial reported a three-year target lesion revascularization (TLR) rate of 3.5% for the Promus Element stent, the lowest TLR rate in any pivotal FDA approval trial, compared to 4.9% for the Xience V Stent (p=0.21). Both the Promus Element and Xience V 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 , MD, Beth Israel Deaconess Medical Center, Boston, 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."