Data from the PLATINUM Workhorse clinical trial were presented by Dean Kereiakes, M.D., F.A.C.C., The Christ Hospital Heart and Vascular Center, Cincinnati, Ohio.
The trial compared the safety and effectiveness of the Boston Scientific Platinum Chromium Everolimus-Eluting Stent System (PtCr EES) to the Abbott Laboratories Cobalt Chromium Everolimus-Eluting Stent System (CoCr EES). The results show low event rates out to four years with PtCr EES confirming excellent long-term performance. At four years, the PtCr EES also continued to demonstrate advantages over the CoCr EES.
Key findings from the study include the following:
- The PtCr EES had a 23 percent lower four-year target lesion revascularization (TLR) than the CoCr EES (4.6 percent to 5.9 percent; p=0.24). This is the lowest TLR rate in any pivotal U.S. Food and Drug Administration (FDA) trial for a DES at four years.
- Both the PtCr EES and CoCr EES demonstrated low rates of ARC definite/probable stent thrombosis of 0.7 percent out to four years.
- Trial results also confirmed a previously reported significant reduction in unplanned (bail-out or emergency) stenting with the PtCr EES compared to the CoCr EES (5.9 percent vs. 9.8 percent, p=0.004), including a significantly lower rate of inadequate lesion coverage (1.4 percent vs. 3.4 percent, 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 PtCr EES relative to the CoCr EES. The reduction in bail-out stenting has also been tied to cost savings per procedure.
"The questions of whether stent metal alloy composition and platform design affect late clinical outcomes are very important," said Dr. Kereiakes. "The data suggest that the greater flexibility and conformability of the platinum chromium platform, as reflected by less vessel straightening and increased fracture resistance when compared with the cobalt chromium platform, translate into exceptional long-term clinical outcomes."
The Promus PREMIER™ Everolimus-Eluting Platinum Chromium Coronary Stent System was recently approved by the FDA. The principal safety and effectiveness data for the Promus PREMIER Stent System are derived from the global PLATINUM Clinical Trial Program, a series of clinical trials conducted on the PROMUS Element™ Stent System, and the NG PROMUS Clinical Trial. The Promus PREMIER Stent System, with its enhanced stent delivery system, offers physicians improved performance in treating patients with coronary artery disease.
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