Data from the PLATINUM Workhorse clinical trial, presented by Dean Kereiakes, The Christ Hospital Heart and Vascular Center, Cincinnati, Ohio, USA, demonstrate low event rates out to four years with Platinum chromium everolimus-eluting stent system confirming excellent long-term performance. At four years, the Platinum chromium everolimus-eluting stent system also continued to demonstrate advantages over the Cobalt chromium everolimus-eluting stent system.
The trial compared the safety and effectiveness of the Boston Scientific Platinum chromium everolimus-eluting stent system to the Abbott Laboratories Cobalt chromium everolimus-eluting stent system.
Key findings from the study include the following:
- The Platinum chromium everolimus-eluting stent system had a 23% lower four-year target lesion revascularisation than the Cobalt chromium everolimus-eluting stent system (4.6% to 5.9%; p=0.24). This is the lowest target lesion revascularisation rate in any pivotal US Food and Drug Administration (FDA) trial for a drug-eluting stent at four years.
- Both the Platinum chromium everolimus-eluting stent system and Cobalt chromium everolimus-eluting stent system demonstrated low rates of ARC definite/probable stent thrombosis of 0.7% out to four years.
- Trial results also confirmed a previously reported significant reduction in unplanned (bail-out or emergency) stenting with the Platinum chromium everolimus-eluting stent system compared to the Cobalt chromium everolimus-eluting stent system (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 Platinum chromium everolimus-eluting stent system relative to the Cobalt chromium everolimus-eluting stent system. 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,” says 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 elatinum 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 programme, 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.
