The Boston Scientific Promus Element stent.
Abbott's Xience V stent. The stent is also sold by Boston Scientific under an agreement with Abbott as the Promus stent.
March 29, 2012 – Two-year follow-up data from the pivotal PLATINUM Workhorse trial comparing the safety and effectiveness of the Promus Element and Xience V everolimus-eluting coronary stents demonstrated superior efficacy of the Promus. The results were presented at the American College of Cardiology (ACC) Annual Scientific Session by Gregg W. Stone, M.D., professor of medicine and director of research and education at the Center for Interventional Vascular Therapy at Columbia University Medical Center/New York-Presbyterian Hospital. He was the global principal investigator of the trial.
The outcomes reported at 12 months remained comparable at two years for the two stents. However, an additional landmark analysis of outcomes from year one to year two demonstrated superior efficacy of the Promus Element during this 12-month period of follow-up.
“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 revascularization,” Stone said. “These long-term results confirm that this device is an effective option for treating patients with coronary artery disease. Of particular note, a statistically significant reduction in recurrent ischemia requiring repeat revascularization procedures was present between the first and second year with the platinum chromium stent. This finding is potentially important, but must be confirmed by longer-term follow-up.”
The trial reported a two-year target lesion failure (TLF) rate of 4.4 percent for the Promus Element, compared to 5.8 percent for the Xience V (p=0.32). The Promus Element demonstrated numerically lower but not statistically different event rates than the Xience V in TLF components at two years, including cardiac death related to the target vessel (0.9 vs. 1.1 percent, respectively, p=0.98), myocardial infarction (MI) related to the target vessel (1.2 vs. 2.1 percent, p=0.28) and ischemia-driven target lesion revascularization (TLR, 2.4 vs. 4 percent, p=0.12). Low rates of target vessel revascularization (TVR, 4.2 percent vs. 5.6 percent, p=0.3) and stent thrombosis (ARC definite/probable, 0.5 percent vs. 0.7 percent, p=0.99) were observed at two years for both stents.
In a landmark analysis of event rates from year one to year two, the Promus Element demonstrated statistically significant differences in TLF (1.2 vs. 3 percent, p=0.04, 56 percent relative reduction), and TLR (0.7 vs. 2.2 percent, p=0.02, 67 percent relative reduction) compared to the Xience V, showing superior efficacy of the Promus Element from 12 months to two years.
Trial results also confirmed a previously reported significant reduction in unplanned (bail-out or emergency) stenting with the Promus Element (5.9 vs. 9.8 percent, p=0.004), including a significantly lower rate of inadequate lesion coverage or “geographic miss” (1.4 vs. 3.4 percent, p=0.01). Boston Scientific said these clinical observations reflect the results of comparative bench and animal studies, which demonstrated the enhanced visibility and deliverability of the Promus Element stent relative to the Xience V stent.
The prospective, multicenter, randomized PLATINUM Workhorse trial enrolled 1,530 patients with up to two de novo lesions at 132 clinical sites worldwide. The trial met its primary endpoint of 12-month target lesion failure demonstrating non-inferiority for the platinum chromium Promus Element compared to the cobalt chromium Xience V. The comprehensive PLATINUM clinical program is evaluating the safety and effectiveness of the Promus Element in six multi-center studies totaling more than 1,900 patients, including single-arm studies evaluating small vessels, long lesions, pharmacokinetics, and quantitative coronary angiography and intravascular ultrasound data.
Boston Scientific received CE mark approval for the Promus Element stent in 2009 and for the Promus Element Plus in 2011. In the United States, the Promus Element Plus stent was approved by the U.S. Food and Drug Administration in 2011.
For more information: www.bostonscientific.com