Feature | March 29, 2012

Trial Data Shows Superior Efficacy of Promus Element Compared to Xience V

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

Related Content

Edwards, Sapien 3 transcatheter heart valve, Canada, approval
News | Heart Valve Technology| July 27, 2016
Edwards Lifesciences Corp. announced that Health Canada has approved the Edwards Sapien 3 transcatheter heart valve for...
PCI outcomes, public reporting, high-risk patients, JAMA Cardiology, Beth Israel Deaconess Medical Center study
News | Cath Lab| July 27, 2016
July 27, 2016 — A number of states mandate public reporting of mortality outcomes following certain cardiac procedure
News | Genetic Testing| July 26, 2016
July 26, 2016 — A new study has identified a genetic error that weakens the aorta, placing patients with this and sim
Abbott, Absorb bioresorbable stent, dissolving, UAB, University of Alabama at Birmingham, first in state
News | Stents Bioresorbable| July 26, 2016
On July 20, Massoud Leesar, M.D., of University of Alabama at Birmingham Hospital implanted a patient with Absorb, the...
CMS, Overall Hospital Quality Star Rating, national distribution, quailty of care
News | Business| July 26, 2016
July 25, 2016 — The Centers for Medicare and Medicaid Services (CMS) announced that it expects to launch its new Over
Stryker Sustainability Solutions, Angiodynamics Soft Vu Omni Flush Angiographic Catheters, recall
News | Angiographic Catheter| July 25, 2016
Stryker Sustainability Solutions (formerly Ascent Healthcare Solutions) is recalling Angiodynamics Soft Vu Omni Flush...
Million Hearts Cardiovascular Disease Risk Reduction Model, CMS, reduce heart attacks and strokes, participants
News | Patient Engagement| July 22, 2016
July 22, 2016 — The Centers for Medicare & Medicaid Services (CMS) recently announced 516 awardees in 47 states,
heart failure, after first heart attack, cancer risk, JACC study
News | Cardiac Diagnostics| July 21, 2016
People who develop heart failure after their first heart attack have a greater risk of developing cancer when compared...
Absorb, bioresorbable stent, BVS

The Abbott Absorb stent gained FDA clearance in July 2016. It has metallic markers at each end so it can be visualized for proper positioning under angiographic X-ray imaging. 

Feature | Stents Bioresorbable| July 21, 2016 | Alphonse Ambrosia, D.O.
Some have labeled bioresorbable scaffolds (BRS), also known as bioresorbable stents, as the fourth evolution of inter
mitral valve surgery outcomes, twisting of the heart, echocardiography, NICSMR, JACC Basic to Translational Science
News | Heart Valve Technology| July 20, 2016
A novel study has found a simple pre-operative echocardiographic measurement of the amount of torsion of the heart...
Overlay Init