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NEW PLATINUM STENT PERFORMS AS WELL AS BENCHMARK COBALT STENT IN PATIENTS WHO UNDERGO ANGIOPLASTY
One-Year Results of the PLATINUM Trial Show No Significant Differences in Clinical Outcomes
New Orleans, LA – In a clinical trial designed to assess the safety and efficacy of a new everolimus-eluting stent, the platinum chromium stent was non-inferior to the predicate cobalt chromium stent, with both leading to similar rates of cardiac death, heart attack, and ischemia-driven target lesion revascularization, according to research presented today at the American College of Cardiology’s 60th Annual Scientific Session. ACC.11 is the premier cardiovascular medical meeting, bringing together cardiologists and cardiovascular specialists to further advances in cardiovascular medicine.
The data are the 12-month pivotal results of the five-year PLATINUM trial, which examines the safety and efficacy of a new metal alloy and modified stent scaffold designed to improve stent conformability, durability, and radiopacity.
“The cobalt chromium everolimus-eluting stent has set the current benchmark for patient outcomes, with the lowest reported rates of both stent thrombosis and restenosis,” said lead study author Gregg W. Stone, M.D., professor of medicine and director of cardiovascular research and education at New York Presbyterian Hospital/Columbia University Medical Center. “The PLATINUM trial has now shown that a new platinum chromium everolimus-eluting stent can deliver comparable clinical outcomes. The platinum chromium stent maintains the same drug and polymer as the predicate stent but uses a new stent design with a novel metallic alloy designed to have favorable mechanical and ease-of-use properties.”
For the study – which was conducted at 132 sites worldwide – 1,530 patients undergoing angioplasty in one or two of their coronary arteries between January 2009 and September 2009 were randomized to receive either the new platinum chromium stent (n = 768) or the control cobalt chromium stent (n = 762). After hospital discharge, the researchers conducted clinical follow-up to determine the rate of the primary endpoint, which was a composite of target vessel-related cardiac death, target vessel-related heart attack, or ischemia-driven target lesion revascularization.
The team found that the platinum chromium stent’s performance was non-inferior to the cobalt chromium stent’s performance, with the rate of the composite endpoint at 3.4 percent and 2.9 percent, respectively (95 percent CI = 0.5 percent [-1.3 percent, +2.3 percent], P noninferiority = 0.001, P superiority = 0.60). In addition, the researchers found no significant differences between the two stent groups in other safety and efficacy measures, including stent thrombosis, which occurred in 0.4 percent of patients in each group, and target lesion revascularization, which occurred in 1.9 percent of patients in each group.
“On the basis of this study, I would expect the FDA to approve this device in the U.S., which will afford physicians another option of an excellent stent to use,” Stone said.
Stone has served on the scientific advisory boards for Boston Scientific and Abbott Vascular and has received honoraria from both. He is also a consultant to Medtronic. Boston Scientific funded the study.
This study will be simultaneously published online in the Journal of the American College of Cardiology (JACC) and will appear in the April 19, 2011, print edition.
Dr. Stone will be available to the media on Monday, April 4 at 12:30 p.m. CDT in Room 338/339.
Dr. Stone will present the study “A Prospective, Randomized, Evaluation of a Novel Everolimus-Eluting CoronarySstent: The PLATINUM Trial” on Monday, April 4 at 10:45 a.m. CDT in the Joint Main Tent: La Nouvelle.
The American College of Cardiology (www.cardiosource.org) represents the majority of board certified cardiovascular care professionals through education, research, promotion, development and application of standards and guidelines – and to influence health care policy. ACC.11 is the largest cardiovascular meeting, bringing together cardiologists and cardiovascular specialists to share the newest discoveries in treatment and prevention, while helping the ACC achieve its mission to address and improve issues in cardiovascular medicine.