November 9, 2011 — Currently under review by the U.S. Food and Drug Administration (FDA), the Resolute drug-eluting stent (DES) from Medtronic Inc. continues to demonstrate consistently positive performance across a variety of studies. These conclusions come from two new data analyses being presented this week at Transcatheter Cardiovascular Therapeutics (TCT) 2011.
The first analysis, RESOLUTE Pooled Diabetics, focuses on outcomes in patients with both coronary artery disease (CAD) and diabetes; the second, RESOLUTE Pooled Safety, focuses on safety outcomes across all patient types.
More than 1,500 patients with diabetes mellitus participated in the global clinical program to evaluate Resolute’s performance in the treatment of CAD. The implantable medical device showed strong results through one year of follow-up.
Prof. Sigmund Silber, M.D., FACC, FESC, director of the Heart Centre at the Isar in Munich, Germany, will present the results of this analysis at TCT. The event is the Cardiovascular Research Foundation’s annual scientific symposium for interventional cardiovascular specialists.
“People with diabetes and heart disease constitute about one-third of the patients that receive percutaneous coronary interventions worldwide,” explained Silber. “They are an especially challenging group of patients to treat because of their increased risk of subsequent cardiovascular events, including heart attack and cardiac death, as well as repeat procedures in the target vessel.”
RESOLUTE Pooled Diabetics
This post-hoc pooled analysis of the Resolute clinical program presents the outcomes of all 1,535 diabetes patients treated with a Resolute DES in five studies to those without diabetes. For contemporary context, it compares these outcomes to those of patients who received a Xience V DES from Abbott Laboratories in the randomized RESOLUTE All Comers trial.
The analysis also presents the outcomes in insulin-dependent and non-insulin-dependent as well as patients without diabetes treated with a Resolute DES.
The study shows very similar and low rates of events across these patient subsets. No differences were observed between the Resolute and Xience arms after propensity adjustment. The RESLOUTE Pooled Diabetics analysis will be presented at the session titled “Intersection of Diabetes and PCI.”
“This pooled data analysis found low event rates for the Resolute DES through one-year of follow-up among patients with or without diabetes, and even among patients with insulin-dependent diabetes, although we need more data in this special subgroup,” Silber concluded.
RESOLUTE Pooled Safety
Following Silber’s presentation, Martin Leon, M.D., of New York-Presbyterian Hospital/Columbia University Medical Center will present two-year safety data from the global Resolute clinical program; more than 5,000 patients treated with the Resolute DES were enrolled. His presentation will occur during the session titled “Predictors and Prevention of Stent Thrombosis.”
The results of this post-hoc analysis, termed RESOLUTE Pooled Safety, were compared to those patients who received a Xience V DES in the RESOLUTE All Comers trial. No differences were observed between the Resolute and Xience arms after propensity adjustment.
RESOLUTE (First-in-Human Study)
Also presented at TCT 2011 will be the final, five-year follow-up from the original feasibility study of the Resolute DES. The results include zero ARC def/prob ST and a target lesion revascularization (TLR) rate of 3.1 percent in 130 patients. Prof. Ian Meredith of Monash Medical Centre in Melbourne, Australia will make this presentation on Tuesday during the session titled “Drug-Eluting Stents II.”
The Resolute DES is commercially available in more than 100 countries outside the United States; where its use is limited by U.S. law to clinical trials approved by the FDA. Medtronic continues to anticipate FDA approval of the device in the first half of 2012.
The clinical program will ultimately enroll more than 6,000 patients worldwide and involves a collaborative effort involving hundreds of medical centers in more than 25 countries.
For more information: www.medtronic.com