Medtronic announced on 17 February 2012 FDA approval of the Resolute Integrity drug-eluting stent for the treatment of coronary artery disease. The new heart device’s FDA approval stems from the results of a global series of studies involving the Resolute drug-eluting stent, which showed consistently powerful clinical performance across a broad spectrum of patients––including those with diabetes. The Resolute Integrity uses the same drug-and-polymer combination as the Resolute device.
The Resolute Integrity drug-eluting stent builds on the success of the market-leading Integrity bare metal stent. The Integrity platform’s rapid adoption in the United States is the result of a proprietary engineering advance called continuous sinusoid technology (CST). CST encompasses one continuous, single strand of wire that is molded into a sinusoidal wave and then wrapped in a helical pattern and laser-fused at certain points, making each stent comparable to a flexible spring.
“The Resolute Integrity drug-eluting stent offers several notable benefits, starting with outstanding deliverability, which means it’s exceptionally easy to navigate the stent on the delivery system through the coronary vasculature to the narrowed arterial segment that requires treatment,” explained Martin B Leon, director of the Center for Interventional Vascular Therapy at New York-Presbyterian/Columbia University Medical Center, founder and chairman emeritus of the Cardiovascular Research Foundation, and a principal investigator of the RESOLUTE US clinical study. “Its approval by the FDA is based on the impressive performance of the Resolute drug-eluting stent in a wide variety of patients. With the device’s compelling combination of deliverability, efficacy and safety, not to mention that it is the first drug-eluting stent approved for patients with diabetes, the Resolute Integrity drug-eluting stent promises to gain rapid acceptance in cath labs nationwide.”
The global RESOLUTE clinical programme consisted of a large randomised controlled trial and a series of confirmatory single-arm studies involving nearly 250 sites in 32 countries. In total, the programme enrolled more than 5,100 patients who received a Resolute drug-eluting stent; about a third (1,535) of these patients had diabetes, a proportion that mirrors the US patient mix.
RESOLUTE US enrolled 1,402 patients across 128 US-based clinical trial sites. It was led by Leon and his co-principal investigators: Laura Mauri, chief scientific officer of the Harvard Clinical Research Institute and an interventional cardiologist at Brigham and Women’s Hospital in Boston; and Alan Yeung, director of interventional cardiology at Stanford University School of Medicine in Palo Alto, USA.
At one year of follow-up in RESOLUTE US, the results included low rates of target lesion failure (TLF, 4.7%), clinically-driven target lesion revascularisation (TLR, 2.8%) and definite/probable stent thrombosis (def/prob ST, 0.1%). These results were achieved despite 34% of the patients in the study having diabetes, which typically drives higher event rates.
One year of follow-up in a pre-specified analysis of patients with diabetes who received a Resolute drug-eluting stent as participants in the Resolute clinical programme also demonstrated low rates of TLF (6.6%), TLR (3.4%) and def/prob ST (0.3%).
In two separate large randomized controlled trials, the Resolute DES matched the safety and effectiveness of Abbott Laboratories’ Xience V® DES, which represents the market-leading drug-eluting stent platform in the United States.
The Resolute All-Comers study, sponsored by Medtronic, enrolled nearly 2,300 patients at 17 centers and was led by Patrick Serruys, director of the Thoraxcenter at Erasmus University in Rotterdam, The Netherlands; Stephan Windecker, with University Hospital in Bern, Switzerland; and Sigmund Silber, of the Heart Catheterization Centre in Munich, Germany. The one- and two-year results of RESOLUTE All Comers were published in The New England Journal of Medicine and The Lancet, respectively.
While not part of the FDA dataset, the TWENTE study, supported jointly by Medtronic and Abbott, enrolled nearly 1,400 patients at a single centre and was led by Clemens von Birgelen, co-director of the Department of Cardiology at Thoraxcentrum Twente and professor of cardiology at the University of Twente in the Netherlands. Von Birgelen presented the one-year results of TWENTE at the 2011 Transcatheter Cardiovascular Therapeutics (TCT) meeting. The results are also reported in a recent issue of the Journal of the American College of Cardiology.
“The new Resolute Integrity DES comes to US cath labs with compelling clinical evidence and a highly differentiated stent platform,” said Sean Salmon, president of Medtronic’s coronary and renal denervation business. “Our next-generation zotarolimus-eluting coronary stent has gained wide global acceptance for its remarkable ability to successfully meet clinical and anatomic challenges that interventional cardiologists confront in their everyday practice. We are excited to provide this important advanced technology to US patients and practitioners.”