WASHINGTON, DC - September 14, 2014 - A new clinical trial comparing the use of everolimus-eluting stents (EES) and drug-eluting balloons (DEB) in treating in-stent restenosis (ISR) from drug-eluting stents found that EES provided superior late angiographic results and better late clinical outcomes.
Findings were reported today at the 26th annual Transcatheter Cardiovascular Therapeutics (TCT) scientific symposium. Sponsored by the Cardiovascular Research Foundation (CRF), TCT is the world's premier educational meeting specializing in interventional cardiovascular medicine.
Treatment of patients with ISR remains a challenge, especially in patients presenting with drug-eluting stent (DES) ISR. In this setting, DEB appear to be as effective as first generation DES. However, the relative value of DEB compared to new generation DES with DES-ISR remains unknown.
RIBS IV was a multicenter prospective randomized trial that compared the efficacy of DEB with that of EES in patients with DES-ISR. The primary endpoint was minimal lumen diameter (MLD) at late angiographic follow up. Secondary endpoints including diameter stenosis, angiographic late lumen loss, and binary restenosis were also analyzed at nine months.
A total of 309 patients with DES-ISR were randomized to receive either EES (n=155) or DEB (n=154). Late angiographic follow up was obtained in 90 percent of eligible patients. At nine months, the EES group reported a larger in-segment MLD than the DEB group (2.03 vs. 1.80, respectively; p=0.004). After one year, the EES group also reported higher rates of freedom from target lesion revascularization (96 percent vs. 87 percent, p=0.008) and freedom from major adverse coronary events, including cardiac death, myocardial infarction, and target vessel revascularizaiton (90 percent vs. 82 percent, p=0.044).
"In patients with DES-ISR, our study found that EES provides superior late angiographic results and better late clinical outcomes compared to DEB," said lead investigator Fernando Alfonso, MD, PhD. Dr. Alfonso is the Head of the Cardiac Department at the Hospital Universitario de La Princesa in Madrid, Spain. "Treatment of DES-ISR remains challenging and associated with poorer clinical and angiographic results than treatment of bare metal stent ISR. Further studies with more patients and longer follow-up are warranted in this adverse setting."
The RIBS IV trial was an investigator driven initiative funded by unrestricted grants from B. Braun and Abbot Vascular. Dr. Alfonso reported no disclosures.
The results of the RIBS IV trial will be presented on Sunday, September 14 at 11:42 AM EDT in the Main Arena (Level 3, Ballroom) of the Walter E. Washington Convention Center.
About CRF and TCT
The Cardiovascular Research Foundation (CRF) is an independent, academically focused nonprofit organization dedicated to improving the survival and quality of life for people with heart disease through high quality research and education. Since its inception in 1991, CRF has played a major role in realizing dramatic improvements in the lives of countless numbers of patients by establishing the safe use of new technologies and therapies in interventional cardiovascular medicine.
Transcatheter Cardiovascular Therapeutics (TCT) is the annual scientific symposium of CRF and the world's premier educational meeting specializing in interventional cardiovascular medicine. For more than 25 years, TCT has featured major medical research breakthroughs and gathered leading researchers and clinicians from around the world to present and discuss the latest evidence-based research in the field.