SAN FRANCISCO, CA – October 30, 2013 – A clinical trial comparing the use of drug-eluting stents (DES) and drug-eluting balloons (DEB) in treating in-stent restenosis (ISR) from bare metal stents found that both techniques yielded positive long term outcomes. Findings from the RIBS V trial were presented today at the 25th 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 in-stent restenosis (ISR) remains a challenge. Drug-eluting balloons (DEB) have demonstrated effectiveness in patients with bare metal stent (BMS) ISR. However, the relative value of DEB versus new generation DES has not been measured.
In RIBS V, patients presenting with BMS ISR (>50 percent diameter stenosis) and angina or objective evidence of ischemia were eligible. Patients with very diffuse ISR (>30 mm), total occlusions or ISR in small vessels (<2.0 mm) were excluded. Patients with short life expectancy and those with severe associated conditions precluding late angiography were also excluded.
The primary endpoint of the study was the comparison of minimal lumen diameter (MLD) at nine month follow-up between the two arms.
A total of 189 patients with BMS ISR were randomized at 25 Spanish University Hospitals. Of these, 95 were allocated to DEB and 94 to EES. Mean age was 66±11 years and 25 patients (13 percent) were female. Cross-over to DES was required in eight patients in the DEB arm. Late angiographic follow-up was obtained in 92 percent of eligible patients.
At follow up, MLD in segment (primary study endpoint) was 2.36 mm in the EES group and 2.01 mm in the DEB group. MLD in lesion was 2.44 mm in the EES group and 2.03 mm in the DEB group. These angiographic differences were statistically significant. However, restenosis rate (4.7 percent and 9.5 percent) and late loss were very low and similar in both groups.
"In patients with BMS-ISR both DEB and EES provide excellent long-term clinical outcomes with very low rate of clinical and angiographic recurrences," said lead investigator Fernando Alfonso, MD, PhD. Dr. Alfonso is Head of the Cardiac Department at the Hospital Universitario de la Princesa in Madrid, Spain.
"However, EES provide superior late angiographic results including MLD, the primary endpoint, and percent diameter stenosis. Further studies (larger and with longer follow-up) are required to elucidate if these superior late angiographic findings eventually translate into a clinical benefit."
The RIBS V trial was an investigators driven initiative (with unrestricted grants obtained from B. Braun Surgical and Abbott Vascular). The study was coordinated from the Hospital Clínico San Carlos in Madrid. Dr. Alfonso reported no disclosures.
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 cardiovascular disease through 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. CRF is the sponsor of the Transcatheter Cardiovascular Therapeutics (TCT) scientific symposium. Celebrating its 25th anniversary this year, TCT is the world's premier educational meeting specializing in interventional cardiovascular medicine. For more information, visit http://www.crf.org and http://www.tctconference.com.
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