November 1, 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 at the 25th annual Transcatheter Cardiovascular Therapeutics scientific symposium (TCT 2013).
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 (> 30mm), total occlusions or ISR in small vessels (< 2.0mm) 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 a 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 everolimus-eluting stent (EES). Mean age was 66±11 years and 25 patients (13 percent) were female. Crossover 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 2.36mm 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,” Fernando Alfonso, M.D., Ph.D., head of the cardiac department, Hospital Universitario de la Princesa in Madrid, Spain and lead investigator.
“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.”
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