Restenosis Intra-Stent of Bare Metal Stents: Paclitaxel-Eluting Balloon vs. Everolimus-Eluting Stent V - RIBS V
The goal of the trial was to evaluate treatment with a drug-eluting balloon compared with an everolimus-eluting stent among patients with bare-metal stent (BMS) restenosis.
Contribution to Literature: The RIBS V trial revealed that among patients with BMS restenosis, treatment with an everolimus-eluting stent was associated with superior late angiographic results.
- Patients ≥20 years of age with stable angina due to BMS restenosis
Number of enrollees: 189 patients
Duration of follow-up: 9 months, 1 year, 3 years
Mean patient age: 66 years
Percentage female: 13%
Ejection fraction: 58%
- Stent location undefined
- Index procedure within the last month
- Thrombus or TIMI 0 flow
- Vessel diameter <2 mm
- In-stent restenosis length >30 mm
- Limited life expectancy
- Intolerance to aspirin or clopidogrel
- Left ventricular ejection fraction <25%
- Minimal lumen diameter at follow-up
- Late loss
- Major adverse cardiac events (MACE)
Patients with stable angina due to BMS restenosis were randomized to drug-eluting balloon angioplasty for 60 seconds (SeQuent Please; n = 95) versus an everolimus-eluting stent (Xience Prime; n = 94).
All patients were pretreated with aspirin and 300-600 mg of clopidogrel.
Overall, 189 patients were randomized. The mean age was 66 years, 13% were women, 26% had diabetes, 60% had prior myocardial infarction (MI), and the mean time from initial implant to in-stent restenosis was 363 days. The reference vessel diameter was 2.62 mm in the drug-eluting balloon group versus 2.63 mm in the everolimus-eluting stent group. Eight patients in the drug-eluting balloon group crossed over to stent placement due to dilatation failure or edge dissection.
The in-segment minimal lumen diameter at 9 months follow-up was 2.01 mm in the drug-eluting balloon group versus 2.36 mm in the everolimus-eluting stent group (p < 0.0001). The percent stenosis at follow-up was greater in the drug-eluting balloon group versus the everolimus-eluting stent group (25% vs. 13%; respectively, p < 0.001). In-segment late loss was 0.14 mm in the drug-eluting balloon group versus 0.04 mm in the everolimus-eluting stent group (p = 0.14).
MACE at 1 year were 8% in the drug-eluting balloon group versus 6% in the everolimus-eluting stent group (p = nonsignificant), respectively.
At 3 years:
- Cardiac death: 2% in the drug-eluting balloon group versus 1% in the everolimus-eluting stent group (p = nonsignificant)
- Target lesion revascularization: 8% in the drug-eluting balloon group versus 2% in the everolimus-eluting stent group (p = 0.04)
Among patients with BMS restenosis, treatment with an everolimus-eluting stent was associated with superior late angiographic results (larger minimal lumen diameter and smaller percent stenosis). MACE at intermediate follow-up were similar in both groups, except for an excess frequency of target lesion revascularization at 3 years in the drug-eluting balloon group. Larger studies are needed to determine the clinical significance of these findings.
Alfonso F, Pérez-Vizcayno MJ, García del Blanco B, et al. Long-Term Results of Everolimus-Eluting Stents Versus Drug-Eluting Balloons in Patients With Bare-Metal In-Stent Restenosis: 3-Year Follow-Up of the RIBS V Clinical Trial. JACC Cardiovasc Interv 2016;9:1246-55.
Editorial Comment: Wiebe J, Colleran R, Kastrati A. Drug-Eluting Balloons or Stents for Bare-Metal Stent Restenosis. JACC Cardiovasc Interv 2016;9:1256-8.
Alfonso F, Pérez-Vizcayno MJ, Cárdenas A, et al. A Randomized Comparison of Drug-Eluting Balloon Versus Everolimus-Eluting Stent in Patients With Bare-Metal Stent In-Stent Restenosis: The RIBS V Clinical Trial. J Am Coll Cardiol 2014;63:1378-86.
Presented by Dr. Fernando Alfonso at the Transcatheter Cardiovascular Therapeutics meeting (TCT 2013), San Francisco, CA, October 30, 2013.
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