Restenosis Intra-Stent of Bare Metal Stents: Paclitaxel-Eluting Balloon vs. Everolimus-Eluting Stent V - RIBS V

Jun 21, 2016
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Author/Summarized by Author:
Anthony A. Bavry, MD, MPH, FACC
Summary Reviewer:
Deepak L. Bhatt, MD, MPH, MBA, FACC
Trial Sponsor:
Unrestricted grants from B. Braun and Abbott Vascular
Date Presented:
10/30/2013
Date Published:
06/20/2016
Date Updated:
06/21/2016
Original Posted Date:
02/23/2014
References

Description:

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.

Study Design

  • Randomized
  • Parallel

Patient Populations:

  • 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%

Exclusions:

  • 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
  • Pregnancy
  • Intolerance to aspirin or clopidogrel
  • Left ventricular ejection fraction <25%

Primary Endpoints:

  • Minimal lumen diameter at follow-up

Secondary Endpoints:

  • Late loss
  • Major adverse cardiac events (MACE)

Drug/Procedures Used:

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.

Principal Findings:

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)

Interpretation:

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.

References:

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.

Keywords: Myocardial Infarction, Follow-Up Studies, Angina, Stable, Metals, Dilatation, Ticlopidine, Constriction, Pathologic, Sirolimus, Angioplasty, Balloon, Coronary, Diabetes Mellitus, Stents


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