Restenosis Intra-Stent of Drug-Eluting Stents: Drug-Eluting Balloon vs Everolimus-Eluting Stent - RIBS IV

May 24, 2018
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Author/Summarized by Author:
Dharam J. Kumbhani, MD, SM, FACC
Summary Reviewer:
Deepak L. Bhatt, MD, MPH, MBA, FACC
Trial Sponsor:
B. Braun and Abbott Vascular
Date Presented:
09/14/2014
Date Published:
05/21/2018
Date Updated:
05/24/2018
Original Posted Date:
09/14/2014
References

Contribution To Literature:

The RIBS IV trial showed that everolimus-eluting stents are superior to drug-coated balloon for the treatment of DES-ISR.

Description:

The optimal treatment of drug-eluting stent (DES)–in-stent restenosis (ISR) remains challenging. The current trial sought to investigate outcomes after drug-eluting balloon (DEB) versus DES implantation for patients with DES-ISR.

Study Design

  • Randomized
  • Parallel

Patient Populations:

  • Mean patient age: 66 years old
  • Percentage female: 17%
  • Number of enrollees: 309
  • Duration of follow-up: 1 year

  • DES-ISR (>50% stenosis)
  • Angina or silent ischemia
  • ISR amenable for both modalities

Exclusions:

  • Stent related:
  • Stent location undefined
  • Unknown stent type
  • ISR <1 month
  • Thrombus
  • Vessel diameter <2 mm
  • ISR length >30 mm
  • ISR outside the stent

  • General:
  • Life expectancy <1 year
  • Female in childbearing age
  • Problems with follow-up angiography
  • Intolerance to aspirin/clopidogrel
  • Left ventricular ejection fraction <25%

Primary Endpoints:

  • MLD at 6-9 months

Secondary Endpoints:

  • Combined clinical and angiographic endpoints at 6-9 months, 1 year, and 3 years
  • Efficacy outcomes:
    - Angiographic: 1) restenosis rate, 2) % diameter stenosis, 3) acute gain, 4) late loss, 5) net gain
    - Composite of death, MI, target vessel revascularization, and analysis of individual events
  • Safety outcomes: stent thrombosis, bleeding episodes

Drug/Procedures Used:

Patients were randomized in a 1:1 ratio to either percutaneous transluminal coronary angioplasty (PTCA) with DEB (SeQuent Please B) or percutaneous coronary intervention (PCI) with everolimus-eluting stent (EES) (Xience Prime).

Principal Findings:

A total of 309 patients were randomized, 154 to DEB and 155 to DES. Baseline characteristics were fairly similar between the two arms. Diabetes was present in 46%. Presenting feature was stable angina or silent ischemia in 49%. >1 stent intervention in the target lesion was noted in 12% of patients. The median time to ISR was 535 days, with left anterior descending artery (LAD) being the target vessel in 48% and right coronary artery in 29%. Prior DES was PES in 25% and limus-type in the remainder.

On quantitative coronary angiography (QCA) analysis at baseline, in-segment reference vessel diameter (2.59 mm vs. 2.67 mm, p = 0.21) and lesion length (10.4 mm vs. 10.7 mm, p = 0.56) were similar between the DEB and DES arms. Post-procedure minimum lesion diameter (MLD) (2.2 vs. 2.49 mm, p < 0.0001) and acute gain (1.31 vs. 1.48 mm, p = 0.006) were lower in the DEB arm.

On 6- to 9-month QCA analysis, the in-segment MLD (1.8 mm vs. 2.03 mm, p = 0.004) and in-lesion MLD (1.89 mm vs. 2.2 mm, p < 0.0001) were significantly lower in the DEB arm. Correspondingly, there was a trend toward greater late lumen loss with DEB use (0.14 mm vs. 0.06 mm, p = 0.06).

Clinical endpoints at 1 year including the composite major adverse cardiac event (MACE; cardiac death, myocardial infarction [MI], target lesion revascularization) endpoint (16% vs. 7%, p = 0.009) and freedom from target lesion revascularization were significantly lower in the DEB arm (87% vs. 95.5%, p = 0.007). Rates of MI were numerically higher (3.2% vs. 1.3%), with two stent thrombosis events in the DEB and one in the EES arm.

3-year follow-up: MACE for DEB vs. EES: 20.1% vs.12.3%, p = 0.04, was mostly driven by TLR: 15.6% vs. 7.1%, p = 0.015.

  • MI: 4.5% vs. 2.6%, p = 0.35
  • Stent thrombosis: 2.6% vs. 1.3%, p = 0.4
  • All-cause mortality: 7.8% vs. 7.1%, p = 0.82

Interpretation:

The results of the RIBS IV trial indicate that PTCA with a DEB is inferior to EES PCI in patients with DES-ISR. Both short-term angiographic outcomes and long-term clinical outcomes were worse. Although rare, DES-ISR remains a challenging lesion subset, with no clear consensus from clinical trials. For BMS-ISR, the late lumen loss was lower in RIBS V with DEB PTCA (0.14 mm) than observed in this trial (0.3 mm), consistent with the observation made by some investigators that DES-ISR is more diffuse and prolific than BMS-ISR. Further data on the optimal treatment of this lesion subset are awaited.

References:

Alfonso F, Pérez-Vizcayno MJ, Cuesta J, et al. 3-Year Clinical Follow-Up of the RIBS IV Clinical Trial: A Prospective Randomized Study of Drug-Eluting Balloons Versus Everolimus-Eluting Stents in Patients With In-Stent Restenosis in Coronary Arteries Previously Treated With Drug-Eluting Stents. JACC Cardiovasc Interv 2018;11:981-91.

Editorial Comment: Kim HS, Rhee TM. Farewell to Drug-Eluting Balloons for In-Stent Restonsis? Appropriate Technique of Drug-Eluting Balloons Implantation Matters. JACC Cardiovasc Interv 2018;11:992-4.

Alfonso F, Pérez-Vizcayno MJ, Cárdenas A, et al. A Prospective Randomized Trial of Drug-Eluting Balloons Versus Everolimus-Eluting Stents in Patients With In-Stent Restenosis of Drug-Eluting Stents: The RIBS IV Randomized Clinical Trial. J Am Coll Cardiol 2015;66:23-33.

Presented by Dr. Fernando Alfonso at the Transcatheter Cardiovascular Therapeutics meeting (TCT 2014), Washington, DC, September 14, 2014.

Keywords: Myocardial Infarction, Coronary Angiography, Thrombosis, Drug-Eluting Stents, Myocardial Revascularization, Sirolimus, Angioplasty, Balloon, Coronary, Stents, Percutaneous Coronary Intervention, Transcatheter Cardiovascular Therapeutics


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