Bare Metal Stent vs. Paclitaxel Eluting Stent in the Setting of Primary Stenting of Intermediate-Length Femoropopliteal Lesions - BATTLE

Feb 19, 2020
Font Size
A
A
A
Author/Summarized by Author:
Anthony A. Bavry, MD, MPH, FACC
Summary Reviewer:
Deepak L. Bhatt, MD, MPH, MBA, FACC
Trial Sponsor:
Terumo Medical Corporation
Date Published:
02/17/2020
Date Updated:
02/19/2020
Original Posted Date:
02/19/2020
References

Contribution To Literature:

The BATTLE trial failed to show that a paclitaxel-eluting stent was superior to a bare-metal stent.

Description:

The goal of the trial was to evaluate a self-expanding nitinol stent versus a polymer-free self-expanding paclitaxel-eluting stent among patients with symptomatic femoropopliteal lesions.


Study Design

  • Randomized
  • Parallel

Patients with symptomatic femoropopliteal disease were randomized to a self-expanding nitinol stent (Misago Rx) (n = 91) versus a polymer-free self-expanding paclitaxel-eluting stent (Zilver PTX) (n = 90).

  • Total number of enrollees: 181
  • Duration of follow-up: 24 months
  • Mean patient age: 68 years
  • Percentage female: 27%
  • Percentage with diabetes: 26%

Inclusion criteria:

  • Symptomatic femoropopliteal disease (Rutherford stages 2-5)
  • Target lesion length 2-14 cm

Exclusion criteria:

  • Asymptomatic lesions
  • Restenosis
  • Absence of atheromatous disease

Other salient features/characteristics:

  • Pre-dilatation was performed in 83%

Principal Findings:

The primary outcome, freedom from in-stent restenosis at 1 year, occurred in 88.6% of the bare-metal stent group compared with 91.0% of the paclitaxel-eluting stent group (p = 0.64).

Secondary outcomes:

  • In-stent restenosis at 2 years: 80.9% of the bare-metal stent group vs. 85.8% of the paclitaxel-eluting stent group (p = 0.64)
  • Thrombosis: 3.8% of the bare-metal stent group vs. 6.1% of the paclitaxel-eluting stent group (p = 0.75)
  • All-cause mortality: 6.4% of the bare-metal stent group vs. 1.2% of the paclitaxel-eluting stent group (p = 0.06)
  • No major amputations occurred in either group

Interpretation:

Among patients with symptomatic femoropopliteal disease undergoing revascularization, a polymer-free paclitaxel-eluting stent was not superior to a bare-metal stent. Most previous studies have compared a paclitaxel-eluting stent with balloon angioplasty for symptomatic femoropopliteal disease. With the paclitaxel-eluting stent, 95% of the drug is released within 24 hours and paclitaxel remains in the vessel wall for <60 days. These release kinetics may not be optimal for in-stent restenosis, which occurs within 1 year.

References:

Gouëffic Y, Sauguet A, Desgranges P, et al. A Polymer-Free Paclitaxel-Eluting Stent Versus a Bare-Metal Stent for De Novo Femoropopliteal Lesions: The BATTLE Trial. JACC Cardiovasc Interv 2020;13:447-57.

Editorial Comment: Aronow HD, Saad M. Femoropopliteal Drug-Eluting Versus Bare-Metal Stents: Lost a BATTLE, But Not the War! JACC Cardiovasc Interv 2020;13:458-60.

Clinical Topics: Cardiac Surgery, Invasive Cardiovascular Angiography and Intervention, Stable Ischemic Heart Disease, Aortic Surgery, Cardiac Surgery and SIHD, Chronic Angina

Keywords: Amputation, Angioplasty, Balloon, Angioplasty, Balloon, Coronary, Coronary Restenosis, Dilatation, Drug-Eluting Stents, Myocardial Revascularization, Paclitaxel, Polymers, Stents, Thrombosis, Vascular Diseases


< Back to Listings