Format

Send to

Choose Destination
J Endovasc Ther. 2015 Dec;22(6):839-46. doi: 10.1177/1526602815608610. Epub 2015 Oct 7.

One-Year Outcomes Following Directional Atherectomy of Infrapopliteal Artery Lesions: Subgroup Results of the Prospective, Multicenter DEFINITIVE LE Trial.

Author information

1
Kardiologie und Angiologie II, Universitäts-Herzzentrum Freiburg-Bad Krozingen, Bad Krozingen, Germany aljoscha.rastan@universitaets-herzzentrum.de.
2
Division of Vascular Surgery, New York Presbyterian Hospital, University Hospital of Columbia and Cornell, New York, NY, USA.
3
Sections of Interventional Cardiology and Vascular Medicine, St. Elizabeth's Medical Center, Tufts University School of Medicine, Boston, MA, USA.
4
The Prairie Heart Institute at St. John's Hospital, Springfield, IL, USA.
5
The Institute for Heart, Vascular and Stroke Care, Massachusetts General Hospital, Boston, MA, USA.
6
Kardiologie und Angiologie II, Universitäts-Herzzentrum Freiburg-Bad Krozingen, Bad Krozingen, Germany.

Abstract

PURPOSE:

To report a subgroup analysis of the prospective, multicenter, single-arm DEFINITIVE LE trial to assess the effectiveness of directional atherectomy for the treatment of infrapopliteal artery lesions at 1 year.

METHODS:

In the DEFINITIVE LE trial, follow-up assessments occurred up to 1 year postprocedure. Of the 800 patients enrolled, 145 subjects with 189 infrapopliteal lesions met the criteria for this analysis. Seventy (48.3%) and 75 (51.7%) patients were suffering critical limb ischemia (CLI) and intermittent claudication, respectively; 68.3% (99/145) had diabetes. The mean lesion length was 58±44 mm (all lesions); 20.2% were occluded. The primary endpoint for patients with claudication was duplex ultrasound-derived primary patency, while for subjects with CLI it was freedom from major amputation of the target limb at 1 year. Endpoints and adverse events were independently assessed.

RESULTS:

Procedure success (≤30% residual stenosis) was achieved in 84% of treated lesions. The 1-year primary patency rate was 84% (claudicants 89.6% and CLI patients 78%, p=0.11), and the freedom from major amputation rate was 97.1% (claudicants 100% and CLI 93.8%, p=0.03). In both claudication and CLI patients, significant improvements in Rutherford category and objective measures of walking distance and quality of life were seen at 1 year in comparison to baseline.

CONCLUSION:

This study demonstrates that directional atherectomy in infrapopliteal arteries results in promising technical and clinical results at 1 year for claudicant as well as CLI patients.

KEYWORDS:

angioplasty; atherectomy; claudication; critical limb ischemia; infrapopliteal arteries; patency; peripheral artery disease; peroneal artery; restenosis; tibial artery

PMID:
26445814
DOI:
10.1177/1526602815608610
[Indexed for MEDLINE]

Supplemental Content

Full text links

Icon for Atypon
Loading ...
Support Center