Journal article
Percutaneous Lower-extremity Arterial Interventions with Primary Balloon Angioplasty Versus SilverHawk Atherectomy and Adjunctive Balloon Angioplasty: Randomized Trial
Journal of vascular and interventional radiology, Vol.22(9), pp.1223-1228
09/01/2011
DOI: 10.1016/j.jvir.2011.05.013
PMID: 21757372
Abstract
Purpose: Target lesion revascularization (TLR) with primary percutaneous transluminal angioplasty (PTA) versus Silver Hawk atherectomy and adjunctive PTA of de novo infrainguinal disease has not been well defined. This study was conducted to compare the two approaches.
Materials and Methods: In this prospective, two-center randomized trial of PTA versus atherectomy of infrainguinal vessels, the primary endpoint of TLR was evaluated at I year. Secondary endpoints included the rate of "bailout" stent placement for suboptimal acute angiographic results and the rate of target vessel revascularization (TVR).
Results: Fifty-eight patients were included in the study. Of these, 29 (36 vessels) were randomized to the atherectomy arm and 29 (48 vessels) to the PTA arm. Final acute angiographic success rates were 100% in the PTA arm and 97.2% in the atherectomy arm (P value not significant). There was no statistical difference in TLR (16.7% vs 11.1%) or TVR (21.4% vs 11.1%) between the PTA and atherectomy groups, respectively. Bailout stent placement was performed in 18 of 29 patients (62.1%) in the PTA arm and eight of 29 patients (27.6%) in the atherectomy arm (P = .017). Major adverse events were similar between the PTA and atherectomy arms. Finally, when embolic filter protection was used, distal macroembolization occurred in 11 of 17 patients (64.7%) treated with atherectomy versus none of 10 in the PTA group (P < .001).
Conclusions: TLR and TVR at 1 year were statistically similar in atherectomy and primary PTA. Atherectomy reduced the need for bailout stent placement compared with primary PTA.
Details
- Title: Subtitle
- Percutaneous Lower-extremity Arterial Interventions with Primary Balloon Angioplasty Versus SilverHawk Atherectomy and Adjunctive Balloon Angioplasty: Randomized Trial
- Creators
- Nicolas W. Shammas - Midwest Cardiovascular Research FoundationDenise Coiner - Midwest Cardiovascular Research FoundationGail A. Shammas - Midwest Cardiovascular Research FoundationEric J. Dippel - Midwest Cardiovascular Research FoundationLori Christensen - Midwest Cardiovascular Research FoundationMichael Jerin - Midwest Cardiovascular Research Foundation
- Resource Type
- Journal article
- Publication Details
- Journal of vascular and interventional radiology, Vol.22(9), pp.1223-1228
- Publisher
- Elsevier
- DOI
- 10.1016/j.jvir.2011.05.013
- PMID
- 21757372
- ISSN
- 1051-0443
- eISSN
- 1535-7732
- Number of pages
- 6
- Grant note
- FoxHollow (ev3, Plymouth, Minnesota) Midwest Cardiovascular Research Foundation Edwards Lifesciences (Irvine, California)
- Language
- English
- Date published
- 09/01/2011
- Academic Unit
- Internal Medicine
- Record Identifier
- 9984691530202771
Metrics
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