Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
Randomized Controlled Trial
. 2017 Jul 25;6(7):e006321.
doi: 10.1161/JAHA.117.006321.

ISAR-PEBIS (Paclitaxel-Eluting Balloon Versus Conventional Balloon Angioplasty for In-Stent Restenosis of Superficial Femoral Artery): A Randomized Trial

Ilka Ott  1 , Salvatore Cassese  2 , Philipp Groha  2 , Birgit Steppich  2 , Felix Voll  2 , Martin Hadamitzky  2 , Tareq Ibrahim  3 , Sebastian Kufner  2 , Karl Dewitz  2 , Theresa Wittmann  2 , Albert Markus Kasel  2 , Karl-Ludwig Laugwitz  3   4 , Heribert Schunkert  2   4 , Adnan Kastrati  2   4 , Massimiliano Fusaro  2
Affiliations
Randomized Controlled Trial

ISAR-PEBIS (Paclitaxel-Eluting Balloon Versus Conventional Balloon Angioplasty for In-Stent Restenosis of Superficial Femoral Artery): A Randomized Trial

Ilka Ott et al. J Am Heart Assoc. .

Abstract

Background: Paclitaxel-eluting balloon (PEB) angioplasty has superior efficacy compared with conventional balloon angioplasty (BA) for de novo lesions of superficial femoral artery (SFA). Studies investigating the angiographic and clinical performance of PEB angioplasty versus BA for in-stent restenosis of SFA are limited. We performed a randomized trial to investigate angiographic and clinical performance of PEB versus BA for in-stent restenosis of SFA.

Methods and results: Patients with symptomatic in-stent restenosis of SFA were randomly assigned to either PEB or BA at 2 centers in Munich, Germany. The primary end point was the percentage diameter stenosis at 6- to 8-month follow-up angiography. Secondary end points were the rate of binary restenosis at follow-up angiography and target lesion revascularization, target vessel thrombosis, ipsilateral amputation, bypass surgery of the affected limb, and all-cause mortality at 24-month follow-up. Seventy patients were assigned to PEB (n=36) or BA (n=34). Mean lesion length was 139±67 mm, and roughly one third of lesions were completely occluded at the time of the index procedure. At control angiography, the percentage diameter stenosis (44±33% versus 65±33%, P=0.01) and binary restenosis were significantly reduced with PEB versus BA (30% versus 59%, P=0.03). At 24-month follow-up, PEB was associated with a significant reduction of target lesion revascularization in comparison to BA (19% versus 50%, P=0.007). There was no difference with respect to other outcomes of interest.

Conclusions: In patients with in-stent restenosis of SFA, a percutaneous therapy with PEB compared with BA has superior angiographic performance at 6 to 8 months and improved clinical efficacy up to 24-month follow-up.

Clinical trial registration: URL: http://www.clinicaltrials.gov. Unique identifier: NCT01083394.

Keywords: in‐stent restenosis; paclitaxel‐eluting balloon; peripheral artery disease.

PubMed Disclaimer

Figures

Figure 1
Figure 1
Flow diagram of the study. Enrollment by random assignment (R), death (all‐cause), and loss to follow‐up over 6 months are shown. BA indicates balloon angioplasty; ISR, in‐stent restenosis; PEB, paclitaxel‐eluting balloon; SFA, superficial femoral artery.
Figure 2
Figure 2
Survival free from target lesion revascularization (TLR) out to 24‐month follow‐up. Kaplan–Meier curves for patients assigned to receive paclitaxel‐eluting balloon (PEB; black line) or balloon angioplasty (BA; red line).
See this image and copyright information in PMC

References

    1. Gerhard‐Herman MD, Gornik HL, Barrett C, Barshes NR, Corriere MA, Drachman DE, Fleisher LA, Fowkes FG, Hamburg NM, Kinlay S, Lookstein R, Misra S, Mureebe L, Olin JW, Patel RA, Regensteiner JG, Schanzer A, Shishehbor MH, Stewart KJ, Treat‐Jacobson D, Walsh ME. 2016 AHA/ACC guideline on the management of patients with lower extremity peripheral artery disease: a report of the American College of Cardiology/American Heart Association Task Force on Clinical Practice Guidelines. J Am Coll Cardiol. 2017;69:e71–e126. - PubMed
    1. Schillinger M, Minar E. Claudication: treatment options for femoropopliteal disease. Prog Cardiovasc Dis. 2011;54:41–46. - PubMed
    1. Cassese S, Byrne RA, Ott I, Ndrepepa G, Nerad M, Kastrati A, Fusaro M. Paclitaxel‐coated versus uncoated balloon angioplasty reduces target lesion revascularization in patients with femoropopliteal arterial disease: a meta‐analysis of randomized trials. Circ Cardiovasc Interv. 2012;5:582–589. - PubMed
    1. Cassese S, Ndrepepa G, Kufner S, Byrne RA, Giacoppo D, Ott I, Laugwitz KL, Schunkert H, Kastrati A, Fusaro M. Drug‐coated balloon angioplasty for in‐stent restenosis of femoropopliteal arteries. A meta‐analysis. EuroIntervention. 2017;13:1–8. pii: EIJ‐D‐16‐00735. DOI: 10.4244/EIJ‐D‐16‐00735. [Epub ahead of print] - DOI - PubMed
    1. Tosaka A, Soga Y, Iida O, Ishihara T, Hirano K, Suzuki K, Yokoi H, Nanto S, Nobuyoshi M. Classification and clinical impact of restenosis after femoropopliteal stenting. J Am Coll Cardiol. 2012;59:16–23. - PubMed

Publication types

MeSH terms

Associated data