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

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

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.

© 2017 The Authors. Published on behalf of the American Heart Association, Inc., by Wiley.

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).

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.
    1. Schillinger M, Minar E. Claudication: treatment options for femoropopliteal disease. Prog Cardiovasc Dis. 2011;54:41–46.
    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.
    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: . [Epub ahead of print]
    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.
    1. Humphries MD, Pevec WC, Laird JR, Yeo KK, Hedayati N, Dawson DL. Early duplex scanning after infrainguinal endovascular therapy. J Vasc Surg. 2011;53:353–358.
    1. Virga V, Stabile E, Biamino G, Salemme L, Cioppa A, Giugliano G, Tesorio T, Cota L, Popusoi G, Pucciarelli A, Esposito G, Trimarco B, Rubino P. Drug‐eluting balloons for the treatment of the superficial femoral artery in‐stent restenosis: 2‐year follow‐up. JACC Cardiovasc Interv. 2014;7:411–415.
    1. Liistro F, Angioli P, Porto I, Ricci L, Ducci K, Grotti S, Falsini G, Ventoruzzo G, Turini F, Bellandi G, Bolognese L. Paclitaxel‐eluting balloon vs. standard angioplasty to reduce recurrent restenosis in diabetic patients with in‐stent restenosis of the superficial femoral and proximal popliteal arteries: the DEBATE‐ISR study. J Endovasc Ther. 2014;21:1–8.
    1. Krankenberg H, Tubler T, Ingwersen M, Schluter M, Scheinert D, Blessing E, Sixt S, Kieback A, Beschorner U, Zeller T. Drug‐coated balloon versus standard balloon for superficial femoral artery in‐stent restenosis: the randomized femoral artery in‐stent restenosis (FAIR) trial. Circulation. 2015;132:2230–2236.
    1. Kinstner CM, Lammer J, Willfort‐Ehringer A, Matzek W, Gschwandtner M, Javor D, Funovics M, Schoder M, Koppensteiner R, Loewe C, Ristl R, Wolf F. Paclitaxel‐eluting balloon versus standard balloon angioplasty in in‐stent restenosis of the superficial femoral and proximal popliteal artery: 1‐year results of the PACUBA trial. JACC Cardiovasc Interv. 2016;9:1386–1392.
    1. Herdeg C, Oberhoff M, Baumbach A, Blattner A, Axel DI, Schroder S, Heinle H, Karsch KR. Local paclitaxel delivery for the prevention of restenosis: biological effects and efficacy in vivo. J Am Coll Cardiol. 2000;35:1969–1976.
    1. Dippel EJ, Makam P, Kovach R, George JC, Patlola R, Metzger DC, Mena‐Hurtado C, Beasley R, Soukas P, Colon‐Hernandez PJ, Stark MA, Walker C; Investigators EI . Randomized controlled study of excimer laser atherectomy for treatment of femoropopliteal in‐stent restenosis: initial results from the EXCITE ISR trial (excimer laser randomized controlled study for treatment of femoropopliteal in‐stent restenosis). JACC Cardiovasc Interv. 2015;8:92–101.
    1. Zeller T, Dake MD, Tepe G, Brechtel K, Noory E, Beschorner U, Kultgen PL, Rastan A. Treatment of femoropopliteal in‐stent restenosis with paclitaxel‐eluting stents. JACC Cardiovasc Interv. 2013;6:274–281.
    1. Bosiers M, Deloose K, Callaert J, Verbist J, Hendriks J, Lauwers P, Schroe H, Lansink W, Scheinert D, Schmidt A, Zeller T, Beschorner U, Noory E, Torsello G, Austermann M, Peeters P. Superiority of stent‐grafts for in‐stent restenosis in the superficial femoral artery: twelve‐month results from a multicenter randomized trial. J Endovasc Ther. 2015;22:1–10.
    1. Iida O, Takahara M, Soga Y, Hirano K, Yamauchi Y, Zen K, Kawasaki D, Nanto S, Yokoi H, Uematsu M; Investigators Z . The characteristics of in‐stent restenosis after drug‐eluting stent implantation in femoropopliteal lesions and 1‐year prognosis after repeat endovascular therapy for these lesions. JACC Cardiovasc Interv. 2016;9:828–834.
    1. Schmidt A, Piorkowski M, Gorner H, Steiner S, Bausback Y, Scheinert S, Banning‐Eichenseer U, Staab H, Branzan D, Varcoe RL, Scheinert D. Drug‐coated balloons for complex femoropopliteal lesions: 2‐year results of a real‐world registry. JACC Cardiovasc Interv. 2016;9:715–724.
    1. Grotti S, Liistro F, Angioli P, Ducci K, Falsini G, Porto I, Ricci L, Ventoruzzo G, Turini F, Bellandi G, Bolognese L. Paclitaxel‐eluting balloon vs standard angioplasty to reduce restenosis in diabetic patients with in‐stent restenosis of the superficial femoral and proximal popliteal arteries: three‐year results of the DEBATE‐ISR study. J Endovasc Ther. 2016;23:52–57.
    1. Gandini R, Del Giudice C, Merolla S, Morosetti D, Pampana E, Simonetti G. Treatment of chronic SFA in‐stent occlusion with combined laser atherectomy and drug‐eluting balloon angioplasty in patients with critical limb ischemia: a single‐center, prospective, randomized study. J Endovasc Ther. 2013;20:805–814.
    1. Zeller T, Baumgartner I, Scheinert D, Brodmann M, Bosiers M, Micari A, Peeters P, Vermassen F, Landini M, Snead DB, Kent KC, Rocha‐Singh KJ; Investigators IPDT . Drug‐eluting balloon versus standard balloon angioplasty for infrapopliteal arterial revascularization in critical limb ischemia: 12‐month results from the IN.PACT DEEP randomized trial. J Am Coll Cardiol. 2014;64:1568–1576.

Source: PubMed

Спонсоры и соавторы

Заболевания

Медикаментозные вмешательства

Подписаться