The Impact of Balloon Pre-dilatation Techniques on Drug-Coated Balloon Therapy for Femoropopliteal Artery Disease: Six-Month Results From the CIVILIAN Registry

Abstract

Objective:

The purpose of this study is to compare the initial outcomes of using the Chocolate balloon pre-dilatation (CLP) and sequential enlarging angioplasty pre-dilatation (sequential balloon pre-dilation [SP]) techniques versus the conventional balloon pre-dilatation (CP) method prior to drug-coated balloon (DCB) treatment for femoropopliteal (FP) lesions.

Methods:

This was a retrospective analysis of prospectively collected data from the CIVILIAN (Clinical InVestigation of different lesIon preparation modaLIty followed by DCB in femoropopliteal Artery occlusioN disease) registry. Between March 2021 and November 2022, 3 pre-dilation techniques used prior to the DCB angioplasty were included. The study endpoint included intraoperative finial severe dissection after provisional stent placement, bailout stenting rate, the diameter of the largest pre-dilation balloon and DCB, as well as major adverse events (MAEs), including death, major limb amputation, or target vessel revascularization at 6 months.

Results:

During the study period, 435 limbs (429 patients) were pre-dilated before DCB treatment in FP lesions, 166 limbs were pre-dilated with Chocolate balloons, 93 limbs with sequential enlarging balloon pre-dilation technique, and 176 limbs with CP. The largest pre-dilation balloon was significantly larger in CLP and SP groups than that in the CP group (CLP 4.74±0.52 mm vs CP 4.36±0.64 mm, p<0.001; SP 4.82±0.69 mm vs CP 4.36±0.63 mm, p<0.001). A consistent result was shown in DCB diameter (CLP 4.86±0.44 mm vs CP 4.71±0.51 mm, p=0.003; SP 4.90±0.58 mm vs CP 4.71±0.51 mm, p=0.006). The bailout stenting rate was significantly lower in the CLP group than that in the CP group (18.1% vs 30.1%, p=0.011). The rates of MAEs at 6 months in the CLP and SP groups were comparable to those in the CP group (7.2% and 8.6% vs 6.3%, p>0.05). The risk for intraoperative bailout stenting rate was related to TASC D classification (3.59, 95% CI: 1.83–7.05, p<0.001), chronic total occlusion (CTO) lesion (1.82, 95% CI: 1.07–3.10, p=0.028), as well as pre-dilated with the conventional balloon (1.64, 95% CI: 1.00–2.69, p=0.048).

Conclusions:

By utilizing chocolate balloon and sequential enlarging angioplasty, it becomes possible to use larger pre-dilation balloons and DCBs. In addition, the use of the chocolate balloon can significantly reduce the need for bailout stenting when compared with conventional balloons.

Clinical Impact

The utilization of a chocolate balloon and sequential enlarging angioplasty has emerged as a promising technique for angioplasty procedures. This approach allows for the use of larger pre-dilation balloons and drug-coated balloons. The use of the chocolate balloon can significantly reduce the need for bail-out stenting when compared to conventional balloons. Further research is required to determine the impact of vessel preparation techniques on the primary patency.

Keywords

femoropopliteal artery disease pre-dilation technique drug-coated balloon

Get full access to this article

View all access options for this article.

References

Aboyans

Ricco

Bartelink

MEL

, et al. 2017 ESC guidelines on the diagnosis and treatment of peripheral arterial diseases, in collaboration with the European Society for Vascular Surgery (ESVS): document covering atherosclerotic disease of extracranial carotid and vertebral, mesenteric, renal, upper and lower extremity arteries. Endorsed by the European Stroke Organization (ESO). The task force for the diagnosis and treatment of peripheral arterial diseases of the European Society of Cardiology (ESC) and of the European Society for Vascular Surgery (ESVS). Eur Heart J. 2018;39(9):763–816.

Schillinger

Sabeti

Loewe

, et al. Balloon angioplasty versus implantation of nitinol stents in the superficial femoral artery. N Engl J Med. 2006;354(18):1879–1888.

Soga

Iida

Hirano

, et al. Mid-term clinical outcome and predictors of vessel patency after femoropopliteal stenting with self-expandable nitinol stent. J Vasc Surg. 2010;52(3):608–615.

Tepe

Laird

Schneider

, et al. Drug-coated balloon versus standard percutaneous transluminal angioplasty for treating superficial femoral and popliteal peripheral artery disease: 12-month results from the IN.PACT SFA randomized trial. Circulation. 2015;131(5):495–502.

Thieme

Von Bilderling

Paetzel

, et al. The 24-month results of the lutonix global SFA registry: worldwide experience with lutonix drug-coated balloon. JACC Cardiovasc Interv. 2017;10(16):1682–1690.

Katsanos

Spiliopoulos

Karunanithy

, et al. Bayesian network meta-analysis of nitinol stents, covered stents, drug-eluting stents, and drug-coated balloons in the femoropopliteal artery. J Vasc Surg. 2014;59(4):1123–1133.

Fanelli

Cannavale

Gazzetti

, et al. Calcium burden assessment and impact on drug-eluting balloons in peripheral arterial disease. Cardiovasc Intervent Radiol. 2014;37(4):898–907.

Tepe

Zeller

Albrecht

, et al. Local delivery of paclitaxel to inhibit restenosis during angioplasty of the leg. N Engl J Med. 2008;358(7):689–699.

Kobayashi

Hirano

Yamawaki

, et al. Simple classification and clinical outcomes of angiographic dissection after balloon angioplasty for femoropopliteal disease. J Vasc Surg. 2018;67(4):1151–1158.

10.

Giannopoulos

Strobel

Rudofker

, et al. Association of postangioplasty femoropopliteal dissections with outcomes after drug-coated balloon angioplasty in the femoropopliteal arteries. J Endovasc Ther. 2021;28(4):593–603.

11.

Mustapha

Lansky

Shishehbor

, et al. A prospective, multi-center study of the chocolate balloon in femoropopliteal peripheral artery disease: the Chocolate BAR registry. Catheter Cardiovasc Interv. 2018;91(6):1144–1148.

12.

Fujihara

Takahara

Sasaki

, et al. Angiographic dissection patterns and patency outcomes after balloon angioplasty for superficial femoral artery disease. J Endovasc Ther. 2017;24(3):367–375.

13.

Zorger

Manke

Lenhart

, et al. Peripheral arterial balloon angioplasty: effect of short versus long balloon inflation times on the morphologic results. J Vasc Interv Radiol. 2002;13(4):355–359.

14.

Sugihara

Mine

Futami

, et al. Efficacy of super slow inflation as lesion preparation for drug-coated balloons in femoropopliteal lesions. Circ Rep. 2020;2(11):682–690.

15.

Horie

Tanaka

Taguri

, et al. Impact of prolonged inflation times during plain balloon angioplasty on angiographic dissection in femoropopliteal lesions. J Endovasc Ther. 2018;25(6):683–691.

16.

Horie

Tanaka

Taguri

, et al. Impact of baseline and postprocedural intravascular ultrasound findings on 1-year primary patency after drug-coated balloon treatment of femoropopliteal lesions. J Endovasc Ther. 2022;29(1):66–75.

17.

Shirai

Mori

Yamaguchi

, et al. Impact of Chocolate percutaneous transluminal angioplasty balloon on vessel preparation in drug-coated balloon angioplasty for femoropopliteal lesion. CVIR Endovascular. 2022;59(1):46.

18.

Micari

Brodmann

Keirse

, et al. Drug-coated balloon treatment of femoropopliteal lesions for patients with intermittent claudication and ischemic rest pain: 2-year results from the IN.PACT global study. JACC Cardiovasc Interv. 2018;11(10):945–953.

19.

Tepe

Micari

Keirse

, et al. Drug-coated balloon treatment for femoropopliteal artery disease: the chronic total occlusion cohort in the IN.PACT Global Study. JACC Cardiovasc Interv. 2019;12(5):484–493.

20.

Shishehbor

Zeller

Werner

, et al. Randomized trial of chocolate touch compared with lutonix drug-coated balloon in femoropopliteal lesions (Chocolate Touch Study). Circulation. 2022;145(22):1645–1654.