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Randomized Controlled Trial
. 2022 Apr 1;17(17):e1445-e1454.
doi: 10.4244/EIJ-D-21-00444.

Paclitaxel-coated balloons versus percutaneous transluminal angioplasty for infrapopliteal chronic total occlusions: the IN.PACT BTK randomised trial

Francesco Liistro  1 , Ido Weinberg  2 , Alexandra Almonacid Popma  3 , Mehdi H Shishehbor  4 , Stefanie Deckers  5 , Antonio Micari  6
Affiliations
Randomized Controlled Trial

Paclitaxel-coated balloons versus percutaneous transluminal angioplasty for infrapopliteal chronic total occlusions: the IN.PACT BTK randomised trial

Francesco Liistro et al. EuroIntervention. .

Abstract

Background: Data are mixed concerning the safety and effectiveness of drug-coated balloons (DCBs) for treating below-the-knee (BTK) lesions.

Aims: The aim of this study was to assess the safety and effectiveness of the IN.PACT 014 paclitaxel-coated balloon catheter versus conventional percutaneous transluminal angioplasty (PTA) for infrapopliteal chronic total occlusions (CTOs) in patients with chronic limb-threatening ischaemia (CLTI).

Methods: The IN.PACT BTK randomised study is a prospective, multicentre, randomised pilot study. Fifty CLTI participants (Rutherford clinical category 4-5) with BTK CTOs were randomised 1:1 to DCB (N=23) or PTA (N=27). The primary effectiveness endpoint was late lumen loss (LLL) at 9 months post procedure. Safety outcomes up to 9 months included all-cause mortality, major target limb amputation, and clinically driven target lesion revascularisation (CD-TLR).

Results: Mean lesion length was 215.41±83.81 mm in the DCB group and 218.19±80.43 mm for PTA (p=0.806). The 9-month angiographic LLL was 0.892±0.774 mm for the DCB group and 1.312±0.720 mm for the PTA group (p=0.070) in a classic analysis, and 0.592±0.944 mm for DCB and 1.260±0.810 mm for PTA (p=0.017) in a subsegmental analysis. The Kaplan-Meier estimated freedom from CD-TLR up to 9 months was 91.1% for DCB and 91.8% for PTA (log-rank p=0.942). At 9 months, 1 patient died in the DCB group and 2 in the PTA group (p=1.000); there were no major target limb amputations in either arm.

Conclusions: The 9-month subsegmental LLL was lower after treatment with the IN.PACT 014 DCB compared with PTA with no differences in safety or revascularisation events in a small complex population of patients with BTK CTOs.

Clinicaltrials: gov: NCT02963649.

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Conflict of interest statement

F. Liistro is an advisory board member for Biotronik, Boston Scientific, Medtronic, and Philips. I. Weinberg is a consultant for Magneto Thrombectomy Solutions, a National Principal Investigator for Penumbra, Inc., and Medical Director of VASCORE, the Vascular Imaging Core Laboratory. A. Almonacid Popma receives no personal fees; her spouse, J. Popma, joined Medtronic as an employee after completion of the analysis but prior to publication. M.H. Shishehbor reports consultant income from Abbott Vascular, Boston Scientific, Medtronic, Philips, and Terumo. S. Deckers is a full-time employee of Medtronic. A. Micari is an advisory board member for Boston Scientific and Medtronic.

Figures

Figure 1
Figure 1. CONSORT flow diagram up to nine months in the IN.PACT BTK randomised study.
Participant numbers reported at each time point are eligible participants. DCB: drug-coated balloon; PTA: percutaneous transluminal angioplasty
Central illustration
Central illustration. Subsegmental array angiographic analysis from pre-procedure up to nine months in the IN.PACT BTK randomised study.
Individual subsegmental MLD values were measured pre-procedure, immediately post procedure, and at nine months post index procedure. Corresponding nine-month subsegmental LLL values are also shown. P-values are for differences in matching subsegmental LLL between groups at nine months post procedure. DCB: drug-coated balloon; LLL: late lumen loss; MLD: minimal lumen diameter; PTA: percutaneous transluminal angioplasty; SD: standard deviation; TLR: target lesion revascularisation
Figure 2
Figure 2. Kaplan-Meier estimates of freedom from CD-TLR up to nine months in the IN.PACT BTK randomised study.
CD-TLR: clinically driven target lesion revascularisation; DCB: drug-coated balloon; PTA: percutaneous transluminal angioplasty
Figure 3
Figure 3. Kaplan-Meier estimates of freedom from composite safety endpoint (A), freedom from MAE (B), and freedom from all-cause death (C) up to nine months in the IN.PACT BTK randomised study.
DCB: drug-coated balloon; MAE: major adverse events; PTA: percutaneous transluminal angioplasty
See this image and copyright information in PMC

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