The Official Journal of EuroPCR and the European Association of Percutaneous Coronary Interventions (EAPCI)

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

DOI: 10.4244/EIJ-D-21-00444

1. San Donato Hospital, Arezzo, Italy; 2. VasCore, Massachusetts General Hospital, Boston, MA, USA; 3. Beth Israel Deaconess Medical Center, Boston, MA, USA; 4. Harrington Heart & Vascular Institute, University Hospital Cleveland Medical Center, Cleveland, OH, USA; 5. Medtronic, Bakken Research Center BV, Maastricht, the Netherlands; 6. Cardiology, University of Messina, Messina, Italy

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. Identifier: NCT02963649.

Sign in to read and download the full article

Forgot your password?
No account yet? Sign up for free!
Create my pcr account

Join us for free and access thousands of articles from EuroIntervention, as well as presentations, videos, cases from

Read next article
A EuroIntervention state of the art on glucose management, diabetes and PCI; a mini focus on chronic total occlusions; early spontaneous reperfusion in patients with STEMI; quantitative flow and resistance reserve measurements for coronary microvascular function; balloon aortic valvuloplasty vs medical therapy for patients with severe aortic stenosis needing urgent non-cardiac surgery; IVUS and OFDI in peripheral interventions; and more…

Latest news