Drug coated balloons (DCB) emerged as an innovative treatment approximately 10 years ago. Since then, numerous randomized studies have shown their effectiveness and benefit in femoropopliteal territory, and even though the use of paclitaxel coated balloons has been called into question, a retrospective study including 168,553 patients was able to show paclitaxel coated balloons were non inferior for mortality compared against non-coated balloons (interim analysis of the SAFE-PAD).
In general, studies showing the superiority of drug coated balloons over conventional uncoated percutaneous transluminal intervention exclude patients with complex lesions (instent restenosis, +18 cm lesions, calcified lesions) which has left out patients more similar to those we find in the daily practice (real-world data).
The aim of the IN.PACT Global Study was to assess the safety and efficacy of the Paclitaxel IN.PACT Admiral DCB (Medtronic) in the treatment of femoropopliteal atherosclerotic disease (superficial femoral and / or popliteal artery lesions) in a real-world patient population, at five years.
It was a single arm study. Patients with aneurysms or acute thrombosis were excluded.
Primary endpoint of efficacy was the absence of culprit lesion revascularization, clinically defined as presence of symptoms or 20% drop of ankle–brachial index (ABI) vs post intervention ABI.
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Safety endpoint was a composite of absence of device or procedure related mortality, absence of treated limb amputation, and absence of new culprit artery revascularization. Major adverse events reported in the study were all-cause mortality, major amputation, or new revascularization.
Data were obtained from 1406 patients from different centers around the world. Primary endpoint was observed in 69.4% at five years (IC 95% 66.7%-72%).
Within five years, new revascularization was done, on average, at day 1470. Safety primary endpoint was observed in 67.4% of cases and when looking at each of adverse events, major amputation was observed in 1.7%, new revascularization in 31.9%, all-cause mortality in 19.5% (IC 95% 17.4%-21.8%).
At multivariable analysis, factors with lower risk of new revascularization were those with larger reference diameter at follow up and confirmed superficial femoral lesions.
Conclusions
This study includes patients that are normally excluded from trials, those presenting complex lesions, since 18% of patients had RIS, which together with the number of patients and long follow up, makes this study relevant.
In these patients it was shown adequate durability and safety of the Admiral drug coated balloon for the treatment of complex lesions in femoropopliteal territory. Even though there was a high mortality rate (19.5%), this is the result of comorbidities rather than chosen device or procedure.
Dr. Omar Tupayachi.
Miembro del Consejo Editorial de SOLACI.org.
Original Title: Paclitaxel-coated balloons for femoropopliteal peripheral arterial disease: final five-year results of the IN.PACT Global Study.
Reference: Zeller, Thomas et al. “Paclitaxel-coated balloons for femoropopliteal peripheral arterial disease: final five-year results of the IN.PACT Global Study.” EuroIntervention : journal of EuroPCR in collaboration with the Working Group on Interventional Cardiology of the European Society of Cardiology, EIJ-D-21-01098. 30 May. 2022, doi:10.4244/EIJ-D-21-01098.
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