Original Title: 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.
Reference: Kinstner CM et al. J Am Coll Cardiol Intv. 2016;9:1386-1392.
Patients with symptomatic femoropopliteal in-stent restenosis (ISR) have better patency at one year if treated with drug eluting balloon (DEB) instead of conventional balloon, according to PACUBA.
Extensive research on ISR treatment has shown contradicting results and this issue remains unclear.
Conventional balloon angioplasty in the PACUBA study (control group) showed a primary patency rate between 13 and 28% and freedom from clinically driven target lesion revascularization was 22 to 42% at one year. These results are not bad enough to consider alternatives.
To this day, the FDA has approved the excimer laser and the coated stent to treat in-stent restenosis; the rest of treatments remain off-label. This practice can be true for the United States but not for other territories where DEB and DES are (sometimes despite scarce evidence) more extensively used.
Drug eluting balloons could have, at least in theory, some advantages in the treatment of femoropopliteal restenosis:
- Local release of drug across the entire surface of the artery
- It prevents embolization or thermal lesion with the excimer laser
- It prevents stent layers and the resulting increase in thrombosis risk
All this with lower periprocedural risk vs. CABG.
A few questions regarding DEBs that remain unanswered:
- High rate of reintervention
- Frequent need to use several to cover the whole lesion, with associated cost and manufacture differences as regards carrier and drug dosage (it hinders the class effect of studies).
The PACUBA study specifically used the Freeway DEB (Eurocor/Opto Eurocor Healthcare) and enrolled 74 patients with superficial femoral in-stent restenosis randomized to conventional angioplasty vs. DEB with Freeway.
Primary patency at 12 months (primary end point) was:
- 40.7% with DEB
- 13.4% with conventional balloon
p=0.02.
Freedom from clinically driven target lesion revascularization:
- 49% for DEB
- 22.1% conventional balloon
p=0.11.
There were no differences between the groups as regards Rutherford class improvement.
Conclusion
Paclitaxel eluting balloons provide better and more significant patency at one year than conventional balloons in the treatment of femoropopliteal in-stent restenosis.
Editorial Comment
Evidence in favor of drug eluting balloons is growing, though it is clear we still don’t have a gold standard to treat restenosis in peripheral territory. We are considering a strategy with 40.7% patency at one year only because conventional balloon angioplasty has even worse results.
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