DEB, the Best Option to Treat Superficial Femoral ISR

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.

 

drug elutin baloon_reestenosis_instrastentPatients 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.

 

We value your opinion. You are more than welcome to leave your comments, thoughts, questions or suggestions here below.

More articles by this author

Endovascular Treatment of Iliofemoral Disease for the Improvement of Heart Failure with Preserved Ejection Fraction

Peripheral artery disease (PAD) is a significant risk factor in the development of difficult-to-treat conditions, such as heart failure with preserved ejection fraction (HFpEF)....

Chronic Thromboembolic Pulmonary Hypertension: Treatment Outcomes According to a Worldwide Registry

Chronic thromboembolic pulmonary hypertension (CTEPH) is a highly limiting condition that, despite its moderate incidence, significantly impacts patient prognosis and quality of life. The...

Contemporary Outcomes of Acute Limb Ischemia Endovascular Revascularization

Acute limb ischemia (ALI) is a vascular emergency with high mortality rate. It has been defined as a sudden occlusion of limb perfusion compromising...

TCT 2024 | SIRONA: Randomized Study Comparing Sirolimus-Coated vs Paclitaxel-Coated Balloon Angioplasty in Femoropopliteal Disease

This prospective, randomized, multicenter, investigator-initiated non-inferiority study compared the use of sirolimus-coated balloon (MagicTouch) vs paclitaxel-coated balloon in endovascular treatment.  The primary objective was to...

LEAVE A REPLY

Please enter your comment!
Please enter your name here

Related Articles

SOLACI Sessionsspot_img

Recent Articles

Severe Tricuspid Regurgitation: Surgical vs. Transcatheter Edge-to-Edge Repair

While highly prevalent, tricuspid regurgitation is a notably undertreated valvulopathy. Its progression has been associated with higher mortality and significant disability. According to the...

ACCESS-TAVI: Comparing Post TAVR Vascular Closure Devices

Transcatheter aortic valve replacement (TAVR) is a well-established option to treat elderly patients with severe symptomatic aortic valve stenosis. Technical advances and device development...

Endovascular Treatment of Iliofemoral Disease for the Improvement of Heart Failure with Preserved Ejection Fraction

Peripheral artery disease (PAD) is a significant risk factor in the development of difficult-to-treat conditions, such as heart failure with preserved ejection fraction (HFpEF)....