The revascularization of tibial arteries in patients with critical lower limb ischemia using drug-coated balloons vs. conventional angioplasty resulted in comparable long-term outcomes in terms of both safety and efficacy.

Paclitaxel exposure was not related to a higher risk of amputation or all-cause mortality at 5 years (which is the good news for much questioned drug-coated balloons). The problem is that the aforementioned devices have not shown higher efficacy than conventional angioplasty in this disease, but they do entail a significant increase in costs.

IN.PACT DEEP was a prospective, randomized, multicenter trial that enrolled 358 patients with critical lower limb ischemia.

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After a 5-year follow-up, freedom from clinically driven revascularization was 70.9% and 76%, and the safety composite endpoint (revascularization, amputation, and all-cause mortality) was 59.8% and 57.5% for the drug-coated balloon group vs. the conventional group, respectively.

Given the recent concern regarding mortality, there was a specific analysis addressing this issue. Paclitaxel was not associated with mortality in any dose tercile.

Conclusion

Paclitaxel-coated balloons and conventional balloons used in infrapopliteal angioplasty in patients with critical ischemia resulted in comparable long-term safety and efficacy. There was no association observed between paclitaxel and the risk of amputation or death at 5 years.

Original title: The IN.PACT DEEP Clinical Drug-Coated Balloon Trial 5-Year Outcomes.

Reference: Thomas Zeller et al.  J Am Coll Cardiol Intv 2020;13:431–43.

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