Single-Center Study Evaluating Long-Term Major Adverse Outcomes with the Use of Paclitaxel-Coated Balloons in Treating Infrainguinal Arterial Disease.

Abstract

Paclitaxel drug-coated balloons (DCB) have been shown to reduce target lesion revascularization (TLR) rate, but recently an association between paclitaxel and an increase in mortality at 5-year was reported. We reviewed the 5-year mortality and freedom from TLR rates from a single center among patients that received DCB. Consecutive patients that received DCB from July 8, 2015 to November 27, 2019 with follow-up obtained from medical records and review of official death certificates were reviewed. The primary objective was total mortality and TLR rates with cumulative exposure to paclitaxel-coated balloons. Demographic, angiographic, clinical, and procedural variables were collected. Causes of mortality were classified according to death certificates. Descriptive analysis was performed on all variables. Kruskal-Wallis test was used to compare the total length of DCBs in those who were alive and those who died by the end of study. Kaplan-Meier (KM) was used to plot the freedom from mortality up to 5 years. A total of 91 symptomatic patients received the Lutonix balloon at index to treat femoropopliteal arterial disease and subsequently received either Lutonix or in.PACT during the follow-up phase for additional procedures. Age was 68.4 ± 10.8 years (56.0% males). Critical limb ischemia was present in 20.9%. There was no statistical difference in mortality between the median total number of balloons used among patients who were alive versus those who died (2.5 vs. 3.0, p -value = 0.89). Also, there was no statistical difference in the total length of DCB balloons used between those who were alive and those who died at the end of the study (p-value = 0.39). There were no in-hospital amputation or death. At 5-year follow-up KM freedom from TLR was 78.5%. A total of 13 patients died during follow-up. Of these 10 received only the Lutonix balloon and 3 did receive both Lutonix and In.PACT. The yearly KM freedom from mortality for the Lutonix only cohort were 92.7, 89.1, 85.5, 83.6, and 81.8% at 1, 2, 3, 4, and 5 years, respectively. Freedom from TLR and mortality at 5 years appears to be favorable with the use of DCB, predominantly Lutonix balloon in this cohort. This data needs to be supported prospectively by a larger number of patients.