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.
Keywords
drug-coated balloon - Lutonix - in.PACT - mortality - target lesion revascularization - amputation
