Outcomes of treatment with paclitaxel-coated devices for peripheral arterial disease.

OBJECTIVE

The treatment of femoropopliteal peripheral artery disease (PAD) using paclitaxel-coated devices (PCDs) has been shown to improve patency in several randomized trials. However, a recent meta-analysis of trial data suggested an increased risk of mortality with PCD usage. Although subsequent studies have found no association with mortality, the subject has remained controversial. Thus, the aim of the present study was to further investigate the outcomes and causes of mortality for patients treated with PCDs.

METHODS

Patients who had undergone endovascular interventions for PAD from 2013 to 2016 at a single institution were reviewed. The patients were stratified by the use of PCDs, which included drug-coated balloons and drug-eluting stents. The cumulative dose of paclitaxel was calculated for the patients who had received multiple interventions. The causes of mortality were identified and compared between the two groups.

RESULTS

Of the 366 included patients, 138 (38%) had received a PCD and 228 (62%) had received a non-drug-coated (NDC) device. Patients treated with PCDs were less likely to have undergone open surgery compared with patients treated with NDC devices. No differences were found in the indications or 30-day outcomes between the two groups. After a mean follow-up of 3.1 ± 1.8 years, no differences were found in the primary patency, reintervention rate, mean number of reinterventions, major amputation (5% vs 4%; P = .465), or mortality (16% vs 20%; P = .363) between the PCD and NDC groups. Also, no overall difference was found in the cause of mortality with and without PCD use or in the Kaplan-Meier survival curves. Furthermore, PCD use was not associated with an increased risk of mortality in Cox regression analysis. The cumulative dose of paclitaxel in patients treated with PCDs ranged from 383 to 49,259 μg (median, 7561 μg). A comparison of the patients treated with a cumulative dose of paclitaxel in the upper 50th percentile compared with the lower 50th percentile showed no significant differences in mortality (13% vs 19%; P = .333).

CONCLUSIONS

PCD use was shown to be safe and not associated with an increased risk of long-term mortality in the present study. Continued monitoring of PCD use is warranted to ensure the safety of this technology.