No Difference in Mid-term and Long-Term Mortality After Vascular Paclitaxel Exposure

Abstract

Background: Concern has been raised over potential paclitaxel-related increase in mortality following treatment with drug-coated balloons. We report mid-term and long-term patient-level mortality in three trials from our institution.

Methods: Patient data from the DRECOREST I and II trials, as well as the FINNPTX-trial, were included for analysis. The DRECOREST I involved patients with stenosis in a bypass vein graft, and the DRECOREST II included patients with stenosis in a dialysis fistula. The FINNPTX-trial randomized patients to either a prosthetic bypass or drug-eluting stent for long femoropopliteal lesions. Since the present retrospective study addressed mortality related to intravascular paclitaxel exposure and population data in Finland are comprehensive, we were able to include all patients exposed to paclitaxel in the three trials. Mortality data were extracted from the population registry, as well as patient records. Survival rates were analyzed for all trials pooled and separately. Late mortality was retrospectively analyzed and cross-referenced with national registry data.

Results: A total of 142 patients were included, 76 treated with paclitaxel-eluting device, and 66 without. The mean follow-up time for survivors was 3.9 years. Overall all-cause mortality was 31.7% during follow-up. In the DRECOREST I-trial, 35.5% of patients died in the paclitaxel group and 37.9% in the control group (P = 0.84). In the DRECOREST II, overall mortality was 55.6% in the paclitaxel group and 44.4% in the control group (P = 0.51). In the FINNPTX-trial 22.2% died in the paclitaxel group and 10.5% in the control group during follow-up (P = 0.30). No single cause of death was overrepresented. The most common causes of death in both groups were cardiovascular death, 59.3% in the paclitaxel group and 52.4% in the control group (P = 0.733), followed by malignancy (14.8% vs. 14.3% in the groups respectively).

Conclusions: No significant difference was seen in the overall analysis between the paclitaxel and the control group. A statistically nonsignificant elevated late mortality in the FINNPTX-trial after paclitaxel exposure was observed. However, the numbers in the individual trials are small and should be interpreted in the context of future patient-level meta-analysis.