No Increased Mortality after Paclitaxel-Coated Balloon Angioplasty: Old Age Combined with Severe Cardiac or Valve Disease Causes of Death

Objectives: The great uncertainty about the safety of paclitaxel-coated balloon angioplasty has still not been finally cleared. In a retrospective single-center study, we assessed the 2-year mortality of patients with peripheral arterial disease (PAD) treated by paclitaxel-coated balloon angioplasty (PCA) and/or with drug eluting-stent (DES) compared with plain angioplasty (PA)

Methods: Between January 2016 and December 2018, a total of 314 angioplasty procedures in 257 patients were analyzed. A total of 118 patients were treated with PA, 30 patients with PCA and DES (PCB + DES), 29 patients solely with DES, and 80 patients with PA. In patients treated multiple times within the observation period, the overall cumulative dose of paclitaxel was calculated. From the large amount of documented data, we present the cumulative dose of paclitaxel and everolimus (E) and correlation with death. Mortality rate was obtained over the period 2016–2019 with questionnaire of the family doctor, hospital medical records, and newspaper obituaries.

Result: Median follow-up was 1.87 years (22 months), and reliable survival rates were available in almost 80% of the patients. Overall mortality rate was 12.84% (n = 33). Mean time of death was 9.36 month (0.78 years.) after angioplasty. Patients who died were significant older (80.5 ± vs. 70.5 years, p < 0.001) and we found a significant correlation between severe mitral valve (MV) and aortic valve (AV) disease, pulmonary hypertension (25 vs. 5.3% MV, 25 vs. 4% AV; chi-square <0.001), as well with reduced LVEF, CAD, nicotine abuse, and Fontaine classification (III–IV). There was neither a correlation with date of death and PCA versus PA or between the overall dose of paclitaxel or paclitaxel and/or E and mortality. Patients treated solely with DES also showed no increased mortality or correlation with the dose of E and mortality within two years.

Conclusion: The findings showed no increased mortality in patients who underwent treatment with PCA or for PCA + DES and there was no correlation between mortality and the overall cumulative dose of paclitaxel or E. We found a significant correlation between mortality and higher age, cardiac valve disease and Fontaine classification. Taken together patients died of very ill old age combined with severe cardiac and valve disease. But would these results influence our therapeutic decision?

Publication History

Article published online:
19 February 2021