January 8, 2020
Real-World Study Finds No Long-Term Increased Mortality With Paclitaxel-Coated Balloon Angioplasty
January 8, 2020—Five-year findings from a real-world study showed no increased mortality for the matched patients who underwent paclitaxel-coated balloon angioplasty (PCBA) using the In.Pact Admiral device (Medtronic) versus patients treated with standard plain old balloon angioplasty (POBA). In addition, there was no correlation between mortality and the dose of paclitaxel used. The study was published by Konstantinos P. Donas, MD, et al in CardioVascular and Interventional Radiology (2020;43:2–7).
The investigators performed a two-step analysis in 238 patients who had met the inclusion criteria between January 2013 and January 2014. In step one, the 5-year mortality of the entire patient population was evaluated regardless of possible differences in patient demographics. In step two, a matched paired analysis was performed using propensity scores. For patients treated with PCBA, the investigators evaluated a possible correlation between dose of paclitaxel and mortality.
In CardioVascular and Interventional Radiology, the investigators reported the following:
- Univariate analysis for the entire group of patients showed a 5-year mortality rate of 26.2% versus 14% (P = .02) for the POBA group (n = 84) versus the PCBA group (n = 121).
- Univariate analysis of 77 pairs of propensity score–matched patients resulted in a mortality rate of 26% in the POBA group versus 20.8% in the PCBA group (P = 0.4), with median follow-up of 61.7 and 61.8 months, respectively (P = 0.8).
- Comparison of the patients treated with PCBA who died versus those who survived showed no correlation between the dose of paclitaxel with increased mortality (P = 0.4).