Konstantinos P Donas1, Anne Sohr2, Georgios A Pitoulias3, Fernando Alfonso4, Giovanni Torsello2. 1. Department of Vascular Surgery, St. Franziskus Hospital Münster, Hohenzollernring 72, 48145, Münster, Germany. konstantinos.donas@gmail.com. 2. Department of Vascular Surgery, St. Franziskus Hospital Münster, Hohenzollernring 72, 48145, Münster, Germany. 3. Department of Surgery, Division of Vascular Surgery, Aristotle University of Thessaloniki, Thessaloniki, Greece. 4. Department of Cardiology, La Princesa University Hospital, Madrid, Spain.
Abstract
PURPOSE: The aim of this study was to assess the long-term mortality of patients treated by the IN.PACT Admiral (Medtronic, Dublin, Ireland) paclitaxel-coated balloon angioplasty (PCBA) compared with standard plain balloon angioplasty (POBA). MATERIALS AND METHODS: Between January 2013 and January 2014, 238 patients met the inclusion criteria. A two-step analysis was performed. In step 1, the 5-year mortality of the whole patient population was evaluated regardless of possible differences in the patient demographics. In step 2, a matched paired analysis was performed using propensity scores. In addition, for those patients who were treated with PCBA, a possible correlation between dose of paclitaxel and mortality was evaluated. RESULTS: Univariate analysis for the whole group of patients (POBA group A, n = 84 and PCBA group B, n = 121) showed a 5-year mortality rate of 26.2% versus 14.0%, p = 0.02, respectively. Univariate analysis of 77 pairs of propensity score-matched patients resulted in mortality of 26.0% versus 20.8%, p = 0.4, of group A and B, respectively (median follow-up of 61.7 and 61.8 months, p = 0.8, respectively). Comparison of the patients of group B who died versus those who survived showed no correlation between the dose of paclitaxel with increased mortality (p = 0.4). CONCLUSION: The 5-year findings of the present real-world study showed no increased mortality for the matched patients who underwent PCBA versus POBA. In addition, there was no correlation between mortality and the dose of paclitaxel used.
PURPOSE: The aim of this study was to assess the long-term mortality of patients treated by the IN.PACT Admiral (Medtronic, Dublin, Ireland) paclitaxel-coated balloon angioplasty (PCBA) compared with standard plain balloon angioplasty (POBA). MATERIALS AND METHODS: Between January 2013 and January 2014, 238 patients met the inclusion criteria. A two-step analysis was performed. In step 1, the 5-year mortality of the whole patient population was evaluated regardless of possible differences in the patient demographics. In step 2, a matched paired analysis was performed using propensity scores. In addition, for those patients who were treated with PCBA, a possible correlation between dose of paclitaxel and mortality was evaluated. RESULTS: Univariate analysis for the whole group of patients (POBA group A, n = 84 and PCBA group B, n = 121) showed a 5-year mortality rate of 26.2% versus 14.0%, p = 0.02, respectively. Univariate analysis of 77 pairs of propensity score-matched patients resulted in mortality of 26.0% versus 20.8%, p = 0.4, of group A and B, respectively (median follow-up of 61.7 and 61.8 months, p = 0.8, respectively). Comparison of the patients of group B who died versus those who survived showed no correlation between the dose of paclitaxel with increased mortality (p = 0.4). CONCLUSION: The 5-year findings of the present real-world study showed no increased mortality for the matched patients who underwent PCBA versus POBA. In addition, there was no correlation between mortality and the dose of paclitaxel used.
Entities:
Keywords:
Drug coated balloon angioplasty; Mortality; Plain balloon angioplasty; Real-world study
Authors: Sabine Steiner; Andrej Schmidt; Thomas Zeller; Gunnar Tepe; Marcus Thieme; Lars Maiwald; Henrik Schröder; Wulf Euringer; Matthias Ulrich; Klaus Brechtel; Steffen Brucks; Erwin Blessing; Johannes Schuster; Ralf Langhoff; Sebastian Schellong; Norbert Weiss; Dierk Scheinert Journal: Eur Heart J Date: 2020-07-14 Impact factor: 29.983
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