Christian-Alexander Behrendt1, Art Sedrakyan2, Frederik Peters3, Thea Kreutzburg3, Marc Schermerhorn4, Daniel J Bertges5, Axel Larena-Avellaneda3, Helmut L'Hoest6, Tilo Kölbel3, Eike Sebastian Debus3. 1. Department of Vascular Medicine, Research Group GermanVasc, University Medical Centre Hamburg-Eppendorf, Hamburg, Germany. Electronic address: behrendt@hamburg.de. 2. Healthcare Policy and Research, Weill Cornell Medical College, New York, NY, USA. 3. Department of Vascular Medicine, Research Group GermanVasc, University Medical Centre Hamburg-Eppendorf, Hamburg, Germany. 4. Department of Vascular and Endovascular Surgery, Beth Israel Deaconess Medical Centre, Boston, MA, USA. 5. Division of Vascular Surgery, University of Vermont Medical Centre, Burlington, VT, USA. 6. BARMER, Wuppertal, Germany.
Abstract
OBJECTIVE: The aim of this study was to determine the survival of patients after use of paclitaxel coated devices (PCX), as a recent meta-analysis of randomised trials reported higher mortality in patients treated with PCX balloons and stents METHODS: A retrospective health insurance claims analysis of patients covered by the second largest insurance fund in Germany, BARMER, was used to identify index femoropopliteal arterial interventions between 1 January 2010 and 31 December 2018. To ensure first PCX exposure, patients with prior deployment of PCX were excluded. The study cohort was stratified into patients with chronic limb threatening ischaemia (CLTI) and intermittent claudication (IC), then into balloons vs. stents cohorts. Within each stratum PCX were compared with uncoated devices. Propensity score matching was used to balance the study groups. Survival was evaluated using the Kaplan-Meier method and Cox regression. RESULTS: There were 37 914 patients (mean age 73.3 years; 48.8% female) included in the study. The annual proportion of PCX use increased from 3% to 39% during the study period for CLTI and from 4% to 48% for IC (both p < .001). Paclitaxel coated balloons and stents were associated with improved overall survival (hazard ratio [HR] 0.83, 95% confidence interval [CI] 0.77-0.90), amputation free survival (HR 0.85, 95% CI 0.78-0.91), and freedom from major cardiovascular events (HR 0.82, 95% CI 0.77-0.89) vs. uncoated devices at five years for CLTI. In IC cohort, mortality was significantly lower after using drug coated balloons (DCB) (HR 0.87, 95% CI 0.76-0.99) or combined DCB and drug eluting stents (HR 0.88, 95% CI 0.80-0.98). CONCLUSION: In this large health insurance claims analysis, rapid adoption of PCX, higher long term survival, better amputation free survival, and lower rates of major cardiovascular events were seen after their use for the treatment of CLTI.
OBJECTIVE: The aim of this study was to determine the survival of patients after use of paclitaxel coated devices (PCX), as a recent meta-analysis of randomised trials reported higher mortality in patients treated with PCX balloons and stents METHODS: A retrospective health insurance claims analysis of patients covered by the second largest insurance fund in Germany, BARMER, was used to identify index femoropopliteal arterial interventions between 1 January 2010 and 31 December 2018. To ensure first PCX exposure, patients with prior deployment of PCX were excluded. The study cohort was stratified into patients with chronic limb threatening ischaemia (CLTI) and intermittent claudication (IC), then into balloons vs. stents cohorts. Within each stratum PCX were compared with uncoated devices. Propensity score matching was used to balance the study groups. Survival was evaluated using the Kaplan-Meier method and Cox regression. RESULTS: There were 37 914 patients (mean age 73.3 years; 48.8% female) included in the study. The annual proportion of PCX use increased from 3% to 39% during the study period for CLTI and from 4% to 48% for IC (both p < .001). Paclitaxelcoated balloons and stents were associated with improved overall survival (hazard ratio [HR] 0.83, 95% confidence interval [CI] 0.77-0.90), amputation free survival (HR 0.85, 95% CI 0.78-0.91), and freedom from major cardiovascular events (HR 0.82, 95% CI 0.77-0.89) vs. uncoated devices at five years for CLTI. In IC cohort, mortality was significantly lower after using drug coated balloons (DCB) (HR 0.87, 95% CI 0.76-0.99) or combined DCB and drug eluting stents (HR 0.88, 95% CI 0.80-0.98). CONCLUSION: In this large health insurance claims analysis, rapid adoption of PCX, higher long term survival, better amputation free survival, and lower rates of major cardiovascular events were seen after their use for the treatment of CLTI.
Authors: Moritz Hadwiger; Nikolaos Dagres; Janina Haug; Michael Wolf; Ursula Marschall; Jan Tijssen; Alexander Katalinic; Fabian Simon Frielitz; Gerhard Hindricks Journal: Eur Heart J Date: 2022-07-14 Impact factor: 35.855
Authors: Peter A Schneider; Marianne Brodmann; Laura Mauri; John Laird; Yoshimitsu Soga; Antonio Micari; Gary Ansel; Mehdi H Shishehbor; Prakash Krishnan; Qi Gao; Kenneth Ouriel; Thomas Zeller Journal: Catheter Cardiovasc Interv Date: 2020-08-24 Impact factor: 2.692
Authors: Moritz Seiffert; Fabian J Brunner; Marko Remmel; Götz Thomalla; Ursula Marschall; Helmut L'Hoest; Laura Acar; Eike S Debus; Stefan Blankenberg; Christian Gerloff; Christian-Alexander Behrendt Journal: Clin Res Cardiol Date: 2020-08-04 Impact factor: 5.460