Long Term Survival after Femoropopliteal Artery Revascularisation with Paclitaxel Coated Devices: A Propensity Score Matched Cohort Analysis

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Long Term Survival after Femoropopliteal Artery Revascularisation with Paclitaxel Coated Devices: A Propensity Score Matched Cohort Analysis : Editor's Choice. / Behrendt, Christian-Alexander; Sedrakyan, Art; Peters, Frederik; Kreutzburg, Thea; Schermerhorn, Marc; Bertges, Daniel J; Larena-Avellaneda, Axel; L'Hoest, Helmut; Kölbel, Tilo; Debus, Eike Sebastian.

In: EUR J VASC ENDOVASC, Vol. 59, No. 4, 08.04.2020, p. 587-596.

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@article{8c97b2564a2546949cba4be96f8b573c,
title = "Long Term Survival after Femoropopliteal Artery Revascularisation with Paclitaxel Coated Devices: A Propensity Score Matched Cohort Analysis: Editor's Choice",
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.",
keywords = "Aged, Aged, 80 and over, Cardiovascular Agents/therapeutic use, Constriction, Pathologic/etiology, Female, Femoral Artery/drug effects, Humans, Intermittent Claudication/mortality, Ischemia/mortality, Male, Middle Aged, Paclitaxel/therapeutic use, Peripheral Arterial Disease/mortality, Retrospective Studies, Vascular Access Devices/statistics & numerical data",
author = "Christian-Alexander Behrendt and Art Sedrakyan and Frederik Peters and Thea Kreutzburg and Marc Schermerhorn and Bertges, {Daniel J} and Axel Larena-Avellaneda and Helmut L'Hoest and Tilo K{\"o}lbel and Debus, {Eike Sebastian}",
note = "Copyright {\textcopyright} 2019 The Author(s). Published by Elsevier B.V. All rights reserved.",
year = "2020",
month = apr,
day = "8",
doi = "10.1016/j.ejvs.2019.12.034",
language = "English",
volume = "59",
pages = "587--596",
journal = "EUR J VASC ENDOVASC",
issn = "1078-5884",
publisher = "W.B. Saunders Ltd",
number = "4",

}

RIS

TY - JOUR

T1 - Long Term Survival after Femoropopliteal Artery Revascularisation with Paclitaxel Coated Devices: A Propensity Score Matched Cohort Analysis

T2 - Editor's Choice

AU - Behrendt, Christian-Alexander

AU - Sedrakyan, Art

AU - Peters, Frederik

AU - Kreutzburg, Thea

AU - Schermerhorn, Marc

AU - Bertges, Daniel J

AU - Larena-Avellaneda, Axel

AU - L'Hoest, Helmut

AU - Kölbel, Tilo

AU - Debus, Eike Sebastian

N1 - Copyright © 2019 The Author(s). Published by Elsevier B.V. All rights reserved.

PY - 2020/4/8

Y1 - 2020/4/8

N2 - 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.

AB - 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.

KW - Aged

KW - Aged, 80 and over

KW - Cardiovascular Agents/therapeutic use

KW - Constriction, Pathologic/etiology

KW - Female

KW - Femoral Artery/drug effects

KW - Humans

KW - Intermittent Claudication/mortality

KW - Ischemia/mortality

KW - Male

KW - Middle Aged

KW - Paclitaxel/therapeutic use

KW - Peripheral Arterial Disease/mortality

KW - Retrospective Studies

KW - Vascular Access Devices/statistics & numerical data

U2 - 10.1016/j.ejvs.2019.12.034

DO - 10.1016/j.ejvs.2019.12.034

M3 - SCORING: Journal article

C2 - 31926836

VL - 59

SP - 587

EP - 596

JO - EUR J VASC ENDOVASC

JF - EUR J VASC ENDOVASC

SN - 1078-5884

IS - 4

ER -