Long Term Outcomes After Revascularisations Below the Knee with Paclitaxel Coated Devices: A Propensity Score Matched Cohort Analysis

TY - JOUR

T1 - Long Term Outcomes After Revascularisations Below the Knee with Paclitaxel Coated Devices: A Propensity Score Matched Cohort Analysis

AU - Heidemann, Franziska

AU - Peters, Frederik

AU - Kuchenbecker, Jenny

AU - Kreutzburg, Thea

AU - Sedrakyan, Art

AU - Marschall, Ursula

AU - L'Hoest, Helmut

AU - Debus, Eike S

AU - Behrendt, Christian-Alexander

N1 - Copyright © 2020 The Author(s). Published by Elsevier B.V. All rights reserved.

PY - 2020/9/24

Y1 - 2020/9/24

N2 - OBJECTIVE: Endovascular revascularisation has become a standard approach for below knee lesions and paclitaxel coated devices have been widely used in patients with chronic limb threatening ischaemia. A recent meta-analysis reported higher mortality in paclitaxel coated devices compared with uncoated devices in femoropopliteal lesions. This study aimed to determine long term outcomes in below the knee interventions using paclitaxel coated devices in routine vascular care using a large and contemporary cohort.METHODS: A large cohort was created using all inclusive health insurance claims data of patients covered by the second largest insurance fund in Germany. The cohort included patients with index revascularisation of arteries below the knee performed from 1 January 2010, to 31 December 2018. Only patients with first paclitaxel coated device exposure were included. The study cohort was stratified into balloon vs. stent treatment and patients with paclitaxel coated devices were matched with uncoated devices using propensity score. Outcomes were evaluated using the Kaplan-Meier method and Cox regression.RESULTS: There were 14 738 patients (mean age 77.6 years, 43.6% female) and 6 568 matched patients included in the study. Increasing use of paclitaxel coated devices was observed during the study period (6% in 2010 vs. 31% in 2018, p < .001), and a total of 2 611 (39.8%) deaths occurred within five years of follow up. In the propensity score matched Cox model, a paclitaxel related reduction of five year mortality (hazards ratio, HR 0.84, 95% confidence interval, CI 0.78-0.91), amputation or death (HR 0.87, 95% CI 0.81-0.94), and cardiovascular event or death (HR 0.86, 95% CI 0.80-0.92) were observed.CONCLUSION: In this propensity score matched cohort, reduced long term all cause mortality, reduced rates of amputation or death and cardiovascular event or death were observed at five years after the use of paclitaxel coated devices when compared with uncoated devices for the treatment of chronic limb threatening ischaemia.

AB - OBJECTIVE: Endovascular revascularisation has become a standard approach for below knee lesions and paclitaxel coated devices have been widely used in patients with chronic limb threatening ischaemia. A recent meta-analysis reported higher mortality in paclitaxel coated devices compared with uncoated devices in femoropopliteal lesions. This study aimed to determine long term outcomes in below the knee interventions using paclitaxel coated devices in routine vascular care using a large and contemporary cohort.METHODS: A large cohort was created using all inclusive health insurance claims data of patients covered by the second largest insurance fund in Germany. The cohort included patients with index revascularisation of arteries below the knee performed from 1 January 2010, to 31 December 2018. Only patients with first paclitaxel coated device exposure were included. The study cohort was stratified into balloon vs. stent treatment and patients with paclitaxel coated devices were matched with uncoated devices using propensity score. Outcomes were evaluated using the Kaplan-Meier method and Cox regression.RESULTS: There were 14 738 patients (mean age 77.6 years, 43.6% female) and 6 568 matched patients included in the study. Increasing use of paclitaxel coated devices was observed during the study period (6% in 2010 vs. 31% in 2018, p < .001), and a total of 2 611 (39.8%) deaths occurred within five years of follow up. In the propensity score matched Cox model, a paclitaxel related reduction of five year mortality (hazards ratio, HR 0.84, 95% confidence interval, CI 0.78-0.91), amputation or death (HR 0.87, 95% CI 0.81-0.94), and cardiovascular event or death (HR 0.86, 95% CI 0.80-0.92) were observed.CONCLUSION: In this propensity score matched cohort, reduced long term all cause mortality, reduced rates of amputation or death and cardiovascular event or death were observed at five years after the use of paclitaxel coated devices when compared with uncoated devices for the treatment of chronic limb threatening ischaemia.

KW - Administrative Claims, Healthcare

KW - Aged

KW - Aged, 80 and over

KW - Amputation

KW - Cardiovascular Agents/administration & dosage

KW - Chronic Disease

KW - Coated Materials, Biocompatible

KW - Databases, Factual

KW - Drug-Eluting Stents

KW - Endovascular Procedures/adverse effects

KW - Female

KW - Germany

KW - Humans

KW - Ischemia/diagnostic imaging

KW - Leg/blood supply

KW - Limb Salvage

KW - Male

KW - Paclitaxel/administration & dosage

KW - Peripheral Arterial Disease/diagnostic imaging

KW - Propensity Score

KW - Retrospective Studies

KW - Risk Assessment

KW - Risk Factors

KW - Time Factors

KW - Treatment Outcome

U2 - 10.1016/j.ejvs.2020.06.033

DO - 10.1016/j.ejvs.2020.06.033

M3 - SCORING: Journal article

C2 - 32807674

VL - 60

SP - 549

EP - 558

JO - EUR J VASC ENDOVASC

JF - EUR J VASC ENDOVASC

SN - 1078-5884

IS - 4

ER -