Clinical trial NCT04647643: Real-World Safety Analysis of Paclitaxel Devices Used for the Treatment of Peripheral Arterial Disease
Official title: Real-World Safety Analysis of Paclitaxel Devices Used for the Treatment of Peripheral Arterial Disease
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Peripheral Arterial Disease
Lead sponsor: Lahey Clinic
Sponsor class: OTHER
Collaborators: name: National Evaluation System for health Technology Coordinating Center
name: Society for Vascular Surgery Patient Safety Organization
First posted: 2020-12-01
Enrollment: 8000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Commercial claims of patients who underwent endovascular interventional treatment of the femoral or popliteal arteries for symptomatic PAD between 1/1/15 and 12/31/2019 will form the study population. Three separate safety analyses will be performed. 1. Paclitaxel Drug coated balloons (DCB) as compared with propensity-matched patients treated with plain transluminal balloon angioplasty (PTA). 2. Paclitaxel delivering Drug-Eluting Stents (DES) as compared with propensity-matched cases using bare-metal stents (BMS). 3. Patients treated with either paclitaxel DCB or paclitaxel DES (any PTX) compared with propensity-matched controls (non-PTX,with DCB patients, matched to patients treated with PTA, and DES patients matched to patients treated with BMS).

Brief summary: Treatment with paclitaxel-based endovascular devices (PED) has become a common treatment option for patients with peripheral artery disease (PAD) involving the femoral-popliteal artery. However, an aggregate level meta-analysis identified an association between the use of PED and increased all-cause mortality at both two and five-year follow-up intervals, though there are significant limitations of these analyses. Exploration of real-world data has been suggested as a means to further investigate the safety of PED. The current study explores the association of PED and mortality in real-world data using U.S. commercial claims from the FAIR Health data warehouse.

Detailed description: Treatment with paclitaxel-based endovascular devices (PED) has become a common treatment option for patients with peripheral artery disease (PAD) involving the femoral-popliteal artery. However, an aggregate level meta-analysis identified an association between the use of PED and increased all-cause mortality at both two and five-year follow-up intervals, though there are significant limitations of these analyses. Exploration of real-world data has been suggested as a means to further investigate the safety of PED. The current study explores the association of PED and mortality in real-world data using U.S. commercial claims from the FAIR Health data warehouse.

This study aims to evaluate the relative safety of paclitaxel used as an antiproliferative agent in the treatment of symptomatic PAD in a real-world scenario. We will analyze Paclitaxel Drug-Coated Balloons (DCB) and Paclitaxel Drug-Eluting Stents (DES), in aggregate and as unique exposures using propensity score-matched survival analysis. (Inverse probability of Treatment Weighting).

Commercial claims of patients who underwent endovascular interventional treatment of the femoral or popliteal arteries for symptomatic PAD between 1/1/15 and 12/31/2019 will form the study population. Three separate safety analyses will be performed. 1. Paclitaxel Drug coated balloons (DCB) as compared with propensity-matched patients treated with plain transluminal balloon angioplasty (PTA). 2. Paclitaxel delivering Drug-Eluting Stents (DES) as compared with propensity-matched cases using bare-metal stents (BMS). 3. Patients treated with either paclitaxel DCB or paclitaxel DES (any PTX) compared with propensity-matched controls (non-PTX,with DCB patients, matched to patients treated with PTA, and DES patients matched to patients treated with BMS).

All proposed analyses will be performed using R 4.01 implemented within the DELTA analytic engine. DELTA is an active surveillance safety system that can monitor clinical data repositories for safety signals and has been validated to support risk-adjusted prospective safety surveillance analyses of complex clinical datasets.

Eligibility criteria: Inclusion Criteria:

* All patients, age 18 or older, who had a health insurance claim for outpatient endovascular treatment of the femoral or popliteal arteries for symptomatic PAD will be included. The diagnosis and treatment of PAD in the femoral and popliteal arteries will be identified by CPT/HCPCS and ICD-9 and ICD-10 PCS codes.
* Presence of at least one additional outpatient or inpatient claims, at least 12 months following the index procedure, in order to demonstrate continued enrollment in health insurance coverage.

Exclusion Criteria:

* Age \<18 years
* No qualifying peripheral arterial endovascular procedure
* Inpatient procedure
* Patients without any linked claim record more than 12 months after the index procedure, not known to have died or entered hospice care within the first 12 months

Primary outcomes:
measure: Survival
timeFrame: 4 years post intervention
Secondary outcomes:
measure: Survival
timeFrame: 2 years post intervention
measure: Retreatment
timeFrame: 2 years post intervention
measure: Amputation
timeFrame: 2 years post intervention
Other outcomes:
measure: Survival for age groups
timeFrame: 4 years and 2 years post intervention
measure: Survival for demographics and special baseline variables
timeFrame: 4 years and 2 years post intervention
measure: Survival for special treatment category
timeFrame: 4 years and 2 years post intervention
Locations:
city: Burlington
country: United States
facility: Lahey Clinic, Inc
state: Massachusetts
Study officials:
affiliation: Lahey Hospital & Medical Center
name: Sourbha S Dani, MD, MSc
role: PRINCIPAL_INVESTIGATOR
affiliation: Lahey Hospital & Medical Center
name: Frederic S Resnic, MD, MSc
role: STUDY_DIRECTOR
affiliation: NESTcc
name: Robbert Zusterzeel, MD, MPH, PhD
role: STUDY_CHAIR
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