Real-World Safety Analysis of Paclitaxel Devices Used for the Treatment of Peripheral Arterial Disease
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Paclitaxel Drug Coated Balloon Patients treated with paclitaxel drug-coated balloon |
Drug: Paclitaxel
Paclitaxel to treat peripheral arterial disease
Other Names:
|
| Paclitaxel Drug Coated Stent Patients treated with paclitaxel drug-coated stent |
Drug: Paclitaxel
Paclitaxel to treat peripheral arterial disease
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Survival [4 years post intervention]
Freedom from death of any cause
Secondary Outcome Measures
- Survival [2 years post intervention]
Freedom from death of any cause
- Retreatment [2 years post intervention]
Retreatment with repeat revascularization (open or endovascular)
- Amputation [2 years post intervention]
Freedom from amputation
Other Outcome Measures
- Survival for age groups [4 years and 2 years post intervention]
Freedom from death in the age groups 18-34, 35-44, 45-54, 55-64, 65-74, 75 and above
- Survival for demographics and special baseline variables [4 years and 2 years post intervention]
Freedom from death in females, patients with claudication, CKD and dialysis, history of CAD, history of cancer
- Survival for special treatment category [4 years and 2 years post intervention]
Freedom from death in patients with patients receiving paclitaxel-coated device as a second procedure
Eligibility Criteria
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.
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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:
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Age <18 years
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No qualifying peripheral arterial endovascular procedure
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Inpatient procedure
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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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Lahey Clinic, Inc | Burlington | Massachusetts | United States | 01805 |
Sponsors and Collaborators
- Lahey Clinic
- National Evaluation System for health Technology Coordinating Center (NESTcc)
- Society for Vascular Surgery Patient Safety Organization
Investigators
- Principal Investigator: Sourbha S Dani, MD, MSc, Lahey Hospital & Medical Center
- Study Director: Frederic S Resnic, MD, MSc, Lahey Hospital & Medical Center
- Study Chair: Robbert Zusterzeel, MD, MPH, PhD, NESTcc
Study Documents (Full-Text)
None provided.More Information
Additional Information:
- U.S. Food and Drug Administration (FDA). FDA Executive Summary: Circulatory System Devices Panel Meeting
- McKeown L. Two trials halted in wake of study linking paclitaxel-coated devices to deaths in PAD
- Society of Vascular Surgery Vascular Quality Initiative.
Publications
None provided.- 20203069FH
- 6292-2020-2AS-1001-Phase1