Rationale and Design of the SAFE-PAD Study

Area of Science:

• Vascular Surgery
• Interventional Cardiology
• Health Outcomes Research

Background:

• Concerns exist regarding the long-term safety of paclitaxel-coated devices for femoropopliteal revascularization.
• Randomized controlled trials have prompted a need for real-world data on device safety.
• The SAFE-PAD study was designed to address these safety concerns with FDA input.

Purpose of the Study:

• To provide a comprehensive, long-term evaluation of mortality risk associated with paclitaxel-coated devices.
• To compare the safety of drug-coated versus nondrug-coated devices in femoropopliteal artery revascularization.
• To generate real-world evidence on the safety of these devices in a broad patient population.

Main Methods:

• Observational cohort study of fee-for-service Medicare beneficiaries (age 66+).
• Identification of patients undergoing femoropopliteal revascularization using ICD-10, CPT, and HCPCS codes (2015-2018).
• Primary safety endpoint: all-cause death, with follow-up exceeding 5 years; subgroup analyses planned.

Main Results:

• Data collection ongoing; specific results not yet available.
• Study aims to enroll a large cohort to ensure statistical power for safety endpoint.
• Subgroup analyses will explore variations in safety by device type, patient factors, and procedure setting.

Conclusions:

• The SAFE-PAD study will evaluate long-term safety of drug-coated devices versus nondrug-coated devices.
• Findings will inform clinical practice and regulatory decisions regarding paclitaxel-coated devices.
• Real-world data will enhance understanding of peripheral artery disease treatment safety.