Drug-Coated Devices for Peripheral Arterial Disease

This perspective reviews the evolving regulatory and safety landscape surrounding drug-coated devices (DCDs)—specifically paclitaxel-coated balloons and stents used in treating atherosclerotic peripheral arterial disease (PAD). While pivotal randomized controlled trials demonstrated reduced reintervention rates with DCDs versus uncoated devices, a 2018 meta-analysis raised concerns about increased long-term mortality. In response, the FDA conducted its own review and acknowledged a possible signal, though with limited certainty due to study heterogeneity, missing data, and lack of mechanistic explanation. A more recent Swedish randomized trial (SWEDEPAD) found no significant mortality difference over 2.5 years, and real-world observational analyses support similar short-term survival. The article emphasizes ongoing trial follow-up, regulatory oversight, and the need to balance risks and benefits based on individual patient profiles, particularly in those with high restenosis risk. The FDA continues to support clinical studies and long-term safety tracking to guide treatment decisions.

This perspective reviews the evolving regulatory and safety landscape surrounding drug-coated devices (DCDs)—specifically paclitaxel-coated balloons and stents used in treating atherosclerotic peripheral arterial disease (PAD). While pivotal randomized controlled trials demonstrated reduced reintervention rates with DCDs versus uncoated devices, a 2018 meta-analysis raised concerns about increased long-term mortality. In response, the FDA conducted its own review and acknowledged a possible signal, though with limited certainty due to study heterogeneity, missing data, and lack of mechanistic explanation. A more recent Swedish randomized trial (SWEDEPAD) found no significant mortality difference over 2.5 years, and real-world observational analyses support similar short-term survival. The article emphasizes ongoing trial follow-up, regulatory oversight, and the need to balance risks and benefits based on individual patient profiles, particularly in those with high restenosis risk. The FDA continues to support clinical studies and long-term safety tracking to guide treatment decisions.