Vessel Patency Alone May Not Improve Outcomes in Below-Knee Artery Disease

Peripheral artery disease affecting the arteries below the knee — known as infrapopliteal PAD — represents one of the most challenging and morbid conditions in vascular medicine. Patients with this disease frequently suffer from critical limb-threatening ischemia, putting them at high risk for amputation and death. Despite decades of interventional advances, outcomes for this population remain poor, raising important questions about whether current treatment paradigms are built on the right foundations.

This editorial, published in the Journal of the American College of Cardiology, takes direct aim at a foundational assumption: that vessel patency — keeping the treated artery open — is a meaningful proxy for clinical benefit. The authors argue that patency-based endpoints have dominated clinical trials in this space without sufficiently demonstrating that open vessels actually reduce amputations, accelerate wound healing, or extend life.

The core argument is that the disconnect between anatomical success and clinical benefit has allowed interventions to gain traction — and potentially widespread use — without robust evidence of meaningful patient benefit. In a disease where the stakes are limb and life, this misalignment between surrogate and patient-centered outcomes is not merely academic; it shapes clinical practice and device approvals.

The authors call for a fundamental shift in how infrapopliteal PAD trials are designed. They advocate for primary endpoints centered on limb salvage, amputation-free survival, wound healing rates, and patient-reported outcomes such as pain and functional status. These endpoints are harder to achieve but reflect what patients and clinicians actually care about.

This editorial arrives at a critical moment as new devices and technologies continue to enter the infrapopliteal space. Reassessing what constitutes success in these trials could redirect investment and clinical energy toward interventions with proven, tangible benefits — ultimately improving care for one of medicine's most vulnerable patient populations.