A critical appraisal of registry-based objective performance goals in peripheral arterial disease.

The multidisciplinary Superficial Femoral Artery-Popliteal EvidencE Development (SPEED) Study Group, under the auspices of the Registry Assessment of Peripheral Interventional Devices (RAPID) partnership, recently published objective performance goals for peripheral vascular interventions in the femoropopliteal arteries. Retrospective outcomes from the Vascular Quality Initiative provided the sole study data source. Strengths and weaknesses of this landmark effort are examined. Critical concerns include the substantial risks of ascertainment bias, flawed end point selection, sparse and variable capture of midterm follow-up data, and lack of expected discrimination between treatment modalities. The current Vascular Quality Initiative registry data thus appear insufficiently robust for the generation of objective performance goals and practice benchmarks; suggestions for redesign are provided. The impact of the statutory framework of the US Food and Drug Administration on device approval pathways and the maturation of an evidence-based approach to peripheral vascular intervention is explored.