Can Real-World Data Be Obtained for Lower-Extremity Revascularization?
As we continue to dissect the data and science for lower-extremity revascularization, do you think it possible to obtain “real-world” data in a scientific way? This question is critical as we see many “registries” comparing to potentially FDA-mandated optimal performance criteria (OPC). The FDA has accepted as “de facto” the OPC (Rocha-Singh CCI 2007) as the metric for all things SFA. How do we obtain reasonable data for “real-world” patients? What is critical in my read of the OPC is that it is based on only 6 good trials both by industry and by single centers where randomization between a stent arm and angioplasty occurred. The OPC suggests a “goal” for patency up to a lesion length of 14 cm and does not apply to lesions above this (i.e., the performance goal at 18 cm is unknown). This manuscript, which was an outstanding compilation from my colleagues and authors, had to deal with competing sources to combine several trials to obtain their final suggested goal. The goal was intuitiv
