The Superficial Femoral Artery-Popliteal EvidencE Development (SPEED) Study Group developed contemporary objective performance goals (OPG) for peripheral vascular interventions (PVI) for superficial femoral (SFA)-popliteal artery disease utilizing the Registry Assessment of Peripheral Interventional Devices (RAPID).
The Society for Vascular Surgery (SVS) Vascular Quality Initiative (VQI) PVI Registry from January 2010-October 2016 was used to develop OPGs based on SFA-popliteal procedures (N= 21, 377) for claudication (IC) and critical limb ischemia (CLI). OPGs included one-year rates for target lesion revascularization (TLR), major amputation, and one and four-year survival. OPGs were calculated for the SFA and popliteal arteries and stratified by four treatments: angioplasty alone (PTA), self-expanding stenting, atherectomy, and any treatment type.. Outcomes were illustrated by unadjusted Kaplan-Meier analyses.
Cohorts included PTA (N= 7,505), stenting (N= 9,217), atherectomy (N= 2,510) and any treatment (N= 21,377). The mean age was 69 years, 58% were male, 79% were white and 52% had CLI. The freedom from TLR OPGs at one year in the SFA were 80.3% (PTA), 83.2% (stenting), 83.9% (atherectomy), and 81.9% (any treatments). The freedom from TLR OPGs at one year in the popliteal were 81.3% (PTA), 81.3% (stenting), 80.2% (atherectomy), and 81.1% (any treatments). The freedom from major amputation OPGs at one year after SFA PVI were 93.4% (PTA), 95.7% (stenting), 95.1% (atherectomy), and 94.8%, (any treatments). The freedom from major amputation OPG at one year after popliteal PVI were 90.5% (PTA), 93.7% (stenting), 91.8% (atherectomy), and 91.8%, (any treatments). Four-year survival OPGs after SFA PVI were 76% (PTA), 80% (stenting), 82% (atherectomy), and 79% (any treatments) and for the popliteal artery were 72% (PTA), 77% (stenting), 82% (atherectomy), and 75% (any treatment). In multivariable analysis, which included patient level, leg level and lesion level covariates, CLI was the single independent factor associated with increased TLR, amputation and mortality.
The SPEED OPGs define a new, contemporary benchmark for SFA-popliteal interventions utilizing a large subset of real-world evidence to inform more efficient peripheral device clinical trial designs to support regulatory and clinical decision making. It is appropriate to discuss proposals intended for regulatory approval with the FDA to refine the OPG to match the specific trial population. The OPGs may be updated using coordinated registry networks to assess long-term real-world device performance.
Copyright © 2020. Published by Elsevier Inc.