High-Risk Characteristics for Clinical Failure after Isolated Femoropopliteal Peripheral Vascular Interventions

Abstract

Recent studies suggesting increased late mortality with paclitaxel-coated devices (PCD) in femoropopliteal peripheral vascular interventions (PVI) prompted the U.S. Food and Drug Administration to recommend limiting the use of PCDs to "patients at particularly high-risk for restenosis". This study's aim is to characterize patients at high-risk for restenosis, and develop a risk score to guide clinicians in selecting patients for treatment with PCDs. Patients who underwent isolated femoropopliteal PVI for claudication or rest pain from 2016-2019 in the Vascular Quality Initiative were included. Patients who received intervention with a PCD, hybrid procedures, died within one year, or had missing follow up data were excluded. The primary endpoint was clinical failure at one year defined as > 50% restenosis, loss of patency, reintervention, or major amputation. Data was split randomly into 2/3 for development and 1/3 for validation. A parsimonious multivariable hierarchical logistic regression for clinical failure was developed and a risk score was created using beta-coefficients. The risk score was applied to the validation dataset and tested for goodness of fit and discrimination. Among 4,856 treated patients, 718 (14.8%) experienced clinical failure within one year. Clinical failure was associated with age ≤ 50, female sex (48.1% vs 39.5%), insulin-dependent diabetes (29.9% vs 23.1%), creatinine >2.0 mg/dL (9.9% vs 5.7%), prior ipsilateral lower extremity revascularization (48.5% vs 38.5%), prior ipsilateral minor amputation (5.3% vs 1.7%), rest pain vs claudication (30.8% vs 18.7%), occlusion length ≥ 20 cm (18.8% vs 15.0%), and Trans-Atlantic Inter-Society Consensus (TASC) II Classification C or D (40.4% vs 28.0%), all P ≤ 0.01. Risk score development was performed using a multivariable regression. The model demonstrated good fit and discrimination (C-statistic 0.71 in development and 0.72 in validation dataset). Predicted clinical failure was 8.9% for standard-risk (45.9% of interventions), 15.5% for high-risk (44.2% of interventions), and 33.8% for very high-risk patients (9.8% of interventions). A novel risk score was created with good discrimination for identifying patients at high-risk for clinical failure at one year after femoropopliteal PVI for claudication and rest pain. Patients at high-risk and very high-risk for clinical failure may benefit from alternative strategies including PCDs.