(PC146) Female Sex Predicts Underutilization of Optimal Medical Therapy following Paclitaxel-Coated Devices in the VQI Registry

Objectives: Paclitaxel-coated devices (PCD) are increasingly appealing endovascular tools due to the lower risk of restenosis. Like other endovascular techniques, optimal medical therapy (OMT) is paramount to ensure long-term outcomes. We sought to investigate the impact of OMT underutilization and its risk factors.

Methods: We examined the Vascular Quality Initiative Peripheral Vascular Intervention (VQI-PVI) module from 2010 to 2022. We included patients with occlusive non-aneurysmal disease without concomitant bypass who received PCD treatment. OMT was defined as being discharged on dual antiplatelet therapy and statin at follow up. Outcomes were failure to be discharged on OMT (FOMT), 2-year mortality, re-intervention, and ipsilateral major amputation. We adjusted for patient-level, procedure-level, and hospital-level factors. Logistic regression analysis was performed to predict FOMT. Survival analyses were used to investigate the 2-year outcomes. We also investigated regional variation of OMT.

Results: 48,150 patients received PCD in the study period. Only 56.7% of them were discharged on OMT. Patients who received OMT were more likely to be younger than 70 years old (55.3%v47.6%; p<.001), male (60.2%vs55.7%; p<.001), and more likely to have commercial insurance (29.7%vs27.0%; p<.001). There was regional variation and sex-base difference in prescribing OMT (P <.001) (Figure1). Adjusted logistic regression analysis, clustering by region, demonstrated that female gender was associated with 25% increased odds of FOMT [adjusted odds ratios (aOR)[95%CI]: 1.25[1.20-1.30]; p<.001]. Other interesting predictors were age>70 [1.22(1.14-1.29); p<.001], infrapopliteal intervention [1.09(1.03-1.16); p=0.003], prior amputation [1.16(1.09-1.23); p<.001], outpatient [1.11(1.03-1.20); p=0.006] and ambulatory compared to inpatient setting [1.41(1.17-1.71); p<.001]. Paradoxically, nonwhite race was associated with protective effect [0.90(0.84-0.97); p=0.004], so as CAD [0.66(0.61-71); p<.001], and prior intervention [0.69(0.66-0.72); p<.001]. OMT improved 2-year survival, freedom from re-intervention and limb salvage (Figure2).

Conclusions: Despite the integral role of OMT in limb salvage and survival, female patients still not receiving OMT. There is regional variation in prescribing OMT, and outpatient settings are less likely to discharge patients on OMT. Further studies are needed to clarify the barriers to prescribing OMT in females.