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Sex-based Analysis of Clinical Outcomes With The Use of Paclitaxel-coated Endovascular Therapies in the VQI Registry
Besma Nejim
1, Maria Penuela
2, Tony Nguyen
2, Jayer Chung
3, Charles J Bailey
2
1Michael E Debakey VA Medical Center, Houston, TX;2University of South Florida, Tampa, FL;3Baylor College of Medicine, Houston, TX
INTRODUCTION: Paclitaxel coated devices (PCD) whether balloons or stents are important tools for management of peripheral arterial disease. The concern over increased late mortality with use of PCD had been negated by extensive patient-level data. Limited research suggested sex-based differences in clinical outcomes, with the use of PCD favoring females. Therefore, we aimed in this study to examine the sex-based differences in outcomes of PCD in a nationally representative database.
METHODS: We examined the Vascular Quality Initiative Peripheral Vascular Intervention (VQI-PVI) module from 2010 to 2022. Analysis was focused on patients with occlusive non-aneurysmal disease who received PCD treatment. We excluded patients undergoing concomitant bypass. Primary outcomes were 30-day and 2-year mortality, re-intervention, and ipsilateral major amputation. We compared outcomes based on sex adjusting for race, ethnicity comorbidities, medications, level of disease, treatment type (drug-coated balloon vs drug-eluting stent), urgency of repair, prior intervention and prior amputation. Logistic regression analysis was performed for 30-day outcomes. Survival analyses, Kaplan-Meier curves and proportional hazard Cox analyses were used to investigate the 2-year outcomes.
RESULTS: We included 48,515 patients. 20,246 (41.7%) were females. Females were more likely to be older than 70 years old (51.6%vs45.6%; p<.001), non-white (25.7%vs19.6%; p<.001), and Hispanic (7.3%vs6.1%; p<.001). They were less likely to have CAD (32.6%vs40.6%; p<.001), diabetes (50.7%vs52.7%; p<.001), smoking history (72.9%vs85.4%; p<.001) and prior amputation (14.9%vs19.0%; p<.001). Females were less likely to have infrapopliteal intervention (25.5%vs29.2%; p<.001). Drug-eluting stents were used less in females (17.1%vs19.8%; p<.001). There was no difference in prior intervention, elective repair, or hypertension (Table). There was no difference in 30-day mortality (1.6%vs1.5%), re-intervention (1.6%vs1.7%), and amputation rates (0.7%vs0.9%; all p>0.05). This held true even after adjustment in the logistic regression analysis. Survival rates at 2-year were similar in both sexes (79.2%vs79.3%; p=.97). Risk of mortality was not different after adjustment (adjusted hazard ratio (aHR) [95%CI]: 1.02 [0.96-1.08]; p=0.57). Freedom from re-intervention at 2 years was less for females (78.1%vs81.4%; p<.001). Re-intervention risk was worse for female patients (aHR [95%CI]: 1.24 [1.16-1.32]; p<.001]. Interestingly, the amputation-free survival at 2-years was slightly better in females (89.8%vs89.0%; p=0.009). However, there was no difference in amputation risk after adjustment (Figure).
CONCLUSIONS: There is no sex-based survival difference in patients receiving paclitaxel coated balloons or stents in the VQI. Females had higher risks of reintervention with slightly greater limb preservation. The 2-year hazard of re-intervention was 24% higher in females compared to males adjusting for level of disease, comorbidities, treatment type (balloon versus stent), prior intervention and medications at discharge. The unadjusted amputation-free survival was slightly better in females despite the higher re-intervention rates, but that difference dissipated with adjustment.
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