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Sex-based Analysis Of Clinical Outcomes With The Use Of Paclitaxel-Coated Endovascular Therapies In The VQI Registry
Besma Nejim, MD MPH
1, Maria Penuela, MD
2, Tony Nguyen, DO
2, Jayer Chung, MD MSc
1, Charles Bailey, MD
2.
1Baylor College of Medicine, Houston, TX, USA,
2University of South Florida, Tampa, FL, USA.
OBJECTIVES: Paclitaxel-coated devices (PCD) are important tools for management of peripheral arterial disease. The concern over increased mortality with PCD had been negated by extensive patient-level data. Limited research suggested sex-based differences in PCD clinical outcomes, 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 (2010-2022). Analysis was focused on patients with occlusive non-aneurysmal disease without concomitant bypass who received PCD treatment. Primary outcomes were 30-day and 2-year mortality, re-intervention, and ipsilateral major amputation. Logistic regression analysis was performed for 30-day outcomes. Survival 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) or drug-eluting stents (17.1%vs19.8%; p<.001). 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. Survival rates at 2-year were similar in both sexes (79.2%vs79.3%; p=.97). 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 PCD 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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