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Premature Peripheral Arterial Disease is Associated with Worse Outcomes After Endovascular Peripheral Vascular Intervention
Rae S Rokosh
1, Laurence Sperling
1, Arshed Ouyyumi
1, Ravi R Rajani
1, Yazan Duwayri
1, Manuel Garcia-Toca
1, Carlos Mena-Hurtado
2, Kim G Smolderen
2, Gaelle Romain
2, Olamide Alabi
1 1Emory University, Atlanta, GA;
2Yale New Haven Health, New Haven, CT
BACKGROUND: Premature peripheral arterial disease (PAD), defined by onset prior to age 50, is increasing in prevalence. The clinical characteristics, treatment patterns, as well as mid- and late-term outcomes of patients with premature PAD undergoing endovascular peripheral vascular intervention (PVI) have not been well defined.
METHODS: The linked Vascular Quality Initiative and Medicare dataset (VQI-VISION) was implemented to examine those who underwent an index PVI for arterial occlusive disease between January 2017 and December 2018. Exclusion criteria included acute limb ischemia and concomitant open revascularization. Patient demographics, operative characteristics, and outcomes were analyzed by group: traditional-age versus premature PAD. Primary outcomes of interest included the risk of major amputation and mortality at 30-days, 90-days, and one-year. Time-to-event analyses were employed to calculate the cumulative incidence and derive the risk in traditional-age versus premature PAD patients for the primary outcomes. Specifically, for major amputation, cumulative incidence was estimated using Alaen-Johansen and groups compared using Gray's test while the risk of major amputation was derived from Fine-Gray competing risk regression model to account for the competing risk of mortality. For mortality, cumulative incidence was calculated using Kaplan-Meier estimator and compared between groups using log-rank test while the risk of mortality was derived from a Cox proportional hazard regression model. Multivariable regression models were implemented to determine the association between premature PAD and outcomes of interest while adjusting for 1) demographic variables (sex, race, ethnicity); 2) disease manifestation on presentation (CLTI, claudication), revascularization urgency, obesity, smoking status, and history of chronic lung disease; 3) target lesion treated (aortoiliac vs. femoropopliteal vs. infrapopliteal), history of prior amputation (minor or major), and guideline directed medical therapy (aspirin and statin).
RESULTS: The distribution of groups amongst the 15,050 patients identified includes 14,699 traditional-age (97.7%) and 351 premature PAD (2.3%) patients. Compared to traditional-age PAD, the premature PAD group had a higher proportion of women (49.0% vs. 41.2%, p=.003), minoritized groups (Black race: 37.6% vs. 15.9%, p<.001; Hispanic ethnicity: 10.3% vs. 4.0%, p<.001), and greater comorbidity burden (obesity, diabetes mellitus, advanced kidney disease and dialysis dependence, active smoking). The premature PAD group was also more likely to present with chronic limb threatening ischemia (79.8% vs. 60.3%, p<.001) and a history of prior amputation, both minor (21.4% vs. 8.4%, p<.001) and major (19.1% vs. 8.7%, p<.001); however, they were less likely to be on guideline directed medical therapy at the time of PVI (antiplatelet: 76.4% vs. 82.2%, p=.005; statin: 69.5% vs. 76.4%, p=.003; active smoker: 41.6% vs. 26.2%, p<.001) and less likely to undergo aortoiliac revascularization (21.7% vs 26.6%, p=.037). Premature PAD patients had a significantly higher cumulative incidence of major amputation at 30-days (4.6% vs 1.9%, p=.006), 90-days (13.7% vs 5.2%, p<.001), and one-year (21.9% vs. 8.9%, p<.001) with a significantly shorter mean time-to-amputation compared to their traditional-age counterparts (14.6 [10.5] months vs. 17.3 [10.3] months, p<0.001). Despite the significant mean age difference between groups (28.3 [4.6] years), there was no significant difference in 30-day, 90-day, or one-year all-cause mortality and similar mean time-to-death between the premature and traditional-age PAD groups (18.2 vs. 18.6 months, p=0.52). In multivariable analysis, premature PAD was not associated with mortality at 30-days (aHR 0.93; 95% CI, 0.49-1.75, p=0.82), 90-days (aHR 0.94; 95% CI, 0.63-1.40, p=0.76), or one-year (aHR 0.83; 95% CI, 0.64-1.07, p=0.15). However, premature PAD remained independently associated with 90-day (aHR 1.62; 95% CI, 1.20-2.19, p<0.001) and one-year major amputation (aHR 1.57; 95% CI, 1.24-1.99, p<0.0001) even after controlling for sex, ethnoracial identity, disease manifestation on presentation, revascularization urgency, obesity, smoking status, history of COPD, target lesions treated, history of prior amputation, and aspirin and statin use.
CONCLUSIONS: Patients with premature PAD undergoing PVI represent a distinct, clinical phenotype characterized by greater comorbidity burden, more advanced disease at presentation, and significantly higher mid- and late-term major amputation compared to traditional-age PAD patients. No mortality differences were seen between groups despite a near 30-year mean age difference. Further investigation focused on the identification of barriers to early access, diagnosis, and guideline directed medical therapy; novel correlated biomarkers; and the development of targeted interventions are needed to reduce early mortality and mitigate limb loss in this vulnerable PAD cohort. This patient population may benefit from improved screening strategies and aggressive implementation of both primary and secondary evidence-based medical prevention strategies, such as PCSK9 inhibitors and low-dose rivaroxaban after PVI, as indicated.
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