Factor Xa Inhibitor in Peripheral Revascularization: A Vascular Quality Initiative Analysis

Abstract

Adding rivaroxaban to standard antiplatelet therapy has been shown to reduce mortality from cardiovascular causes, myocardial infarction (MI), stroke, and lower acute limb ischemia (ALI). To determine the generalizability of these results and assess the effects of adding a factor Xa inhibitor (FXI) to antiplatelet therapy in peripheral revascularization, an analysis was conducted with a large, multinational database. A retrospective cohort study of all patients undergoing infrainguinal interventions within the Vascular Quality Initiative from 2015 to 2020 was conducted. Patients prescribed single antiplatelet therapy (SAPT: aspirin or clopidogrel) or dual antiplatelet therapy (DAPT: aspirin and clopidogrel) combined with a FXI at discharge were compared with those on SAPT and DAPT alone. Outcomes were all-cause mortality, MI, major amputations, artery reintervention, target lesion revascularization, and ALI. A χ2 test of association was used for group comparisons. Propensity score matching, based on preoperative demographics, was used to generate uniform cohorts for analysis of the SAPT with FXI and DAPT groups. Overall all-cause mortality rates were significantly lower with the addition of a FXI to the SAPT or DAPT regimen compared with SAPT or DAPT alone; however, 30-day, 6-month, and 1-year analysis did not produce a similar pattern (Table I). FXI did not influence the rates of major amputations nor postoperative MI, but correlated with increased artery reintervention, target lesion revascularization, and ALI. There were 7288 patients from the DAPT and SAPT with FXI cohorts (14,576 total) who were identified via propensity score matching for further analysis of the most clinically applicable groups (Table II). Overall all-cause mortality was lower in SAPT with FXI compared with DAPT (11.67 vs 14.13; P < .0001), but there was no difference in 30-day, 6-month, and 1-year all-cause mortality. Rates of postoperative MI did not differ between the two groups. Compared with DAPT, SAPT with FXI correlated with lower rates of major amputation (2.11 vs 2.24; P < .0001), but was associated with increased artery reintervention, target lesion revascularization (intervention: 2.55 vs 1.45; P < .0001; surgery: 0.55 vs 0.38; P < .0001), and ALI (0.1 vs 0.07; P < .0001). Addition of a FXI correlated with decreased overall all-cause mortality and rates of major amputation but also with increased rates of target vessel or lesion reintervention and ALI in a large, multinational database. Further analysis is needed to investigate the real-world application of FXI in peripheral revascularization.Table IGroup comparisons of outcomesSAPTDAPTSAPT with FXIDAPT with FXIP value(n = 30,075)(n = 62,492)(n = 9074)(n = 2731)All-cause mortality Overall5097 (16.95)8984 (14.38)1060 (11.69)300 (10.98)<.0001 30 days342 (1.14)491 (0.79)98 (1.08)23 (0.84) 6 months1821 (6.06)2880 (4.61)509 (5.61)135 (4.95) 1 year2773 (9.22)4682 (7.49)757 (8.34)204 (7.48)Postoperative MI None18,876 (99.72)41,301 (99.58)8629 (99.53)2533 (99.37) Troponin only32 (0.17)81 (0.20)24 (0.28)9 (0.35) EKG or clinical21 (0.11)92 (0.22)17 (0.20)7 (0.27) Major amputation1202 (6.95)1879 (4.95)191 (5.59)59 (4.92)Artery reintervention None10,264 (84.26)23,254 (86.75)1786 (82.19)617 (79.31)<.0001 Interventional962 (8.18)2547 (9.50)289 (13.30)114 (15.65) Surgical521 (4.43)964 (3.60)90 (4.14)42 (5.40) Both15 (0.13)40 (0.15)8 (0.37)5 (0.64)Target lesion revascularization Intervention426 (2.46)1249 (3.29)220 (6.44)84 (7.00)<.0001 Surgery123 (0.71)300 (0.79)48 (1.41)28 (2.33)<.0001 Acute limb ischemia18 (0.10)45 (0.12)9 (0.26)4 (0.33)<.0001DAPT, Dual antiplatelet therapy; EKG, electrocardiogram; FXI, factor Xa inhibitor; MI, myocardial infarction; SAPT, single antiplatelet therapy.Values are number (%). Open table in a new tab Table IIPropensity-scored analysis of dual antiplatelet therapy (DAPT) vs single antiplatelet therapy (SAPT) with factor Xa inhibitor (FXI)DAPTSAPT with FXIP value(n = 7288)(n = 7288)All-cause mortality Overall1030 (14.13)850 (11.67)<.0001 30 days59 (0.81)79 (1.08).087 6 months380 (5.21)406 (5.57).3394 1 year605 (8.30)614 (8.43).7858Postoperative MI None5084 (99.59)6931 (99.55).0681 Troponin only6 (0.12)19 (0.27) EKG or clinical15 (0.29)12 (0.17) Major amputation163 (2.24)154 (2.11)<.0001Artery reintervention None2480 (34.03)1435 (19.69)<.0001 Interventional215 (2.95)240 (3.29) Surgical91 (1.25)77 (1.06) Both5 (0.07)8 (0.11) Unknown4497 (61.70)5528 (75.85)Target lesion revascularization Intervention106 (1.45)186 (2.55)<.0001 Surgery28 (0.38)40 (0.55)<.0001 Acute limb ischemia5 (0.07)7 (0.1)<.0001EKG, Electrocardiogram; MI, myocardial infarction.Values are number (%). Open table in a new tab