Comparative Outcomes of Peripheral Vascular Intervention in Patients Discharged on Clopidogrel in Combination With Factor Xa Inhibitors or Aspirin

Dual antiplatelet therapy with clopidogrel and aspirin (DAPT) is commonly prescribed following peripheral vascular interventions (PVI) for peripheral arterial disease (PAD). Although clopidogrel is frequently used after PVI for various indications, its use in combination with Factor Xa inhibitors (FXaI) has not been assessed. While societal guidelines provide mixed support for combination antithrombotic regimens in patients with PAD, the utility of FXaI and clopidogrel (FXaI+C) in comparison to DAPT following PVI remains unexplored. This study aims to investigate outcomes of PVI for PAD in patients discharged on FXaI+C compared with those receiving traditional DAPT. The Vascular Quality Initiative-PVI (VQI-PVI) database was used. For patients with multiple PVI in the database, only the index procedure was analyzed. Patients with a history of atrial fibrillation or absent follow-up data were excluded. All remaining patients discharged on DAPT or FXaI+C without aspirin were included. Nearest neighbor logistic regression propensity score matching was used to generate patient populations with similar comorbidities and procedural characteristics. Patient demographics, procedural details, and outcomes following PVI were compared. Cox proportional hazard regression and Kaplan-Meier curves were used to assess patient survival outcomes. A total of 225,514 PVI were reviewed, and 161,550 patients undergoing primary PVI were included. Following index PVI, 50.9% (n = 82,255) of patients received DAPT and 3.3% (n = 5291) received FXaI+C at discharge. Excluding individuals with a history of atrial fibrillation, 52,584 patients were discharged on either DAPT (30.7%; n = 49,571) or FXaI+C (1.9%; n = 3013). After four-to-one matching, 8356 patients receiving DAPT were compared with 2089 patients taking FXaI+C. Patient demographics, procedural indication, and urgency were comparable between the matched groups (Table). After mean follow-up of 400 days, patients discharged on FXaI+C had significantly higher rates of reintervention (20.4% vs 15.9%; P < .001) and 1-year mortality (13.3% vs 11.3%; P < .001) compared with patients discharged on DAPT (Table). Kaplan-Meier analysis demonstrated that patients discharged on DAPT had improved survival compared with those discharged on FXaI+C (Fig). Cox proportional hazard regression analysis showed that discharge on FXaI+C was independently associated with increased mortality compared with DAPT (HR, 1.22; 95% CI, 1.01-1.47), but was not significantly associated with combined amputation or death (HR, 1.11; 95% CI, 0.85-1.45) after PVI. Discharge regimens of FXaI in combination with clopidogrel after PVI seem to be associated with worse outcomes compared to traditional DAPT. Further research is needed to determine the optimal combination of antithrombotic medications for patients with PAD undergoing PVI.TableBaseline patient characteristics, procedural indications, and outcomes for propensity score-matched patients discharged on DAPT and FXaI+C.CharacteristicClopidogrel and aspirin (DAPT), n = 8356aClopidogrel and FXaI (FXaI+C), n = 2089aP-valuebPatient Characteristics Age, years69 (11)69 (12).479 Sex assigned at birth: male5,094 (61.0%)1,286 (61.6%).616 Race.889African American1,526 (18.3%)372 (17.8%)Others634 (7.6%)160 (7.7%)White6,196 (74.2%)1,557 (74.5%) BMI, kg/m228 (6)28 (6).251 Hypertension7,281 (87.1%)1,826 (87.4%).736 Diabetes4,548 (54.4%)1,114 (53.3%).366 History of smoking (current or former)6,174 (73.9%)1,550 (74.2%).772 History of COPD2,190 (26.2%)557 (26.7%).673 History of cerebrovascular disease1,469 (17.6%)366 (17.5%).949 History of PCI2,210 (26.4%)549 (26.3%).877 History of CAD3,041 (36.4%)756 (36.2%).863 History of CHF2,279 (27.3%)567 (27.1%).904 History of dysrhythmia (AFib excluded)1,857 (22.2%)474 (22.7%).647 History of CABG1,778 (21.3%)448 (21.4%).867 History of carotid intervention (CEA/CAS)611 (7.3%)154 (7.4%).925 History of aneurysm268 (3.2%)71 (3.4%).659 Preoperative renal status.855CKD5,831 (69.8%)1,470 (70.4%)ESRD720 (8.6%)174 (8.3%)Normal function1,805 (21.6%)445 (21.3%) History of LER3,905 (46.7%)986 (47.2%).702 History of LE amputation1,462 (17.5%)357 (17.1%).661 Preoperative living status.599Home7,949 (95.1%)1,993 (95.4%)Nursing home/homeless407 (4.9%)96 (4.6%) Preoperative ambulatory status.721Assisted2,315 (27.7%)562 (26.9%)Independent5,422 (64.9%)1,375 (65.8%)Non-ambulatory619 (7.4%)152 (7.3%)Procedural indications Indication for procedure.240Claudication2,644 (31.6%)689 (33.0%)CLTI5,712 (68.4%)1,400 (67.0%) Urgency of procedureElective6,612 (79.1%)1,667 (79.8%).499Urgent1,744 (20.9%)422 (20.2%)Outcomes Amputation432 (7.2%)109 (7.6%).569 Reintervention904 (15.9%)281 (20.4%)< .001 One-year mortality948 (11.3%)277 (13.3%).015 Mean follow-up time, days403 (190)388 (200).003BMI, Body mass index; CABG, coronary artery bypass grafting; CAS / CEA, carotid artery stenting / carotid endarterectomy; CKD, chronic kidney disease; CLTI, chronic limb-threatening ischemia; COPD, chronic obstructive pulmonary disease; ESRD, end-stage renal disease; LE, lower extremity; LER, lower extremity revascularization; PCI, percutaneous coronary intervention.Bold signifies a statistically significant difference, P < .05.aData are presented as number (%), mean (standard deviation), or median (interquartile range).bWilcoxon rank sum test; Pearson χ2 test, Fisher exact test. 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