Abstract 14280: Real-World Study of Fondaparinux in Chinese Non-ST-Segment Elevation Acute Coronary Syndrome Patients: REFOCAS

Abstract

Introduction: In NSTE-ACS patients, fondaparinux appears to have superior benefits than LWMH, however its application in patients with different risk stratification is still not obvious. Hypothesis: The use of fondaparinux or LMWH has an impact on prognosis in NSTE-ACS patients with different ischemic and bleeding risks. Methods: A multicenter, prospective, open-label, real-world study was conducted in 8066 adult patients with non-emergency PCI at 89 hospitals from July 2019 to July 2021. Patients received fondaparinux (2.5 mg/d) or LMWH (1 mg/kg, twice/day) , they were followed-up within 6-month. The GRACE and CRUSADE scores were used to stratify the included patients. The primary outcome was the incidence of NACCE (all-cause death, reinfarction, nonfatal stroke, or BARC≥type 2 bleeding) at 30 days, and secondary endpoints included BARC≥type 2 bleeding or MACE during hospitalization, 30 days, and six months. Results: In total, 5430 patients received fondaparinux treatment and 2636 received LMWH treatment, with 4976 and 2477 completed the trial respectively. The primary outcome occurred in 136 patients (2.7%) receiving fondaparinux and in 110 patients (4.4%) in LMWH [HR=0.608(0.471,0.785), p<0.001]. The rate of BARC≥2 bleeding at 30-day was significantly lower in the fondaparinux group compared with the LMWH group[68(1.4%) vs. 66(2.6%), HR=0.509(0.361,0.716), P<0.001]. Reduction in rate of NACCE and BARC ≥ type 2 bleeding were still observed during hospitalization and at six-month follow-up in fondaparinux group. In low bleeding risk individuals (CRUSADE score≤40), fondaparinux reduced the rate of BARC≥2 bleeding at 30-day by 0.9% compared with LMWH, which decreased by 3.1% in high bleeding risk individuals(CRUSADE score>40). Among patients with low ischemic risk (GRACE score≤140 ), fondaparinux significantly reduced the incidence of NACCE, MACE, and BARC ≥ 2 bleeding at each follow-up visits. Conclusions: In Chinese patients with NSTE-ACS, fondaparinux reduced the incidence of the composite endpoint event of bleeding and ischemia of 30 days compared with LMWH. Meanwhile, fondaparinux exhibited better safety in patients with high bleeding risk, and in the low ischemic risk group, the overall efficacy and safety were also better than LMWH.