P156 Efficacy and safety of anticoagulation in patients with digital gangrene and an underlying connective tissue disease: an open label randomized controlled trial

Abstract Background/Aims Gangrene is frequently reported in CTDs. However, no definitive treatment guidelines exist. Role of vasodilators, steroids, and immunosuppression is described in literature, but data is scarce regarding use of anticoagulation vs antiplatelets, which our study aimed to investigate. Aim: Efficacy and safety of anticoagulation vs antiplatelet in patients with CTD associated gangrene. Methods Study Design: single-centre, open-label, RCT (Superiority trial); Study period: 1.5 years; Study Site: IPGMER; Ethics approval: IEC (IPGME CTRI No: CTRI/2024/03/063481; Sample size: 22/arm (P1(anticoagulation)-P2(antiplatelet)=40%); Inclusion criteria: Patients with CTD having gangrene of duration≤1 month; Age: 18-65 years; Exclusion criteria: APS/aPL antibodies, prothrombotic drugs, infection, CKD/CLD, Contraindications to heparin/warfarin/aspirin; Intervention: Randomization: Anticoagulation arm (UFH 333 IU/kg subcutaneous followed by 250 IU/kg BD for 10 days, followed by Warfarin (target INR: 2-3)) and Antiplatelet arm (Aspirin 75-150 mg/day). Standard background therapy included steroids (Methyloprednisolone pulse or prednisolone 0.5-1 mg/kg (except Scleroderma: uptil 10-15 mg/day), immunosuppressant, statin, vasodilators (CCBs, PDE5i), painkillers; Follow-up: 24 weeks; Primary outcome: All-cause digital outcome (recovery) at 24 weeks; Secondary outcomes: All-cause digital outcome (recovery) at 2 weeks, Incidence of surgical/auto-amputation, Cause-specific mortality at 24 weeks, Amputation-free-survival at 24 weeks, Functional outcome (UEFI-15, LEFS) at 24 weeks, Adverse events Results Demographics and outcomes depicted in Table-1. CTDs enrolled: Scleroderma (35%), overlap syndrome (22.5%), SLE (15%), MCTD (15%), Vasculitis (10%), Sjogren syndrome (2.5%). All-cause digital outcome at 24 weeks: 70% (anticoagulation) vs 95% patients (antiplatelet), respectively (p = 0.046). ESR, CRP, functional outcomes improved in both groups. Longer amputation-free-survival in antiplatelet group (p = 0.033). Etiologies identified - Vasculitis, Vasculopathy, Atherosclerosis, Thromboembolism, Hypercoagulability; 60% cases were multifactorial. Predictors of amputation: established gangrene, anticoagulation use; Predictors of mortality: Symmetrical peripheral gangrene Conclusion 1) In the background of corticosteroids, immunosuppressants, vasodilators and statins, use of antiplatelet might have better recovery and fewer side effects as compared to anticoagulation, for managing gangrene in CTD patients 2) CTD associated gangrene has good recovery (82.5%) with appropriate treatment 3) ESR/CRP and UEFI-15/LEFS may serve as useful tools for monitoring treatment and functional outcomes, respectively. 4) CTD associated gangrene can be multifactorial, thus warranting an initial all-inclusive treatment rather than targeted approach Disclosure R. Goel: None. D. Roychowdhury: None. M. G: None. I. Haque: None. S. Haldar: None. S. Mondal: None. G. Sircar: None.